30-Day Federal Register Notice

Vol. 83

Thursday,

No. 134

July 12, 2018

Pages 32191–32562

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OFFICE OF THE FEDERAL REGISTER

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II

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018

The FEDERAL REGISTER (ISSN 0097–6326) is published daily,
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.
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III

Contents

Federal Register
Vol. 83, No. 134
Thursday, July 12, 2018

Agricultural Marketing Service

Comptroller of the Currency

RULES

NOTICES

Establishment of Handler Diversions, Reporting
Requirements, and New Information Collections:
Cranberries Grown in States of Massachusetts, et al.,
32193–32198

Agency Information Collection Activities; Proposals,
Submissions, and Approvals:
Subordinated Debt Licensing Requirements, 32335–32337
Defense Department
See Engineers Corps

PROPOSED RULES

Promotion, Research, and Information Orders:
Reopening and Extension of Comment Period on
Amendment to Include Frozen Mangos, 32215

NOTICES

Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 32286
Environmental Assessments; Availability, etc.:
Hazardous Materials Warehouses and Gas Cylinder Sheds
at Naval Station Norfolk and Naval Support Activity
Norfolk Naval Shipyard, Virginia, 32286–32287
Upgrade of the Main Gate Access Control Point at
Defense Distribution Depot, San Joaquin, CA, and
Surrounding Area, 32287

Agriculture Department
See Agricultural Marketing Service
See Animal and Plant Health Inspection Service
See Forest Service
Animal and Plant Health Inspection Service
NOTICES

Engineers Corps

Agency Information Collection Activities; Proposals,
Submissions, and Approvals:
Animal Welfare, 32260–32261

PROPOSED RULES

Definition of Waters of the United States—Recodification of
Preexisting Rule, 32227–32252
Environmental Protection Agency

Centers for Disease Control and Prevention

RULES

NOTICES

Air Quality State Implementation Plans; Approvals and
Promulgations:
California, Yolo-Solano Air Quality Management District,
32211–32213
Delaware; Interstate Transport Requirements for the 2012
Fine Particulate Matter Standard, 32209–32211
National Emission Standards for Hazardous Air Pollutants:
Chemical Recovery Combustion Sources at Kraft, Soda,
Sulfite, and Stand-Alone Semichemical Pulp Mills,
32213–32214

Meetings:
Advisory Board on Radiation and Worker Health,
National Institute for Occupational Safety and
Health, 32299
Healthcare Infection Control Practices Advisory
Committee, 32299–32300
Centers for Medicare & Medicaid Services
PROPOSED RULES

Medicaid Program:
Reassignment of Medicaid Provider Claims, 32252–32255
Medicare and Medicaid Programs:
CY 2019 Home Health Prospective Payment System Rate
Update and CY 2020 Case-Mix Adjustment
Methodology Refinements; etc., 32340–32522
NOTICES

Meetings:
Washington Medicaid State Plan Amendment;
Reconsideration of Disapproval: Hearing, 32300–
32301

PROPOSED RULES

Definition of Waters of the United States—Recodification of
Preexisting Rule, 32227–32252
Federal Aviation Administration
RULES

Airworthiness Directives:
Bell Helicopter Textron Canada Limited Helicopters,
32201–32203
Rolls-Royce Corporation Turboshaft Engines, 32203–
32206
The Boeing Company Airplanes, 32198–32201
PROPOSED RULES

Coast Guard

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RULES

Safety Zones:
Alaska Marine Highway System Port Valdez Ferry
Terminal, Port Valdez; Valdez, AK, 32208–32209
Special Local Regulations:
Marine City Water Ski Show, St. Clair River, Marine City,
MI, 32206–32207

Airworthiness Directives:
Bombardier, Inc., Airplanes, 32215–32218
Hoffmann Propeller GmbH and Co. KG Propellers,
32219–32221
NOTICES

Petitions for Exemptions; Summaries:
3GLP, Inc. dba Precision Flight Devices, 32334–32335
NextEra Energy, Inc., 32335
Federal Communications Commission

Commerce Department
See Foreign-Trade Zones Board
See International Trade Administration
See National Oceanic and Atmospheric Administration

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PROPOSED RULES

New FM Radio Broadcast Class C4 and to Modify the
Requirements for Designating Short-Spaced
Assignments, 32255–32259

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IV
NOTICES

General Services Administration

Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 32287–32289
Meetings:
Open Commission, 32289–32290

NOTICES

Agency Information Collection Activities; Proposals,
Submissions, and Approvals:
Background Investigations for Child Care Workers,
32296–32297
CDP Supply Chain Climate Change, 32298–32299
Contract Financing Final Payment, 32295
Contractor’s Qualifications and Financial Information,
32297–32298
Environmental Conservation, Occupational Safety, and
Drug-Free Workplace, 32296

Federal Deposit Insurance Corporation
NOTICES

Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 32290–32293
Federal Election Commission
NOTICES

Health and Human Services Department
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health

Meetings; Sunshine Act, 32293
Federal Reserve System
NOTICES

Formations of, Acquisitions by, and Mergers of Bank
Holding Companies, 32293

Health Resources and Services Administration
NOTICES

Federal Trade Commission

Meetings:
Advisory Committee on Heritable Disorders in Newborns
and Children, 32312–32313

NOTICES

Proposed Consent Agreements:
ReadyTech Corporation, 32293–32295
Food and Drug Administration
PROPOSED RULES

Food Labeling:
Calorie Labeling of Articles of Food Sold from Certain
Vending Machines; Front of Package Type Size,
32221–32227
NOTICES

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Charter Renewals:
Advisory Committee; Allergenic Products Advisory
Committee, 32310–32311
Advisory Committee; Science Advisory Board to the
National Center for Toxicological Research, 32301
Psychopharmacologic Drugs Advisory Committee, 32301–
32302
Guidance:
Chemistry, Manufacturing, and Control Information for
Human Gene Therapy Investigational New Drug
Applications, 32307–32308
Human Gene Therapy for Hemophilia, 32306–32307
Human Gene Therapy for Rare Diseases, 32303–32305
Human Gene Therapy for Retinal Disorders, 32302–32303
Long Term Follow-Up After Administration of Human
Gene Therapy Products, 32311–32312
Testing of Retroviral Vector-Based Human Gene Therapy
Products for Replication Competent Retrovirus
During Product Manufacture and Patient Follow-up,
32309–32310
Withdrawal of Approval of 29 New Drug Applications:
Concordia Pharmaceuticals, Inc., et al., 32305–32306
Foreign-Trade Zones Board
NOTICES

Production Activities:
PBR, Inc. d/b/a SKAPS Industries, Foreign-Trade Zone
26, Atlanta, GA, 32262

Homeland Security Department
See Coast Guard
See U.S. Customs and Border Protection
Interior Department
See National Park Service
See Surface Mining Reclamation and Enforcement Office
Internal Revenue Service
RULES

Inversions and Related Transactions, 32524–32561
International Trade Administration
NOTICES

Antidumping or Countervailing Duty Investigations, Orders,
or Reviews:
Certain Activated Carbon from the People’s Republic of
China, 32269–32270
Certain Steel Nails from the Republic of Korea, 32265–
32268
Initiation of Administrative Reviews, 32270–32283
Supercalendered Paper from Canada, 32262–32263,
32268–32269
Tapered Roller Bearings and Parts Thereof, Finished and
Unfinished, from the People’s Republic of China,
32263–32265
International Trade Commission
NOTICES

Antidumping or Countervailing Duty Investigations, Orders,
or Reviews:
Ammonium Nitrate from Ukraine, 32329
Investigations; Determinations, Modifications, and Rulings,
etc.:
Steel Propane Cylinders from China and Thailand, 32329
Justice Department

Forest Service

NOTICES

NOTICES

Proposed Consent Decrees:
Oil Pollution Act, 32329–32330

New Fee Sites, 32261–32262

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V

National Institutes of Health

Surface Mining Reclamation and Enforcement Office

NOTICES

NOTICES

Meetings:
National Center for Advancing Translational Sciences,
32313
National Center for Complementary and Integrative
Health, 32313

Agency Information Collection Activities; Proposals,
Submissions, and Approvals:
Abandoned Mine Land Problem Area Description Form,
32327–32328
General (Procedures and Requirements), 32326
Nomination and Request for Payment Form for OSMRE’s
National Technical Training Courses, 32328
Petition Process for Designation of Federal Lands as
Unsuitable for All or Certain Types of Surface Coal
Mining Operations and for Termination of Previous
Designations, 32324–32325
Reclamation on Private Lands, 32326–32327
State Regulatory Authority: Inspection and Enforcement,
32325

National Oceanic and Atmospheric Administration
NOTICES

Agency Information Collection Activities; Proposals,
Submissions, and Approvals, 32284–32286
Endangered and Threatened Species:
Take of Anadromous Fish, 32283–32284
National Park Service
NOTICES

Inventory Completions:
Heard Museum, Phoenix, AZ, 32319–32320
Museum of Ojibwa Culture and Marquette Mission Park,
City of St. Ignace, MI, 32322–32323
San Diego Museum of Man, San Diego, CA, 32323–32324
St. Joseph Museums, Inc., St. Joseph, MO, 32316–32317
State Historic Preservation Office, Lansing, MI, 32315–
32316
Tongass National Forest, Juneau Ranger District, Juneau,
AK, 32317–32318
University of Michigan, Ann Arbor, MI, 32321–32322
University of San Diego, San Diego, CA, 32318–32319
Repatriation of Cultural Items:
Berkshire Museum, Pittsfield, MA, 32314–32315
Grand Canyon National Park, Grand Canyon, AZ, 32320–
32321

Transportation Department
See Federal Aviation Administration
Treasury Department
See Comptroller of the Currency
See Internal Revenue Service
NOTICES

Meetings:
Financial Research Advisory Committee, 32337
U.S. Customs and Border Protection
NOTICES

Commercial Gaugers and Laboratories; Accreditations and
Approvals:
Saybolt LP (Nederland, TX), 32313–32314
Veterans Affairs Department
NOTICES

Meetings:
Creating Options for Veterans Expedited Recovery
Commission, 32337–32338

National Science Foundation
NOTICES

Meetings; Sunshine Act, 32330–32331
Occupational Safety and Health Review Commission

Separate Parts In This Issue

NOTICES

Privacy Act; Systems of Records, 32331–32333

Part II
Health and Human Services Department, Centers for
Medicare & Medicaid Services, 32340–32522

Personnel Management Office
RULES

Federal Employees Health Benefits Program and Federal
Employees Dental and Vision Insurance Program:
Expiration of Coverage of Children of Same-Sex Domestic
Partners; Federal Flexible Benefits Plan: Pre-Tax
Payment of Health Benefits Premiums, 32191–32193

Reader Aids
Consult the Reader Aids section at the end of this issue for
phone numbers, online resources, finding aids, and notice
of recently enacted public laws.

Postal Regulatory Commission
NOTICES

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New Postal Products, 32333–32334

To subscribe to the Federal Register Table of Contents
electronic mailing list, go to https://public.govdelivery.com/
accounts/USGPOOFR/subscriber/new, enter your e-mail
address, then follow the instructions to join, leave, or
manage your subscription.

Small Business Administration
NOTICES

Disaster Declarations:
Nebraska, 32334

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Treasury Department, Internal Revenue Service, 32524–
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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Contents

CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the
Reader Aids section at the end of this issue.
5 CFR
890...................................32191
892...................................32191
894...................................32191
7 CFR
929...................................32193
Proposed Rules:

1206.................................32215
14 CFR
39 (3 documents) ...........32198,
32201, 32203
Proposed Rules:

39 (2 documents) ...........32215,
32219
21 CFR
Proposed Rules:

101...................................32221
26 CFR
1.......................................32524
33 CFR
100...................................32206
165...................................32208
Proposed Rules:

328...................................32227
40 CFR
52 (2 documents) ...........32209,
32211
63.....................................32213
Proposed Rules:

110...................................32227
112...................................32227
116...................................32227
117...................................32227
122...................................32227
230...................................32227
232...................................32227
300...................................32227
302...................................32227
401...................................32227
42 CFR
Proposed Rules:

409...................................32340
424...................................32340
447...................................32252
484...................................32340
486...................................32340
488...................................32340
47 CFR
Proposed Rules:

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73.....................................32255

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Rules and Regulations

Federal Register
Vol. 83, No. 134
Thursday, July 12, 2018

This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents.

OFFICE OF PERSONNEL
MANAGEMENT
5 CFR Parts 890, 892, and 894
RIN 3206–AN34

Federal Employees Health Benefits
Program and Federal Employees
Dental and Vision Insurance Program:
Expiration of Coverage of Children of
Same-Sex Domestic Partners; Federal
Flexible Benefits Plan: Pre-Tax
Payment of Health Benefits Premiums:
Conforming Amendments
U.S. Office of Personnel
Management.
ACTION: Final rule.
AGENCY:

On October 30, 2013, OPM
published final regulations in the
Federal Register to expand coverage for
children of same-sex domestic partners
under the Federal Employees Health
Benefits (FEHB) Program and the
Federal Employees Dental and Vision
Insurance Program (FEDVIP). The
regulation allowed children of same-sex
domestic partners living in states that
did not allow same-sex couples to marry
to be covered family members under the
FEHB and the FEDVIP. Due to a
subsequent Supreme Court decision
legalizing same-sex marriage in all
states, OPM published an interim final
regulation on December 2, 2016, that
created a regulatory exception that only
allowed children of same-sex domestic
partners living overseas to maintain
their FEHB and FEDVIP coverage until
September 30, 2018. OPM recognized
that there were additional requirements
placed on overseas federal employees
that did not apply to other civilian
employees with duty stations in the
United States making it difficult to
travel to the United States to marry their
same-sex partners. Understanding that
we have provided agencies with
additional time for compliance given
that overseas federal employees may not
have been able to marry immediately
following the Supreme Court decision,

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SUMMARY:

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OPM is issuing a final rule removing
references to domestic partners and
domestic partnerships from the
regulations. Based on the Supreme
Court decision and the two additional
year’s lead time for domestic partners
overseas to marry, the current language
in the CFR is not needed and may be
somewhat confusing. There is no change
in coverage for children whose same-sex
partners are married.
DATES: This rule is effective on
September 30, 2018.
FOR FURTHER INFORMATION CONTACT:
Michael W. Kaszynski, Senior Policy
Analyst, at [email protected]
or (202) 606–0004.
SUPPLEMENTARY INFORMATION:
Authority for This Rulemaking
The Federal Employees Health
Benefits (FEHB) Program is
administered by the Office of Personnel
Management (OPM) in accordance with
Title 5, Chapter 89 United States Code
and our implementing regulations (title
5, parts 890, 892, 894 and title 48,
chapter 16). The statute establishes the
basic rules for benefits, enrollment, and
participation in the Federal insurance
programs.
Background
The Federal Employees Health
Benefits (FEHB) Program provides
health insurance to about 8.2 million
Federal employees, retirees, and their
dependents each year. It is the largest
employer-sponsored health insurance
program in the country providing more
than $53 billion in health care benefits
annually. Coverage options available to
eligible individuals include self only,
self plus one or self and family coverage
in an approved health benefits plan.
Eligible family members include the
spouse of an employee or annuitant and
a child under 26 years of age, including
adopted children, stepchildren or foster
children or a child regardless of age who
is incapable of self-support because of
mental or physical disability which
existed before age 26.
Effective January 1, 2014, the Office of
Personnel Management (OPM)
published the ‘‘Federal Employees
Health Benefits Program and Federal
Employees Dental and Vision Insurance
Program: Expanding Coverage of
Children; Federal Flexible Benefits Plan:
Pre-Tax Payment of Health Benefits
Premiums: Conforming Amendments’’

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final rule (78 FR 64873) to extend FEHB
and FEDVIP coverage to children of
same-sex domestic partners of Federal
employees and annuitants who would
marry their partners but live in states
that did not allow same-sex couples to
marry. As the result of the June 26,
2015, Supreme Court Obergefell v.
Hodges decision, all U.S. states now
allow same-sex couples to marry.
Accordingly, as of January 2016,
coverage of an enrollee’s stepchild(ren)
is only allowed if the couple is married.
OPM also published an interim final
regulation (81 FR 86905) on December
2, 2016. The rule amended §§ 890.302
and 894.101 of title 5, Code of Federal
Regulations. The amendments allow an
employing agency to request, and for
OPM to grant, a continued coverage
exception for children of an employee’s
same-sex domestic partner living
outside the United States. Any coverage
under such an exception will not extend
beyond September 30, 2018. The OPM
recognized there were additional
requirements placed on overseas
employees (as compared to civilian
employees with duty stations in the
United States) making it difficult to
travel to the United States to marry
same-sex partners. Therefore, OPM
created the authority to allow an
exception for children of Federal
employees in a domestic partnership
and living outside of the United States.
If requested by an enrollee’s agency,
coverage of children of same-sex
domestic partners can be continued
under self and family or self plus one
enrollment in the FEHB and FEDVIP
Programs. This regulation removes this
continued coverage exception which
expires for overseas employees on
September 30, 2018.
Comments Received on the Interim
Rule
We received five comments on the
Interim rule. All commenters were in
support of the rule. No commenters
recommended changes to the rule.
Therefore, no changes have been made
to this Final rule based on the
comments received.
Expected Impact of Changes
This rule eliminates all regulatory
language in FEHB, FEDVIP and FedFlex
that authorizes coverage for children of
same-sex domestic partners, effective
September 30, 2018. This rule amends

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

the regulations to remove the language
that authorizes coverage of children of
same-sex domestic partners since all
enrollees now have the right to marry in
the United States. The regulatory
language that authorized coverage for
children of same-sex domestic partners
overseas is also being removed from the
regulation effective September 30, 2018.
There is no change to the population of
children who have access to coverage
based on this rule.
Executive Order 13563 and 12866
Requirements
Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This rule
has been designated a not significant
regulatory action under Executive Order
12866.
Paperwork Reduction Act
Requirements

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Notwithstanding any other provision
of law, no person is required to respond
to, nor shall any person be subject to a
penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.) (PRA), unless that collection of
information displays a currently valid
Office of Management and Budget
(OMB) Control Number. With this rule
there is no change to an existing OMB
approved collection of information
subject to the PRA—OMB No. 3206–
0160, Health Benefits Election Form.
The system of record notice for this
collection is OPM/Central 1 Civil
Service Retirement and Insurance
Records, available at https://
www.opm.gov/informationmanagement/privacy-policy/sorn/opmsorn-central-1-civil-service-retirementand-insurance-records.pdf.
Regulatory Flexibility Act
I certify that these regulations will not
have a significant economic impact on
a substantial number of small entities.

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Executive Order 13771: Reducing
Regulation and Controlling Regulatory
Costs
This rule is not an E.O. 13771
regulatory action because this rule is not
significant under E.O. 12866.
List of Subjects
5 CFR Part 890
Administration and general
provisions, Administrative practice and
procedure, Administrative sanctions
imposed against health care providers,
Benefits for former spouses, Benefits for
United States hostages in Iraq and
Kuwait and United States hostages
captured in Lebanon, Benefits in
medically underserved areas,
Contributions and withholdings,
Department of Defense Federal
Employees Health Benefits Program
demonstration project, Employee benefit
plans, Enrollment, Government
employees, Health benefits plans, Limit
on inpatient hospital charges, physician
charges, and FEHB benefit payments,
Reporting and recordkeeping
requirements, Retirement, Temporary
continuation of coverage, Temporary
extension of coverage and conversion,
Transfers from retired FEHB Program.
5 CFR Part 892
Administrative practice and
procedure, Government employees’
health insurance, Pre-tax payment of
health benefits premiums, Taxes,
Wages.
5 CFR Part 894
Administrative practice and
procedure, Government employees,
Health insurance, Taxes, Wages.
U.S. Office of Personnel Management.
Jeff T.H. Pon,
Director.

Accordingly, OPM is amending title 5,
Code of Federal Regulations as follows:
PART 890—FEDERAL EMPLOYEES
HEALTH BENEFITS PROGRAM
1. The authority citation for part 890
continues to read as follows:

■

Authority: 5 U.S.C. 8913; Sec. 890.301
also issued under sec. 311 of Pub. L. 111–03,
123 Stat. 64; Sec. 890.111 also issued under
section 1622(b) of Pub. L. 104–106, 110 Stat.
521; Sec. 890.112 also issued under section
1 of Pub. L. 110–279, 122 Stat. 2604; 5 U.S.C.
8913; Sec. 890.803 also issued under 50
U.S.C. 403p, 22 U.S.C. 4069c and 4069c–1;
subpart L also issued under sec. 599C of Pub.
L. 101–513, 104 Stat. 2064, as amended; Sec.
890.102 also issued under sections 11202(f),
11232(e), 11246 (b) and (c) of Pub. L. 105–
33, 111 Stat. 251; and section 721 of Pub. L.
105–261, 112 Stat. 2061; Pub. L. 111–148, as
amended by Pub. L. 111–152.

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2. In § 890.302, revise paragraphs
(a)(2)(iii) and (b)(2) and remove
paragraphs (b)(3) through (7) to read as
follows:

■

§ 890.302

Coverage of family members.

(a) * * *
(2) * * *
(iii) Children are entitled to receive
benefits under only one enrollment
regardless of whether the children
qualify as family members under the
enrollment of both parents or of a parent
and a stepparent and regardless of
whether the parents are married,
unmarried, divorced, or legally
separated. To ensure that no person
receives benefits under more than one
enrollment, each enrollee must
promptly notify the insurance carrier as
to which family members will be
covered under his or her enrollment.
These individuals are not covered under
the other enrollment.
(b) * * *
(2) For purposes of this part, the term
‘‘stepchild’’ refers to the child of an
enrollee’s spouse and shall continue to
refer to such child after the enrollee’s
divorce from the spouse or death of the
spouse, so long as the child continues
to live with the enrollee in a regular
parent-child relationship.
*
*
*
*
*
PART 892—FEDERAL FLEXIBLE
BENEFITS PLAN: PRE-TAX PAYMENT
OF HEALTH BENEFITS PREMIUMS
3. The authority citation for part 892
continues to read as follows:

■

Authority: 5 U.S.C. 8913; 5 U.S.C.
1103(a)(7); 26 U.S.C. 125.

4. In § 892.101, the definition of a
‘‘Qualifying life event’’ is amended by
revising the introductory text to read as
follows:

■

§ 892.101

Definitions.

*

*
*
*
*
Qualifying life (QLE) event means an
event that may permit changes to your
FEHB enrollment as well as changes to
your premium conversion election as
described in Treasury regulations at 26
CFR 1.125–4. Such events include the
following:
*
*
*
*
*
■ 5. Section 892.102 is revised to read
as follows:
§ 892.102 What is premium conversion
and how does it work?

Premium conversion is a method of
reducing your taxable income by the
amount of your contribution to your
FEHB insurance premium. If you are a
participant in the premium conversion
plan, Section 125 of the Internal

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
Revenue Code allows you to reduce
your salary (through an employer
allotment) and provide that portion of
your salary back to your employer.
Instead of being paid to you as taxable
income, this allotted amount is used to
purchase your FEHB insurance for you.
The effect is that your taxable income is
reduced. Because taxable income is
reduced, the amount of tax you pay is
reduced. You save on Federal income
tax, Social Security and Medicare tax
and in most States and localities, State
and local income taxes.
PART 894—FEDERAL EMPLOYEES
DENTAL AND VISION INSURANCE
PROGRAM
6. The authority citation for part 894
continues to read as follows:

Authority: 5 U.S.C. 8962; 5 U.S.C. 8992;
Subpart C also issued under section 1 of Pub.
L. 110–279, 122 Stat. 2604.

7. In § 894.101, the definitions for
‘‘Domestic partner’’ and ‘‘Domestic
partnership’’ are removed and the
definition for ‘‘Stepchild’’ is revised to
read as follows:

■

Definitions.

*

*
*
*
*
Stepchild means your spouse’s child
born within or outside marriage or his
or her adopted child. The child of your
spouse shall continue to be considered
your stepchild after your divorce from
your spouse or the death of your spouse
so long as the child continues to live
with you in a regular parent-child
relationship.
*
*
*
*
*
8. In § 894.403, paragraph (a) is
revised to read as follows:

■

§ 894.403 Are FEDVIP premiums paid on a
pre-tax basis?

(a) Your FEDVIP premiums are paid
on a pre-tax basis (called premium
conversion) if you are an active
employee, your salary is sufficient to
make the premium allotments, and your
agency will be able to make pre-tax
allotments.
*
*
*
*
*
[FR Doc. 2018–14938 Filed 7–11–18; 8:45 am]

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Agricultural Marketing Service
7 CFR Part 929
[Doc. No. AMS–SC–17–0066; SC17–929–3
FR]

Cranberries Grown in States of
Massachusetts, et al.; Establishment of
Handler Diversion and Reporting
Requirements and New Information
Collection
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:

This rule implements a
recommendation to establish handler
diversion and reporting requirements
under the marketing order for
cranberries grown in the production
area (Order). This action establishes the
procedures handlers use to divert fruit
through disposal or into noncompetitive
outlets. The reporting requirements
support the diversion procedures by
providing the necessary documentation
to help ensure compliance when a
volume regulation is established.
DATES: Effective August 13, 2018.
FOR FURTHER INFORMATION CONTACT:
Doris Jamieson, Marketing Specialist, or
Christian D. Nissen, Regional Director,
Southeast Marketing Field Office,
Marketing Order and Agreement
Division, Specialty Crops Program,
AMS, USDA; Telephone: (863) 324–
3375, Fax: (863) 291–8614, or Email:
[email protected] or
[email protected].
Small businesses may request
information on complying with this
regulation by contacting Richard Lower,
Marketing Order and Agreement
Division, Specialty Crops Program,
AMS, USDA, 1400 Independence
Avenue SW, STOP 0237, Washington,
DC 20250–0237; Telephone: (202) 720–
2491, Fax: (202) 720–8938, or Email:
[email protected].
SUPPLEMENTARY INFORMATION: This final
rule, pursuant to 5 U.S.C. 553, amends
regulations used to carry out a
marketing order as defined in 7 CFR
900.2(j). This final rule is issued under
Marketing Agreement and Order No.
929, as amended (7 CFR part 929),
regulating the handling of cranberries
grown in the states of Massachusetts,
Rhode Island, Connecticut, New Jersey,
Wisconsin, Michigan, Minnesota,
Oregon, Washington, and Long Island in
the State of New York. Part 929 (referred
to as the ‘‘Order’’) is effective under the
Agricultural Marketing Agreement Act
of 1937, as amended (7 U.S.C. 601–674),
SUMMARY:

■

§ 894.101

DEPARTMENT OF AGRICULTURE

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hereinafter referred to as the ‘‘Act.’’ The
Committee locally administers the
Order and is comprised of growers of
cranberries operating within the
production area, and a public member.
The Department of Agriculture
(USDA) is issuing this rule in
conformance with Executive Orders
13563 and 13175. This action falls
within a category of regulatory actions
that the Office of Management and
Budget (OMB) exempted from Executive
Order 12866 review. Additionally,
because this rule does not meet the
definition of a significant regulatory
action, it does not trigger the
requirements contained in Executive
Order 13771. See OMB’s Memorandum
titled ‘‘Interim Guidance Implementing
Section 2 of the Executive Order of
January 30, 2017, titled ‘Reducing
Regulation and Controlling Regulatory
Costs’ ’’ (February 2, 2017).
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. This final rule is not intended
to have retroactive effect.
The Act provides that administrative
proceedings must be exhausted before
parties may file suit in court. Under
section 608c(15)(A) of the Act, any
handler subject to an order may file
with USDA a petition stating that the
order, any provision of the order, or any
obligation imposed in connection with
the order is not in accordance with law
and request a modification of the order
or to be exempted therefrom. A handler
is afforded the opportunity for a hearing
on the petition. After the hearing, USDA
would rule on the petition. The Act
provides that the district court of the
United States in any district in which
the handler is an inhabitant, or has his
or her principal place of business, has
jurisdiction to review USDA’s ruling on
the petition, provided an action is filed
not later than 20 days after the date of
the entry of the ruling.
This final rule establishes handler
diversion and reporting requirements
under the Order. This rule establishes
procedures handlers use to divert fruit
through disposal or into noncompetitive
outlets. The reporting requirements
support the diversion procedures by
providing the necessary documentation
to help ensure compliance when a
volume regulation is established. This
action was recommended by the
Committee at its August 31, 2017,
September 15, 2017, and October 13,
2017, meetings.
The Order provides for the use of
volume regulation to stabilize prices
and improve grower returns during
periods of oversupply. Section
929.51(a)(2) specifies that a handler
withholding program must be

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recommended by the Committee no
later than August 31 and that such
recommendation shall include the free
and restricted percentages for the crop
year. On August 31, 2017, the
Committee met and recommended free
and restricted percentages of 85 percent
free and 15 percent restricted. Handler
diversion is one method that handlers
can utilize to meet restricted percentage
requirements.
Section 929.54 provides, in part, that
whenever the Secretary of Agriculture
(Secretary) has fixed the free and
restricted percentages for any fiscal
period, each handler shall withhold
from handling a portion of the
cranberries acquired during such
period. This section also provides the
authority for the Committee to establish,
with the approval of the Secretary, rules
and regulations necessary to administer
this section. Section 929.56 provides
special provisions relating to withheld
(restricted) cranberries, and § 929.57
provides authority for the Committee to
establish, with the approval of the
Secretary, outlets for withheld
cranberries which are noncompetitive
with outlets for unrestricted (free
percentage) cranberries.
Section 929.62 provides, in part,
authority to require handlers to submit
reports of cranberries acquired, held in
inventory, quantity handled, total
cranberries withheld from handling, the
portion of such withheld cranberries on
hand, and the quantity and manner of
disposition of any such withheld
cranberries diverted. Section 929.62(f)
further provides authority for the
Committee, with the approval of the
Secretary, to collect other reports and
information from handlers needed to
perform its duties.
This final rule uses these authorities
to establish new §§ 929.157 and
929.162. Section 929.157 establishes the
procedures to be used for handler
diversion when free and restricted
percentages are instituted. Section
929.162 requires handlers of
cranberries, during years when free and
restricted percentages are applied, to
report to the Committee diversion plans
and year-end reports, information on
cranberries diverted and cranberries
shipped to noncompetitive outlets, and
other information to verify compliance
with the program, using six specific
Committee forms.
The Committee recommended
establishing free and restricted
percentages under a handler
withholding volume regulation for the
2017–18 season in response to
historically high inventory levels for
cranberries. As this is the first time the
Committee has used this volume

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regulation provision under the Order, it
recognized the need to establish
procedures outlining the diversion
requirements for restricted fruit.
Free percentage cranberries can be
used to supply any available market,
including juice, sweetened dried
cranberries, sauce, and frozen
cranberries. Restricted percentage
cranberries can be diverted through
disposal or utilized in markets that are
noncompetitive with free cranberries.
Possible outlets for restricted
cranberries include, in part, for fresh
export, except to Canada; charity;
research and development projects; and
any nonhuman food use. Handlers also
have the option to divert processed
products in lieu of fresh fruit to meet up
to 50 percent of their restricted
obligation.
At the 2017 meetings in August,
September, and October, the Committee
discussed the handler diversion
procedures and the associated reporting
requirements necessary to help ensure
compliance with a free and restricted
percentage volume regulation. As a
result, the Committee developed and
approved six specific forms and related
procedures to be used during seasons
when free and restricted percentages are
established for volume regulation.
Committee members discussed the
need for Committee staff to know how
handlers plan to meet their restricted
percentage obligation and if, at the end
of the season, they met their diversion
requirement. As a result, the Committee
developed two specific forms to be
added to the reporting requirements
under the Order.
With the first form, the Handler
Withholding Report (CMC–JUN),
handlers provide information on how
they plan to meet their restricted
percentage obligation. The form will be
submitted to the Committee by June 1
during years with established free and
restricted percentages and requires the
following information: The name and
address of the handler, the amount of
cranberries to be acquired, the amount
of cranberries to be diverted by disposal,
the amount of cranberries to be diverted
to noncompetitive outlets, and the types
of cranberry products to be withheld.
The Committee will use this
information to estimate the amount of
fruit that will be taken off the market,
the proposed disposition of the fruit,
and as a starting point for tracking
handler compliance.
The second form, the Final Handler
Withholding Report (CMC–AUG), will
be submitted by the end of the crop
year. The report requires the same
information as the Handler Withholding
Report but provides the Committee with

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the actual year-end seasonal totals. This
form is due by August 31. The final
report will be used to verify that
handlers met their restricted percentage
obligation.
Handlers have several diversion
options available to meet their restricted
percentage obligation. One method of
diversion available to handlers is the
disposal of fresh cranberries or
cranberry products. In its discussions,
Committee members expressed concern
regarding verifying the accuracy of the
amount of fruit or processed product
diverted using this method. The
Committee recommended that all
disposals take place under the
supervision of a non-industry-related
third party who will review the
handler’s disposal documentation,
witness the disposal whenever possible,
and certify as to the completion of the
disposal process. The Committee
initially agreed to hire two inspectors to
supervise and verify handler
compliance. However, due to the size of
the production area, the Committee
hired four inspectors, one from each of
the primary growing regions, who will
perform these tasks. The inspection and
verification costs will be paid by the
handler.
To facilitate this process, the
Committee recommended establishing
another form. This form, the Handler
Disposal Certification (CMC–DISP), will
be the primary form used to initiate,
track, and certify this method of
diversion during years in which a free
and restricted percentage volume
regulation has been established. The
form will be used to notify the
Committee of the handler’s intent to
dispose of cranberries or cranberry
products. Information required on the
form include the handler’s name and
address; the amount of fruit to be
diverted; the type of cranberry product
to be diverted; the amount of processed
fruit diverted, if any; and the lot
identification information.
Upon receipt of the form, the
Committee office will notify the
inspector in the handler’s growing
region. The inspector will contact the
handler to schedule a date for the
disposal to take place, usually within a
week of receipt of the notification. The
inspector will meet with the handler on
that date to verify the documentation
provided and, when possible, witness
the disposal.
The Committee recognized that, due
to scheduling conflicts, the inspector
may not be available to visually witness
each disposal of restricted cranberries.
Therefore, the Committee agreed that,
should the inspector not be available to
witness the diversion within seven

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days, the handler may proceed with the
disposal. The inspector will then verify
and complete the certification upon the
inspector’s next visit to the handler’s
facility. If the cranberries or cranberry
product were disposed of at a landfill,
through composting, incineration, at a
wastewater treatment facility, or any
other site, the inspector may request
receipts, visual proof, or any other
additional information needed to
support the disposal as reported on the
form. Once the verification process is
completed, the inspector will sign the
certification section of the form, and
return it to the Committee.
Another method of diversion
available is to divert cranberries or
cranberry products to noncompetitive
outlets. Section 929.57 specifies that
cranberries withheld from handling may
be disposed of only through diversion to
such outlets as the Committee, with the
approval of the Secretary, finds are
noncompetitive to outlets for
unrestricted (free percentage)
cranberries. The Committee discussed
various outlets and recommended the
following: Foreign countries, except
Canada; charitable institutions; any
nonhuman food use; and research and
development projects approved by the
Committee dealing with the
development of foreign and domestic
markets, including but not limited to
dehydration, radiation, freeze drying, or
freezing of cranberries. The Committee
further recommended that cranberries
may not be converted into canned,
frozen, or dehydrated cranberries or
other cranberry products by any
commercial process when being
diverted to foreign countries. The
specific outlets are being considered
under a separate rulemaking action.
The Agricultural Marketing Service
(AMS) submitted and received OMB’s
approval on the five initial forms.
Handlers complete the forms and
submit them to the Committee for
purposes of tracking compliance with
the handler withholding requirement.
OMB approved the forms on October 16,
2017, and assigned them OMB No.
0581–0304. Upon full completion of the
forms-approval process, AMS will seek
to merge the five forms into the OMBapproved 0581–0189 Fruit Crops
containing other forms related to the
Federal marketing order for cranberries.
Two specific reporting requirements
relating to the diversion of fruit to
noncompetitive outlets are added to part
929: A Handler Application for Outlets
for Withheld Fruit (CMC–OUT) and a
Third-Party Confirmation of Receipt of
Withheld Fruit (CMC–CONF). Should a
handler elect to divert cranberries or
cranberry products to noncompetitive

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outlets, the handler must first request
Committee approval of the outlet or
research project using the Handler
Application for Outlets for Withheld
Fruit prior to each disposal activity of
this type. Information requested on the
form includes, among other things, the
handler’s name and address,
information identifying the
noncompetitive outlet, the amount and
type of cranberry products to be
diverted, and how the cranberries will
be utilized. The Committee will review
the information and approve or
disapprove the diversion request.
If the request is approved and the
product is delivered, the receiving
outlet needs to acknowledge receipt of
the product by completing the ThirdParty Confirmation of Receipt of
Withheld Fruit form, and the handler
then returns the completed form to the
Committee.
The two above-described reporting
requirements help track the disposition
of withheld cranberries in
noncompetitive outlets and facilitates
the compliance process under the
recommended handler withholding.
The last form approved by the
Committee provides handlers a method
for appealing any decision made by the
Committee relating to the diversion
process. Should a handler disagree with
a Committee decision, such as denying
the request for approval of a
noncompetitive outlet, or a
determination that diversion could not
be verified, the handler can appeal the
decision by submitting a Handler
Withholding Appeal form (CMC–APPL).
The handler making the appeal is
required to submit the form within 30
days of receiving the determination
from the Committee. This form includes
information about why the handler is
making the appeal and provides
additional information to support the
appeal. The appeal request is reviewed
by an Appeals Subcommittee
(Subcommittee) for re-consideration.
The Subcommittee consists of two
independent growers, two members
from the major cooperative, and one
public member. The handler will be
notified of the Subcommittee’s
determination within 30 days. If the
appeal is denied by the Subcommittee,
the handler has the option of appealing
the decision to the Secretary within 15
days after the notification of the
Subcommittee’s findings.
In order to enable the Committee to
inform the industry of the information
needed for handlers to manage their
inventories in a way that complies with
the industry-supported handler
withholding program, the five initial
forms were previously submitted to

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32195

OMB for approval. These five forms
(CMC–JUN, CMC–DISP, CMC–OUT,
CMC–CONF and CMC–APPL) were
approved by OMB on October 16, 2017,
for use for a six-month period,
beginning the date of approval. This
final rule is necessary for the industry
to use the forms beyond the six-month
period.
Establishing these handler diversion
and reporting requirements facilitates
the implementation of, and ensures
compliance with, free and restricted
percentages when recommended by the
Committee.
Final Regulatory Flexibility Analysis
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601–612), AMS has considered
the economic impact of this action on
small entities. Accordingly, AMS has
prepared this final regulatory flexibility
analysis.
The purpose of the RFA is to fit
regulatory actions to the scale of
businesses subject to such actions in
order that small businesses will not be
unduly or disproportionately burdened.
Marketing orders issued pursuant to the
Act, and rules issued thereunder, are
unique in that they are brought about
through group action of essentially
small entities acting on their own
behalf.
There are approximately 1,100
cranberry growers in the regulated area
and approximately 65 cranberry
handlers subject to regulation under the
Order. Small agricultural producers are
defined by the Small Business
Administration (SBA) as those having
annual receipts of less than $750,000,
and small agricultural service firms are
defined as those whose annual receipts
are less than $7,500,000 (13 CFR
121.201).
According to industry and Committee
data, the average grower price for
cranberries during the 2016–17 crop
year was $23.50 per barrel, and total
sales were around 9.5 million barrels.
The value for cranberries that crop year
totaled $223,250,000 ($23.50 per barrel
multiplied by 9.5 million barrels).
Taking the total value of production for
cranberries and dividing it by the total
number of cranberry growers (1,100)
provides an average return per grower of
$202,955. Based on USDA’s Market
News reports, the average free on board
(f.o.b.) price for cranberries was around
$30.00 per barrel. Multiplying the f.o.b.
price by total utilization of 9.5 million
barrels results in an estimated handlerlevel cranberry value of $285 million.
Dividing this figure by the number of
handlers (65) yields an estimated
average annual handler receipt of $4.3

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million, which is below the SBA
threshold for small agricultural service
firms. Therefore, the majority of growers
and handlers of cranberries may be
classified as small entities.
This final rule establishes handler
diversion and reporting requirements
under the Order. This final rule
establishes procedures handlers will use
to divert fruit through disposal or into
noncompetitive outlets. The reporting
requirements support the diversion
procedures by providing the necessary
documentation to help ensure
compliance when a volume regulation is
established. This rule establishes new
§§ 929.157 and 929.162. The authority
for this action is provided in §§ 929.54,
929.56, 929.57, and 929.62.
These actions could result in some
additional costs to the industry.
Specifically, handlers could incur some
additional costs as a result of inspector
verification and certification of the
diversion process. In addition, requiring
reports of cranberries acquired, handled,
and withheld imposes an increase in the
reporting burden on all cranberry
handlers. However, the benefits are
expected to outweigh the costs and
increase in reporting burden. The
provisions considered in this action will
help facilitate the implementation of
any recommended handler withholding
volume regulation and help ensure
compliance with the recommended
regulation. Consequently, these changes
will help provide important guidance
during times when market conditions
support the need for establishing
volume regulation.
The impact of this rule will be
beneficial to growers and handlers.
Establishing diversion procedures
benefits the entire industry by ensuring
handler diversion is conducted
consistently and accurately by all
handlers, which also helps ensure
compliance with the handler
withholding program. Authorizing
various diversion outlets means
handlers are not required to divert
cranberries only through destruction.
Instead, fruit can be utilized in
noncompetitive outlets, such as for
charitable purposes. The benefits of this
rule are expected to be equally available
to all cranberry growers and handlers,
regardless of their size, and are greater
than any associated costs.
The Committee discussed other
alternatives to this action, including
using different methods of ensuring
accurate diversion of restricted fruit.
One method considered was allowing
handlers to self-report their diversion of
restricted fruit without a formal
verification process. However, the
Committee deemed this insufficient

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verification to ensure compliance with
the program. Members were concerned
that fruit could be re-routed to a
different handling facility for
processing, and without established
verification procedures, the industry
would not have confidence that
restricted fruit was being properly
diverted. The Committee also
considered the value and importance of
each of the forms and whether all were
required. However, the Committee
agreed each of the recommended forms
provide important information for the
industry and for administering the
Order. Therefore, these alternatives
were rejected.
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), this collection has been
submitted to OMB for approval. The five
currently approved forms in 0581–0304
and one additional form will be merged
with forms currently approved under
OMB No. 0581–0189, Fruit Crops. This
final rule establishes the use of six new
reporting requirements and six new
Committee forms, which impose a total
annual burden increase of 38.4 hours.
The forms, ‘‘Handler Withholding
Report,’’ ‘‘Handler Disposal
Certification,’’ ‘‘Handler Application for
Outlets for Withheld Fruit,’’ ‘‘ThirdParty Confirmation of Receipt of
Withheld Fruit,’’ ‘‘Handler Withholding
Appeal,’’ and ‘‘Final Handler
Withholding Report,’’ require the
minimum information necessary to
effectively carry out the requirements of
the Order. The information will enable
the Committee to ensure compliance
when a volume regulation is
established.
As with all Federal marketing order
programs, reports and forms are
periodically reviewed to reduce
information requirements and
duplication by industry and public
sector agencies.
As noted in the initial regulatory
flexibility analysis, USDA has not
identified any relevant Federal rules
that duplicate, overlap, or conflict with
this rule. Further, the public comment
received concerning the proposal did
not address the initial regulatory
flexibility analysis.
AMS is committed to complying with
the E-Government Act, to promote the
use of the internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Further, the Committee’s meetings
were widely publicized throughout the
cranberry industry, and all interested
persons were invited to attend the
meetings and participate in Committee

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deliberations on all issues. Additionally,
the Committee’s meetings held August
31, September 15, and October 13, 2017,
were public meetings, and all entities,
both large and small, were able to
express views on this issue.
A proposed rule concerning this
action was published in the Federal
Register on February 15, 2018 (83 FR
6800). Copies of the proposed rule were
sent via email to Committee members
and cranberry handlers. Finally, the
proposed rule was made available
through the internet by USDA and the
Office of the Federal Register. A 60-day
comment period ending April 16, 2018,
was provided to allow interested
persons to respond to the proposal.
Two comments were received which
did not address the merits of the
proposed rule. Accordingly, no changes
will be made to the rule as proposed
based on the comments received.
The proposed rule contained
administrative revisions to the Order’s
subpart headings to bring the language
into conformance with the Office of
Federal Register requirements. These
revisions are not included in this rule as
they were included in a final rule
published in the Federal Register on
April 4, 2018 (83 FR 14350).
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: http://www.ams.usda.gov/
rules-regulations/moa/small-businesses.
Any questions about the compliance
guide should be sent to Richard Lower
at the previously mentioned address in
the FOR FURTHER INFORMATION CONTACT
section.
After consideration of all relevant
matter presented, including the
information and recommendation of the
Committee and other available
information, it is hereby found that this
rule, as hereinafter set forth, will tend
to effectuate the declared policy of the
Act.
List of Subjects in 7 CFR Part 929
Cranberries, Marketing agreements,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, 7 CFR part 929 is amended as
follows:
PART 929—CRANBERRIES GROWN IN
STATES OF MASSACHUSETTS,
RHODE ISLAND, CONNECTICUT, NEW
JERSEY, WISCONSIN, MICHIGAN,
MINNESOTA, OREGON,
WASHINGTON, AND LONG ISLAND IN
THE STATE OF NEW YORK
1. The authority citation for part 929
continues to read as follows:

■

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
Authority: 7 U.S.C. 601–674.
■

2. Add § 929.157 to read as follows:

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§ 929.157

Handler diversion.

(a) Methods of diversion. Handlers
may divert cranberries by disposing of
cranberries or cranberry products.
Diversion by disposal may take place
prior to placing the cranberries into the
processing line or after processing.
Handlers may also divert cranberries or
cranberry products to approved,
noncompetitive outlets for withheld
fruit. Whole berries or processed
products diverted must come from the
current crop year. Any information
collected of a confidential and/or
proprietary nature would be held in
confidence pursuant to § 929.65.
(1) Diversion through disposal. This
type of diversion is to be carried out
under the supervision of the Committee,
and the cost of such supervision is to be
paid by the handler. Handlers shall
notify the Committee of their intent to
dispose of cranberries or cranberry
products using Form CMC–DISP as
specified in § 929.162(c). Following
notification, a Committee inspector will
meet with the handler to verify the
documentation provided and, when
possible, witness the destruction. The
Committee inspector may request
receipts, visual proof, or any other
information needed to support the
disposal as reported. Once the
verification process has been completed,
the Committee inspector will sign the
certification section of Form CMC–DISP
and return it to the Committee.
(2) Diversion through noncompetitive
outlets. To divert cranberries or
cranberry products to a noncompetitive
outlet, handlers must apply to the
Committee using Form CMC–OUT as
specified in § 929.162(d) prior to each
disposal activity of this type. The
Committee will review the information
and approve or disapprove the diversion
request. Once the cranberries or
cranberry products are delivered to the
approved noncompetitive outlets, the
Committee must receive satisfactory
documentation of the transaction using
Form CMC–CONF as specified in
§ 929.162(e).
(b) Committee notification and
handler plan. Any handler intending to
divert cranberries or cranberry products
pursuant to § 929.54 must notify the
Committee of such intent and provide a
plan by June 1 that shows how the
handler intends to meet the restricted
percentage obligation. The handler shall
submit this plan using Form CMC–JUNE
as specified in the reporting
requirements under § 929.162(a). The
handler will have until August 31 to
fulfill the plan, by which time the

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handler shall submit a final report
detailing how the restricted percentage
obligation was met using Form CMC–
AUG as specified in § 929.162(b).
(c) Request for review. (1) If a handler
is dissatisfied with a determination
made by the Committee which affects
such handler, the handler may submit to
the Committee within 30 days after
receipt of the Committee’s
determination, a request for a review by
an appeals subcommittee composed of
two independent growers and two
cooperative representatives, as well as a
public member. The appeals
subcommittee shall be appointed by the
Committee chairperson. The handler
may forward with the request any
pertinent materials for consideration of
the appeal.
(2) The subcommittee shall review the
information submitted by the handler
and render a decision within 30 days of
receipt of such appeal. The
subcommittee shall notify the handler of
its decision, accompanied by the
reasons for its conclusions and findings.
(3) The handler may further appeal to
the Secretary, within 15 days after
notification of the subcommittee’s
findings, if such handler is not satisfied
with the appeals subcommittee’s
decision. The Committee shall forward
a file to the Secretary with all pertinent
information related to the handler’s
appeal. The Secretary shall inform the
handler and all interested parties of the
Secretary’s decision. All decisions by
the Secretary are final.
■

3. Add § 929.162 to read as follows:

§ 929.162

Handler diversion reports.

(a) Handler withholding report.
Handlers shall submit to the Committee,
by June 1, a handler withholding report.
The report shall be submitted using
Form CMC–JUN and contain the
following information:
(1) The name and address of the
handler;
(2) The amount of cranberries
acquired;
(3) The amount of cranberries
withheld by disposal;
(4) The amount of cranberries
diverted to noncompetitive outlets;
(5) The form of cranberry products
withheld; and
(6) The total withholding obligation.
(b) Handler Withholding Final Report.
Handlers shall submit to the Committee,
by August 31, a final handler
withholding report. The final report
shall be submitted using Form CMC–
AUG and contain the following
information:
(1) The name and address of the
handler;

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32197

(2) The seasonal total of cranberries
acquired;
(3) The seasonal total of cranberries
withheld by disposal;
(4) The seasonal total of cranberries
diverted to noncompetitive outlets;
(5) The form of cranberry products
withheld during the season; and
(6) The total withholding obligation.
(c) Handler disposal certification.
Handlers shall submit to the Committee
Form CMC–DISP for each lot of
cranberries or cranberry products to be
diverted through disposal. The form
shall contain the following information:
(1) Name and address of the handler;
(2) Marketable cranberries in whole
fruit or processed cranberries converted
to whole fruit equivalent disposed of in
this lot;
(3) Form of cranberries;
(4) Volume if in processed form;
(5) Lot details;
(6) Disposal site and method; and
(7) Inspector certification of the
completion of the disposal.
(d) Handler application for outlets for
withheld fruit. Handlers shall submit to
the Committee Form CMC–OUT for
approval for each lot of cranberries or
cranberry products to be diverted to
noncompetitive outlets in accordance
with § 929.57. The form shall contain
the following information:
(1) Name and address of the handler;
(2) Project type;
(3) Product form;
(4) Quantity of cranberries in whole
fruit or processed cranberries converted
to whole fruit equivalent diverted;
(5) A description of the project and
how the cranberries will be used.
(e) Third-party confirmation of receipt
of withheld fruit. Handlers shall submit
to the Committee Form CMC–CONF for
each diversion to a noncompetitive
outlet to verify the receipt of the
cranberries or cranberry product by the
approved outlet. The form shall contain
the following information:
(1) Name and address of the handler;
(2) Project type;
(3) Product form;
(4) Quantity of cranberries in whole
fruit or processed cranberries converted
to whole fruit equivalent utilized; and
(5) Confirmation or documentation of
receipt from the receiving outlet.
(f) Handler withholding appeal.
Handlers may appeal a determination
made by the Committee relating to a
handler withholding regulation using
the appeals process outlined in
§ 929.157(c) and Form CMC–APPL,
which shall contain the following
information:
(1) Name and address of the handler;
(2) Reason for appeal; and
(3) Information in support of appeal.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

Dated: July 9, 2018.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2018–14939 Filed 7–11–18; 8:45 am]
BILLING CODE 3410–02–P

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2018–0588; Product
Identifier 2017–NM–105–AD; Amendment
39–19328; AD 2018–14–08]
RIN 2120–AA64

Airworthiness Directives; The Boeing
Company Airplanes
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; request for
comments.
AGENCY:

We are adopting a new
airworthiness directive (AD) for certain
The Boeing Company Model 777–200LR
series airplanes. This AD requires
revising certain documents to provide
revised operating limitations. For
certain airplanes, modification of the
water and fuel scavenge systems in the
fuel tanks, electrical changes in the
main equipment center, and installation
of new electrical load management
system (ELMS2) software is an
acceptable alternative to the documents
revision. This AD was prompted by
reports of unreliable performance of the
water and fuel scavenge systems. We are
issuing this AD to address the unsafe
condition on these products.
DATES: This AD is effective July 27,
2018.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in this AD
as of July 27, 2018.
We must receive comments on this
AD by August 27, 2018.
ADDRESSES: You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC 20590.
• Hand Delivery: Deliver to Mail
address above between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.

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SUMMARY:

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For service information identified in
this final rule, contact Boeing
Commercial Airplanes, Attention:
Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110–SK57,
Seal Beach, CA 90740–5600; telephone
562–797–1717; internet https://
www.myboeingfleet.com. You may view
this service information at the FAA,
Transport Standards Branch, 2200
South 216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
It is also available on the internet at
http://www.regulations.gov by searching
for and locating Docket No. FAA–2018–
0588.
Examining the AD Docket
You may examine the AD docket on
the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0588; or in person at the Docket
Management Facility between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket
contains this final rule, the regulatory
evaluation, any comments received, and
other information. The street address for
the Docket Office (phone: 800–647–
5527) is in the ADDRESSES section.
Comments will be available in the AD
docket shortly after receipt.
FOR FURTHER INFORMATION CONTACT:
Kevin Nguyen, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax: 206–
231–3555; email: Kevin.Nguyen@
faa.gov.
SUPPLEMENTARY INFORMATION:

Discussion
Operators have reported unreliable
performance of the water and fuel
scavenge systems. During flight, any
water in the fuel can sink to the bottom
of the fuel tank. This water can enter the
fuel scavenge inlets and can then freeze
as it travels from the body center fuel
tank into the colder fuel scavenge tubes
in the left and right cheek center fuel
tanks (outboard of the side of body ribs).
The frozen water can restrict the flow of
scavenge fuel from the center fuel tank
to the main fuel tanks, causing the fuel
flow to decrease or stop. When this
occurs, as much as 700 pounds of fuel
can remain unavailable during flight. If
the flightcrew is not aware that this fuel
is unavailable and the fuel quantity
decreases to the quantity of the
unavailable fuel, then fuel exhaustion
will occur, which could lead to
subsequent power loss of all engines
due to loss of capability to scavenge fuel
in the center fuel tank.

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Related Rulemaking
We issued AD 2016–11–03,
Amendment 39–18530 (81 FR 34867,
June 1, 2016) (‘‘AD 2016–11–03’’), that
applied to certain Boeing Model 777–
200LR series airplanes equipped with or
without auxiliary fuel tanks. For
airplanes with auxiliary fuel tanks,
variable numbers WD049–WD053
inclusive only, AD 2016–11–03 requires
modification of the water and fuel
scavenge systems after removal of the
auxiliary fuel tanks. This AD requires
incorporation of revised operating
limitations for those airplanes, which
terminates the associated requirements
of AD 2016–11–03. This AD also
provides the option of modifying the
water and fuel scavenge systems in the
fuel tanks, making electrical changes in
the main equipment center, and
installing new ELMS2 software after
removal of the auxiliary fuel tanks.
Either compliance method terminates
the requirements of paragraphs (g), (h),
and (i) of AD 2016–11–03 for those
airplanes.
Additionally, paragraph (g) of this AD
requires a revision to certain documents
to provide revised operating limitations
for airplane variable numbers WD011
through WD015 inclusive and WD016
through WD018 inclusive. These
airplanes are not affected by AD 2016–
11–03, which refers to Boeing Special
Attention Service Bulletin 777–28–
0078, Revision 1, dated April 27, 2015,
for the applicability.
Airplane variable numbers WD011
through WD015 inclusive are included
in the effectivity of Boeing Special
Attention Service Bulletin 777–28–
0078, Revision 3, dated December 19,
2017; therefore, this AD provides a
modification of the water and fuel
scavenge systems in the fuel tanks,
electrical changes in the main
equipment center, and installation of
new ELMS2 software as an acceptable
alternative to the documents revision.
However, there is no approved service
information for airplane variable
numbers WD016 through WD018
inclusive for the modification of the
water and fuel scavenge systems in the
fuel tanks, electrical changes in the
main equipment center, and installation
of new ELMS2 software; therefore, there
is no alternative to the documents
revision specified in this AD for these
airplanes.
Related Service Information Under
1 CFR Part 51
We reviewed Boeing Special
Attention Service Bulletin 777–28–
0078, Revision 3, dated December 19,
2017. The service information describes

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
accomplishment of the actions specified
in the service information described
previously, as an acceptable alternative
to the documents revision.

procedures for the removal of the
auxiliary fuel tanks and modification of
the water and fuel scavenge systems in
the fuel tanks, electrical changes in the
main equipment center, and installation
of new ELMS2 software. This service
information is reasonably available
because the interested parties have
access to it through their normal course
of business or by the means identified
in the ADDRESSES section.

FAA’s Justification and Determination
of the Effective Date
There are currently no domestic
operators of this product. Therefore, we
find that notice and opportunity for
prior public comment are unnecessary
and that good cause exists for making
this amendment effective in less than 30
days.

FAA’s Determination
We are issuing this AD because we
evaluated all the relevant information
and determined the unsafe condition
described previously is likely to exist or
develop in other products of the same
type design.

Comments Invited
This AD is a final rule that involves
requirements affecting flight safety and
was not preceded by notice and an
opportunity for public comment.
However, we invite you to send any
written data, views, or arguments about
this final rule. Send your comments to
an address listed under the ADDRESSES
section. Include the docket number

AD Requirements
This AD requires revising certain
documents to provide revised operating
limitations. For certain airplanes, this
AD provides for the optional

FAA–2018–0588 and Product Identifier
2017–NM–105–AD at the beginning of
your comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this final rule. We will
consider all comments received by the
closing date and may amend this final
rule because of those comments.
We will post all comments we
receive, without change, to http://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this final rule.
Costs of Compliance
Currently, there are no affected U.S.registered airplanes. If an affected
airplane is imported and placed on the
U.S. Register in the future, we provide
the following cost estimates to comply
with this AD:

ESTIMATED COSTS FOR REQUIRED ACTIONS
Action

Labor cost

Revise operating limitations .........................................

1 work-hour × $85 per hour = $85 ...............................

Cost per
product

Parts cost
$0

$85

ESTIMATED COSTS FOR OPTIONAL ACTIONS
Action

Labor cost

Modification .................................................................

Up to 253 work-hours × $85 per hour = up to
$21,505.

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Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
This AD is issued in accordance with
authority delegated by the Executive
Director, Aircraft Certification Service,

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as authorized by FAA Order 8000.51C.
In accordance with that order, issuance
of ADs is normally a function of the
Compliance and Airworthiness
Division, but during this transition
period, the Executive Director has
delegated the authority to issue ADs
applicable to transport category
airplanes to the Director of the System
Oversight Division.
Regulatory Findings
This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect on the States, on
the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,

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Parts cost
$66,960

Cost per
product
Up to $88,465.

(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation
in Alaska, and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:

■

Authority: 49 U.S.C. 106(g), 40113, 44701.

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32200

[Amended]

2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):

■

2018–14–08 The Boeing Company:
Amendment 39–19328; Docket No.
FAA–2018–0588; Product Identifier
2017–NM–105–AD.
(a) Effective Date
This AD is effective July 27, 2018.
(b) Affected ADs
This new AD affects AD 2016–11–03,
Amendment 39–18530 (81 FR 34867, June 1,
2016) (‘‘AD 2016–11–03’’).

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(1) Insert the information specified in
figure 1 to the introductory text of paragraph
(g) of this AD into the ‘‘Fuel-System—
Loading’’ section of the ‘‘Certificate
Limitations’’ section of the FAA-approved
Boeing Model 777 Airplane Flight Manual.
(2) Insert the information specified in
figure 1 to the introductory text of paragraph
(g) of this AD into the ‘‘Loading Limitations’’
section of the ‘‘Fuel Loading Procedures’’
section of the ‘‘Fuel Management’’ section of
the FAA-approved Boeing Model 777 Weight
and Balance Control and Loading Manual.
(h) Optional Terminating Action for V/Ns
WD049–WD053 Inclusive and WD011–
WD015 Inclusive
For airplane V/Ns WD049 through WD053
inclusive, and WD011 through WD015
inclusive: Accomplishment of the actions
specified in paragraphs (h)(1) and (h)(2) of
this AD terminates the requirements of
paragraph (g) of this AD.
(1) Remove the auxiliary fuel tanks in
accordance with step 1. of the
Accomplishment Instructions of Boeing
Special Attention Service Bulletin 777–28–
0078, Revision 3, dated December 19, 2017.
(2) Modify the water and fuel scavenge
systems in the fuel tanks, make electrical
changes in the main equipment center, and
install new electrical load management
system (ELMS2) software, by doing all
applicable actions identified as ‘‘RC’’
(required for compliance) in, and in
accordance with, the Accomplishment
Instructions of Boeing Special Attention
Service Bulletin 777–28–0078, Revision 3,
dated December 19, 2017.
(i) Credit for Previous Actions
(1) This paragraph provides credit for the
actions specified in paragraphs (h)(1) and
(h)(2) of this AD, if those actions were
performed before the effective date of this AD

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(c) Applicability
This AD applies to The Boeing Company
Model 777–200LR series airplanes,
certificated in any category, variable numbers
(V/Ns) WD011 through WD015 inclusive,
WD016 through WD018 inclusive, and
WD049 through WD053 inclusive.

power loss of all engines due to loss of access
to fuel in the center fuel tank.

(d) Subject
Air Transport Association (ATA) of
America Code 28, Fuel.

(g) Revision to Operating Limitations

(e) Unsafe Condition
This AD was prompted by reports of
unreliable performance of the water and fuel
scavenge systems. We are issuing this AD to
prevent fuel exhaustion and subsequent

using Boeing Special Attention Service
Bulletin 777–28–0078, Revision 2, dated
October 5, 2016.
(2) This paragraph provides credit for
airplane V/Ns WD049 through WD053
inclusive for the actions specified in
paragraphs (h)(1) and (h)(2) of this AD, if
those actions were performed before the
effective date of this AD using April 27, 2015;
or Boeing Special Attention Service Bulletin
777–28–0078, Revision 1, dated April 27,
2015.
(j) Parts Installation Prohibition
After completion of the actions specified in
paragraph (h) of this AD, no person may
install an auxiliary fuel tank on that airplane.
(k) Terminating Action for AD 2016–11–03
for V/Ns WD049–WD053 Inclusive
Accomplishment of the actions required by
paragraph (g) or (h) of this AD terminates the
requirements of paragraphs (g), (h), and (i) of
AD 2016–11–03 for that airplane, V/Ns
WD049 through WD053 inclusive only.
(l) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Seattle ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards
District Office, as appropriate. If sending
information directly to the manager of the
certification office, send it to the attention of
the person identified in paragraph (m) of this
AD. Information may be emailed to [email protected].
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.

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(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
Except as provided by paragraph (h) of this
AD: Within 36 months after the effective date
of this AD, revise the applicable section of
the documents specified in paragraphs (g)(1)
and (g)(2) of this AD to include the
information specified in figure 1 to the
introductory text of paragraph (g) of this AD.

(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by the Boeing
Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Seattle ACO
Branch, FAA, to make those findings. To be
approved, the repair method, modification
deviation, or alteration deviation must meet
the certification basis of the airplane, and the
approval must specifically refer to this AD.
(4) For service information that contains
steps that are labeled as Required for
Compliance (RC), the provisions of
paragraphs (l)(4)(i) and (l)(4)(ii) of this AD
apply.
(i) The steps labeled as RC, including
substeps under an RC step and any figures
identified in an RC step, must be done to
comply with the AD. If a step or substep is
labeled ‘‘RC Exempt,’’ then the RC
requirement is removed from that step or
substep. An AMOC is required for any
deviations to RC steps, including substeps
and identified figures.
(ii) Steps not labeled as RC may be
deviated from using accepted methods in
accordance with the operator’s maintenance
or inspection program without obtaining
approval of an AMOC, provided the RC steps,
including substeps and identified figures, can
still be done as specified, and the airplane
can be put back in an airworthy condition.
(m) Related Information
For more information about this AD,
contact Kevin Nguyen, Aerospace Engineer,
Propulsion Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines,
WA 98198; phone and fax: 206–231–3555;
email: [email protected].

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§ 39.13

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
(n) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Boeing Special Attention Service
Bulletin 777–28–0078, Revision 3, dated
December 19, 2017.
(ii) Reserved.
(3) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd.,
MC 110–SK57, Seal Beach, CA 90740–5600;
telephone 562–797–1717; internet https://
www.myboeingfleet.com.
(4) You may view this service information
at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: http://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Des Moines, Washington, on June
29, 2018.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft
Certification Service.
[FR Doc. 2018–14702 Filed 7–11–18; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2017–0757; Product
Identifier 2017–SW–022–AD; Amendment
39–19327; AD 2018–14–07]
RIN 2120–AA64

Airworthiness Directives; Bell
Helicopter Textron Canada Limited
Helicopters
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
We are adopting a new
airworthiness directive (AD) for certain
serial numbered Bell Helicopter Textron
Canada Limited (BHTC) Model 429
helicopters. This AD requires marking a
serial number on life-limited forward
spars and actuator fitting assemblies.
The actions of this AD are intended to
prevent an unsafe condition on these
products.
DATES: This AD is effective August 16,
2018.

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Examining the AD Docket
You may examine the AD docket on
the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2017–
0757; or in person at Docket Operations
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The AD docket contains this AD, the
Transport Canada Civil Aviation
(Transport Canada) AD, any
incorporated-by-reference service
information, the economic evaluation,
any comments received, and other
information. The street address for
Docket Operations (phone: 800–647–
5527) is U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE,
Washington, DC 20590.
FOR FURTHER INFORMATION CONTACT:
Helene Gandy, Aviation Safety
Engineer, Regulations & Policy Section,
Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone (817) 222–5413; email
[email protected].
SUPPLEMENTARY INFORMATION:
Discussion

AGENCY:

SUMMARY:

The Director of the Federal Register
approved the incorporation by reference
of a certain document listed in this AD
as of August 16, 2018.
ADDRESSES: For service information
identified in this final rule, contact Bell
Helicopter Textron Canada Limited,
12,800 Rue de l’Avenir, Mirabel, Quebec
J7J1R4; telephone (450) 437–2862 or
(800) 363–8023; fax (450) 433–0272; or
at http://www.bellcustomer.com/files/.
You may review the referenced service
information at the FAA, Office of the
Regional Counsel, Southwest Region,
10101 Hillwood Pkwy, Room 6N–321,
Fort Worth, TX 76177. It is also
available on the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2017–
0757.

On January 26, 2018, at 83 FR 3628,
the Federal Register published our
notice of proposed rulemaking (NPRM),
which proposed to amend 14 CFR part
39 by adding an AD that would apply
to Bell Model 429 helicopters, serial
number (S/N) 57150, 57168, 57176,
57210 through 57216, 57265, 57266,
57267, and 57287, with a forward spar
part number (P/N) 429–031–213–103 or
429–031–213–104 or actuator fitting
assembly P/N 429–031–222–101 or 429–
031–222–102 installed.
The NPRM proposed to require
marking a serial number on life-limited
forward spars and actuator fitting

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32201

assemblies. The proposed requirements
were intended to prevent the forward
spar or actuator fitting assembly from
remaining in service after reaching its
life limit. This condition could result in
failure of a forward spar or actuator
fitting assembly and subsequent
collapse of the landing gear.
The NPRM was prompted by AD No.
CF–2017–02, dated January 16, 2017,
issued by Transport Canada, which is
the aviation authority for Canada, to
correct an unsafe condition for Bell
Model 429 helicopters, S/N 57150,
57168, 57176, 57210, 57211 through
57216, 57265, 57266, 57267, and 57287.
Transport Canada advises that forward
spars P/N 429–031–213–103 and 429–
031–213–104 and actuator fitting
assembly P/N 429–031–222–101 and
429–031–222–102 have life limits of
30,000 and 19,000 Retirement Index
Numbers, respectively. However,
Transport Canada states these parts are
not serialized, and therefore their
accumulated usage is difficult to track,
which creates a risk that these parts
could remain in service beyond their
life limits. This condition could result
in failure of the part.
Comments
We gave the public the opportunity to
participate in developing this AD, but
we received no comments on the NPRM.
FAA’s Determination
These helicopters have been approved
by the aviation authority of Canada and
are approved for operation in the United
States. Pursuant to our bilateral
agreement with Canada, Transport
Canada, its technical representative, has
notified us of the unsafe condition
described in the Transport Canada AD.
We are issuing this AD because we
evaluated all information provided by
Transport Canada and determined the
unsafe condition exists and is likely to
exist or develop on other helicopters of
these same type designs and that air
safety and the public interest require
adopting the AD requirements as
proposed.
Differences Between This AD and the
Transport Canada AD
The Transport Canada AD requires
compliance within 12 months from its
effective date, unless already
accomplished. This AD requires
compliance within 800 hours time-inservice.
Related Service Information Under 1
CFR Part 51
We reviewed Bell Helicopter Alert
Service Bulletin 429–16–34, dated
November 10, 2016, which specifies

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

procedures for permanently marking
each forward spar and actuator fitting
assembly with the serial number of the
helicopter.
This service information is reasonably
available because the interested parties
have access to it through their normal
course of business or by the means
identified in the ADDRESSES section.
Other Related Service Information
We also reviewed Bell Helicopter
Model 429 Maintenance Manual BHT–
429–MM–1, Chapter 4, Airworthiness
Limitations Schedule, Revision 26,
dated September 9, 2016, which
specifies airworthiness life limits and
inspection intervals for parts installed
on Model 429 helicopters.
Costs of Compliance

List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.

We estimate that this AD affects 6
helicopters of U.S. Registry and that
labor costs average $85 per work-hour.
We estimate that marking the forward
spars and actuator fitting assemblies
requires 1 work-hour, and no parts are
needed. Based on these estimates, we
expect a total cost of $85 per helicopter
and $510 for the U.S. fleet.

Adoption of the Amendment

Authority for This Rulemaking

■

Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII:
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
helicopters identified in this rulemaking
action.
Regulatory Findings

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(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
(3) Will not affect intrastate aviation
in Alaska to the extent that it justifies
making a regulatory distinction; and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared an economic evaluation
of the estimated costs to comply with
this AD and placed it in the AD docket.

This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect on the States, on
the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:

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Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13

[Amended]

2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):

■

2018–14–07 Bell Helicopter Textron
Canada Limited: Amendment 39–19327;
Docket No. FAA–2017–0757; Product
Identifier 2017–SW–022–AD.
(a) Applicability
This AD applies to Bell Helicopter Textron
Canada Limited Model 429 helicopters, serial
number (S/N) 57150, 57168, 57176, 57210
through 57216, 57265, 57266, 57267, and
57287, with a forward spar part number
(P/N) 429–031–213–103 or 429–031–213–104
or actuator fitting assembly P/N 429–031–
222–101 or 429–031–222–102 installed,
certificated in any category.
(b) Unsafe Condition
This AD defines the unsafe condition as a
forward spar or actuator fitting assembly
remaining in service after reaching its life
limit. This condition could result in failure
of a forward spar or actuator fitting assembly
and subsequent collapse of the landing gear.
(c) Effective Date
This AD becomes effective August 16,
2018.
(d) Compliance
You are responsible for performing each
action required by this AD within the
specified compliance time unless it has
already been accomplished prior to that time.

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Fmt 4700

Sfmt 4700

(e) Required Actions
(1) Within 800 hours time-in-service, clean
and identify each forward spar and actuator
fitting assembly with the helicopter serial
number in accordance with the
Accomplishment Instructions, paragraphs 3
through 5 and with reference to Figure 1 of
Bell Helicopter Alert Service Bulletin 429–
16–34, dated November 10, 2016.
(2) After the effective date of this AD, do
not install a forward spar P/N 429–031–213–
103 or 429–031–213–104 or actuator fitting
assembly P/N 429–031–222–101 or 429–031–
222–102 on any helicopter unless it has been
marked with a serial number in accordance
with paragraph (e)(1) of this AD.
(f) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Safety Management
Section, FAA, may approve AMOCs for this
AD. Send your proposal to: Helene Gandy,
Aviation Safety Engineer, Regulations &
Policy Section, Rotorcraft Standards Branch,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone (817) 222–5413; email [email protected].
(2) For operations conducted under a 14
CFR part 119 operating certificate or under
14 CFR part 91, subpart K, we suggest that
you notify your principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office or
certificate holding district office before
operating any aircraft complying with this
AD through an AMOC.
(g) Additional Information
(1) Bell Helicopter Model 429 Maintenance
Manual BHT–429–MM–1, Chapter 4,
Airworthiness Limitations Schedule,
Revision 26, dated September 9, 2016, which
is not incorporated by reference, contains
additional information about the subject of
this AD. For service information identified in
this AD, contact Bell Helicopter Textron
Canada Limited, 12,800 Rue de l’Avenir,
Mirabel, Quebec J7J1R4; telephone (450)
437–2862 or (800) 363–8023; fax (450) 433–
0272; or at http://www.bellcustomer.com/
files/. You may review the referenced service
information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101
Hillwood Pkwy., Room 6N–321, Fort Worth,
TX 76177.
(2) The subject of this AD is addressed in
Transport Canada AD No. CF–2017–02, dated
January 16, 2017. You may view the
Transport Canada AD on the internet at
http://www.regulations.gov in Docket No.
FAA–2017–0757.
(h) Subject
Joint Aircraft Service Component (JASC)
Code: 1100, Placards and Markings.
(i) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference of
the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Bell Helicopter Alert Service Bulletin
429–16–34, dated November 10, 2016.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
(ii) Reserved.
(3) For Bell Helicopter Textron Canada
Limited service information identified in this
AD, contact Bell Helicopter Textron Canada
Limited, 12,800 Rue de l’Avenir, Mirabel,
Quebec J7J1R4; telephone (450) 437–2862 or
(800) 363–8023; fax (450) 433–0272; or at
http://www.bellcustomer.com/files/.
(4) You may view this service information
at FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy.,
Room 6N–321, Fort Worth, TX 76177. For
information on the availability of this
material at the FAA, call (817) 222–5110.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
(202) 741–6030, or go to: http://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Fort Worth, Texas, on June 1,
2018.
James A. Grigg,
Acting Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2018–14701 Filed 7–11–18; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Examining the AD Docket
You may examine the AD docket on
the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2017–
1118; or in person at Docket Operations
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The AD docket contains this final rule,
the regulatory evaluation, any
comments received, and other
information. The address for Docket
Operations (phone: 800–647–5527) is
Docket Operations, U.S. Department of
Transportation, Docket Operations,
M–30, West Building Ground Floor,
Room W12–140, 1200 New Jersey
Avenue SE, Washington, DC 20590.

[Docket No. FAA–2017–1118; Product
Identifier 2017–NE–40–AD; Amendment 39–
19313; AD 2018–13–01]

John
Tallarovic, Aerospace Engineer, Chicago
ACO Branch, FAA, 2300 E. Devon Ave.,
Des Plaines, IL 60018; phone: 847–294–
8180; fax: 847–294–7834; email:
[email protected].

RIN 2120–AA64

SUPPLEMENTARY INFORMATION:

Airworthiness Directives; Rolls-Royce
Corporation Turboshaft Engines

Discussion

FOR FURTHER INFORMATION CONTACT:

14 CFR Part 39

Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:

We are adopting a new
airworthiness directive (AD) for certain
Rolls-Royce Corporation (RRC) model
250–C turboshaft engines. This AD was
prompted by several reports of engine
power loss, one of which resulted in a
fatal helicopter accident. This AD
requires removal of the power turbine
governor (PTG) bearing assembly, part
number (P/N) 2544198, and its
replacement with a bearing assembly
eligible for installation. We are issuing
this AD to address the unsafe condition
on these products.
DATES: This AD is effective August 16,
2018.
ADDRESSES: For service information
identified in this final rule, contact
Rolls-Royce Corporation, 450 South
Meridian Street, Mail Code NB–02–05,
Indianapolis, IN 46225; phone: 317–
230–3774; email: indy.pubs.services@
SUMMARY:

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rolls-royce.com; internet: www.rollsroyce.com. You may view this service
information at the FAA, Engine and
Propeller Standards Branch, 1200
District Avenue, Burlington, MA. For
information on the availability of this
material at the FAA, call 781–238–7759.
It is also available on the internet at
http://www.regulations.gov by searching
for and locating Docket No. FAA–2018–
1118.

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We issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would
apply to certain Rolls-Royce
Corporation (RRC) model 250–C
turboshaft engines. The NPRM
published in the Federal Register on
February 1, 2018 (83 FR 4609). The
NPRM was prompted by several reports
of loss of engine power on certain RRC
model 250–C turboshaft engines
installed on single-engine helicopters.
One of these instances of power loss
resulted in a fatal helicopter accident on
May 4, 2016. The NPRM proposed to
require removal of the affected PTG
bearing assembly and replace it with a
bearing assembly with a new design. We
are issuing this AD to address the unsafe
condition on these products.
Comments
We gave the public the opportunity to
participate in developing this final rule.
The following presents the comments
received on the NPRM and the FAA’s
response to each comment.

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32203

Request To Specify the New Bearing
Assembly
The NTSB and Honeywell Aerospace
requested that the AD prohibit the
installation of bearing assembly, P/N
2544198, and specify the installation of
the new bearing assembly, P/N 2526146.
The NTSB expressed concern that
differences between the proposed AD
and the actions described in the
Honeywell SB and Rolls-Royce CEBs
could lead to the reinstallation of a
dual-spool bearing into an affected PTG.
We partially agree. We agree with the
request to prohibit the installation of
another bearing assembly, P/N 2544198,
because our intent is to remove them
from service. We disagree with the
request to specify the installation of the
new bearing assembly, P/N 2526146,
because of the possibility of a new
bearing P/N being introduced or the
specified P/N being discontinued in the
future. We added an installation
prohibition paragraph to this AD to
prohibit the installation of bearing
assembly, P/N 2544198.
Request To Re-Identify the PTG After
Changing the Bearing Assembly
The NTSB and Honeywell Aerospace
requested that the AD require reidentifying the PTG P/N after changing
the bearing assembly in accordance with
the related service information.
Honeywell Aerospace reasoned that
maintenance personnel and operators
could easily determine if the service
bulletin has been accomplished. This
increases the efficiency of operations
and reduces the potential for
misunderstandings about whether the
bearing assembly has been replaced.
We disagree. While re-identifying the
PTG after changing the bearing assembly
is helpful for maintenance personnel,
we are not requiring this action within
this AD. During the replacement of the
bearing assembly, P/N 2544198, the
related service information instructs
personnel to re-identify the PTG. We
did not change this AD.
Request To Reduce the Compliance
Time
Honeywell Aerospace requested that
we reduce the compliance time to 50
hours or within 90 days for PTGs that
have greater than 750 hours. The
commenter reasoned that the original
compliance schedule was established 10
years ago based on field experience at
that time. The fatal accident referenced
in the NPRM occurred on a PTG with
1,048.7 hours since new.
We disagree. The compliance time for
removing the bearing assembly, P/N
2544198, in this AD is based on Rolls-

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

Royce Corporation Commercial Engine
Bulletin (CEB) 1402, Revision 2, dated
February 4, 2009. The failure history
shows that the number of bearing
assembly failures fell sharply following
the initial publication of RRC CEB 1402
in 2008. The replacement strategy has
proven successful. As a result, we
believe that the majority of the fleet has
replaced the bearing assembly, P/N
2544198, and only a few remain in
service. Besides the fatal accident, there
have not been any other bearing failures
noted between 2012 and 2018. We,
therefore, find it unnecessary to reduce
the compliance time as noted by the
commenter. We did not change this AD.
Request To Increase the Number of
Affected Engines
Honeywell Aerospace noted that only
1,200 engines installed on airplanes of
U.S. registry may be affected, compared
with the 2,928 mentioned in the NPRM,
based on a review of modification
records provided to Honeywell by repair
stations.
We disagree. We are estimating the
total number of engines affected by this
AD based on the data available to us.
We did not change this AD.
Request To Clarify the Affected Engines
An individual commenter requested
that we clarify that only those engine
models that have bearing assembly, P/N
2544198, installed are affected.
We agree. We have updated paragraph
(c) of this AD to clarify that engines
with bearing assembly, P/N 2544198,
installed are affected.
Request To Identify the Model, Brand,
and P/N of the PTG
Aircraft Maintenance Netherlands
requested that this AD identify the
model, brand, and P/N of the affected
PTG that must be replaced. The
commenter reasoned that various PTG
models can be installed on the affected
engines.
We disagree. This AD provides the
overall engine model applicability. The

related service information provides
specific information regarding the PTGs,
including the manufacturer, model, and
P/Ns. We did not change this AD.
Question on Not Issuing the AD Earlier
An individual commenter asked why
an AD was not issued in 2009 when
RRC issued a statement regarding the
failure of the bearing assembly.
The FAA uses a risk-based approach
to make continued operational safety
decisions. When RRC issued CEB 1402,
Revision 2, in 2009, our evaluation of
the fleet risk did not support an AD. We
update our fleet risk evaluation
periodically as new information
becomes available and have now
determined that an AD is justified. We
did not change this AD.
Question if Replacement Part
Verification Testing Was Completed
An individual commenter asked if
tests or procedures were completed to
verify that the replacement bearing
assembly resolves the failure of bearing
assembly, P/N 2544198, due to the lack
of lubrication.
We note that replacement parts, such
as this replacement bearing assembly,
undergo design analysis and testing
before being approved for use by the
FAA. No change is requested. We did
not change this AD.
Request for Clarification on the Number
of Affected Engines
An individual commenter noted that
the NPRM estimates that 2,928 model
250–C turboshaft engines are affected,
however, the RRC website estimates that
there are an estimated 16,000 model
250–C engines currently in service.
This AD applies to all RRC model
250–C turboshaft engines that could
have the bearing assembly, P/N
2544198, installed. Many of those
engines have already had the bearing
assembly, P/N 2544198, replaced when
new parts became available. Based on
the available data, we estimate that
2,928 engines may still have the bearing

assembly, P/N 2544198, installed. We
did not change this AD.
Question on the Availability of a
Replacement Bearing Assembly
An individual commenter asked if
RRC still needs to design a new bearing
assembly or if a replacement bearing
assembly is already available.
A replacement bearing assembly, P/N
2526146, is available for installation.
We did not change this AD.
Support for the AD
An individual commenter expressed
support for the NPRM as written.
Conclusion
We reviewed the relevant data,
considered the comments received, and
determined that air safety and the
public interest require adopting this
final rule with the changes described
previously. We have determined that
these minor changes:
• Are consistent with the intent that
was proposed in the NPRM for
addressing the unsafe condition; and
• Do not add any additional burden
upon the public than was already
proposed in the NPRM.
We also determined that these
changes will not increase the economic
burden on any operator or increase the
scope of this final rule.
Related Service Information
We reviewed Rolls-Royce Corporation
Commercial Engine Bulletin (CEB) 1402,
Revision 2, dated February 4, 2009. The
CEB provides guidance on replacing the
PTG bearing assembly, P/N 2544198,
with a bearing assembly eligible for
installation.
Costs of Compliance
We estimate that this AD affects 2,928
engines installed on airplanes of U.S.
registry.
We estimate the following costs to
comply with this AD:

ESTIMATED COSTS
Action

Labor cost

Remove and replace PTG bearing assembly

8 work-hours × $85 per hour = $680 .............

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Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII:
Aviation Programs, describes in more

VerDate Sep<11>2014

16:03 Jul 11, 2018

Jkt 244001

Parts cost

detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with

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$1,700

Cost per
product
$2,380

Cost on U.S.
operators
$6,968,640

promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

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Regulatory Findings

(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
■

(2) After such removal, replace the affected
PTG bearing assembly with a part eligible for
installation before further flight.

(i) Alternative Methods of Compliance
(AMOCs)

(h) Installation Prohibition
After the effective date of this AD, do not
install PTG bearing assembly, P/N 2544198,
on any engine.

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16:03 Jul 11, 2018

Jkt 244001

1. The authority citation for part 39
continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
[Amended]

2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):

■

2018–13–01 Roll-Royce Corporation (Type
Certificate previously held by Allison
Engine Company): Amendment 39–
19313; Docket No. FAA–2017–1118;
Product Identifier 2017–NE–40–AD.
(a) Effective Date
This AD is effective August 16, 2018.
(b) Affected ADs
None.

(1) The Manager, Chicago ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards
District Office, as appropriate. If sending
information directly to the manager of the
Chicago ACO Branch, send it to the attention

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This AD applies to Rolls-Royce
Corporation (RRC) model 250–C10D, 250–
C18, 250–C18A, 250–C18B, 250–C18C, 250–
C19, 250–C20, 250–C20B, 250–C20C, 250–
C20F, 250–C20J, 250–C20R, 250–C20R/1,
250–C20R/2, 250–C20R/4, 250–C20S, 250–
C20W, 250–C28, 250–C28B, 250–C28C, 250–
C30, 250–C30G, 250–C30G/2, 250–C30M,
250–C30P, 250–C30S, and 250–C30U
turboshaft engines with power turbine
governor (PTG) bearing assembly, part
number (P/N) 2544198, installed.
(d) Subject
Joint Aircraft System Component (JASC)
Code 7323, Turbine Governor.
(e) Unsafe Condition

This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect on the States, on
the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Is not a ‘‘significant rule’’ under
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation
in Alaska, and

§ 39.13

(c) Applicability

This AD was prompted by several reports
of loss of power, one of which resulted in a
fatal helicopter accident. We are issuing this
AD to prevent failure of the PTG bearing
assembly. The unsafe condition, if not
addressed, could result in failure of the PTG,
failure of the engine, in-flight shutdown, and
forced autorotation landing or accident.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
(1) Remove the bearing assembly, P/N
2544198, from the PTG in accordance with
the compliance times in Figure 1 to
paragraph (g) of this AD, or within 90 days
after the effective date of this AD, whichever
occurs later.

of the person identified in paragraph (j) of
this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(j) Related Information
For more information about this AD,
contact John Tallarovic, Aerospace Engineer,

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ER12JY18.017

that is likely to exist or develop on
products identified in this rulemaking
action.
This AD is issued in accordance with
authority delegated by the Executive
Director, Aircraft Certification Service,
as authorized by FAA Order 8000.51C.
In accordance with that order, issuance
of ADs is normally a function of the
Compliance and Airworthiness
Division, but during this transition
period, the Executive Director has
delegated the authority to issue ADs
applicable to engines, propellers, and
associated appliances to the Manager,
Engine and Propeller Standards Branch,
Policy and Innovation Division.

32205

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

Chicago ACO Branch, FAA, 2300 E Devon
Ave., Des Plaines, IL 60018; phone: 847–294–
8180; fax: 847–294–7834; email:
[email protected].
(k) Material Incorporated by Reference
None.
Issued in Burlington, Massachusetts, on
July 6, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller
Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018–14801 Filed 7–11–18; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2018–0662]
RIN 1625–AA08

Special Local Regulation; Marine City
Water Ski Show, St. Clair River, Marine
City, MI
Coast Guard, DHS.
Temporary final rule.

AGENCY:
ACTION:

The Coast Guard is
establishing a special local regulation
for certain navigable waters of the St.
Clair River, Marine City, MI. This action
is necessary and is intended to ensure
safety of life on navigable waters
immediately prior to, during, and
immediately after the Marine City Water
Ski Show.
DATES: This temporary final rule is
effective from 1 p.m. though 5 p.m. on
August 4, 2018.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to http://
www.regulations.gov, type USCG–2018–
0662 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
rule, call or email Tracy Girard,
Prevention Department, Sector Detroit,
Coast Guard; telephone (313) 568–9564,
or email [email protected].
SUPPLEMENTARY INFORMATION:
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SUMMARY:

I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
§ Section
COTP Captain of the Port

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16:03 Jul 11, 2018

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U.S.C.

United States Code

II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because doing
so would be impracticable. The Coast
Guard just recently received the final
details of this water ski show, which
does not provide sufficient time to
publish an NPRM prior to the event.
Thus, delaying the effective date of this
rule to wait for a comment period to run
would be contrary to public interest
because it would inhibit the Coast
Guard’s ability to protect participants,
mariners and vessels from the hazards
associated with this event. It is
impracticable to publish an NPRM
because we lack sufficient time to
provide a reasonable comment period
and then consider those comments
before issuing this rule.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Delaying the effective date of
this rule would inhibit the Coast
Guard’s ability to protect participants,
mariners and vessels from the hazards
associated with this event.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 1233. The
Captain of the Port Detroit (COTP) has
determined that the likely combination
of recreation vessels, commercial
vessels, and an unknown number of
spectators in close proximity to a water
ski show along the water pose extra and
unusual hazards to public safety and
property. Therefore, the COTP is
establishing a special local regulation
around the event location to help
minimize risks to safety of life and
property during this event.
IV. Discussion of the Rule
This rule establishes a special local
regulation from 1 p.m. though 5 p.m. on
August 4, 2018. The special local
regulation will encompass all U.S.
navigable waters of the St. Clair River,

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Marine City, MI, bound by: 200 feet
seaward of latitude position 42°43.382′
N and 200 feet seaward of latitude
position 42°42.983′ N (NAD 83). The
special local regulation will be enforced
from 1 p.m. to 1:45 p.m. and from 4 p.m.
to 4:45 p.m. on August 4, 2018. No
vessel or person will be permitted to
enter the special local regulation
without obtaining permission from the
COTP or his designated representative.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
Executive orders, and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13771 directs agencies
to control regulatory costs through a
budgeting process. This rule has not
been designated a ‘‘significant
regulatory action,’’ under Executive
Order 12866. Accordingly, this rule has
not been reviewed by the Office of
Management and Budget (OMB), and
pursuant to OMB guidance it is exempt
from the requirements of Executive
Order 13771.
This regulatory action determination
is based on the size, location, duration,
and time-of-year of the special local
regulation. Vessel traffic will be able to
safely transit around this special local
regulation zone which will impact a
small designated area of the St. Clair
River from 1 p.m. until 5 p.m. on
August 4, 2018. Moreover, the Coast
Guard will issue Broadcast Notice to
Mariners via VHF–FM marine channel
16 about the special local regulation and
the rule allows vessels to seek
permission to enter the area.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires Federal agencies to consider
the potential impact of regulations on
small entities during rulemaking. The
term ‘‘small entities’’ comprises small
businesses, not-for-profit organizations
that are independently owned and
operated and are not dominant in their
fields, and governmental jurisdictions
with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
significant economic impact on a
substantial number of small entities.
While some owners or operators of
vessels intending to transit the special
local regulation may be small entities,
for the reasons stated in section V.A
above, this rule will not have a
significant economic impact on any
vessel owner or operator.
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this rule. If the rule
would affect your small business,
organization, or governmental
jurisdiction and you have questions
concerning its provisions or options for
compliance, please contact the person
listed in the FOR FURTHER INFORMATION
CONTACT section.
Small businesses may send comments
on the actions of Federal employees
who enforce, or otherwise determine
compliance with, Federal regulations to
the Small Business and Agriculture
Regulatory Enforcement Ombudsman
and the Regional Small Business
Regulatory Fairness Boards. The
Ombudsman evaluates these actions
annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call 1–
888–REG–FAIR (1–888–734–3247). The
Coast Guard will not retaliate against
small entities that question or complain
about this rule or any policy or action
of the Coast Guard.
C. Collection of Information
This rule will not call for a new
collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).

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D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, this rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,

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16:03 Jul 11, 2018

Jkt 244001

because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section
above.
E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Directive 023–01 and Commandant
Instruction M16475.1D, which guide the
Coast Guard in complying with the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves a
special local regulation lasting less than
four hours that will prohibit entry into
a designated area. It is categorically
excluded from further review under
paragraph L[61] of Appendix A, Table 1
of DHS Instruction Manual 023–01–
001–01, Rev. 01. A Record of
Environmental Consideration
supporting this determination is
available in the docket where indicated
under ADDRESSES.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.

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32207

List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water),
Reporting and recordkeeping
requirements, Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 100 as follows:
PART 100—SAFETY OF LIFE ON
NAVIGABLE WATERS
1. The authority citation for part 100
continues to read as follows:

■

Authority: 33 U.S.C. 1233; 33 CFR 1.05–1.

2. Add § 100.T09–0662 to read as
follows:

■

§ 100.T09–0662 Special Local Regulation;
Marine City Water Ski Show, St. Clair River,
Marine City, MI.

(a) Regulated areas. The following
regulated area is established to include
all U.S. navigable waters of the St. Clair
River, Marine City, MI, bound by: 200
feet seaward of latitude position
42°43.382′ N and 200 feet seaward of
latitude position 42°42.983′ N (NAD 83).
(b) Enforcement date. The regulated
area described in paragraph (a) of this
section will be in effect from 1 p.m.
though 5 p.m. on August 4, 2018. The
special local regulation will be enforced
from 1 p.m. to 1:45 p.m. and from 4 p.m.
to 4:45 p.m. on August 4, 2018.
(c) Special local regulations. (1)
Vessels transiting through the regulated
area are to maintain the minimum
speeds for safe navigation.
(2) Vessel operators desiring to
operate in the regulated area must
contact the Coast Guard Patrol
Commander to obtain permission to do
so. The Captain of the Port Detroit
(COTP) or his on-scene representative
may be contacted via VHF Channel 16
or at 313–568–9560. Vessel operators
given permission to operate within the
regulated area must comply with all
directions given to them by the COTP or
his on-scene representative.
(3) The ‘‘on-scene representative’’ of
the COTP Detroit is any Coast Guard
commissioned, warrant or petty officer
or a Federal, State, or local law
enforcement officer designated by or
assisting the Captain of the Port Detroit
to act on his behalf.
Dated: July 5, 2018.
Kevin D. Floyd,
Commander, U.S. Coast Guard, Acting
Captain of the Port Detroit.
[FR Doc. 2018–14919 Filed 7–11–18; 8:45 am]
BILLING CODE 9110–04–P

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
RIN 1625–AA00
[Docket Number USCG–2018–0578]

Safety Zone; Alaska Marine Highway
System Port Valdez Ferry Terminal,
Port Valdez; Valdez, AK
Coast Guard, DHS.
Final rule.

AGENCY:
ACTION:

The Coast Guard is
republishing its 2014 rule that
established a permanent safety zone on
the navigable waters of Port Valdez
within a 200-yard radius of the Alaska
Marine Highway System (AMHS) Port
Valdez Ferry Terminal. The safety zone
restricts all vessels except AMHS
vessels from entering within 200-yards
of the AMHS Port Valdez Ferry
Terminal whenever an AMHS ferry is
underway within 200 yards of the
terminal and there is a declared
Commercial Salmon Fishery Opener.
This safety zone is necessary to provide
for the safety of life, property and the
environment during periods of vessel
traffic congestion during a declared
Commercial Salmon Fishery Opener.
DATES: This rule is effective July 12,
2018.
SUMMARY:

To view documents
mentioned in this preamble as being
available in the docket, go to http://
www.regulations.gov, type USCG–2018–
0578 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this
rulemaking, call or email LTJG, Carlos
M. Quintero, MSU Valdez, U.S. Coast
Guard; telephone 907–835–7209, email
[email protected].
SUPPLEMENTARY INFORMATION:
ADDRESSES:

I. Table of Abbreviations

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AMHS Alaska Marine Highway System
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
§ Section
U.S.C. United States Code

II. Background Information and
Regulatory History
The Coast Guard is issuing this rule
without prior notice and opportunity to
comment pursuant to authority under
section 4(a) of the Administrative
Procedure Act (5 U.S.C. 553(b)). This

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Jkt 244001

provision authorizes an agency to issue
a rule without prior notice and
opportunity to comment when the
agency for good cause finds that those
procedures are impracticable,
unnecessary, or contrary to the public
interest. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing a notice of proposed
rulemaking with respect to this rule
because it is unnecessary to do so. This
is a republication, without change, of a
previously issued rule.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. The Coast Guard finds that
good cause exists because it is
unnecessary to do so. This is a
republication, without change of a
previously issued rule.
On February 4, 2014, the Coast Guard
published a rule that established a
permanent safety zone on the navigable
waters of Port Valdez within a 200-yard
radius of the Alaska Marine Highway
System (AMHS) Port Valdez Ferry
Terminal (79 FR 6468). The safety zone
restricts all vessels except AMHS
vessels from entering within 200-yards
of the AMHS Port Valdez Ferry
Terminal whenever an AMHS ferry is
underway within 200 yards of the
terminal and there is a declared
Commercial Salmon Fishery Opener.
That original rule, however, contained a
clerical error that prevented the Office
of the Federal Register from codifying
the rule into the Code of Federal
Regulations. The 2014 final rule
inadvertently used a pre-existing
number assigned to a different
regulation. Because the rule could not
be codified at the stated location, the
Office of the Federal Register, instead,
added an editorial note to 33 CFR
165.1712 noting the publication of the
2014 AMHS Port Valdez Ferry Terminal
rule.
The purpose of this rule is to
republish that 2014 rule, without
change, to a different section number so
that it can be codified into the Code of
Federal Regulations.
The authority to re-issue this safety
zone is 33 U.S.C. 1231. This safety zone
continues to be necessary to provide for
the safety of life, property and the
environment during periods of vessel
traffic congestion during a declared
Commercial Salmon Fishery Opener.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
Below we summarize our analyses

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Fmt 4700

Sfmt 4700

based on a number of these statutes and
Executive orders.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13771 directs agencies
to control regulatory costs through a
budgeting process. This rule has not
been designated a ‘‘significant
regulatory action,’’ under Executive
Order 12866. Accordingly, this rule has
not been reviewed by the Office of
Management and Budget (OMB), and
pursuant to OMB guidance it is exempt
from the requirements of Executive
Order 13771. This regulatory action
determination is based on the fact that
this is a republication, without change,
of a previously published rule.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires federal agencies to consider the
potential impact of regulations on small
entities during rulemaking. The term
‘‘small entities’’ comprises small
businesses, not-for-profit organizations
that are independently owned and
operated and are not dominant in their
fields, and governmental jurisdictions
with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a
significant economic impact on a
substantial number of small entities.
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this rule. If the rule
would affect your small business,
organization, or governmental
jurisdiction and you have questions
concerning its provisions or options for
compliance, please contact the person
listed in the FOR FURTHER INFORMATION
CONTACT section. Small businesses may
send comments on the actions of federal
employees who enforce, or otherwise
determine compliance with, federal
regulations to the Small Business and
Agriculture Regulatory Enforcement
Ombudsman and the Regional Small
Business Regulatory Fairness Boards.
The Ombudsman evaluates these
actions annually and rates each agency’s
responsiveness to small business. If you
wish to comment on actions by
employees of the Coast Guard, call 1–
888–REG–FAIR (1–888–734–3247). The
Coast Guard will not retaliate against
small entities that question or complain

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12JYR1

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
about this rule or any policy or action
of the Coast Guard.
C. Collection of Information
This rule will not call for a new
collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
D. Federalism and Indian Tribal
Governments
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on the States, on the relationship
between the national government and
the states, or on the distribution of
power and responsibilities among the
various levels of government. We have
analyzed this rule under that Order and
have determined that it is consistent
with the fundamental federalism
principles and preemption requirements
described in Executive Order 13132.
Also, this rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have a substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes. If you
believe this rule has implications for
federalism or Indian tribes, please
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section
above.

amozie on DSK3GDR082PROD with RULES

E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
state, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Directive 023–01 and Commandant
Instruction M16475.1D, which guide the
Coast Guard in complying with the
National Environmental Policy Act of
1969 (42 U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves the

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16:03 Jul 11, 2018

Jkt 244001

republication, without change, of a
previously published rule. It is
categorically excluded from further
review under paragraph L60a of
Appendix A, Table 1 of DHS Instruction
Manual 023–01–001–01, Rev. 01. A
Record of Environmental Consideration
supporting this determination is
available in the docket where indicated
under ADDRESSES.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:

■

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
■

2. Add § 165.1714 to read as follows:

§ 165.1712a Safety Zone; Alaska Marine
Highway System Port Valdez Ferry
Terminal, Port Valdez; Valdez, AK.

(a) Location. The following area is a
safety zone: All navigable waters of Port
Valdez extending 200 yards in all
directions from the edges of the Alaska
Marine Highway System Terminal dock
located in Port Valdez at 61°07′26″ N
and 146°21′50″ W.
(b) Enforcement period. The rule will
be enforced whenever there is an Alaska
Marine Highway System Ferry vessel
transiting within the area described in
paragraph (a) of this section and there
is a Commercial Salmon Fishery Opener
that includes the navigable waters
within the safety zone. Each
enforcement period will be announced
by a broadcast notice to mariners when
the Commercial Salmon Fishery Opener
is announced.
(c) Definitions. The following
definitions apply to this section:
(1) The term ‘‘designated
representative’’ means any Coast Guard
commissioned, warrant or petty officer
of the U.S. Coast Guard who has been
designated by the Captain of the Port,
Prince William Sound, to act on his or
her behalf.
(2) The term ‘‘official patrol vessel’’
may consist of any Coast Guard, Coast
Guard Auxiliary, state, or local law
enforcement vessels assigned or
approved by the COTP, Prince William
Sound.
(3) The term ‘‘AMHS vessel’’ means
any vessel owned or operated by the

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32209

Alaska Marine Highway System,
including, but not limited to: M/V
AURORA, M/V CHENEGA, M/V
COLUMBIA, M/V FAIRWEATHER, M/V
KENNICOTT, M/V LECONTE, M/V
LITUYA, M/V MALASPINA, M/V
MATANUSKA, M/V TAKU and M/V
TUSTUMENA.
(d) Regulations. (1) The general
regulations contained in 33 CFR 165.23,
as well as the requirements in
paragraphs (d)(2) through (5) of this
section, apply.
(2) No vessels, except for AMHS
ferries and vessels owned or operated by
AMHS will be allowed to transit the
safety zone without the permission of
the COTP Prince William Sound or the
designated representative during
periods of enforcement.
(3) All persons and vessels shall
comply with the instructions of the
COTP or the designated representative.
Upon being hailed by a U.S. Coast
Guard vessel or other official patrol
vessel by siren, radio, flashing light or
other means, the operator of the hailed
vessel shall proceed as directed.
(4) Vessel operators desiring to enter
or operate within the regulated area may
contact the COTP or the designated
representative via VHF channel 16 or
907–835–7205 (Prince William Sound
Vessel Traffic Service) to request
permission to do so.
(5) The COTP, Prince William Sound
may be aided by other Federal, state,
borough, and local law enforcement
officials in the enforcement of this
regulation. In addition, members of the
Coast Guard Auxiliary may be present to
inform vessel operators of this
regulation.
Dated: July 6, 2018.
M.R. Franklin,
Commander, U.S. Coast Guard, Captain of
the Port, Prince William Sound.
[FR Doc. 2018–14863 Filed 7–11–18; 8:45 am]
BILLING CODE 9110–04–P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2017–0152; FRL–9980–
62—Region 3]

Approval and Promulgation of Air
Quality Implementation Plans;
Delaware; Interstate Transport
Requirements for the 2012 Fine
Particulate Matter Standard
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:

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The Environmental Protection
Agency (EPA) is approving a state
implementation plan (SIP) revision
submitted by the State of Delaware. This
revision pertains to the infrastructure
requirement for interstate transport of
pollution with respect to the 2012 fine
particulate matter (PM2.5) national
ambient air quality standards (NAAQS).
EPA is approving this revision in
accordance with the requirements of the
Clean Air Act (CAA).

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SUMMARY:

II. Summary of SIP Revision and EPA
Analysis

Delaware’s December 14, 2015 SIP
submittal asserted that the State’s SIP
presently contains adequate provisions
prohibiting sources from emitting air
pollutants in amounts which will
contribute significantly to
nonattainment or interfere with
maintenance of the 2012 PM2.5 NAAQS.
Delaware also asserted under Delaware
Code, Title 7, Chapter 60, Subsection
DATES: This final rule is effective on
6010(c), ‘‘Rules and regulations; plans,’’
August 13, 2018.
that the State has the legal authority to
regulate sources whose emission could
ADDRESSES: EPA has established a
transport to areas in nonattainment or to
docket for this action under Docket ID
Number EPA–R03–OAR–2017–0152. All areas currently attaining the NAAQS.
Delaware also describes ambient air
documents in the docket are listed on
the http://www.regulations.gov website. quality data for New Castle, Kent, and
Sussex Counties as all being below the
Although listed in the index, some
NAAQS.
information is not publicly available,
EPA used the information in the 2016
e.g., confidential business information
PM2.5 Memorandum 1 and additional
(CBI) or other information whose
information to evaluate the submittal
disclosure is restricted by statute.
and came to the same conclusion as
Certain other material, such as
Delaware. As discussed in greater detail
copyrighted material, is not placed on
in the technical support document
the internet and will be publicly
(TSD) for this action, EPA identified the
available only in hard copy form.
potential downwind nonattainment and
Publicly available docket materials are
maintenance receptors identified in the
available through http://
2016 PM2.5 Memorandum, and then
www.regulations.gov, or please contact
the person identified in the FOR FURTHER evaluated them to determine if
Delaware’s emissions could potentially
INFORMATION CONTACT section for
contribute to nonattainment and
additional availability information.
maintenance problems in 2021, the
FOR FURTHER INFORMATION CONTACT:
attainment year for moderate PM2.5
Joseph Schulingkamp, (215) 814–2021,
nonattainment areas. EPA concluded
or by email at schulingkamp.joseph@
Delaware was not significantly
epa.gov.
contributing to nonattainment nor
interfering with maintenance with 2012
SUPPLEMENTARY INFORMATION:
PM2.5 NAAQS by any other state. A
detailed summary of Delaware’s
I. Background
submittal and EPA’s review and
On December 14, 2015, the State of
rationale for approval of this SIP
Delaware, through the Department of
revision as meeting CAA section
Natural Resources and Environmental
110(a)(2)(D)(i)(I) for the 2012 PM2.5
Control (DNREC) submitted a SIP
NAAQS may be found in the NPR and
revision addressing the infrastructure
TSD for this rulemaking action, which
requirements under section 110(a)(2) of
are available online at
the CAA for the 2012 PM2.5 NAAQS. On www.regulations.gov, Docket number
September 22, 2017, EPA approved all
EPA–R03–OAR–2017–0152.
portions of Delaware’s submittal except
III. Public Comments
for the portion addressing section
110(a)(2)(D)(i)(I) regarding the interstate
One anonymous public comment was
transport of emissions. See 82 FR 44318. received during the public comment
As explained in the final rule, EPA
period, but the comment was
intended to take separate action on that
determined to not be relevant nor
portion of Delaware’s submittal and is
specific to this rulemaking action. Thus
doing so with today’s proposed action.
no response is provided.
On May 15, 2018 (83 FR 22436), EPA
published a notice of proposed
1 ‘‘Information on the Interstate Transport ‘‘Good
rulemaking (NPR) for the State of
Neighbor’’ Provision for the 2012 Fine Particulate
Delaware. In the NPR, EPA proposed
Matter National Ambient Air Quality Standards
under Clean Air Act Section 110(a)(2)(D)(i)(I),’’
approval of Delaware’s submittal to
Memorandum from Stephen D. Page, Director, EPA
address the infrastructure requirements
Office of Air Quality Planning and Standards
under section 110(a)(2)(D)(i) of the CAA (March 17, 2016). A copy is included in the docket
for this rulemaking action.
for the 2012 PM2.5 NAAQS.

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16:03 Jul 11, 2018

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IV. Final Action
EPA is approving the December 14,
2015 SIP revision addressing the
interstate transport requirements for the
2012 PM2.5 NAAQS to the Delaware SIP
because the submittal adequately
addresses section 110(a)(2)(D)(i)(I) of the
CAA.
V. Statutory and Executive Order
Reviews
A. General Requirements
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
CAA and applicable federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
federal requirements and does not
impose additional requirements beyond
those imposed by state law. For that
reason, this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866.
• does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
• does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
B. Submission to Congress and the
Comptroller General
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other

*

*

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2018–0104; FRL–9980–
43—Region 9]

Approval of California Air Plan
Revisions, Yolo-Solano Air Quality
Management District
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:

The Environmental Protection
Agency (EPA) is taking final action to
approve a revision to the Yolo-Solano
Air Quality Management District
(YSAQMD or ‘‘District’’) portion of the
California State Implementation Plan

SUMMARY:

16:03 Jul 11, 2018

State
submittal
date
*
12/14/2015

*

BILLING CODE 6560–50–P

amozie on DSK3GDR082PROD with RULES

Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by September 10, 2018. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action,
addressing Delaware’s interstate
transport for the 2012 PM2.5 NAAQS,
may not be challenged later in
proceedings to enforce its requirements.
(See section 307(b)(2).)

*
Statewide ..........

[FR Doc. 2018–14838 Filed 7–11–18; 8:45 am]

VerDate Sep<11>2014

C. Petitions for Judicial Review

Applicable
geographic
area

Name of non-regulatory SIP revision

*
*
Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5 NAAQS.

required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).

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Fmt 4700

Dated: June 19, 2018.
Cosmo Servidio,
Regional Administrator, Region III.

40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:

■

Authority: 42 U.S.C. 7401 et seq.

Subpart I—Delaware
2. In § 52.420, the table in paragraph
(e) is amended by adding a second entry
for Section 110(a)(2) Infrastructure
Requirements for the 2012 PM2.5
NAAQS after the first entry. The revised
text reads as follows:
■

§ 52.470

*

Identification of plan.

*
*
(e) * * *

*

*

Additional explanation

*
7/12/2018, [Insert
Federal Register
citation].

*
*
Docket 2017–0152. This action addresses the infrastructure element of CAA
section 110(a)(2)(D)(i)(I).

*

Frm 00021

Environmental protection, Air
pollution control, Incorporation by
reference, Particulate matter.

EPA
approval
date

*

(SIP). This revision concerns emissions
of volatile organic compounds (VOCs)
from architectural coatings. We are
approving a local rule that regulates
these emission sources under the Clean
Air Act (CAA or the Act).
DATES: This rule is effective on August
13, 2018.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R09–OAR–2018–0104. All
documents in the docket are listed on
the http://www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available through http://

PO 00000

List of Subjects in 40 CFR Part 52

Sfmt 4700

*

*

www.regulations.gov, or please contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section for
additional availability information.
FOR FURTHER INFORMATION CONTACT:

Arnold Lazarus, EPA Region IX, (415)
972–3024, [email protected].
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to the EPA.

Table of Contents
I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Proposed Action
On May 3, 2018 (83 FR 19495), the
EPA proposed to approve the following
rule into the California SIP.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
Local agency

Rule No.

YSAQMD ................................

2.14

We proposed to approve this rule
because we determined that it complies
with the relevant CAA requirements.
Our proposed action contains more
information on the rule and our
evaluation.
II. Public Comments and EPA
Responses
The EPA’s proposed action provided
a 30-day public comment period. During
this period, we received one comment
in support of regulating VOC emissions,
and another that was not germane to
this rule.
III. EPA Action
No comments were submitted that
change our assessment of the rule as
described in our proposed action.
Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully
approving this rule into the California
SIP.
IV. Incorporation by Reference
In this rule, the EPA is finalizing
regulatory text that includes
incorporation by reference. In
accordance with requirements of 1 CFR
51.5, the EPA is finalizing the
incorporation by reference of the
YSAQMD rule described in the
amendments to 40 CFR part 52 set forth
below. The EPA has made, and will
continue to make, these documents
available through www.regulations.gov
and at the EPA Region IX Office (please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of
this preamble for more information).

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V. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, the EPA’s role is to
approve state choices, provided that
they meet the criteria of the Clean Air
Act. Accordingly, this action merely
approves state law as meeting Federal
requirements and does not impose
additional requirements beyond those
imposed by state law. For that reason,
this action:
• Is not a significant regulatory action
subject to review by the Office of
Management and Budget under
Executive Orders 12866 (58 FR 51735,

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16:03 Jul 11, 2018

Jkt 244001

Rule title

Revised

Architectural Coatings ............................................................

October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because SIP approvals are
exempted under Executive Order 12866;
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where the EPA or
an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a

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Fmt 4700

Sfmt 4700

10/12/2016

Submitted
01/24/2017

copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
and other required information to the
U.S. Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by September 10,
2018. Filing a petition for
reconsideration by the Administrator of
this final rule does not affect the finality
of this action for the purposes of judicial
review nor does it extend the time
within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: June 22, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.

Part 52, chapter I, title 40 of the Code
of Federal Regulations is amended as
follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:

■

Authority: 42 U.S.C. 7401 et seq.

Subpart F—California
2. Section 52.220 is amended by
adding paragraphs (c)(293)(i)(B)(2) and
(c)(497)(i)(D)(2) to read as follows:

■

§ 52.220

*

Identification of plan-in part.

*
*
(c) * * *
(293) * * *

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12JYR1

*

*

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Rules and Regulations
(i) * * *
(B) * * *
(2) Previously approved on January 2,
2004 in paragraph (c)(293)(i)(B)(1) of
this section and now deleted with
replacement in (c)(497)(i)(D)(2), Rule
2.14, adopted on November 14, 2001.
*
*
*
*
*
(497) * * *
(i) * * *
(D) * * *
(2) Rule 2.14, ‘‘Architectural
Coatings,’’ revised on October 12, 2016.
*
*
*
*
*
[FR Doc. 2018–14946 Filed 7–11–18; 8:45 am]
BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2014–0741; FRL–9980–84–
OAR]

National Emission Standards for
Hazardous Air Pollutants for Chemical
Recovery Combustion Sources at
Kraft, Soda, Sulfite, and Stand-Alone
Semichemical Pulp Mills
Environmental Protection
Agency (EPA).
ACTION: Notification of final action
denying petition for reconsideration.
AGENCY:

The U.S. Environmental
Protection Agency (EPA) is providing
notice that it has responded to a petition
for reconsideration of the final National
Emission Standards for Hazardous Air
Pollutants (NESHAP) for Chemical
Recovery Combustion Sources at Kraft,
Soda, Sulfite, and Stand-Alone
Semichemical Pulp Mills published in
the Federal Register on October 11,
2017. The Acting Administrator denied
the petition in a separate letter to the
petitioners. The letter, which provides a
full explanation of the agency’s
rationale for the denial, is in the
rulemaking docket.
DATES: July 12, 2018.
FOR FURTHER INFORMATION CONTACT: Dr.
Kelley Spence, Sector Policies and
Programs Division (E143–03), Office of
Air Quality Planning and Standards,
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711; telephone number: (919) 541–
3158; fax number: (919) 541–0516;
email address: [email protected].
SUPPLEMENTARY INFORMATION:

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SUMMARY:

I. How can I get copies of this document
and other related information?
This Federal Register document, the
petition for reconsideration, and the

VerDate Sep<11>2014

16:03 Jul 11, 2018

Jkt 244001

letter denying the petition for
reconsideration are available in the
docket the EPA established under
Docket ID No. EPA–HQ–OAR–2014–
0741. All documents in the docket are
listed on the www.regulations.gov
website. Although listed, some
information is not publicly available,
e.g., confidential business information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy at
the EPA Docket Center (EPA/DC), Room
3334, EPA WJC West Building, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744 and
the telephone number for the Air Docket
is (202) 566–1742.
II. Judicial Review
Section 307(b)(1) of the Clean Air Act
(CAA) indicates which Federal Courts of
Appeals have venue for petitions for
review of final EPA actions. This section
provides, in part, that the petitions for
review must be filed in the United
States Court of Appeals for the District
of Columbia Circuit if: (1) The agency
action consists of ‘‘nationally applicable
regulations promulgated, or final action
taken, by the Administrator,’’ or (2) such
actions are locally or regionally
applicable, if ‘‘such action is based on
a determination of nationwide scope or
effect and if in taking such action the
Administrator finds and publishes that
such action is based on such a
determination.’’
The EPA has determined that its
action denying the petition for
reconsideration is nationally applicable
for purposes of CAA section 307(b)(1)
because the action directly affects the
NESHAP for Chemical Recovery
Combustion Sources at Kraft, Soda,
Sulfite, and Stand-Alone Semichemical
Pulp Mills, which are nationally
applicable CAA section 112 standards.
Any petitions for review of the letter
denying the petition for reconsideration
must be filed in the United States Court
of Appeals for the District of Columbia
Circuit by September 10, 2018.
III. Description of Action
On October 11, 2017, pursuant to
sections 112(d)(6) and (f)(2) of the CAA,
the EPA published the final residual
risk and technology review (RTR) of the

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‘‘National Emission Standards for
Hazardous Air Pollutants for Chemical
Recovery Combustion Sources at Kraft,
Soda, Sulfite, and Stand-Alone
Semichemical Pulp Mills.’’ 82 FR
47328. Following publication of the
final RTR amendments, the
Administrator received a petition for
reconsideration of two aspects of the
final RTR pursuant to CAA section
307(d)(7)(B). The petitioners,
Earthjustice on behalf of Crossett
Concerned Citizens for Environmental
Justice, Louisiana Environmental Action
Network, PT AirWatchers, and Sierra
Club, claimed: (1) It was impracticable
to object to the EPA’s rationale for not
setting additional standards for
uncontrolled emissions when the EPA
was conducting the review required by
CAA section 112(d)(6), and their
objections on this issue are of central
relevance to the outcome of the rule;
and (2) it was impracticable to object
during the comment period to the EPA’s
use of census block centroids to account
for the residual risk to the most exposed
individual, and their objections on this
issue are of central relevance to the
outcome of the rule.
CAA section 307(d)(7)(B) requires the
EPA to convene a proceeding for
reconsideration of a rule if a party
raising an objection to the rule ‘‘can
demonstrate to the Administrator that it
was impracticable to raise such
objection within [the public comment
period] or if the grounds for such
objection arose after the period for
public comment (but within the time
specified for judicial review) and if such
objection is of central relevance to the
outcome of the rule.’’ The requirement
to convene a proceeding to reconsider a
rule is, thus, based on the petitioner
demonstrating to the EPA both: (1) That
it was impracticable to raise the
objection during the comment period, or
that the grounds for such objection arose
after the comment period, but within
the time specified for judicial review
(i.e., within 60 days after publication of
the final rulemaking in the Federal
Register, see CAA section 307(b)(1));
and (2) that the objection is of central
relevance to the outcome of the rule.
The EPA carefully reviewed the
petition for reconsideration and
evaluated the issues raised to determine
if they meet the CAA section
307(d)(7)(B) criteria for reconsideration.
In a separate letter to the petitioners, the
EPA Acting Administrator, Andrew R.
Wheeler, denied the petition for
reconsideration. The letter is available
in the docket for this action.

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Dated: July 9, 2018.
Andrew R. Wheeler,
Acting Administrator.
[FR Doc. 2018–15023 Filed 7–11–18; 8:45 am]

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32215

Proposed Rules

Federal Register
Vol. 83, No. 134
Thursday, July 12, 2018

This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.

DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1206
[Document. No. AMS–SC–17–0002]

Mango Promotion, Research, and
Information Order; Reopening and
Extension of Comment Period on
Amendment To Include Frozen Mangos
AGENCY:

Agricultural Marketing Service,

USDA.
Reopening and extension of
comment period.

ACTION:

Notice is hereby given that
the comment period on the proposed
rule to amend the Mango Promotion,
Research, and Information Order to
include frozen mangos is reopened and
extended. Also, the comment period is
extended for the frozen mangos
information and collection requirements
by the Office of Management and
Budget (OMB) which is necessary to
include frozen mangos under the
current program.
DATES: Comments must be received by
August 13, 2018. Pursuant to the
Paperwork Reduction Act (PRA),
comments on the information collection
burden that would result from this
proposal must be received by August 13,
2018.
ADDRESSES: Interested persons are
invited to submit written comments
concerning this proposal. Comments
may be submitted on the internet at:
http://www.regulations.gov or to the
Promotion and Economics Division,
Specialty Crops Program, AMS, USDA,
1400 Independence Avenue SW, Room
1406–S, Stop 0244, Washington, DC
20250–0244; facsimile: (202) 205–2800.
All comments should reference the
docket number and the date and page
number of this issue of the Federal
Register and will be made available for
public inspection, including name and
address, if provided, in the above office
during regular business hours or it can

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SUMMARY:

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be viewed at http://
www.regulations.gov.
Pursuant to the PRA, comments
regarding the accuracy of the burden
estimate, ways to minimize the burden,
including the use of automated
collection techniques or other forms of
information technology, or any other
aspect of this collection of information,
should be sent to the above address. In
addition, comments concerning the
information collection should also be
sent to the Desk Office for Agriculture,
Office of Information and Regulatory
Affairs, OMB, New Executive Office
Building, 725 17th Street NW, Room
725, Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT:
Jeanette Palmer, Marketing Specialist,
Promotion and Economics Division,
Specialty Crops Program, AMS, USDA,
1400 Independence Avenue SW, Room
1406–S, Stop 0244, Washington, DC
20250–0244; telephone: (202) 720–9915;
facsimile: (202) 205–2800; or electronic
mail: [email protected].
SUPPLEMENTARY INFORMATION: A
proposed rule was published in the
Federal Register on April 6, 2018 (83 FR
14771). That rule proposed to amend
the Mango Promotion, Research, and
Information Order to include frozen
mangos.
The rule also announced the
Agricultural Marketing Service’s intent
to request approval from OMB of new
information collection requirements and
recordkeeping requirements for the
frozen mango industry. Information
collection and recordkeeping
requirements for the fresh mango
program (part 1206) have previously
been approved under OMB control nos.
0581–0093 and 0505–0001. Upon
approval of this action and associated
burden, AMS would submit a
Justification for Change to merge this
new burden for frozen mangos into the
currently approved collection for fresh
mangos.
USDA received a letter from industry
requesting that the comment period be
extended to allow additional time for
interested persons to review the
proposal and submit comments.
USDA is reopening and extending the
comment period an additional 30 days
to allow interested persons more time to
review the proposed rule, perform an
analysis, and submit written comments.
Authority: 7 U.S.C. 7411–7425; 7 U.S.C.
7401.

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Dated: July 9, 2018.
Bruce Summers,
Administrator.
[FR Doc. 2018–14940 Filed 7–11–18; 8:45 am]
BILLING CODE 3410–02–P

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2018–0634; Product
Identifier 2018–NM–050–AD]
RIN 2120–AA64

Airworthiness Directives; Bombardier,
Inc., Airplanes
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:

We propose to adopt a new
airworthiness directive (AD) for certain
Bombardier, Inc., Model CL–600–2C10
(Regional Jet Series 700, 701 & 702)
airplanes, Model CL–600–2D15
(Regional Jet Series 705) airplanes,
Model CL–600–2D24 (Regional Jet
Series 900) airplanes, and Model CL–
600–2E25 (Regional Jet Series 1000)
airplanes. This proposed AD was
prompted by reports of a fractured main
landing gear (MLG) orifice support tube
(OST). This proposed AD would require
replacing the MLG OST, and revising
the maintenance or inspection program,
as applicable, to incorporate new or
more restrictive maintenance
requirements and airworthiness
limitations. We are proposing this AD to
address the unsafe condition on these
products.
DATES: We must receive comments on
this proposed AD by August 27, 2018.
ADDRESSES: You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE,
Washington, DC 20590.
• Hand Delivery: Deliver to Mail
address above between 9 a.m. and 5
SUMMARY:

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p.m., Monday through Friday, except
Federal holidays.
For service information identified in
this NPRM, contact Bombardier, Inc.,
400 Coˆte-Vertu Road West, Dorval,
Que´bec H4S 1Y9, Canada; Widebody
Customer Response Center North
America toll-free telephone 866–538–
1247 or direct-dial telephone 514–855–
2999; fax 514–855–7401; email ac.yul@
aero.bombardier.com; internet http://
www.bombardier.com. You may view
this service information at the FAA,
Transport Standards Branch, 2200
South 216th St., Des Moines, WA. For
information on the availability of this
material at the FAA, call 206–231–3195.
Examining the AD Docket
You may examine the AD docket on
the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0634; or in person at Docket Operations
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The AD docket contains this NPRM, the
regulatory evaluation, any comments
received, and other information. The
street address for Docket Operations
(phone: 800–647–5527) is in the
ADDRESSES section. Comments will be
available in the AD docket shortly after
receipt.
FOR FURTHER INFORMATION CONTACT: Aziz
Ahmed, Aerospace Engineer, Airframe
and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY
11590; telephone 516–228–7329; fax
516–794–5531; email 9-avs-nyaco-cos@
faa.gov.
SUPPLEMENTARY INFORMATION:
Comments Invited
We invite you to send any written
relevant data, views, or arguments about
this proposal. Send your comments to
an address listed under the ADDRESSES
section. Include ‘‘Docket No. FAA–
2018–0634; Product Identifier 2018–
NM–050–AD’’ at the beginning of your
comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this NPRM. We will consider
all comments received by the closing

date and may amend this NPRM
because of those comments.
We will post all comments we
receive, without change, to http://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this NPRM.
Discussion
Transport Canada Civil Aviation
(TCCA), which is the aviation authority
for Canada, has issued Canadian AD
CF–2018–02, dated January 16, 2018
(referred to after this as the Mandatory
Continuing Airworthiness Information,
or ‘‘the MCAI’’), to correct an unsafe
condition for certain Bombardier, Inc.,
Model CL–600–2C10 (Regional Jet
Series 700, 701 & 702) airplanes, Model
CL–600–2D15 (Regional Jet Series 705)
airplanes, Model CL–600–2D24
(Regional Jet Series 900) airplanes, and
Model CL–600–2E25 (Regional Jet Series
1000) airplanes. The MCAI states:
Five cases of fractured Main Landing Gear
(MLG) Orifice Support Tube (OST) have been
reported. Subsequent analysis determined
that the MLG OST is unable to withstand the
loads generated during a hard landing event.
A MLG OST fracture cannot be detected
during routine maintenance and if not
corrected, a fractured MLG OST can lead to
aeroplane structural damage and/or collapse
of the MLG.
This [Canadian] AD mandates the
replacement of the existing MLG OSTs with
a re-designed part, and the implementation of
a new airworthiness limitation task.

You may examine the MCAI in the
AD docket on the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0634.
Related Service Information Under 1
CFR Part 51
Bombardier has issued Service
Bulletin SB 670BA–32–058, dated
September 26, 2016. The service
information describes procedures for
replacing each MLG OST.
Bombardier has also issued
Temporary Revision ALI–0593, dated
December 18, 2017. The service
information describes new life limits for
the MLG OSTs.

These service information are
reasonably available because the
interested parties have access to it
through their normal course of business
or by the means identified in the
ADDRESSES section.
FAA’s Determination
This product has been approved by
the aviation authority of another
country, and is approved for operation
in the United States. Pursuant to our
bilateral agreement with the State of
Design Authority, we have been notified
of the unsafe condition described in the
MCAI and service information
referenced above. We are proposing this
AD because we evaluated all the
relevant information and determined
the unsafe condition described
previously is likely to exist or develop
on other products of the same type
design.
This AD requires revisions to certain
operator maintenance documents to
include new actions (e.g., inspections).
Compliance with these actions is
required by 14 CFR 91.403(c). For
airplanes that have been previously
modified, altered, or repaired in the
areas addressed by this proposed AD,
the operator may not be able to
accomplish the actions described in the
revisions. In this situation, to comply
with 14 CFR 91.403(c), the operator
must request approval for an alternative
method of compliance according to
paragraph (i) of this proposed AD. The
request should include a description of
changes to the required actions that will
ensure the continued damage tolerance
of the affected structure.
Proposed AD Requirements
This proposed AD would require
replacing the MLG OST and revising the
maintenance or inspection program, as
applicable, to incorporate new or more
restrictive maintenance requirements
and airworthiness limitations.
Costs of Compliance
We estimate that this proposed AD
affects 542 airplanes of U.S. registry. We
estimate the following costs to comply
with this proposed AD:

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ESTIMATED COSTS
Action

Labor cost

Parts cost

Replacement (left- and right-hand sides) .......

24 work-hours × $85 per hour = $2,040 ........

* $0

Cost per
product
$2,040

Cost on U.S.
operators
$1,105,680

* We have received no definitive data that would enable us to provide cost estimates for the parts cost in this AD.

We have determined that revising the
maintenance or inspection program

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takes an average of 90 work-hours per
operator, although we recognize that

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this number may vary from operator to
operator. In the past, we have estimated

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
that this action takes 1 work-hour per
airplane. Since operators incorporate
maintenance or inspection program
changes for their affected fleet(s), we
have determined that a per-operator
estimate is more accurate than a perairplane estimate. Therefore, we
estimate the total cost per operator to be
$7,650 (90 work-hours × $85 per workhour).
Authority for This Rulemaking

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Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII:
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in Subtitle VII,
Part A, Subpart III, Section 44701:
‘‘General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
This proposed AD is issued in
accordance with authority delegated by
the Executive Director, Aircraft
Certification Service, as authorized by
FAA Order 8000.51C. In accordance
with that order, issuance of ADs is
normally a function of the Compliance
and Airworthiness Division, but during
this transition period, the Executive
Director has delegated the authority to
issue ADs applicable to transport
category airplanes to the Director of the
System Oversight Division.

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Regulatory Findings
We determined that this proposed AD
would not have federalism implications
under Executive Order 13132. This
proposed AD would not have a
substantial direct effect on the States, on
the relationship between the national
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify this proposed regulation:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in
Alaska; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:

1. The authority citation for part 39
continues to read as follows:

■

Authority: 49 U.S.C. 106(g), 40113, 44701.
[Amended]

2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):

■

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Bombardier, Inc.: Docket No. FAA–2018–
0634; Product Identifier 2018–NM–050–
AD.
(a) Comments Due Date
We must receive comments by August 27,
2018.
(b) Affected ADs
None.
(c) Applicability
This AD applies to the Bombardier, Inc.,
airplanes specified in paragraphs (c)(1),
(c)(2), and (c)(3) of this AD, certificated in
any category.
(1) Model CL–600–2C10 (Regional Jet
Series 700, 701 & 702) airplanes, serial
numbers 10003 through 10345 inclusive.
(2) Model CL–600–2D15 (Regional Jet
Series 705) airplanes and Model CL–600–
2D24 (Regional Jet Series 900) airplanes,
serial numbers 15001 through 15429
inclusive.
(3) Model CL–600–2E25 (Regional Jet
Series 1000) airplanes, serial numbers 19001
through 19052 inclusive.
(d) Subject
Air Transport Association (ATA) of
America Code 32, Main landing gear.
(e) Reason
This AD was prompted by reports of a
fractured main landing gear (MLG) orifice
support tube (OST). We are issuing this AD
to address a fractured MLG OST, which can
lead to structural damage to the airplane and
collapse of the MLG.
(f) Compliance

PART 39—AIRWORTHINESS
DIRECTIVES

§ 39.13

32217

Comply with this AD within the
compliance times specified, unless already
done.
(g) Replacement
Within the compliance times specified in
figure 1 to paragraph (g) of this AD: Replace
each MLG OST, in accordance with the
Accomplishment Instructions of Bombardier
Service Bulletin SB 670BA–32–058, dated
September 26, 2016.

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(h) Maintenance or Inspection Program
Revision
Within 90 days after the effective date of
this AD, revise the maintenance or inspection
program, as applicable, to incorporate
Bombardier Temporary Revision ALI–0593,
dated December 18, 2017. The initial
compliance time for accomplishing the
actions is at the applicable time specified in
Bombardier Temporary Revision ALI–0593,
dated December 18, 2017; or within 90 days
after the effective date of this AD; whichever
occurs later.
(i) No Alternative Actions or Intervals
After the maintenance or inspection
program has been revised as required by
paragraph (h) of this AD, no alternative
actions (e.g., inspections) or intervals may be
used unless the actions or intervals are
approved as an alternative method of
compliance (AMOC) in accordance with the
procedures specified in paragraph (j)(1) of
this AD.
(j) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, New York ACO
Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In

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accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to ATTN: Program Manager,
Continuing Operational Safety, FAA, New
York ACO Branch, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone
516–228–7300; fax 516–794–5531. Before
using any approved AMOC, notify your
appropriate principal inspector, or lacking a
principal inspector, the manager of the local
flight standards district office/certificate
holding district office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, New York ACO Branch,
FAA; or Transport Canada Civil Aviation
(TCCA); or Bombardier, Inc.’s TCCA Design
Approval Organization (DAO). If approved by
the DAO, the approval must include the
DAO-authorized signature.
(k) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) Canadian
AD CF–2018–02, dated January 16, 2018, for
related information. This MCAI may be
found in the AD docket on the internet at

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http://www.regulations.gov by searching for
and locating Docket No. FAA–2018–0634.
(2) For more information about this AD,
contact Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section,
FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590;
telephone 516–228–7329; fax 516–794–5531;
email [email protected].
(3) For service information identified in
this AD, contact Bombardier, Inc., 400 CoˆteVertu Road West, Dorval, Que´bec H4S 1Y9,
Canada; Widebody Customer Response
Center North America toll-free telephone
866–538–1247 or direct-dial telephone 514–
855–2999; fax 514–855–7401; email ac.yul@
aero.bombardier.com; internet http://
www.bombardier.com. You may view this
service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195.
Issued in Des Moines, Washington, on July
3, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2018–14804 Filed 7–11–18; 8:45 am]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2018–0281; Product
Identifier 2018–NE–06–AD]
RIN 2120–AA64

Airworthiness Directives; Hoffmann
Propeller GmbH & Co. KG Propellers
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:

We propose to adopt a new
airworthiness directive (AD) for certain
Hoffmann Propeller GmbH & Co. KG
model HO–V 62 propellers. This
proposed AD was prompted by the
failure of the propeller blade lag screws.
This proposed AD would require
removal of the affected propeller blades
and installation of modified propeller
blades marked with change letter ‘‘A’’ or
‘‘B.’’ We are proposing this AD to
address the unsafe condition on these
products.

SUMMARY:

We must receive comments on
this proposed AD by August 27, 2018.
ADDRESSES: You may send comments,
using the procedures found in 14 CFR
11.43 and 11.45, by any of the following
methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 202–493–2251.
• Mail: U.S. Department of
Transportation, Docket Operations, M–
30, West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE,
Washington, DC 20590.
• Hand Delivery: Deliver to Mail
address above between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays.
For service information identified in
this NPRM, contact Hoffmann Propeller
GmbH & Co. KG, Sales and Service,
Ku¨pferlingstrasse 9, 83022 Rosenheim,
Germany; phone: +49 (0) 8031 1878 0;
fax: +49 (0) 8031 1878 78; email: info@
hoffmann-prop.com. You may view this
service information at the FAA, Engine
& Propeller Standards Branch, 1200
District Avenue, Burlington, MA. For
information on the availability of this
material at the FAA, call 781–238–7759.

amozie on DSK3GDR082PROD with PROPOSALS1

DATES:

Examining the AD Docket
You may examine the AD docket on
the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0281; or in person at Docket Operations

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between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
The AD docket contains this NPRM, the
mandatory continuing airworthiness
information (MCAI), the regulatory
evaluation, any comments received, and
other information. The address for
Docket Operations (phone: 800–647–
5527) is listed above. Comments will be
available in the AD docket shortly after
receipt.
FOR FURTHER INFORMATION CONTACT:
Maureen Maisttison, Aerospace
Engineer, AIR–7B1, FAA, 1200 District
Ave, Burlington, MA 01803; phone:
781–238–7076; fax: 781–238–7151;
email: [email protected].
SUPPLEMENTARY INFORMATION:
Comments Invited
We invite you to send any written
relevant data, views, or arguments about
this proposal. Send your comments to
an address listed under the ADDRESSES
section. Include ‘‘Docket No. FAA–
2018–0281; Product Identifier 2018–
NE–06–AD’’ at the beginning of your
comments. We specifically invite
comments on the overall regulatory,
economic, environmental, and energy
aspects of this NPRM. We will consider
all comments received by the closing
date and may amend this NPRM
because of those comments.
We will post all comments we
receive, without change, to http://
www.regulations.gov, including any
personal information you provide. We
will also post a report summarizing each
substantive verbal contact we receive
about this NPRM.
Discussion
The European Aviation Safety Agency
(EASA), which is the Technical Agent
for the Member States of the European
Community, has issued EASA AD 2017–
0220, dated November 10, 2017
(referred to hereinafter as ‘‘the MCAI’’),
to address the unsafe condition on these
products. The MCAI states:
In 1983, occurrences were reported of
fatigue failure of propeller blade lag screws,
at rotation speeds between 2950 and 3250
revolutions per minute (RPM) in flight.
This condition, if not detected and
corrected, could lead to in-flight propeller
blade detachment, possibly resulting in
damage to the powered sailplane and/or
injury to persons on the ground.
To address this potential unsafe condition,
Hoffmann issued Service Bulletin (SB) 4,
providing the necessary instructions.
Consequently, LBA Germany issued AD 83–
150 (later revised), which applied only to
HO–V 62 propellers with R/L 160T blades,
when in combination with a Limbach L 2000
engine, to require a limitation of continuous
operation to 2 900 RPM, to prohibit aerobatic
flights, calibrate the tachometer, install a

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32219

placard, and inspection of the propeller
blades. LBA AD 83–150/4 also required
overhaul and replacement of the affected
propeller blades with modified blades, either
having 5 lag screws with 12 mm diameter, or
6 screws, and required implementing a time
between overhaul (TBO) of 600 flight hours
(FH).
Since that AD was issued, based on a stress
analysis of lag screws on blades with
continuous operating speed above 2 900
RPM, it was determined that the 6-screws
configuration or the 5 screws configuration
with increased strength is necessary to
ensure safe propeller operation. In addition,
since the LBA AD applied only to a limited
population (Limbach engine only), many
propellers have not been modified as
described in Hoffmann SB 4C. Consequently,
Hoffmann issued SB E34 Revision B, to
provide blade replacement instructions.

You may obtain further information
by examining the MCAI in the AD
docket on the internet at http://
www.regulations.gov by searching for
and locating Docket No. FAA–2018–
0281.
Related Service Information
We reviewed Hoffmann Propeller
GmbH & Co. KG Service Bulletin (SB)
E34, Rev. B, dated September 18, 2017.
The SB describes the instructions for the
removal and installation of the propeller
blades.
FAA’s Determination
This product has been approved by
EASA, and is approved for operation in
the United States. Pursuant to our
bilateral agreement with the European
Community, EASA has notified us of
the unsafe condition described in the
MCAI and service information
referenced above. We are proposing this
AD because we evaluated all the
relevant information provided by EASA
and determined the unsafe condition
previously described is likely to exist or
develop in other products of the same
type design.
Proposed AD Requirements
This proposed AD would require
removal of the affected propeller blades
and installation of the modified
propeller blades marked with change
letter ‘‘A’’ or ‘‘B’’ on the blade.
Differences Between This Proposed AD
and the MCAI or Service Information
EASA AD 2017–0220 partially
restates the requirements of AD 83–150,
issued on December 21, 1984, by
German aviation authority LuftfahrtBundesamt (LBA), which is based on
Propellerwerk Hoffmann Rosenheim SB
4, Revision C, dated February 20, 1984.
EASA AD 2017–0220 also adds new
requirements based on the issuance of

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

Hoffmann Propeller GmbH & Co. KG SB
E34, Rev. B dated September 18, 2017.
In restating LBA AD 83–150, EASA
AD 2017–0220 maintains a requirement
to remove certain propellers from
service within 10 flight hours after
December 21, 1984, but not later than 31
March 31, 1985. Service Bulletin E34
requires a mandatory immediate
maximum propeller rotational speed
limitation until the permanent
corrective action is completed, within
50 flight hours. The EASA AD 2017–

0220 partially restated requirements of
SB 4. Additionally, Hoffmann Propeller
GmbH & Co. KG SB E34 Revision B and
SB 4 Revision C temporarily prohibit
acrobatic flight. EASA AD 2017–0220
also adds a new requirement for a
mandatory maximum propeller
rotational speed limitation within 30
days until the propeller is replaced
within 50 flight hours.
This proposed AD does not require a
propeller speed limitation but would
require removal of the affected propeller

blades and installation of modified
propeller blades within 30 days of the
effective date of this AD.
Costs of Compliance
We estimate that this proposed AD
affects 50 propellers installed on
airplanes of U.S. registry.
We estimate the following costs to
comply with this proposed AD:

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ESTIMATED COSTS
Action

Labor cost

Replace Blades between overhaul .................
Replace Blades at overhaul ............................

3.0 work-hours × $85 per hour = $255.00 .....
0 work-hours × $85 per hour = $0.00 ............

Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs,’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in ‘‘Subtitle VII,
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
This AD is issued in accordance with
authority delegated by the Executive
Director, Aircraft Certification Service,
as authorized by FAA Order 8000.51C.
In accordance with that order, issuance
of ADs is normally a function of the
Compliance and Airworthiness
Division, but during this transition
period, the Executive Director has
delegated the authority to issue ADs
applicable to engines, propellers, and
associated appliances to the Manager,
Engine and Propeller Standards Branch,
Policy and Innovation Division.
Regulatory Findings
We determined that this proposed AD
would not have federalism implications
under Executive Order 13132. This
proposed AD would not have a
substantial direct effect on the States, on
the relationship between the national

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Parts cost

Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify this proposed regulation:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
(2) Is not a ‘‘significant rule’’ under
the DOT Regulatory Policies and
Procedures (44 FR 11034, February 26,
1979),
(3) Will not affect intrastate aviation
in Alaska, and
(4) Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:

■

Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13

[Amended]

2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):

■

Hoffmann Propeller GmbH & Co. KG: Docket
No. FAA–2018–0281; Product Identifier
2018–NE–06–AD.

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$3,150.00
3,150.00

Cost per
product
$3,405.00
3,150.00

Cost on U.S.
operators
$85,125.00
78,750.00

(a) Comments Due Date
We must receive comments by August 27,
2018.
(b) Affected ADs
None.
(c) Applicability
This AD applies to Hoffmann Propeller
GmbH & Co. KG model HO–V 62 propellers
without modified blades marked with change
letter ‘‘A’’ or ‘‘B’’ suffix to the S/N.
(d) Subject
Joint Aircraft System Component (JASC)
Code 6110, Propeller Assembly.
(e) Unsafe Condition
This AD was prompted by the failure of the
propeller blade lag screws. We are issuing the
AD to prevent failure of the propeller. The
unsafe condition, if not addressed, could
result in the release of the propeller blade,
damage to the aircraft, injury and/or loss of
life.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
Within 30 days of the effective date of this
AD, remove the applicable propeller blades
and install modified propeller blades marked
with a change letter ‘‘A’’ or ‘‘B’’ suffix to the
S/N marked on the blade.
(h) Installation Prohibition
After the effective date of this AD, do not
install a propeller blade if it is not marked
with a change letter ‘‘A’’ or ‘‘B’’ suffix to the
S/N marked on the blade.
(i) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Boston ACO Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or local Flight Standards

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
District Office, as appropriate. If sending
information directly to the manager of the
Boston ACO Branch, send it to the attention
of the person identified in paragraph (j)(1) of
this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(j) Related Information
(1) For more information about this AD,
contact Maureen Maisttison, Aerospace
Engineer, AIR–7B1, FAA, 1200 District Ave,
Massachusetts, 01803; phone: 781–238–7076;
fax: 781–238–7151; email:
[email protected].
(2) Refer to European Aviation Safety
Agency AD 2017–0220, dated November 10,
2017, for more information. You may
examine the EASA AD in the AD docket on
the internet at http://www.regulations.gov by
searching for and locating it in Docket No.
FAA–2018–0281.
(3) For service information identified in
this proposed AD, contact Hoffmann
Propeller GmbH & Co. KG, Sales and Service,
Ku¨pferlingstrasse 9, 83022 Rosenheim,
Germany; phone: +49 (0) 8031 1878 0; fax:
+49 (0) 8031 1878 78; email: [email protected]. You may view this referenced
service information at the FAA, Engine &
Propeller Standards Branch, 1200 District
Avenue, Burlington, MA. For information on
the availability of this material at the FAA,
call 781–238–7759.
Issued in Burlington, Massachusetts, on
July 6, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller
Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018–14862 Filed 7–11–18; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration

[Docket No. FDA–2011–F–0171]
RIN 0910–AH83

Food Labeling: Calorie Labeling of
Articles of Food Sold From Certain
Vending Machines; Front of Package
Type Size
Food and Drug Administration,

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HHS.
ACTION:

Proposed rule.

The Food and Drug
Administration (FDA, the Agency, or
we) proposes to revise the type size
labeling requirements for front of
package (FOP) calorie declarations for
packaged food sold from glass front
vending machines. We are taking this

SUMMARY:

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Submit either electronic or
written comments on the proposed rule
by September 25, 2018. Please note that
late, untimely filed comments will not
be considered.
ADDRESSES: You may submit comments
as follows:
DATES:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions

21 CFR Part 101

AGENCY:

action in response to requests from the
vending and packaged foods industries
to reduce the regulatory burden and
increase flexibility, while continuing to
provide calorie declarations for certain
articles of food sold from vending
machines.

Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–F–0171 for ‘‘Food Labeling:
Calorie Labeling of Articles of Food
Sold From Certain Vending Machines;
Front of Package Type Size.’’ Received

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32221

comments, those filed in a timely
manner (see DATES), will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: http://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Marjan Morravej, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of This Proposed Rule
B. Summary of the Major Provisions of the
Proposed Rule

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

C. Legal Authority
D. Costs and Benefits
II. Background
A. Requirements for Calorie Labeling of
Articles of Food in Vending Machines
and Our Consideration of Front of
Package Labeling Issues
B. Challenges of Existing Type Size
Requirement, and Proposed Change to
‘‘150 Percent of the Size of the Net
Quantity of Contents Declaration’’
C. Other Approaches
III. Legal Authority
IV. Description of the Proposed Rule
(Proposed § 101.8(b)(2))
V. Proposed Effective and Compliance Dates
VI. Economic Analysis of Impacts
A. Introduction
B. Summary of Benefits and Costs of the
Proposed Rule
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

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A. Purpose of This Proposed Rule
We are proposing to amend our
vending machine labeling regulations in
21 CFR part 101 by revising § 101.8(b)(2)
(21 CFR 101.8(b)(2)), in order to revise
the type size requirement when FOP
labeling is used to meet the calorie
declaration requirements for articles of
food sold from certain vending
machines. When using FOP labeling,
our existing regulations at § 101.8(b)(2)
require that the type size of the calorie
declaration for articles of food sold from
certain vending machines be at least 50
percent of the size of the largest printed
matter on the label. We propose,
instead, to require that the type size of
the calorie declaration on the front of
the package be at least 150 percent (one
and one-half times) the size of the net
quantity of contents (i.e., net weight)
declaration on the package of the
vended food. We are proposing this
change to reduce regulatory burdens
that the vending and packaged foods
industries shared with us after the final
rule implementing the vending machine
labeling requirements (79 FR 71259,
December 1, 2014) was issued, while
continuing to provide calorie
declarations for certain articles of food
sold from vending machines. Electronic
comments must be submitted on or
before September 25, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
September 25, 2018. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.

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B. Summary of the Major Provisions of
the Proposed Rule
This proposed rule would revise the
type size requirement for calories
labeled on the front of the package of
vended foods in § 101.8(b)(2). We are
proposing that the type size be anchored
to the net quantity of contents
statement, such that the minimum type
size is 150 percent (one and one-half
times) the size of the net quantity of
contents, instead of being based on the
largest printed matter on the label. The
proposed rule would only apply when
calories are displayed on the front of the
package of foods sold in glass front
vending machines.
C. Legal Authority
This action is consistent with our
authority in section 403(q)(5)(H) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 343(q)(5)(H)).
The FD&C Act, at section 403(q)(5)(H),
requires certain vending machine
operators to provide calorie declarations
for certain articles of food sold from
vending machines. In addition, we are
issuing this proposed rule consistent
with our authority in sections 201(n),
403(a)(1), and 403(f), of the FD&C Act
(21 U.S.C. 321(n), 343(a)(1), and 343(f)).
Further, we are issuing this proposed
rule under section 701(a) of the FD&C
Act (21 U.S.C. 371(a)), which gives us
the authority to issue regulations for the
efficient enforcement of the FD&C Act.
We discuss our legal authority in greater
detail in Section III, ‘‘Legal Authority.’’
D. Costs and Benefits
In response to requests from the
vending and packaged foods industries
to reduce the regulatory burden and
increase flexibility, FDA is proposing to
revise the existing type size
requirements when calories are
displayed on the front of the package of
foods sold in glass front vending
machines. Because this rule only
proposes minor revisions to FOP calorie
labeling type size requirements, we
estimate there are no costs to vending
machine operators and potential costs
savings to vending machine operators
and packaged food manufacturers. We
welcome data that would help us to
better estimate these impacts.
II. Background
A. Requirements for Calorie Labeling of
Articles of Food in Vending Machines
and Our Consideration of Front of
Package Labeling Issues
Section 403(q)(5)(H) of the FD&C Act
requires certain vending machine
operators to provide calorie declarations
for certain articles of food sold from

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vending machines. Under section
403(q)(5)(H)(viii) of the FD&C Act, if an
article of food is sold from a vending
machine that does not permit a
prospective purchaser to examine the
Nutrition Facts label before purchasing
the article, or does not otherwise
provide visible nutrition information at
the point of purchase; and is operated
by a person who is engaged in the
business of owning or operating 20 or
more vending machines, the vending
machine operator must ‘‘provide a sign
in close proximity to each article of food
or the selection button that includes a
clear and conspicuous statement
disclosing the number of calories
contained in the article.’’
In the Federal Register of December 1,
2014 (79 FR 71259), we issued a final
rule to implement the vending machine
labeling requirements in section
403(q)(5)(H) of the FD&C Act. The final
rule, which became effective on
December 1, 2016, requires vending
machine operators that own or operate
20 or more vending machines (or that
voluntarily register with us to be subject
to the final rule) to provide calorie
declarations for certain articles of food
sold from vending machines. The final
rule describes which foods are subject to
the calorie declaration requirement. The
final rule also establishes type size,
color, and contrast requirements for
calorie declarations in, or on, the
vending machines and for calorie
declarations on signs adjacent to the
vending machines. The final rule also
clarifies that vending machine operators
do not have to provide calorie
information for a food if a prospective
purchaser can view certain calorie
information on the front of the package,
in the Nutrition Facts label on the food,
or in a reproduction of the Nutrition
Facts label for the food, subject to
certain requirements. The calorie
declaration requirements covered in the
final rule are codified at § 101.8.
In the Federal Register of August 1,
2016 (81 FR 50303), we issued a final
rule that extended the compliance date
for final calorie declaration
requirements for certain food products
sold from glass-front vending machines
to July 26, 2018. The extended
compliance date applies only to those
products in glass front vending
machines that provide FOP calorie
disclosures and that comply with all
aspects of the final vending machine
labeling rule except that the disclosure
is not 50 percent of the size of the
largest print on the label.
In the preamble of the proposed rule
(published in the Federal Register of
April 6, 2011 (76 FR 19237 at 19244)),
we stated that FOP labeling could be a

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
way to provide ‘‘visible nutrition
information,’’ as long as the criteria for
color, font, and type size are met, and
total calories contained in the vended
food are included. We also tentatively
concluded that the visible nutrition
information must be in a type size
reasonably related to the most
prominent printed matter on the
labeling, among other things, such that
a purchaser is able to notice and read
the information. The preamble to the
proposed rule (76 FR 19237 at 19244)
explained that we considered
‘‘reasonably related’’ to mean a type size
at least 50 percent of the size of the
largest print on the label. This type size
as specified in the preamble to the
proposed rule is consistent with
interpretations we have used in food
labeling guidance when determining the
type size of the statement of identity on
packaged foods (Ref. 1).
In the preamble to the final rule (79
FR 71259 at 71269), we noted that many
comments supported the idea that FOP
labeling could provide visible nutrition
information; these comments said that
FOP labeling is the most efficient way
to satisfy section 403(q)(5)(H)(viii) of the
FD&C Act. Other comments stated that
vending machine operators are likely to
prefer food products with FOP labeling
because operators selling such food
products in their vending machines
would not have to provide calorie
declarations in compliance with section
403(q)(5)(H)(viii)(I)(bb) of the FD&C Act.
We also discussed several comments
that said that interpreting ‘‘reasonably
related’’ to mean a type size that is at
least 50 percent of the size of the largest
print on the label would require a type
size that is too large. One comment
suggested revising the rule to specify a
ratio for the size of the FOP calorie
disclosure relative to other printed
material on the label. The comment
stated that ‘‘reasonably related’’ would
be hard to enforce, and we should
require the FOP calorie disclosure to be
at least two-thirds the size of the largest
type size of any other writing on the
package, with a minimum size of onehalf square inch. Other comments stated
we should omit type size or prominence
requirements for the FOP calorie
disclosure.
In response to comments to the
proposed rule, we revised the rule by
removing the words ‘‘reasonably
related’’ at § 101.8(b)(2) and instead
required the calorie labeling print to be
‘‘at least 50 percent of the size of the
largest printed matter on the label.’’ We
also noted that vending machine
operators had other options for
satisfying section 403(q)(5)(H)(viii) of
the FD&C Act, including using a

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vending machine that provides
electronic reproductions of Nutrition
Facts labels, as provided in
§ 101.8(b)(1), or posting signs with
calorie declarations, as provided in
§ 101.8(c).
B. Challenges of Existing Type Size
Requirement, and Proposed Change to
‘‘150 Percent of the Size of the Net
Quantity of Contents Declaration’’
Since the publication of the final rule,
several industry representatives
indicated that the 50 percent type size
requirement for FOP calorie labeling
presents significant technical challenges
to the packaged foods industry (Refs. 2
and 3). They said it would make the
calorie declaration very large on some
products and would make label redesign
difficult or not practical. They
explained that, for glass front vending
machines without electronic displays,
FOP labeling assures that consumers
will get accurate calorie information for
vended foods. The industry
representatives also said that many
packaged food manufacturers who wish
to help vending machine operators
comply with the regulations by
providing packaged foods with FOP
labeling will have to redesign their
labels at great expense. They noted the
existence of several voluntary FOP
labeling programs where calorie
information is presented in a FOP type
size that ranges from 100 to 150 percent
of the size of the net quantity of
contents statement on the principal
display panel. They acknowledged these
labeling programs do not meet our type
size requirements, and said that
complying with the type size
requirement for calorie labeling would
significantly disrupt their FOP nutrition
labeling programs because there would
no longer be enough room on the label
to accommodate both the voluntary FOP
information and our calorie labeling
requirement. Thus, they said that the
nutrition information beyond calorie
labeling that is presently provided
under industry FOP programs may no
longer be included. Additionally, they
said that, while the existing FOP
labeling may not be at least 50 percent
of the size of the largest printed matter
on the label, as required by our rule, the
calorie information is nonetheless
visible to consumers. Finally, they
stated that, in most cases, industry
would be able to comply with a rule that
linked the FOP type size for calorie
labeling if it were no larger than 150
percent of the type size of the net
quantity of contents statement. Other
industry representatives also have
expressed support for using the 150

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percent standard for purposes of the
FOP type size requirement (Refs. 4–7).
Consequently, the proposed rule
would remove the requirement
specifying the FOP labeling be at least
50 percent of the size of the largest
printed matter on the label and instead
link the type size to the size of the net
quantity of contents statement.
Specifically, the proposed rule would
revise § 101.8(b)(2) pertaining to
‘‘articles of food not covered’’ to state
that the visible nutrition information
must be in a type size at least 150
percent of the size of the net quantity of
contents declaration on the front of the
package.
This revision, if finalized, would
allow for greater flexibility for the use
of FOP calorie labeling in glass front
vending machines, while still ensuring
that a FOP calorie declaration would be
visible for the consumer, regardless of
the size of the package. It also would
minimize the need for label changes for
foods that currently have voluntary FOP
calorie declarations that are 150 percent
of the size of the net quantity of content
statement provided the calorie
declarations meet the other criteria in
the final rule. It is our understanding
that many packaged food products sold
in glass front vending machines that
currently bear FOP calorie labeling
would meet the 150 percent
requirement that we are proposing.
However, to more fully understand the
current marketplace, we specifically
invite comment and data on the
percentage of food products commonly
sold in glass front vending machines
bearing voluntary FOP calorie labeling,
and for those products that currently
bear voluntary FOP calorie labeling, the
type size of the FOP calorie labeling
used on the products.
C. Other Approaches
Data and information currently
available to FDA indicate that the
proposed rule is consistent with some
existing voluntary FOP calorie
declarations currently used on food
product labels and it is feasible for other
foods that may be sold in vending
machines. We also evaluated two other
approaches for providing visible
nutrition information that would meet
the criteria in section 403(q)(5)(H)(viii)
of the FD&C Act, such that the food
would not be subject to the vending
machine calorie labeling requirements.
We invite comment on these two
alternative approaches, described more
fully below.

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2. Alternative Approach B—Not
Specifying Any Size

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1. Alternative Approach A—At Least
100 Percent of the Size of the Net
Quantity of Contents Declaration
The first alternative approach would
be to require the visible nutrition
information to be in a type size that is
at least 100 percent of the size of the net
quantity of contents declaration. Our
existing food labeling regulations for
packaged foods, at 21 CFR 101.7(i),
require that the declaration of net
quantity be in letters and numerals in a
type size that is established in relation
to the area of the principal display panel
of the package and that the declaration
be uniform for all packages of
substantially the same size. The
regulation prescribes the following size
specifications for net quantity
declarations:
• Not less than one-sixteenth inch in
height on packages the principal display
panel of which has an area of 5 square
inches or less;
• Not less than one-eighth inch in
height on packages the principal display
panel of which has an area of more than
5 but not more than 25 square inches;
• Not less than three-sixteenths inch
in height on packages the principal
display panel of which has an area of
more than 25 but not more than 100
square inches; and
• Not less than one-fourth inch in
height on packages the principal display
panel of which has an area of more than
100 square inches, except not less than
1⁄2 inch in height if the area is more than
400 square inches.
If the declaration is blown, embossed,
or molded on a glass or plastic surface
rather than by printing, typing, or
coloring, then the lettering sizes are to
be increased by one-sixteenth of an
inch.
We considered requiring the visible
nutrition information to be in a type size
that is at least 100 percent of the size of
the net quantity of contents declaration
on the front of the package; in other
words, the visible nutrition information
would, at a minimum, be the same size
as the net quantity of contents
declaration. We invite comment on the
impact of meeting the visible nutrition
information criteria, required under
section 403(q)(5)(H)(viii) of the FD&C
Act, especially on food in smaller
packages, such as small candy bars or
single serve bags of nuts, that are sold
in glass front vending machines under
this alternative approach where the FOP
calorie declaration is at least the same
size as the net quantity of contents
declaration.
FDA invites comment on the
advantages and disadvantages of this
alternative.

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The second alternative approach
would be to not specify any size for the
visible nutrition information. This
option would give the packaged food
industry considerable flexibility in
deciding how large—or how small—
voluntary FOP calorie labeling could be,
and may reduce the need for packaging
changes for some manufacturers. We
note that in developing the final
vending machine labeling rule, we
considered, but disagreed with
comments asking that we omit
requirements for prominence or type
size of FOP calorie disclosures. As we
discussed in the preamble to that final
rule, ‘‘When a vending machine food is
in a vending machine, a prospective
purchaser cannot handle the product to
make it easier for the purchaser to read
the nutrition information. Therefore,
‘visible nutrition information’ on the
front of package must be large enough,
and prominent enough, for prospective
purchasers to see and use the
information’’ (79 FR 71259 at 71269).
We invite comment on the advantages
and disadvantages of this alternative.
III. Legal Authority
We are proposing to revise the
labeling requirements for providing
calorie declarations for food sold from
certain vending machines, as set forth in
this proposed rule, consistent with our
authority in section 403(q)(5)(H) of the
FD&C Act. Under section 403(q)(5)(H),
certain vending machine operators must
provide calorie declarations for certain
articles of food sold from vending
machines. Under section 403(a)(1) of the
FD&C Act, such information must be
truthful and non-misleading. Under
section 403(f) of the FD&C Act, any
word, statement, or other information
required by or under the FD&C Act to
appear on the label or labeling of an
article of food must be prominently
placed thereon with such
conspicuousness (as compared with
other words, statements, designs, or
devices, in the labeling) and in such
terms as to render it likely to be read
and understood by the ordinary
individual under customary conditions
of purchase and use. Under section
403(a), (f), or (q) of the FD&C Act, food
to which these requirements apply is
deemed misbranded if these
requirements are not met. In addition,
under section 201(n) of the FD&C Act,
the labeling of food is misleading if it
fails to reveal facts that are material in
light of representations made in the
labeling or with respect to consequences
that may result from use. Thus, we are

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issuing this proposed rule under
sections 201(n), 403(a)(1), 403(f), and
403(q)(5)(H) of the FD&C Act, as well as
under section 701(a) of the FD&C Act,
which gives us the authority to issue
regulations for the efficient enforcement
of the FD&C Act.
IV. Description of the Proposed Rule
(Proposed § 101.8(b)(2))
The proposed rule would make a
change to the existing rule for calorie
labeling of food sold from vending
machines, in order to reduce the
regulatory burden and increase
flexibility while continuing to provide
calorie declarations for certain articles
of food sold from vending machines. We
propose to revise § 101.8(b)(2) to remove
the requirement that the type size of the
visible calorie declaration for articles of
food be at least 50 percent of the size of
the largest printed matter on the label
and, instead, to require the type size to
be at least 150 percent (one and one-half
times) the size of the net quantity of
contents (i.e., net weight) declaration on
the package of the vended food. We also
would make a minor editorial correction
to the same sentence in § 101.8(b)(2),
substituting the word ‘‘prospective’’ in
place of ‘‘perspective.’’
We also would revise the first
sentence of § 101.8(b)(2) by inserting a
comma after the word ‘‘minimum.’’ This
change corrects a punctuation error.
V. Proposed Effective and Compliance
Dates
We are proposing that any final rule
resulting from this rulemaking have an
effective date of 30 days after the date
of its publication in the Federal
Register. We also are proposing that
covered vending machine operators
comply with any final rule resulting
from this rulemaking by January 1,
2020. We are proposing this compliance
date in order to provide sufficient time
for the packaged food industry to revise
their labels, as appropriate, consistent
with any new requirements.
As discussed in section II.A., by July
26, 2018, vending machine operators
with glass front vending machines will
have to comply with all vending
machine requirements of the final rule
issued in 2014. However, it is unlikely
that we will be able to complete the
current rulemaking to revise the type
size labeling requirements for FOP
calorie declarations before the July 26,
2018 compliance date. Therefore,
pending completion of this rulemaking,
FDA intends to exercise enforcement
discretion with respect to the July 26,
2018 compliance date for products sold
in glass front vending machines that
provide a FOP calorie disclosure and

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
the product complies with all aspects of
the final vending machine labeling rule
except that the disclosure is not 50
percent of the size of the largest print on
the label.
Further, as previously noted, vending
machine operators with glass front
vending machines will have to comply
by July 26, 2018, with all vending
machine requirements, including
complying with calorie disclosure
requirements in 21 CFR 101.8(c)(2).
Although these requirements cover
gums, mints, and roll candy products
sold in glass front machines, FDA
intends to exercise enforcement
discretion, at least until January 1, 2020,
with respect to gums, mints, and roll
candy products sold in glass front
machines in packages that are too small
to bear FOP labeling. FDA intends to
consider this issue further.

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VI. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563,
Executive Order 13771, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). Executive Order
13771 requires that the costs associated
with significant new regulations ‘‘shall,
to the extent permitted by law, be offset
by the elimination of existing costs
associated with at least two prior
regulations.’’ This proposed rule has
been designated as a significant
regulatory action as defined by
Executive Order 12866. This proposed
rule is expected to be an Executive
Order 13771 deregulatory action.
Additional details can be found in the
proposed rule’s preliminary economic
analysis.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. The vending machine final rule
does not impose burdens to the
suppliers of vending machine foods.
While suppliers are not obliged to
engage in FOP calorie labeling, this
proposed rule, if finalized, would allow
for greater flexibility for the use of FOP
calorie labeling in glass front vending
machines than the existing regulations,

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potentially reducing the burden on
covered vending machine operators of
providing additional calorie labeling.
Thus, we propose to certify that the
proposed rule will not have a significant
economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $150 million,
using the most current (2017) Implicit
Price Deflator for the Gross Domestic
Product. This proposed rule would not
result in an expenditure in any year that
meets or exceeds this amount.
B. Summary of Benefits and Costs of the
Proposed Rule
FDA proposes to revise the type size
labeling requirements for providing FOP
calorie declarations for packaged food
sold from certain vending machines. We
are taking this action in response to
requests from the vending and packaged
foods industries to reduce the regulatory
burden and increase flexibility. The
proposed rule would revise the type size
requirements for FOP calorie labeling on
packaged foods displayed for sale in
glass front vending machines.
There are currently several voluntary
FOP labeling programs where calorie
information is presented. If finalized,
this proposal may provide an increased
incentive for packaged food
manufacturers to add new or amend
current FOP calorie labeling to foods in
order to comply with the updated
standard. If so, glass front vending
machine operators carrying exclusively
those products will not have to provide
signs with calorie information for the
food, providing an opportunity to
reduce operator costs. To the extent this
occurs, some costs may shift from the
vending machine operator to the
manufacturer. Packaged food
manufacturing firms may choose to
incur additional costs associated with
amending the FOP label in order to
retain revenue streams from current
customers, including vending machine
operators. If total revenue is greater than
total cost, this proposed rule will
provide cost savings for packaged food
manufacturing firms. We expect the
potential cost savings to both vending
machine operators and packaged food
manufacturers to outweigh the costs to

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32225

packaged food manufacturers and thus
the net effect to be positive, but lack the
data to quantify this effect. We welcome
data that would help us to better
estimate these impacts.
We have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of the proposed
rule. The full analysis of economic
impacts is available in the docket for
this proposed rule (Ref. 8) and at
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
VII. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(k) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VIII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
proposed rule contains no new
collection of information beyond what
was described in the December 2014
final rule and approved under OMB
control number 0910–0782. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
IX. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. Section
4(a) of the Executive Order requires
Agencies to construe a Federal statute to
preempt State law only where the
statute contains an express preemption
provision or there is some other clear
evidence that the Congress intended
preemption of State law, or where the
exercise of State authority conflicts with
the exercise of Federal authority under
the Federal statute. Federal law includes
an express preemption provision that
preempts any nutrition labeling
requirement of food that is not identical
to the requirement of section 403(q) of
the FD&C Act, except that this provision
does not apply to food that is offered for
sale in a restaurant or similar retail food
establishment that is not part of a chain
with 20 or more locations doing
business under the same name and
offering for sale substantially the same
menu items unless such restaurant or
similar retail food establishment elects
to comply voluntarily with the nutrition
information requirements under section
403(q)(5)(H)(ix) of the FD&C Act. The
proposed rule would create
requirements for nutrition labeling of
food under section 403(q) of the FD&C

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Act that would preempt certain nonidentical State and local nutrition
labeling requirements.
Section 4205 of the Patient Protection
and Affordable Care Act (ACA), which
amended the FD&C Act to require
certain vending machine operators to
provide calorie declarations for certain
articles of food sold from vending
machines, also included a Rule of
Construction providing that nothing in
the amendments made by section 4205
of the ACA shall be construed: (1) To
preempt any provision of State or local
law, unless such provision establishes
or continues into effect nutrient content
disclosures of the type required under
section 403(q)(5)(H) of the FD&C Act
and is expressly preempted under
subsection (a)(4) of such section; (2) to
apply to any State or local requirement
respecting a statement in the labeling of
food that provides for a warning
concerning the safety of the food or
component of the food; or (3) except as
provided in section 403(q)(5)(H)(ix) of
the FD&C Act, to apply to any restaurant
or similar retail food establishment
other than a restaurant or similar retail
food establishment described in section
403(q)(5)(H)(i) of the FD&C Act (see Pub.
L. 111–148, section 4205(d) of the ACA,
124 Stat. 119, 576 (2010)).
We interpret the provisions of section
4205 of the ACA related to preemption
to mean that States and local
governments may not impose nutrition
labeling requirements for food sold from
vending machines that must comply
with the Federal requirements of section
403(q)(5)(H) of the FD&C Act, unless the
State or local requirements are identical
to the Federal requirements. In other
words, States and localities cannot have
additional or different nutrition labeling
requirements for food sold either: (1)
From vending machines that are
operated by a person engaged in the
business of owning or operating 20 or
more vending machines subject to the
requirements of section
403(q)(5)(H)(viii) of the FD&C Act; or (2)
from vending machines operated by a
person not subject to the requirements
of section 403(q)(5)(H)(viii) of the FD&C
Act who voluntarily elects to be subject
to those requirements by registering
biannually under section
403(q)(5)(H)(ix) of the FD&C Act.
Otherwise, for food sold from vending
machines not subject to the nutrition
labeling requirements of section
403(q)(5)(H)(viii) of the FD&C Act,
States and localities may impose
nutrition labeling requirements. Under
our interpretation of section 4205(d)(1)
of the ACA, nutrition labeling for food
sold from these vending machines
would not be nutrient content

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disclosures of the type required under
section 403(q)(5)(H)(viii) of the FD&C
Act and, therefore, would not be
preempted. Under this interpretation,
States and localities would be able to
continue to require nutrition labeling for
food sold from vending machines that
are exempt from nutrition labeling
under section 403(q)(5) of the FD&C Act.
This interpretation is consistent with
the fact that Congress included vending
machine operators in the voluntary
registration provision of section
403(q)(5)(H)(ix) of the FD&C Act. There
would have been no need to include
vending machine operators in the
provision that allows opting into the
Federal requirements if States and
localities could not otherwise require
non-identical nutrition labeling for food
sold from any vending machines.
In addition, the express preemption
provisions of 21 U.S.C. 343–1(a)(4) do
not preempt any State or local
requirement respecting a statement in
the labeling of food that provides for a
warning concerning the safety of the
food or component of the food. This is
clear from both the literal language of 21
U.S.C. 343–1(a)(4) with respect to the
scope of preemption and from the Rule
of Construction at section 4205(d)(2) of
the ACA.

Food Safety and Applied Nutrition,
dated June 28, 2016.
4. Letter from Karin F. R. Moore, Senior Vice
President and General Counsel, Grocery
Manufacturers Association, and cosigned
by the American Beverage Association,
National Automated Merchandising
Association, National Confectioners
Association, and SNAC International, to
Scott Gottlieb, M.D., Commissioner of
Food and Drugs, FDA, dated July 19,
2017.
5. Letter from Jason Eberstein, Director, State
& Federal Government Affairs, National
Automatic Merchandising Association,
to Scott Gottlieb, M.D., Commissioner of
Food and Drugs, FDA, dated November
21, 2017.
6. Letter from Brad G. Figel, Vice President,
North America Public Affairs, Mars, Inc.,
to Mick Mulvaney, Director, Office of
Management and Budget, dated January
30, 2018.
7. Letter from Elizabeth Avery, President and
CEO, SNAC International, to Dockets
Management Staff, FDA, dated February
12, 2018.
8. FDA, ‘‘Food Labeling: Calorie Labeling of
Articles of Food Sold From Certain
Vending Machines; Front of Package
Type Size, Preliminary Regulatory
Impact Analysis, Initial Regulatory
Flexibility Analysis, Preliminary Small
Entity Analysis,’’ dated June 2018. Also
available at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.

X. References

List of Subjects in 21 CFR Part 101

The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.

Food labeling, Nutrition, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, we propose that 21
CFR part 101 be amended as follows:

1. FDA, ‘‘Guidance for Industry: A Food
Labeling Guide (4. Name of Food)’’, last
updated January 2013. Retrieved from
https://www.fda.gov/downloads/Food/
GuidanceRegulation/UCM265446.pdf.
2. Letter from Karin F. R. Moore, Vice
President and General Counsel, Grocery
Manufacturers Association, and cosigned
by the American Beverage Association,
National Automated Merchandising
Association, National Confectioners
Association, and SNAC International, to
Susan Mayne, Ph.D., Director, Center for
Food Safety and Applied Nutrition,
dated March 31, 2016.
3. Letter from Karin F. R. Moore, Senior Vice
President and General Counsel, Grocery
Manufacturers Association, and cosigned
by the American Beverage Association,
National Automated Merchandising
Association, National Confectioners
Association, and SNAC International, to
Susan Mayne, Ph.D., Director, Center for

Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.

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PART 101—FOOD LABELING
1. The authority citation for part 101
continues to read as follows:

■

2. Section 101.8 is amended by
revising paragraph (b)(2) to read as
follows:

■

§ 101.8

Vending machines.

*

*
*
*
*
(b) * * *
(2) The prospective purchaser can
otherwise view visible nutrition
information, including, at a minimum,
the total number of calories for the
article of food as sold at the point of
purchase. This visible nutrition
information must appear on the food
label itself. The visible nutrition
information must be clear and
conspicuous and able to be easily read
on the article of food while in the

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vending machine, in a type size at least
150 percent of the size of the net
quantity of contents declaration on the
front of the package, and with sufficient
color and contrasting background to
other print on the label to permit the
prospective purchaser to clearly
distinguish the information.
*
*
*
*
*
Dated: July 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14906 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF DEFENSE
Department of the Army, Corps of
Engineers
33 CFR Part 328
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 110, 112, 116, 117, 122,
230, 232, 300, 302, and 401
[EPA–HQ–OW–2017–0203; FRL–9980–52–
OW]
RIN 2040–AF74

Definition of ‘‘Waters of the United
States’’—Recodification of Preexisting
Rule
Department of Defense,
Department of the Army, Corps of
Engineers; Environmental Protection
Agency (EPA).
ACTION: Supplemental notice of
proposed rulemaking.
AGENCY:

The purpose of this
supplemental notice is for the
Environmental Protection Agency (EPA)
and the Department of the Army
(agencies) to clarify, supplement and
seek additional comment on an earlier
proposal, published on July 27, 2017, to
repeal the 2015 Rule Defining Waters of
the United States (‘‘2015 Rule’’), which
amended portions of the Code of
Federal Regulations (CFR). As stated in
the agencies’ July 27, 2017 Notice of
Proposed Rulemaking (NPRM), the
agencies propose to repeal the 2015
Rule and restore the regulatory text that
existed prior to the 2015 Rule, as
informed by guidance in effect at that
time. If this proposal is finalized, the
regulations defining the scope of federal
Clean Water Act (CWA) jurisdiction
would be those portions of the CFR as
they existed before the amendments
promulgated in the 2015 Rule. Those
preexisting regulatory definitions are

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the ones that the agencies are currently
implementing in light of the agencies’
final rule published on February 6,
2018, adding a February 6, 2020
applicability date to the 2015 Rule, as
well as judicial decisions preliminarily
enjoining and staying the 2015 Rule.
DATES: Comments must be received on
or before August 13, 2018.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OW–2017–0203, at http://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from Regulations.gov.
The agencies may publish any comment
received to the public docket. Do not
submit electronically any information
you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The agencies will generally not
consider comments or comment content
located outside of the primary
submission (i.e., on the web, cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
http://www2.epa.gov/
dockets.commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
Michael McDavit, Office of Water
(4504–T), Environmental Protection
Agency, 1200 Pennsylvania Avenue
NW, Washington, DC 20460; telephone
number: (202) 566–2428; email address:
[email protected]; or Stacey Jensen,
Regulatory Community of Practice
(CECW–CO–R), U.S. Army Corps of
Engineers, 441 G Street NW,
Washington, DC 201314; telephone
number: (202) 761–6903; email address:
[email protected].
SUPPLEMENTARY INFORMATION: The
agencies propose to repeal the Clean
Water Rule: Definition of ‘‘Waters of the
United States,’’ 80 FR 37054, and
recodify the regulatory definitions of
‘‘waters of the United States’’ that
existed prior to the August 28, 2015
effective date of the 2015 Rule. Those
preexisting regulatory definitions are
the ones that the agencies are currently
implementing in light of the agencies’
final rule (83 FR 5200, February 6,
2018), which added a February 6, 2020
applicability date to the 2015 Rule.
Judicial decisions currently enjoin the

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2015 Rule in 24 States as well. If this
proposal is finalized, the agencies
would administer the regulations
promulgated in 1986 and 1988 in
portions of 33 CFR part 328 and 40 CFR
parts 110, 112, 116, 117, 122, 230, 232,
300, 302, and 401, and would continue
to interpret the statutory term ‘‘waters of
the United States’’ to mean the waters
covered by those regulations, as the
agencies are currently implementing
those regulations consistent with
Supreme Court decisions and
longstanding practice, as informed by
applicable guidance documents,
training, and experience.
State, tribal, and local governments
have well-defined and established
relationships with the federal
government in implementing CWA
programs. Those relationships are not
affected by this proposed rule, which
would not alter the jurisdiction of the
CWA compared to the regulations and
practice that the agencies are currently
applying. The proposed rule would
permanently repeal the 2015 Rule,
which amended the longstanding
definition of ‘‘waters of the United
States’’ in portions of 33 CFR part 328
and 40 CFR parts 110, 112, 116, 117,
122, 230, 232, 300, 302, and 401, and
restore the regulations as they existed
prior to the amendments in the 2015
Rule.1
The agencies are issuing this
supplemental notice of proposed
rulemaking (SNPRM) to clarify,
supplement and give interested parties
an opportunity to comment on certain
important considerations and reasons
for the agencies’ proposal. The agencies
clarify herein the scope of the
solicitation of comment and the actions
proposed. In response to the July 27,
2017 NPRM, (82 FR 34899), the agencies
received numerous comments on the
impacts of repealing the 2015 Rule in its
entirety. Others commented in favor of
retaining the 2015 Rule, either as
written or with modifications. Some
commenters interpreted the proposal as
restricting their opportunity to provide
such comments either supporting or
opposing repeal of the 2015 Rule. In this
SNPRM, the agencies reiterate that this
regulatory action is intended to
permanently repeal the 2015 Rule in its
entirety, and we invite all interested
persons to comment on whether the
2015 Rule should be repealed.
1 While EPA administers most provisions in the
CWA, the Department of the Army, Corps of
Engineers (Corps) administers the permitting
program under section 404. During the 1980s, both
agencies adopted substantially similar definitions of
‘‘waters of the United States.’’ See 51 FR 41206,
Nov. 13, 1986, amending 33 CFR 328.3; 53 FR
20764, June 6, 1988, amending 40 CFR 232.2.

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The agencies are also issuing this
SNPRM to clarify that the rule adding
an applicability date to the 2015 Rule
does not change the agencies’ decision
to proceed with this proposed repeal.
For the reasons discussed in this notice,
the agencies propose to conclude that
regulatory certainty would be best
served by repealing the 2015 Rule and
recodifying the scope of CWA
jurisdiction currently in effect. The
agencies propose to conclude that rather
than achieving its stated objectives of
increasing predictability and
consistency under the CWA, see 80 FR
37055, the 2015 Rule is creating
significant confusion and uncertainty
for agency staff, regulated entities,
states, tribes, local governments, and the
public, particularly in view of court
decisions that have cast doubt on the
legal viability of the rule. To provide for
greater regulatory certainty, the agencies
propose to repeal the 2015 Rule and to
recodify the pre-2015 regulations,
thereby maintaining a longstanding
regulatory framework that is more
familiar to and better-understood by the
agencies, states, tribes, local
governments, regulated entities, and the
public.
Further, court rulings against the 2015
Rule suggest that the interpretation of
the ‘‘significant nexus’’ standard as
applied in the 2015 Rule may not
comport with and accurately implement
the legal limits on CWA jurisdiction
intended by Congress and reflected in
decisions of the Supreme Court. At a
minimum, the agencies find that the
interpretation of the statute adopted in
the 2015 Rule is not compelled and
raises significant legal questions. In
light of the substantial uncertainty
associated with the 2015 Rule,
including by virtue of a potential stay,
injunction, or vacatur of the 2015 Rule
in various legal challenges, as well as
the substantial experience the agencies
already possess implementing the
preexisting regulations that the agencies
are implementing today, the agencies
propose to conclude that administrative
goals of regulatory certainty would be
best served by repealing the 2015 Rule.
The agencies also propose to conclude
that the 2015 Rule exceeded the
agencies’ authority under the CWA by
adopting such an interpretation of
Justice Kennedy’s ‘‘significant nexus’’
standard articulated in Rapanos v.
United States and Carabell v. United
States, 547 U.S. 715 (2006) (‘‘Rapanos’’)
as to be inconsistent with important
aspects of that opinion and to cover
waters outside the scope of the Act,
even though that concurring opinion
was identified as the basis for the
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the 2015 Rule. The agencies also
propose to conclude that, contrary to
conclusions articulated in support of the
rule, the 2015 Rule appears to have
expanded the meaning of tributaries and
adjacent wetlands to include waters
well beyond those regulated by the
agencies under the preexisting
regulations, as applied by the agencies
following decisions of the Supreme
Court in Rapanos and Solid Waste
Agency of Northern Cook County v. U.S.
Army Corps of Engineers, 531 U.S. 159
(2001) (‘‘SWANCC’’). The agencies
believe that the 2015 Rule may have
altered the balance of authorities
between the federal and State
governments, contrary to the agencies’
statements in promulgating the 2015
Rule and in contravention of CWA
section 101(b), 33 U.S.C. 1251(b).
I. Background
The agencies refer the public to the
Executive Summary for the NPRM, 82
FR 34899 (July 27, 2017), and
incorporate it by reference herein.
A. The 2015 Rule
On June 29, 2015, the agencies issued
a final rule (80 FR 37054) amending
various portions of the CFR that set
forth definitions of ‘‘waters of the
United States,’’ a term contained in the
CWA section 502(7) definition of
‘‘navigable waters,’’ 33 U.S.C. 1362(7).
A primary purpose of the 2015 Rule
was to ‘‘increase CWA program
predictability and consistency by
clarifying the scope of ‘waters of the
United States’ protected under the Act.’’
80 FR 37054. The 2015 Rule attempted
to clarify the geographic scope of the
CWA by placing waters into three
categories: (A) Waters that are
categorically ‘‘jurisdictional by rule’’ in
all instances (i.e., without the need for
any additional analysis); (B) waters that
are subject to case-specific analysis to
determine whether they are
jurisdictional, and (C) waters that are
categorically excluded from jurisdiction.
Waters that are ‘‘jurisdictional by rule’’
include (1) waters which are currently
used, were used in the past, or may be
susceptible to use in interstate or foreign
commerce, including all waters which
are subject to the ebb and flow of the
tide; (2) interstate waters, including
interstate wetlands; (3) the territorial
seas; (4) impoundments of waters
otherwise identified as jurisdictional;
(5) tributaries of the first three categories
of ‘‘jurisdictional by rule’’ waters; and
(6) waters adjacent to a water identified
in the first five categories of
‘‘jurisdictional by rule’’ waters,
including wetlands, ponds, lakes,

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oxbows, impoundments, and similar
waters. See id. at 37104.
The 2015 Rule added new definitions
of key terms such as ‘‘tributaries’’ and
revised previous definitions of terms
such as ‘‘adjacent’’ (by adding a new
definition of ‘‘neighboring’’ that is used
in the definition of ‘‘adjacent’’) that
would determine whether waters are
‘‘jurisdictional by rule.’’ See id. at
37105. Specifically, a tributary under
the 2015 Rule is a water that contributes
flow, either directly or through another
water, to a water identified in the first
three categories of ‘‘jurisdictional by
rule’’ waters and that is characterized by
the presence of the ‘‘physical
indicators’’ of a bed and banks and an
ordinary high water mark. ‘‘These
physical indicators demonstrate there is
volume, frequency, and duration of flow
sufficient to create a bed and banks and
therefore an ordinary high water mark,
and thus to qualify as a tributary.’’ Id.
The 2015 Rule does not delineate
jurisdiction specifically based on
categories with established scientific
meanings such as ephemeral,
intermittent, and perennial waters that
are based on the source of the water and
nature of the flow. See id. at 37076
(‘‘Under the rule, flow in the tributary
may be perennial, intermittent, or
ephemeral.’’). Under the 2015 Rule,
tributaries need not be demonstrated to
possess any specific volume, frequency,
or duration of flow, or to contribute flow
to a traditional navigable water in any
given year or specific time period.
Tributaries under the 2015 Rule can be
natural, man-altered, or man-made, and
they do not lose their status as a
tributary if, for any length, there are one
or more constructed breaks (such as
bridges, culverts, pipes, or dams), or one
or more natural breaks (such as
wetlands along the run of a stream,
debris piles, boulder fields, or a stream
that flows underground) so long as a bed
and banks and an ordinary high water
mark can be identified upstream of the
break. Id. at 37105–06.
In the 2015 Rule, the agencies did not
expressly amend the longstanding
definition of ‘‘adjacent’’ (defined as
‘‘bordering, contiguous, or
neighboring’’), but the agencies added a
new definition of ‘‘neighboring’’ that
impacted the interpretation of
‘‘adjacent.’’ The 2015 Rule defined
‘‘neighboring’’ to encompass all waters
located within 100 feet of the ordinary
high water mark of a category (1)
through (5) ‘‘jurisdictional by rule’’
water; all waters located within the 100year floodplain of a category (1) through
(5) ‘‘jurisdictional by rule’’ water and
not more than 1,500 feet from the
ordinary high water mark of such water;

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all waters located within 1,500 feet of
the high tide line of a category (1)
though (3) ‘‘jurisdictional by rule’’
water; and all waters within 1,500 feet
of the ordinary high water mark of the
Great Lakes. Id. at 37105. The entire
water is considered neighboring if any
portion of it lies within one of these
zones. See id. This regulatory text did
not appear in the proposed rule, and
thus the agencies did not receive public
comment on these numeric measures.
In addition to the six categories of
‘‘jurisdictional by rule’’ waters, the 2015
Rule identifies certain waters that are
subject to a case-specific analysis to
determine if they have a ‘‘significant
nexus’’ to a water that is jurisdictional.
Id. at 37104–05. The first category
consists of five specific types of waters
in specific regions of the country:
Prairie potholes, Carolina and Delmarva
bays, pocosins, western vernal pools in
California, and Texas coastal prairie
wetlands. Id. at 37105. The second
category consists of all waters located
within the 100-year floodplain of any
category (1) through (3) ‘‘jurisdictional
by rule’’ water and all waters located
within 4,000 feet of the high tide line or
ordinary high water mark of any
category (1) through (5) ‘‘jurisdictional
by rule’’ water. Id. These quantitative
measures did not appear in the
proposed rule, and thus the agencies did
not receive public comment on these
specific measures.
The 2015 Rule defines ‘‘significant
nexus’’ to mean a water, including
wetlands, that either alone or in
combination with other similarly
situated waters in the region,
significantly affects the chemical,
physical, or biological integrity of a
category (1) through (3) ‘‘jurisdictional
by rule’’ water. 80 FR 37106. ‘‘For an
effect to be significant, it must be more
than speculative or insubstantial.’’ Id.
The term ‘‘in the region’’ means ‘‘the
watershed that drains to the nearest’’
primary water.2 Id. This definition is
different than the test articulated by the
agencies in their 2008 Rapanos
Guidance.3 That guidance interpreted
‘‘similarly situated’’ to include all
wetlands (not waters) adjacent to the
2 In this notice, a ‘‘primary’’ water is a category
(1) through (3) ‘‘jurisdictional by rule’’ water.
3 See U.S. EPA and U.S. Army Corps of Engineers.
Clean Water Act Jurisdiction Following the U.S.
Supreme Court’s Decision in Rapanos v. United
States & Carabell v. United States at 1 (Dec. 2, 2008)
(‘‘Rapanos Guidance’’), available at https://
www.epa.gov/sites/production/files/2016-02/
documents/cwa_jurisdiction_following_
rapanos120208.pdf. The agencies acknowledge that
the Rapanos Guidance did not impose legally
binding requirements, see id. at 4 n.17, but believe
that this guidance is relevant to the discussion in
this notice.

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same tributary, a much less expansive
treatment of similarly situated waters
than in the 2015 Rule.
Under the 2015 Rule, to determine
whether a water, alone or in
combination with similarly situated
waters across a watershed, has such an
effect, one must look at nine functions
such as sediment trapping, runoff
storage, provision of life cycle
dependent aquatic habitat, and other
functions. It is sufficient for determining
whether a water has a significant nexus
if any single function performed by the
water, alone or together with similarly
situated waters in the watershed,
contributes significantly to the
chemical, physical, or biological
integrity of the nearest category (1)
through (3) ‘‘jurisdictional by rule’’
water. Id. Taken together, the
enumeration of the nine functions and
the more expansive consideration of
‘‘similarly situated’’ in the 2015 Rule
could mean that the vast majority of
water features in the United States may
come within the jurisdictional purview
of the federal government.4 Indeed, the
agencies stated in the 2015 Rule that the
‘‘the chemical, physical, and biological
integrity of downstream waters is
directly related to the aggregate
contribution of upstream waters that
flow into them, including any
tributaries and connected wetlands.’’ Id.
at 37066.
The agencies also retained exclusions
from the definition of ‘‘waters of the
United States’’ for prior converted
cropland and waste treatment systems.
Id. at 37105. In addition, the agencies
codified several exclusions that
reflected longstanding agency practice,
and added others such as ‘‘puddles’’
and ‘‘swimming pools’’ in response to
concerns raised by stakeholders during
the public comment period on the
proposed 2015 Rule. Id. at 37096–98,
37105.
B. Legal Challenges to the 2015 Rule
Following the 2015 Rule’s
publication, 31 States 5 and 53 non-state
4 ‘‘[T]he vast majority of the nation’s water
features are located within 4,000 feet of a covered
tributary, traditional navigable water, interstate
water, or territorial sea.’’ U.S. EPA and Department
of the Army. Economic Analysis of the EPA-Army
Clean Water Rule at 11 (May 20, 2015) (‘‘2015 Rule
Economic Analysis’’) (Docket ID: EPAHQ–OW–
2011–0880–20866), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-20866.
5 Alabama, Alaska, Arizona, Arkansas, Colorado,
Florida, Georgia, Idaho, Indiana, Kansas, Kentucky,
Louisiana, Michigan, Mississippi, Missouri,
Montana, Nebraska, Nevada, New Mexico
(Environment Department and State Engineer),
North Carolina (Department of Environment and
Natural Resources), North Dakota, Ohio, Oklahoma,
South Carolina, South Dakota, Tennessee, Texas,

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parties, including environmental
groups, and groups representing
farming, recreational, forestry, and other
interests, filed complaints and petitions
for review in multiple federal district 6
and appellate 7 courts challenging the
2015 Rule. In those cases, the
challengers alleged procedural
deficiencies in the development and
promulgation of the 2015 Rule and
substantive deficiencies in the 2015
Rule itself. Some challengers argued
that the 2015 Rule was too expansive
while others argued that it excluded too
many waters from federal jurisdiction.
The day before the 2015 Rule’s
August 28, 2015 effective date, the U.S.
District Court for the District of North
Dakota preliminarily enjoined the 2015
Rule in the 13 States that challenged the
rule in that court.8 The district court
found those States were ‘‘likely to
succeed’’ on the merits of their
challenge to the 2015 Rule because,
among other reasons, ‘‘it appears likely
that the EPA has violated its
Congressional grant of authority in its
promulgation of the Rule.’’ In particular,
the court noted concern that the 2015
Rule’s definition of tributary ‘‘includes
vast numbers of waters that are unlikely
to have a nexus to navigable waters.’’
Further, the court found that ‘‘it appears
likely that the EPA failed to comply
with [Administrative Procedure Act
(APA)] requirements when
promulgating the Rule,’’ suggesting that
certain distance-based measures were
not a logical outgrowth of the proposal
to the 2015 Rule. North Dakota v. EPA,
127 F. Supp. 3d 1047, 1051, 1056, 1058
(D.N.D. 2015). No party sought an
interlocutory appeal.
The petitions for review filed in the
courts of appeals were consolidated in
the U.S. Court of Appeals for the Sixth
Circuit. In that litigation, state and
industry petitioners raised concerns
about whether the 2015 Rule violates
the Constitution and the CWA and
whether its promulgation violated
Utah, West Virginia, Wisconsin, and Wyoming.
Iowa joined the legal challenge later in the process,
bringing the total to 32 States.
6 U.S. District Courts for the Northern and
Southern District of Georgia, District of Minnesota,
District of North Dakota, Southern District of Ohio,
Northern District of Oklahoma, Southern District of
Texas, District of Arizona, Northern District of
Florida, District of the District of Columbia,
Western District of Washington, Northern District of
California, and Northern District of West Virginia.
7 U.S. Court of Appeals for the Second, Fifth,
Sixth, Eighth, Ninth, Tenth, Eleventh, and District
of Columbia Circuits.
8 Alaska, Arizona, Arkansas, Colorado, Idaho,
Missouri, Montana, Nebraska, Nevada, New
Mexico, North Dakota, South Dakota, and
Wyoming. Iowa’s motion to intervene in the case
was granted after issuance of the preliminary
injunction.

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procedural requirements under the APA
and other statutes. Environmental
petitioners also challenged the 2015
Rule, including exclusions therein. On
October 9, 2015, approximately six
weeks after the 2015 Rule took effect in
the 37 States that were not subject to the
preliminary injunction issued by the
District of North Dakota, the Sixth
Circuit stayed the 2015 Rule nationwide
after finding, among other things, that
State petitioners had demonstrated ‘‘a
substantial possibility of success on the
merits of their claims.’’ In re EPA &
Dep’t of Def. Final Rule, 803 F.3d 804
(6th Cir. 2015) (‘‘In re EPA’’).
On January 13, 2017, the U.S.
Supreme Court granted certiorari on the
question of whether the courts of
appeals have original jurisdiction to
review challenges to the 2015 Rule. See
Nat’l Ass’n of Mfrs. v. Dep’t of Defense,
137 S. Ct. 811 (2017). The Sixth Circuit
granted petitioners’ motion to hold in
abeyance the briefing schedule in the
litigation challenging the 2015 Rule
pending a Supreme Court decision on
the question of the court of appeals’
jurisdiction. On January 22, 2018, the
Supreme Court, in a unanimous
opinion, held that the 2015 Rule is
subject to direct review in the district
courts. Nat’l Ass’n of Mfrs. v. Dep’t of
Def., 138 S. Ct. 617, 624 (2018).
Throughout the pendency of the
Supreme Court litigation (and for a short
time thereafter), the Sixth Circuit’s
nationwide stay remained in effect. In
response to the Supreme Court’s
decision, on February 28, 2018, the
Sixth Circuit lifted the stay and
dismissed the corresponding petitions
for review. See In re Dep’t of Def. & EPA
Final Rule, 713 Fed. App’x 489 (6th Cir.
2018).
Since the Supreme Court’s
jurisdictional ruling, district court
litigation regarding the 2015 Rule has
resumed. At this time, the 2015 Rule
continues to be subject to a preliminary
injunction issued by the District of
North Dakota as to 13 States: Alaska,
Arizona, Arkansas, Colorado, Idaho,
Missouri, Montana, Nebraska, Nevada,
North Dakota, South Dakota, Wyoming,
and New Mexico. The 2015 Rule also is
subject to a preliminary injunction
issued by the U.S. District Court for the
Southern District of Georgia as to 11
more States: Georgia, Alabama, Florida,
Indiana, Kansas, Kentucky, North
Carolina, South Carolina, Utah, West
Virginia, and Wisconsin. See Georgia v.
Pruitt, No. 15–cv–79 (S.D. Ga.). In
another action, the U.S. District Court
for the Southern District of Texas is
considering preliminary injunction
motions filed by parties including the
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Mississippi. See Texas v. EPA, No.
3:15–cv–162 (S.D. Tex.); Am. Farm
Bureau Fed’n et al. v. EPA, No. 3:15–cv–
165 (S.D. Tex.). At least three additional
States are seeking a preliminary
injunction in the U.S. District Court for
the Southern District of Ohio as well.
See, e.g., States’ Supplemental
Memorandum in Support of Preliminary
Injunction, Ohio v. EPA, No. 2:15–cv–
02467 (S.D. Ohio June 20, 2018) (brief
filed by the States of Ohio, Michigan,
and Tennessee in support of the States’
motion for a preliminary injunction
against the 2015 Rule).
C. Executive Order 13778, the Notice of
Proposed Rulemaking, and the
Applicability Date Rule
The agencies are engaged in a twostep process intended to review and
repeal or revise, as appropriate and
consistent with law, the definition of
‘‘waters of the United States’’ as set
forth in the 2015 Rule. This process
began in response to Executive Order
13778 issued on February 28, 2017, by
the President entitled ‘‘Restoring the
Rule of Law, Federalism, and Economic
Growth by Reviewing the ‘Waters of the
United States’ Rule.’’ Section 1 of the
Executive Order states, ‘‘[i]t is in the
national interest to ensure the Nation’s
navigable waters are kept free from
pollution, while at the same time
promoting economic growth,
minimizing regulatory uncertainty, and
showing due regard for the roles of the
Congress and the States under the
Constitution.’’ The Order directed the
EPA and the Army to review the 2015
Rule for consistency with the policy
outlined in Section 1 of the Order and
to issue a proposed rule rescinding or
revising the 2015 Rule as appropriate
and consistent with law (Section 2). The
Executive Order also directed the
agencies to ‘‘consider interpreting the
term ‘navigable waters’ . . . in a manner
consistent with’’ Justice Scalia’s
plurality opinion in Rapanos (Section
3).
On March 6, 2017, the agencies
published a notice of intent to review
the 2015 Rule and provide notice of a
forthcoming proposed rulemaking
consistent with the Executive Order. 82
FR 12532. Shortly thereafter, the
agencies announced that they would
implement the Executive Order in a
two-step approach. On July 27, 2017,
the agencies published a NPRM (82 FR
34899) that proposed to rescind the
2015 Rule and restore the regulatory text
that governed prior to the promulgation
of the 2015 Rule, which the agencies
have been implementing since the
judicial stay of the 2015 Rule consistent
with Supreme Court decisions and

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informed by applicable guidance
documents and longstanding agency
practice. The agencies invited comment
on the NPRM over a 62-day period.
Shortly after the Supreme Court
decided that the courts of appeals do
not have original jurisdiction to review
challenges to the 2015 Rule and directed
the Sixth Circuit to dismiss the
consolidated challenges to the 2015
Rule for lack of jurisdiction, the
agencies issued a final rule (83 FR 5200,
Feb. 6, 2018), after providing notice and
an opportunity for public comment, that
added an applicability date to the 2015
Rule. The applicability date was
established as February 6, 2020. When
adding the applicability date to the 2015
Rule, the agencies clarified that they
will continue to implement nationwide
the previous regulatory definition of
‘‘waters of the United States,’’ consistent
with the practice and procedures the
agencies implemented before and
immediately following the issuance of
the 2015 Rule pursuant to the
preliminary injunction issued by the
District of North Dakota and the
nationwide stay issued by the Sixth
Circuit. The agencies further explained
that the final applicability date rule
would ensure regulatory certainty and
consistent implementation of the CWA
nationwide while the agencies
reconsider the 2015 Rule and
potentially pursue further rulemaking to
develop a new definition of ‘‘waters of
the United States.’’ The applicability
date rule was challenged in a number of
district courts. Generally, the challenges
raise concerns that the agencies’ action
was arbitrary and capricious because the
agencies did not address substantive
comments regarding the 2015 Rule, as
well as procedural concerns with
respect to the length of the public
comment period for the proposed
applicability date rule. At this time,
these challenges remain pending in the
district courts where they were filed.
D. Comments on the Original Notice of
Proposed Rulemaking
The agencies accepted comments on
the NPRM from July 27, 2017, through
September 27, 2017. The agencies
received more than 685,000 comments
on the NPRM from a broad spectrum of
interested parties. The agencies are
continuing to review those extensive
comments. Some commenters expressed
support for the agencies’ proposal to
repeal the 2015 Rule, stating, among
other things, that the 2015 Rule exceeds
the agencies’ statutory authority. Other
commenters opposed the proposal,
stating, among other things, that
repealing the 2015 Rule will increase

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regulatory uncertainty and adversely
impact water quality.
Based on the agencies’ careful and
ongoing review of the comments
submitted in response to the NPRM, the
agencies believe that it is in the public
interest to provide further explanation
and allow interested parties additional
opportunity to comment on the
proposed repeal of the 2015 Rule.
Because some commenters interpreted
the NPRM as restricting their ability to
comment on the legal and policy
reasons for or against the repeal of the
2015 Rule while others submitted
comments addressing these topics, the
agencies wish to make clear that
comments on that subject are solicited.
Additionally, some commenters
appeared to be confused by whether the
agencies proposed a temporary or
interim, as opposed to a permanent,
repeal of the 2015 Rule. While the
agencies did refer to the July 2017
proposal as an ‘‘interim action’’ (82 FR
34902), that was in the context of
explaining that the proposal to repeal
the 2015 Rule is the first step of a twostep process, as described above, and
that the agencies are planning to take
the additional, second step of
conducting a separate notice and
comment rulemaking to propose a new
definition of ‘‘waters of the United
States.’’ In this notice, the agencies are
clarifying that, regardless of the timing
or ultimate outcome of that additional
rulemaking, the agencies are proposing
a permanent repeal of the 2015 Rule at
this stage. This was also our intent in
the NPRM. Finally, some commenters
did not fully understand the precise
action the NPRM proposed to take, e.g.,
repealing, staying, or taking some other
action with respect to the 2015 Rule.
The agencies are issuing this SNPRM
and are inviting all interested persons to
comment on whether the agencies
should repeal the 2015 Rule and
recodify the regulations currently being
implemented by the agencies.
E. Comments on This Supplemental
Notice of Proposed Rulemaking
As discussed in the next sections, the
agencies are proposing to permanently
repeal the 2015 Rule. The agencies
welcome comment on all issues that are
relevant to the consideration of whether
to repeal the 2015 Rule. In response to
the initial NPRM, many commenters
have already provided comment on
considerations and issues that weigh in
favor of or against repeal, including
many of the issues articulated below.
The agencies will consider all of those
previously submitted comments, in
addition to any new comments
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in taking a final action on this
rulemaking. As such, commenters need
not resubmit comments already
provided in response to the agencies’
July 27, 2017 NPRM (82 FR 34899).
II. Proposal To Repeal the 2015 Rule
A. Legal Authority To Repeal
The agencies’ ability to repeal an
existing regulation through notice-andcomment rulemaking is well-grounded
in the law. The APA defines rulemaking
to mean ‘‘agency process for
formulating, amending, or repealing a
rule.’’ 5 U.S.C. 551(5). The CWA
complements this authority by
providing the Administrator with broad
authority to ‘‘prescribe such regulations
as are necessary to carry out the
functions under this Act.’’ 33 U.S.C.
1361(a). This broad authority includes
regulations that repeal or revise CWA
implementing regulations promulgated
by a prior administration.
The Supreme Court has made clear
that ‘‘[a]gencies are free to change their
existing policies as long as they provide
a reasoned explanation for the change,’’
and ‘‘[w]hen an agency changes its
existing position, it ‘need not always
provide a more detailed justification
than what would suffice for a new
policy created on a blank slate.’ ’’
Encino Motorcars, LLC v. Navarro, 136
S. Ct. 2117, 2125 (2016) (citations
omitted). The NPRM discussed how the
agencies may revise or repeal the
regulatory definition of ‘‘waters of the
United States’’ so long as the agencies’
action is based on a reasoned
explanation. See 82 FR 34901. The
agencies can do so based on changes in
circumstance, or changes in statutory
interpretation or policy judgments. See,
e.g., FCC v. Fox Television Stations,
Inc., 556 U.S. 502, 514–15 (2009); Ctr.
for Sci. in Pub. Interest v. Dep’t of
Treasury, 797 F.2d 995, 998–99 & n.1
(D.C. Cir. 1986). The agencies’
interpretation of the statutes they
administer, such as the CWA, are not
‘‘instantly carved in stone’’; quite the
contrary, the agencies ‘‘must consider
varying interpretations and the wisdom
of [their] policy on a continuing basis,
. . . for example, in response to . . . a
change in administrations.’’ Nat’l Cable
& Telecommc’ns Ass’n v. Brand X
Internet Servs., 545 U.S. 967, 981–82
(2005) (‘‘Brand X’’) (internal quotation
marks omitted) (quoting Chevron
U.S.A., Inc. v. NRDC, 467 U.S. 837, 863–
64 (1984)) (citing Motor Vehicle Mfrs.
Ass’n v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29, 59 (1983) (Rehnquist, J.,
concurring in part and dissenting in
part)). The Supreme Court and lower
courts have acknowledged an agency’s

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ability to repeal regulations
promulgated by a prior administration
based on changes in agency policy
where ‘‘the agency adequately explains
the reasons for a reversal of policy.’’ See
Brand X, 545 U.S. at 981. A revised
rulemaking based ‘‘on a reevaluation of
which policy would be better in light of
the facts’’ is ‘‘well within an agency’s
discretion,’’ and ‘‘[a] change in
administration brought about by the
people casting their votes is a perfectly
reasonable basis for an executive
agency’s reappraisal’’ of its regulations
and programs. Nat’l Ass’n of Home
Builders v. EPA, 682 F.3d 1032, 1038 &
1043 (D.C. Cir. 2012) (‘‘NAHB’’).
B. Legal Background
1. The Clean Water Act
Congress amended the Federal Water
Pollution Control Act (FWPCA), or
Clean Water Act (CWA) as it is
commonly called,9 in 1972 to address
longstanding concerns regarding the
quality of the nation’s waters and the
federal government’s ability to address
those concerns under existing law. Prior
to 1972, the ability to control and
redress water pollution in the nation’s
waters largely fell to the Corps under
the Rivers and Harbors Act of 1899.
Congress had also enacted the Water
Pollution Control Act of 1948, Public
Law 80–845, 62 Stat. 1155 (June 30,
1948), to address interstate water
pollution, and subsequently amended
that statute in 1956 (giving the statute is
current formal name), 1961, and 1965.
The early versions of the CWA
promoted the development of pollution
abatement programs, required states to
develop water quality standards, and
authorized the federal government to
bring enforcement actions to abate water
pollution.
These early statutory efforts, however,
proved inadequate to address the
decline in the quality of the nation’s
waters, see City of Milwaukee v. Illinois,
451 U.S. 304, 310 (1981), so Congress
performed a ‘‘total restructuring’’ and
‘‘complete rewriting’’ of the existing
statutory framework in 1972, id. at 317
(quoting legislative history of 1972
amendments). That restructuring
resulted in the enactment of a
comprehensive scheme designed to
prevent, reduce, and eliminate pollution
in the nation’s waters generally, and to
regulate the discharge of pollutants into
navigable waters specifically. See, e.g.,
9 The FWPCA is commonly referred to as the
CWA following the 1977 amendments to the
FWPCA. Public Law 95–217, 91 Stat. 1566 (1977).
For ease of reference, the agencies will generally
refer to the FWPCA in this notice as the CWA or
the Act.

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S.D. Warren Co. v. Maine Bd. of Envtl.
Prot., 547 U.S. 370, 385 (2006) (‘‘[T]he
Act does not stop at controlling the
‘addition of pollutants,’ but deals with
‘pollution’ generally[.]’’).
The objective of the new statutory
scheme was ‘‘to restore and maintain
the chemical, physical, and biological
integrity of the Nation’s waters.’’ 33
U.S.C. 1251(a). In order to meet that
objective, Congress declared two
national goals: (1) ‘‘that the discharge of
pollutants into the navigable waters be
eliminated by 1985;’’ and (2) ‘‘that
wherever attainable, an interim goal of
water quality which provides for the
protection and propagation of fish,
shellfish, and wildlife and provides for
recreation in and on the water be
achieved by July 1, 1983. . . .’’ Id. at
1251(a)(1)–(2).
Congress established several key
policies that direct the work of the
agencies to effectuate those goals. For
example, Congress declared as a
national policy ‘‘that the discharge of
toxic pollutants in toxic amounts be
prohibited; . . . that Federal financial
assistance be provided to construct
publicly owned waste treatment works;
. . . that areawide waste treatment
management planning processes be
developed and implemented to assure
adequate control of sources of pollutants
in each State; . . . [and] that programs
for the control of nonpoint sources of
pollution be developed and
implemented in an expeditious manner
so as to enable the goals of this Act to
be met through the control of both point
and nonpoint sources of pollution.’’ Id.
at 1251(a)(3)–(7).
Congress envisioned a major role for
the states in implementing the CWA,
and the CWA also recognizes the
importance of preserving the states’
independent authority and
responsibility in this area. The CWA
balances the traditional power of states
to regulate land and water resources
within their borders with the need for
a federal water quality regulation to
protect the waters of the United States.
For example, the statute reflects ‘‘the
policy of the Congress to recognize,
preserve, and protect the primary
responsibilities and rights of States to
prevent, reduce, and eliminate
pollution’’ and ‘‘to plan the
development and use . . . of land and
water resources. . . .’’ Id. at 1251(b).
Congress also declared as a national
policy that states manage the major
construction grant program and
implement the core permitting programs
authorized by the statute, among other
responsibilities. Id. Congress added that
‘‘nothing in this Act shall . . . be
construed as impairing or in any

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manner affecting any right or
jurisdiction of the States with respect to
the waters (including boundary waters)
of such States.’’ Id. at 1370. Congress
also pledged to provide technical
support and financial aid to the states
‘‘in connection with the prevention,
reduction, and elimination of
pollution.’’ Id. at 1251(b).
To carry out these policies, Congress
broadly defined ‘‘pollution’’ to mean
‘‘the man-made or man-induced
alteration of the chemical, physical,
biological, and radiological integrity of
water,’’ id. at 1362(19), to parallel the
broad objective of the Act ‘‘to restore
and maintain the chemical, physical,
and biological integrity of the Nation’s
waters,’’ id. at 1251(a). Congress then
crafted a non-regulatory statutory
framework to provide technical and
financial assistance to the states to
prevent, reduce, and eliminate pollution
in the broader set of the nation’s waters.
For example, section 105 of the Act,
‘‘Grants for research and development,’’
authorized EPA ‘‘to make grants to any
State or States or interstate agency to
demonstrate, in river basins or portions
thereof, advanced treatment and
environmental enhancement techniques
to control pollution from all sources,
. . . including nonpoint sources, . . .
[and] for research and demonstration
projects for prevention of pollution of
any waters by industry including, but
not limited to, the prevention,
reduction, and elimination of the
discharge of pollutants.’’ 33 U.S.C.
1255(b)–(c) (emphases added); see also
id. at 1256(a) (authorizing EPA to issue
‘‘grants to States and to interstate
agencies to assist them in administering
programs for the prevention, reduction,
and elimination of pollution’’). Section
108, ‘‘Pollution control in the Great
Lakes,’’ authorized EPA to enter into
agreements with any state to develop
plans for the ‘‘elimination or control of
pollution, within all or any part of the
watersheds of the Great Lakes.’’ Id. at
1258(a) (emphasis added); see also id. at
1268(a)(3)(C) (defining the ‘‘Great Lakes
System’’ as ‘‘all the streams, rivers,
lakes, and other bodies of water within
the drainage basin of the Great Lakes’’).
Similar broad pollution control
programs were created for other major
watersheds, including, for example, the
Chesapeake Bay, see id. at 1267(a)(3),
Long Island Sound, see id. at
1269(c)(2)(D), and Lake Champlain, see
id. at 1270(g)(2).
For the narrower set of the nation’s
waters identified as ‘‘navigable waters’’
or ‘‘the waters of the United States,’’ id.
at 1362(7), Congress created a federal
regulatory permitting program designed
to address the discharge of pollutants

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into those waters. Section 301 contains
the key regulatory mechanism: ‘‘Except
as in compliance with this section and
sections 302, 306, 307, 318, 402, and
404 of this Act, the discharge of any
pollutant by any person shall be
unlawful.’’ Id. at 1311(a). A ‘‘discharge
of a pollutant’’ is defined to include
‘‘any addition of any pollutant to
navigable waters from any point
source,’’ such as a pipe, ditch or other
‘‘discernible, confined and discrete
conveyance.’’ Id. at 1362(12), (14)
(emphasis added). The term
‘‘pollutant,’’ as compared to the broader
term ‘‘pollution,’’ id. at 1362(19), means
‘‘dredged spoil, solid waste, incinerator
residue, sewage, garbage, sewage sludge,
munitions, chemical wastes, biological
materials, radioactive materials, heat,
wrecked or discarded equipment, rock,
sand, cellar dirt and industrial,
municipal, and agricultural waste
discharged into water.’’ Id. at 1362(6).
Thus, it is unlawful to discharge
pollutants into navigable waters
(defined in the Act as ‘‘the waters of the
United States’’) from a point source
unless the discharge complies with
certain enumerated sections of the
CWA, including obtaining
authorizations to discharge pollutants
pursuant to the section 402 National
Pollutant Discharge Elimination System
(NPDES) permit program and the
section 404 dredged or fill material
permit program. See id. at 1342 and
1344.
Under this statutory scheme, the
states are responsible for developing
water quality standards for waters of the
United States within their borders and
reporting on the condition of those
waters to EPA every two years. Id. at
1313, 1315. States are also responsible
for developing total maximum daily
loads (TMDLs) for waters that are not
meeting established water quality
standards and must submit those
TMDLs to EPA for approval. Id. at
1313(d). States also have authority to
issue water quality certifications or
waive certification for every federal
permit or license issued within their
borders that may result in a discharge to
navigable waters. Id. at 1341. A change
to the interpretation of ‘‘waters of the
United States’’ may change the scope of
waters subject to CWA jurisdiction and
thus may change the scope of waters for
which states may assume these
responsibilities under the Act.
These same regulatory authorities can
be assumed by Indian tribes under
section 518 of the CWA, which
authorizes EPA to treat eligible Indian
tribes in a manner similar to states for
a variety of purposes, including
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CWA regulatory programs. Id. at
1377(e). In addition, states and tribes
retain sovereign authority to protect and
manage the use of those waters that are
not navigable waters under the CWA.
See, e.g., id. at 1251(b), 1251(g), 1370,
1377(a). Forty-seven states administer
the CWA section 402 permit program for
those waters of the United States within
their boundaries, and two administer
the section 404 permit program. At
present, no tribes administer the section
402 or 404 programs.
The agencies must develop regulatory
programs designed to ensure that the
full statute is implemented as Congress
intended. See, e.g., Hibbs v. Winn, 542
U.S. 88, 101 (2004) (‘‘A statute should
be construed so that effect is given to all
its provisions, so that no part will be
inoperative or superfluous, void or
insignificant.’’). This includes pursuing
the overall ‘‘objective’’ of the CWA to
‘‘restore and maintain the chemical,
physical, and biological integrity of the
Nation’s waters,’’ 33 U.S.C. 1251(a),
while implementing the specific
‘‘policy’’ directives from Congress to,
among other things, ‘‘recognize,
preserve, and protect the primary
responsibilities and rights of States to
prevent, reduce, and eliminate
pollution’’ and ‘‘to plan the
development and use . . . of land and
water resources,’’ id. at 1251(b). See
Webster’s II, New Riverside University
Dictionary (1994) (defining ‘‘policy’’ as
a ‘‘plan or course of action, as of a
government[,] designed to influence and
determine decisions and actions;’’ an
‘‘objective’’ is ‘‘something worked
toward or aspired to: Goal’’). To
maintain that balance, the agencies must
determine what Congress had in mind
when it defined ‘‘navigable waters’’ in
1972 as simply ‘‘the waters of the
United States’’—and must do so in light
of, inter alia, the policy directive to
preserve and protect the states’ rights
and responsibilities.
Congress’ authority to regulate
navigable waters derives from its power
to regulate the ‘‘channels of interstate
commerce’’ under the Commerce
Clause. Gibbons v. Ogden, 22 U.S. (9
Wheat.) 1 (1824); see also United States
v. Lopez, 514 U.S. 549, 558–59 (1995)
(describing the ‘‘channels of interstate
commerce’’ as one of three areas of
congressional authority under the
Commerce Clause). The Supreme Court
explained in SWANCC that the term
‘‘navigable’’ indicates ‘‘what Congress
had in mind as its authority for enacting
the Clean Water Act: its traditional
jurisdiction over waters that were or had
been navigable in fact or which could
reasonably be so made.’’ 531 U.S. 159,
172 (2001). The Court further explained

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that nothing in the legislative history of
the Act provides any indication that
‘‘Congress intended to exert anything
more than its commerce power over
navigation.’’ Id. at 168 n.3.
The Supreme Court has cautioned
that one must look to the underlying
purpose of the statute to determine the
scope of federal authority being
exercised over navigable waters under
the Commerce Clause. See PPL
Montana, LLC v. Montana, 132 S. Ct.
1215, 1228 (2012). The Supreme Court
did that in United States v. Riverside
Bayview Homes, for example, and
determined that Congress had intended
‘‘to exercise its powers under the
Commerce Clause to regulate at least
some waters that would not be deemed
‘navigable’ under the classical
understanding of that term.’’ 474 U.S.
121, 133 (1985) (‘‘[T]he evident breadth
of congressional concern for protection
of water quality and aquatic ecosystems
suggests that it is reasonable for the
Corps to interpret the term ‘waters’ to
encompass wetlands adjacent to waters
as more conventionally defined.’’); see
also SWANCC, 531 U.S. at 167 (noting
that the Riverside Bayview ‘‘holding was
based in large measure upon Congress’
unequivocal acquiescence to, and
approval of, the Corps’ regulations
interpreting the CWA to cover wetlands
adjacent to navigable waters’’).
The classical understanding of the
term navigable was first articulated by
the Supreme Court in The Daniel Ball:
Those rivers must be regarded as public
navigable rivers in law which are navigable
in fact. And they are navigable in fact when
they are used, or are susceptible of being
used, in their ordinary condition, as
highways of commerce, over which trade and
travel are or may be conducted in the
customary modes of trade and travel on
water. And they constitute navigable waters
of the United States within the meaning of
the Acts of Congress, in contradistinction
from the navigable waters of the States, when
they form in their ordinary condition by
themselves, or by uniting with other waters,
a continued highway over which commerce
is or may be carried on with other States or
foreign countries in the customary modes in
which such commerce is conducted by water.

77 U.S. (10 Wall.) 557, 563 (1871). Over
the years, this traditional test has been
expanded to include waters that had
been used in the past for interstate
commerce, see Economy Light & Power
Co. v. United States, 256 U.S. 113, 123
(1921), and waters that are susceptible
for use with reasonable improvement,
see United States v. Appalachian Elec.
Power Co., 311 U.S. 377, 407–10 (1940).
By the time the 1972 CWA
amendments were enacted, the Supreme
Court had also made clear that Congress’
authority over the channels of interstate

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commerce was not limited to regulation
of the channels themselves, but could
extend to activities necessary to protect
the channels. See Oklahoma ex rel.
Phillips v. Guy F. Atkinson Co., 313 U.S.
508, 523 (1941) (‘‘Congress may exercise
its control over the non-navigable
stretches of a river in order to preserve
or promote commerce on the navigable
portions.’’). The Supreme Court had also
clarified that Congress could regulate
waterways that formed a part of a
channel of interstate commerce, even if
they are not themselves navigable or do
not cross state boundaries. See Utah v.
United States, 403 U.S. 9, 11 (1971).
These developments were discussed
during the legislative process leading up
to the passage of the 1972 CWA
amendments, and certain members
referred to the scope of the amendments
as encompassing waterways that serve
as ‘‘links in the chain’’ of interstate
commerce as it flows through various
channels of transportation, such as
railroads and highways. See, e.g., 118
Cong. Rec. 33756–57 (1972) (statement
of Rep. Dingell); 118 Cong. Rec. 33699
(Oct. 4, 1972) (statement of Sen.
Muskie).10 Other references suggest that
congressional committees at least
contemplated applying the ‘‘control
requirements’’ of the Act ‘‘to the
navigable waters, portions thereof, and
their tributaries.’’ S. Rep. No. 92–414,
92nd Cong., 1st Sess. at 77 (1971). And
in 1977, when Congress authorized
State assumption over the section 404
dredged or fill material permitting
program, Congress limited the scope of
assumable waters by requiring the Corps
to retain permitting authority over
Rivers and Harbors Act waters (as
identified by the Daniel Ball test) plus
wetlands adjacent to those waters,
minus historic use only waters. See 33
U.S.C. 1344(g)(1).11 This suggests that
Congress had in mind a broader scope
of waters subject to CWA jurisdiction
than waters traditionally understood as
navigable. See SWANCC, 531 U.S. at
171; Riverside Bayview, 474 U.S. at 138
n.11.
Thus, Congress intended to assert
federal authority over more than just
waters traditionally understood as
navigable, and Congress rooted that
10 The agencies recognize that individual member
statements are not a substitute for full congressional
intent, but they do help provide context for issues
that were discussed during the legislative debates.
For a detailed discussion of the legislative history
of the 1972 CWA amendments, see Albrecht &
Nickelsburg, Could SWANCC Be Right? A New Look
at the Legislative History of the Clean Water Act,
32 ELR 11042 (Sept. 2002).
11 For a detailed discussion of the legislative
history supporting the enactment of section 404(g),
see Final Report of the Assumable Waters
Subcommittee (May 2017), App. F.

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authority in ‘‘its commerce power over
navigation.’’ SWANCC, 531 U.S. at 168
n.3. However, there must necessarily be
a limit to that authority and to what
water is subject to federal jurisdiction.
How the agencies should exercise that
authority has been the subject of dispute
for decades, but the Supreme Court on
three occasions has analyzed the issue
and provided some instructional
guidance.
2. U.S. Supreme Court Precedent
a. Adjacent Wetlands
In Riverside Bayview, the Supreme
Court considered the Corps’ assertion of
jurisdiction over ‘‘low-lying, marshy
land’’ immediately abutting a water
traditionally understood as navigable on
the grounds that it was an ‘‘adjacent
wetland’’ within the meaning of the
Corps’ then-existing regulations. 474
U.S. at 124. The Court addressed the
question whether non-navigable
wetlands may be regulated as ‘‘waters of
the United States’’ on the basis that they
are ‘‘adjacent to’’ navigable-in-fact
waters and ‘‘inseparably bound up
with’’ them because of their ‘‘significant
effects on water quality and the aquatic
ecosystem.’’ See id. at 131–35 & n.9.
In analyzing the meaning of
adjacency, the Court captured the
difficulty in determining where the
limits of federal jurisdiction end, noting
that the line is somewhere between
open water and dry land:

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In determining the limits of its power to
regulate discharges under the Act, the Corps
must necessarily choose some point at which
water ends and land begins. Our common
experience tells us that this is often no easy
task: The transition from water to solid
ground is not necessarily or even typically an
abrupt one. Rather, between open waters and
dry land may lie shallows, marshes,
mudflats, swamps, bogs—in short, a huge
array of areas that are not wholly aquatic but
nevertheless fall far short of being dry land.
Where on this continuum to find the limit of
‘‘waters’’ is far from obvious.

Id. at 132 (emphasis added). Within this
statement, the Supreme Court identifies
a basic principle for adjacent wetlands:
The limits of jurisdiction lie within the
‘‘continuum’’ or ‘‘transition’’ ‘‘between
open waters and dry land.’’ Observing
that Congress intended the CWA ‘‘to
regulate at least some waters that would
not be deemed ‘navigable,’ ’’ the Court
therefore held that it is ‘‘a permissible
interpretation of the Act’’ to conclude
that ‘‘a wetland that actually abuts on a
navigable waterway’’ falls within the
‘‘definition of ‘waters of the United
States.’ ’’ Id. at 133, 135. Thus, a
wetland that abuts a navigable water
traditionally understood as navigable is
subject to CWA permitting because it is

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‘‘inseparably bound up with the ‘waters’
of the United States.’’ Id. at 134. ‘‘This
holds true even for wetlands that are not
the result of flooding or permeation by
water having its source in adjacent
bodies of open water.’’ Id. The Court
also noted that the agencies can
establish categories of jurisdiction for
adjacent wetlands. See id. at 135 n.9.
The Supreme Court in Riverside
Bayview declined to decide whether
wetlands that are not adjacent to
navigable waters could also be regulated
by the agencies. See id. at 124 n.2 & 131
n.8. In SWANCC, however, the Supreme
Court analyzed a similar question in the
context of an abandoned sand and
gravel pit located some distance from a
traditional navigable water, with
excavation trenches that ponded—some
only seasonally—and served as habitat
for migratory birds. 531 U.S. at 162–65.
The Supreme Court rejected the
government’s stated rationale for
asserting jurisdiction over these
‘‘nonnavigable, isolated, intrastate
waters.’’ Id. at 171–72. In doing so, the
Supreme Court noted that Riverside
Bayview upheld ‘‘jurisdiction over
wetlands that actually abutted on a
navigable waterway’’ because the
wetlands were ‘‘inseparably bound up
with the ‘waters’ of the United States.’’
Id. at 167.12 As summarized by the
SWANCC majority:

The Court dismissed the argument
that the use of the abandoned ponds by
migratory birds fell within the power of
Congress to regulate activities that in the
aggregate have a substantial effect on
interstate commerce, or that the targeted
use of the ponds as a municipal landfill
was commercial in nature. Id. at 173.
Such arguments, the Court noted, raised
‘‘significant constitutional questions.’’
Id. ‘‘Where an administrative
interpretation of a statute invokes the
outer limits of Congress’ power, we
expect a clear indication that Congress
intended that result.’’ Id. at 172–73
(‘‘Congress does not casually authorize
administrative agencies to interpret a
statute to push the limit of
congressional authority.’’). This is
particularly true ‘‘where the
administrative interpretation alters the
federal-state framework by permitting
federal encroachment upon a traditional
state power.’’ Id. at 173; see also
Atascadero State Hospital v. Scanlon,
473 U.S. 234, 242–43 (1985) (finding
that where Congress intends to alter the
‘‘usual constitutional balance between
the States and the Federal Government,’’
it must make its intention to do so
‘‘unmistakably clear in the language of
the statute’’); Gregory v. Ashcroft, 501
U.S. 452, 460–61 (1991) (‘‘[The] plain
statement rule . . . acknowledg[es] that
the States retain substantial sovereign
powers under our constitutional
It was the significant nexus between the
scheme, powers with which Congress
wetlands and ‘‘navigable waters’’ that
does not readily interfere.’’). ‘‘Rather
informed our reading of the CWA in
Riverside Bayview Homes. Indeed, we did not than expressing a desire to readjust the
federal-state balance in this manner,
‘‘express any opinion’’ on the ‘‘question of
Congress chose [in the CWA] to
authority of the Corps to regulate discharges
of fill material into wetlands that are not
‘recognize, preserve, and protect the
adjacent to bodies of open water. . . . In
primary responsibilities and rights of
order to rule for [the Corps] here, we would
States . . . to plan the development and
have to hold that the jurisdiction of the Corps use . . . of land and water resources.
extends to ponds that are not adjacent to
. . .’’ SWANCC, 531 U.S. at 174
open water. But we conclude that the text of
(quoting 33 U.S.C. 1251(b)). The Court
the statute will not allow this.
therefore found no clear statement from
Id. at 167–68 (internal citations
Congress that it had intended to permit
omitted). That is because the text of
federal encroachment on traditional
section 404(a)—the permitting provision state power, and construed the CWA to
at issue in the case—included the word
avoid the significant constitutional
‘‘navigable’’ as its operative phrase, and questions related to the scope of federal
signaled a clear direction to the Court
authority authorized therein. Id.
that ‘‘Congress had in mind . . . its
The Supreme Court considered the
traditional jurisdiction over waters that
concept of adjacency again several years
were or had been navigable in fact or
later in consolidated cases arising out of
which could reasonably be so made.’’
the Sixth Circuit. See Rapanos v. United
Id. at 172.
States, 547 U.S. 715 (2006). In one case,
the Corps had determined that wetlands
12 For additional context, at oral argument during
on three separate sites were subject to
Riverside Bayview, the government attorney
CWA jurisdiction because they were
characterized the wetland at issue as ‘‘in fact an
adjacent to ditches or man-made drains
adjacent wetland, adjacent—by adjacent, I mean it
is immediately next to, abuts, adjoins, borders,
that eventually connected to traditional
whatever other adjective you might want to use,
navigable waters several miles away
navigable waters of the United States.’’ Transcript
through other ditches, drains, creeks,
of Oral Argument at 16, United States v. Riverside
and/or rivers. Id. at 719–20, 729. In
Bayview Homes, Inc., 474 U.S. 121 (1985) (No. 84–
701).
another case, the Corps had asserted

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jurisdiction over a wetland separated
from a man-made drainage ditch by a
four-foot-wide man-made berm. Id. at
730. The ditch emptied into another
ditch, which then connected to a creek,
and eventually connected to Lake St.
Clair, a traditional navigable water,
approximately a mile from the parcel at
issue. The berm was largely or entirely
impermeable, but may have permitted
occasional overflow from the wetland to
the ditch. Id. The Court, in a fractured
opinion, vacated and remanded the
Sixth Circuit’s decision upholding the
Corps’ asserted jurisdiction over the
four wetlands at issue, with Justice
Scalia writing for the plurality and
Justice Kennedy concurring in the
judgment. Id. at 757 (plurality), 787
(Kennedy, J.).
The plurality determined that CWA
jurisdiction only extended to adjacent
‘‘wetlands with a continuous surface
connection to bodies that are ‘waters of
the United States’ in their own right, so
that there is no clear demarcation
between ‘waters’ and wetlands.’’ Id. at
742. The plurality then concluded that
‘‘establishing that wetlands . . . are
covered by the Act requires two
findings: first, that the adjacent channel
contains a ‘wate[r] of the United States,’
(i.e., a relatively permanent body of
water connected to traditional interstate
navigable waters); and second, that the
wetland has a continuous surface
connection with that water, making it
difficult to determine where the ‘water’
ends and the ‘wetland’ begins.’’ Id.
(alteration in original).
In order to reach the adjacency
conclusion of this two-part test, the
plurality interpreted the Riverside
Bayview decision, and subsequent
SWANCC decision characterizing
Riverside Bayview, as authorizing
jurisdiction over wetlands that
physically abutted traditional navigable
waters. Id. at 740–42. The plurality
focused on the ‘‘inherent ambiguity’’
described in Riverside Bayview in
determining where on the continuum
between open waters and dry land the
scope of federal jurisdiction should end.
Id. at 740. It was ‘‘the inherent
difficulties of defining precise bounds to
regulable waters,’’ id. at 741 n.10,
according to the plurality, that
prompted the Court in Riverside
Bayview to defer to the Corps’ inclusion
of adjacent wetlands as ‘‘waters’’ subject
to CWA jurisdiction based on ecological
considerations. Id. at 740–41 (‘‘When
we characterized the holding of
Riverside Bayview in SWANCC, we
referred to the close connection between
waters and the wetlands they gradually
blend into: ‘It was the significant nexus
between the wetlands and ‘navigable

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waters’ that informed our reading of the
CWA in Riverside Bayview Homes.’ ’’).
The plurality also noted that ‘‘SWANCC
rejected the notion that the ecological
considerations upon which the Corps
relied in Riverside Bayview . . .
provided an independent basis for
including entities like ‘wetlands’ (or
‘ephemeral streams’) within the phrase
‘the waters of the United States.’
SWANCC found such ecological
considerations irrelevant to the question
whether physically isolated waters
come within the Corps’ jurisdiction.’’ Id.
at 741–42 (emphasis in original).
Justice Kennedy disagreed with the
plurality’s determination that adjacency
requires a ‘‘continuous surface
connection’’ to covered waters. Id. at
772. In reading the phrase ‘‘continuous
surface connection’’ to mean a
continuous ‘‘surface-water connection,’’
id. at 776, and interpreting the
plurality’s standard to include a
‘‘surface-water-connection
requirement,’’ id. at 774, Justice
Kennedy stated that ‘‘when a surfacewater connection is lacking, the
plurality forecloses jurisdiction over
wetlands that abut navigable-in-fact
waters—even though such navigable
waters were traditionally subject to
federal authority,’’ id. at 776, even after
the Riverside Bayview Court ‘‘deemed it
irrelevant whether ‘the moisture
creating the wetlands . . . find[s] its
source in the adjacent bodies of water,’’
id. at 772 (internal citations omitted).
This is one reason why Justice Kennedy
stated that ‘‘Riverside Bayview’s
observations about the difficulty of
defining the water’s edge cannot be
taken to establish that when a clear
boundary is evident, wetlands beyond
that boundary fall outside the Corps’
jurisdiction.’’ Id. at 773.
The plurality did not directly address
the precise distinction raised by Justice
Kennedy, but did note in response that
the ‘‘Riverside Bayview opinion
required’’ a ‘‘continuous physical
connection,’’ id. at 751 n.13 (emphasis
added), and focused on evaluating
adjacency between a ‘‘water’’ and a
wetland ‘‘in the sense of possessing a
continuous surface connection that
creates the boundary-drawing problem
we addressed in Riverside Bayview.’’ Id.
at 757. The plurality also noted that its
standard includes a ‘‘physicalconnection requirement’’ between
wetlands and covered waters. Id. at 751
n.13. In other words, the plurality
appeared to be more focused on the
abutting nature rather than the source of
water creating the wetlands at issue in
Riverside Bayview to describe the legal
constructs applicable to adjacent
wetlands, see id. at 747; see also

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Webster’s II, New Riverside University
Dictionary (1994) (defining ‘‘abut’’ to
mean ‘‘to border on’’ or ‘‘to touch at one
end or side of something’’), and indeed
agreed with Justice Kennedy and the
Riverside Bayview Court that ‘‘[a]s long
as the wetland is ‘adjacent’ to covered
waters . . . its creation vel non by
inundation is irrelevant.’’ Id. at 751
n.13.13
Because physically disconnected
wetlands do not raise the same
boundary-drawing concerns presented
by actually abutting wetlands, the
plurality determined that the rationale
in Riverside Bayview does not apply to
such features. The plurality stated that
‘‘[w]etlands with only an intermittent,
physically remote hydrologic
connection to ‘waters of the United
States’ do not implicate the boundarydrawing problem of Riverside Bayview,
and thus lack the necessary connection
to covered waters that we described as
a ‘significant nexus’ in SWANCC[.]’’ Id.
at 742. The plurality supported this
position by referring to the Court’s
treatment of isolated waters in SWANCC
as non-jurisdictional. Id. at 726, 741–42
(‘‘[W]e held that ‘nonnavigable, isolated,
intrastate waters’—which, unlike the
wetlands at issue in Riverside Bayview,
did not ‘actually abu[t] on a navigable
waterway,’—were not included as
‘waters of the United States.’ ’’). The
plurality found ‘‘no support for the
inclusion of physically unconnected
wetlands as covered ‘waters’ ’’ based on
Riverside Bayview’s treatment of the
Corps’ definition of adjacent. Id. at 746–
47; see also id. at 746 (‘‘[T]he Corps’
definition of ‘adjacent’ . . . has been
extended beyond reason.’’).
Concurring in the judgment, Justice
Kennedy focused on the ‘‘significant
nexus’’ between the adjacent wetlands
and traditional navigable waters as the
basis for determining whether a wetland
is a water subject to CWA jurisdiction:
‘‘It was the significant nexus between
wetlands and navigable waters . . . that
informed our reading of the [Act] in
Riverside Bayview Homes. Because such
a nexus was lacking with respect to
isolated ponds, [in SWANCC] the Court
held that the plain text of the statute did
not permit the Corps’ action.’’ Id. at 767
(internal quotations and citations
omitted). Justice Kennedy noted that the
wetlands at issue in Riverside Bayview
were ‘‘adjacent to [a] navigable-in-fact
waterway[ ],’’ while the ‘‘ponds and
13 The agencies’ Rapanos Guidance recognizes
the plurality’s ‘‘continuous surface connection’’
does not refer to a continuous surface water
connection. See, e.g., Rapanos Guidance at 7 n.28
(‘‘A continuous surface connection does not require
surface water to be continuously present between
the wetland and the tributary.’’).

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mudflats’’ considered in SWANCC
‘‘were isolated in the sense of being
unconnected to other waters covered by
the Act.’’ Id. at 765–66. ‘‘Taken together,
these cases establish that in some
instances, as exemplified by Riverside
Bayview, the connection between a
nonnavigable water or wetland and a
navigable water may be so close, or
potentially so close, that the Corps may
deem the water or wetland a ‘navigable
water’ under the Act. In other instances,
as exemplified by SWANCC, there may
be little or no connection. Absent a
significant nexus, jurisdiction under the
Act is lacking.’’ Id. at 767.
According to Justice Kennedy,
whereas the isolated ponds and
mudflats in SWANCC lack the
‘‘significant nexus’’ to navigable waters,
it is the ‘‘conclusive standard for
jurisdiction’’ based on ‘‘a reasonable
inference of ecological interconnection’’
between adjacent wetlands and
navigable-in-fact waters that allows for
their categorical inclusion as waters of
the United States. Id. at 780 (‘‘[T]he
assertion of jurisdiction for those
wetlands [adjacent to navigable-in-fact
waters] is sustainable under the act by
showing adjacency alone.’’). Justice
Kennedy surmised that it may be that
the same rationale ‘‘without any inquiry
beyond adjacency . . . could apply
equally to wetlands adjacent to certain
major tributaries,’’ noting that the Corps
could establish by regulation categories
of tributaries based on volume of flow,
proximity to navigable waters, or other
factors that ‘‘are significant enough that
wetlands adjacent to them are likely, in
the majority of cases, to perform
important functions for an aquatic
system incorporating navigable waters.’’
Id. at 780–81. However, ‘‘[t]he Corps’
existing standard for tributaries’’
provided Justice Kennedy ‘‘no such
assurance’’ to infer the categorical
existence of a requisite nexus between
waters traditionally understood as
navigable and wetlands adjacent to
nonnavigable tributaries. Id. at 781. That
is because:
the breadth of [the tributary] standard—
which seems to leave wide room for
regulation of drains, ditches, and streams
remote from any navigable-in-fact water and
carrying only minor water volumes towards
it—precludes its adoption as the
determinative measure of whether adjacent
wetlands are likely to play an important role
in the integrity of an aquatic system
comprising navigable waters as traditionally
understood. Indeed, in many cases wetlands
adjacent to tributaries covered by this
standard might appear little more related to
navigable-in-fact waters than were the
isolated ponds held to fall beyond the Act’s
scope in SWANCC.

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Id. at 781–82.
Justice Kennedy stated that, absent
development of a more specific
regulation, the Corps ‘‘must establish a
significant nexus on a case-by-case basis
when it seeks to regulate wetlands based
on adjacency to nonnavigable
tributaries. Given the potential
overbreadth of the Corps’ regulations,
this showing is necessary to avoid
unreasonable applications of the
statute.’’ Id. at 782. Justice Kennedy
explained that ‘‘wetlands possess the
requisite nexus, and thus come within
the statutory phrase ‘navigable waters,’
if the wetlands, either alone or in
combination with similarly situated
lands in the region, significantly affect
the chemical, physical, and biological
integrity of other covered waters more
readily understood as ‘navigable.’ ’’ Id.
at 780. ‘‘Where an adequate nexus is
established for a particular wetland, it
may be permissible, as a matter of
administrative convenience or
necessity, to presume covered status for
other comparable wetlands in the
region.’’ Id. at 782.
In describing this significant nexus
test, Justice Kennedy relied, in part, on
the overall objective of the CWA to
‘‘restore and maintain the chemical,
physical, and biological integrity of the
Nation’s waters.’’ Id. at 779 (quoting 33
U.S.C. 1251(a)). Justice Kennedy also
agreed with the plurality that
‘‘environmental concerns provide no
reason to disregard limits in the
statutory text.’’ Id. at 778. With respect
to wetlands adjacent to nonnavigable
tributaries, Justice Kennedy therefore
determined that ‘‘mere adjacency . . . is
insufficient. A more specific inquiry,
based on the significant-nexus standard,
is . . . necessary.’’ Id. at 786. Not
requiring adjacent wetlands to possess a
significant nexus with navigable waters,
Justice Kennedy noted, would allow a
finding of jurisdiction ‘‘whenever
wetlands lie alongside a ditch or drain,
however remote and insubstantial, that
eventually may flow into traditional
navigable waters. The deference owed
the Corps’ interpretation of the statute
does not extend so far.’’ Id. at 778–79.
Based on the agencies’ review of this
Supreme Court precedent, although the
plurality and Justice Kennedy
established different standards to
determine the jurisdictional status of
wetlands adjacent to nonnavigable
tributaries, they both appear to agree in
principle that the determination must be
made using a two-part test that
considers: (1) The proximity of the
wetland to the tributary; and (2) the
status of the tributary with respect to
downstream traditional navigable
waters. The plurality and Justice

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Kennedy also agree that the proximity
between the wetland and the tributary
must be close. The plurality refers to
that proximity as a ‘‘continuous surface
connection’’ or ‘‘continuous physical
connection,’’ as demonstrated in
Riverside Bayview. Id. at 742, 751 n.13.
Justice Kennedy recognized that ‘‘the
connection between a nonnavigable
water or wetland and a navigable water
may be so close, or potentially so close,
that the Corps may deem the water or
wetland a ‘navigable water’ under the
Act.’’ Id. at 767. The second part of the
two-part tests established by the
plurality and Justice Kennedy is
addressed in the next section.
b. Tributaries
The definition of tributaries was not
addressed in either Riverside Bayview or
SWANCC. And while the focus of
Rapanos was on whether the Corps
could regulate wetlands adjacent to
nonnavigable waters, the plurality and
concurring opinions provide some
guidance on the regulatory status of
tributaries to navigable-in-fact waters.
The plurality and Justice Kennedy
both recognized that the jurisdictional
scope of the CWA is not restricted to
traditional navigable waters. See id. at
731 (plurality) (‘‘[T]he Act’s term
‘navigable waters’ includes something
more than traditional navigable
waters.’’); id. at 767 (Justice Kennedy)
(‘‘Congress intended to regulate at least
some waters that are not navigable in
the traditional sense.’’). Both also agree
that federal authority under the Act is
not without limit. See id. at 731–32
(plurality) (‘‘[T]he waters of the United
States . . . cannot bear the expansive
meaning that the Corps would give it.’’);
id. at 778–79 (Justice Kennedy) (‘‘The
deference owed to the Corps’
interpretation of the statute does not
extend’’ to ‘‘wetlands’’ which ‘‘lie
alongside a ditch or drain, however
remote or insubstantial, that eventually
may flow into traditional navigable
waters.’’).
With respect to tributaries
specifically, both the plurality and
Justice Kennedy focus in large part on
a tributary’s contribution of flow to, and
connection with, traditional navigable
waters. The plurality would include as
waters of the United States ‘‘only
relatively permanent, standing or
flowing bodies of water’’ and would
define such ‘‘waters’’ as including
streams, rivers, oceans, lakes and other
bodies of waters that form geographical
features, noting that all such ‘‘terms
connote continuously present, fixed
bodies of water . . . .’’ Id. at 732–33,
739. On the other hand, the plurality
would likely exclude ephemeral streams

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and related features. Id. at 733–34, 739,
741. Justice Kennedy would likely
exclude some streams considered
jurisdictional under the plurality’s test.
Id. at 769 (noting that under the
plurality’s test, ‘‘[t]he merest trickle, if
continuous, would count as a ‘water’
subject to federal regulation, while
torrents thundering at irregular intervals
through otherwise dry channels would
not’’).
In addition, both the plurality and
Justice Kennedy would likely include
some intermittent streams as waters of
the United States. See id. at 732–33 &
n.5 (plurality); id. at 769–70 (Justice
Kennedy). The plurality noted that its
reference to ‘‘relatively permanent’’
waters did ‘‘not necessarily exclude
streams, rivers, or lakes that might dry
up in extraordinary circumstances, such
as drought,’’ or ‘‘seasonal rivers, which
contain continuous flow during some
months of the year but no flow during
dry months . . . .’’ Id. at 732 n.5
(emphasis in original). However, neither
the plurality nor Justice Kennedy
defined with precision where to draw
the line. Nevertheless, the plurality
provided that ‘‘navigable waters’’ must
have ‘‘at bare minimum, the ordinary
presence of water,’’ id. at 734, and
Justice Kennedy noted that the Corps
can identify by regulation categories of
tributaries based on volume of flow,
proximity to navigable waters, or other
factors that ‘‘are significant enough that
wetlands adjacent to them are likely, in
the majority of cases, to perform
important functions for an aquatic
system incorporating navigable waters.’’
Id. at 780–81. And both the plurality
and Justice Kennedy agreed that the
Corps’ assertion of jurisdiction over the
wetlands adjacent to the ‘‘drains,
ditches, and streams remote from any
navigable-in-fact water,’’ id. at 781
(Kennedy), at issue in Rapanos raised
significant jurisdictional questions. Id.
at 737–38 (plurality); id. at 781–82
(Kennedy).
3. Principles and Considerations
From this legal foundation, a few
important principles emerge from which
the agencies can evaluate their
authorities. First, the power conferred
on the agencies to regulate the waters of
the United States is grounded in
Congress’ commerce power over
navigation. The agencies can choose to
regulate beyond waters more
traditionally understood as navigable
given the broad purposes of the CWA,
including some tributaries to those
traditional navigable waters, but must
provide a reasonable basis grounded in
the language and structure of the Act for
determining the extent of jurisdiction.

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The agencies also can choose to regulate
wetlands adjacent to the traditional
navigable waters and some tributaries, if
the wetlands are in close proximity to
the tributaries, such as in the
transitional zone between open waters
and dry land. In the agencies’ view, it
would not be consistent with Justice
Kennedy’s Rapanos opinion or the
Rapanos plurality opinion to regulate
wetlands adjacent to all tributaries, no
matter how small or remote from
navigable water. The Court’s opinion in
SWANCC also calls into serious
question the agencies’ authority to
regulate nonnavigable, isolated,
intrastate waters that lack a sufficient
connection to traditional navigable
waters, and suggests that the agencies
should avoid regulatory interpretations
of the CWA that raise constitutional
questions regarding the scope of their
statutory authority. The agencies can,
however, regulate certain waters by
category, which could improve
regulatory predictability and certainty
and ease administrative burden while
still effectuating the purposes of the Act.
In developing a clear and predictable
regulatory framework, the agencies also
must respect the primary
responsibilities and rights of States and
Tribes to regulate their land and water
resources. See 33 U.S.C. 1251(b), 1370.
The oft-quoted objective of the CWA to
‘‘restore and maintain the chemical,
physical, and biological integrity of the
Nation’s waters,’’ id. at 1251(a), must be
implemented in a manner consistent
with Congress’ policy directives to the
agencies. The Supreme Court long ago
recognized the distinction between
federal waters traditionally understood
as navigable and waters ‘‘subject to the
control of the States.’’ The Daniel Ball,
77 U.S. (10 Wall.) 557, 564–65 (1871).
Over a century later, the Supreme Court
in SWANCC reaffirmed the State’s
‘‘traditional and primary power over
land and water use.’’ 531 U.S. at 174;
accord Rapanos, 547 U.S. at 738 (Scalia,
J., plurality opinion). Ensuring that
States and Tribes retain authority over
their land and water resources pursuant
to CWA section 101(b) and section 510
helps carry out the overall objective of
the CWA, and ensures that the agencies
are giving full effect and consideration
to the entire structure and function of
the Act, including Congress’ intent as
reflected in dozens of non-regulatory
grant, research, nonpoint source,
groundwater, and watershed planning
programs to assist the states in
controlling pollution in the nation’s
waters, not just its navigable waters.
Further, the agencies are cognizant
that the ‘‘Clean Water Act imposes
substantial criminal and civil penalties

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for discharging any pollutant into
waters covered by the Act without a
permit. . . .’’ U.S. Army Corps of Eng’rs
v. Hawkes Co., 136 S. Ct. 1807, 1812
(2016); see also Sackett v. EPA, 566 U.S.
120, 132–33 (2012) (Alito, J.,
concurring) (‘‘[T]he combination of the
uncertain reach of the Clean Water Act
and the draconian penalties imposed for
the sort of violations alleged in this case
still leaves most property owners with
little practical alternative but to dance
to the EPA’s tune.’’). As the Chief Justice
observed in Hawkes, ‘‘[i]t is often
difficult to determine whether a
particular piece of property contains
waters of the United States, but there are
important consequences if it does.’’ 136
S. Ct. at 1812; see also id. at 1816–17
(Kennedy, J., concurring) (‘‘[T]he reach
and systemic consequences of the Clean
Water Act remain a cause for concern,’’
and the Act ‘‘continues to raise
troubling questions regarding the
Government’s power to cast doubt on
the full use and enjoyment of private
property throughout the Nation.’’).
Given the significant civil and criminal
penalties associated with the CWA, it is
important for the agencies to promote
regulatory certainty while striving to
provide fair and predictable notice of
the limits of federal jurisdiction. See,
e.g., Sessions v. Dimaya, 138 S. Ct.
1204, 1223–25 (2018) (Gorsuch, J.,
concurring in part and concurring in the
judgment) (characterizing fair notice as
possibly the most fundamental of the
protections provided by the
Constitution’s guarantee of due process,
and stating that vague laws are an
exercise of ‘‘arbitrary power . . . leaving
the people in the dark about what the
law demands and allowing prosecutors
and courts to make it up’’).
C. Proposed Reasons for Repeal
The agencies’ proposal is based on
our view that regulatory certainty may
be best served by repealing the 2015
Rule and recodifying the preexisting
scope of CWA jurisdiction. Specifically,
the agencies are concerned that rather
than achieving their stated objectives of
increasing regulatory predictability and
consistency under the CWA, retaining
the 2015 Rule creates significant
uncertainty for agency staff, regulated
entities, and the public, which is
compounded by court decisions that
have increased litigation risk and cast
doubt on the legal viability of the rule.
To provide for greater regulatory
certainty, the agencies propose to revert
to the pre-2015 regulations, a regulatory
regime that is more familiar to and
better-understood by the agencies,
States, Tribes, local governments,
regulated entities, and the public.

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Further, as a result of the agencies’
review and reconsideration of their
statutory authority and in light of the
court rulings against the 2015 Rule that
have suggested that the agencies’
interpretation of the ‘‘significant nexus’’
standard as applied in the 2015 Rule
was expansive and does not comport
with and accurately implement the
limits on jurisdiction reflected in the
CWA and decisions of the Supreme
Court, the agencies are also concerned
that the 2015 Rule lacks sufficient
statutory basis. The agencies are
proposing to conclude in the alternative
that, at a minimum, the interpretation of
the statute adopted in the 2015 Rule is
not compelled, and a different policy
balance can be appropriate.
Considering the substantial
uncertainty associated with the 2015
Rule resulting from its legal challenges,
and the substantial experience the
agencies and others possess with the
longstanding regulatory framework
currently being administered by the
agencies, the agencies conclude that
clarity, predictability, and consistency
may be best served by repealing the
2015 Rule and thus are proposing to do
so. The agencies may still propose
changes to the definition of ‘‘waters of
the United States’’ in a future
rulemaking.
Further, the agencies are concerned
that certain findings and assumptions
supporting adoption of the 2015 Rule
were not correct, and that these
conclusions, if erroneous, may
separately justify repeal of the 2015
Rule. The agencies are concerned and
seek comment on whether the 2015 Rule
significantly expanded jurisdiction over
the preexisting regulatory program, as
implemented by the agencies, and
whether that expansion altered State,
tribal, and local government
relationships in implementing CWA
programs. The agencies therefore
propose to repeal the 2015 Rule in order
to restore those preexisting relationships
and better serve the balance of
authorities envisioned in CWA section
101(b).
1. The 2015 Rule Fails To Achieve
Regulatory Certainty
The agencies are proposing to repeal
the 2015 Rule because it does not
appear to achieve one of its primary
goals of providing regulatory certainty
and consistency. When promulgating
the 2015 Rule, the agencies concluded
the rule would ‘‘increase CWA program
predictability and consistency by
clarifying the scope of ‘waters of the
United States’ protected under the Act.’’
80 FR 37054. The agencies stated that
the 2015 ‘‘rule reflect[ed] the judgment

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of the agencies in balancing the science,
the agencies’ expertise, and the
regulatory goals of providing clarity to
the public while protecting the
environment and public health,
consistent with the law.’’ Id. at 37065.
Since then, developments in the
litigation against the 2015 Rule and
concerns raised since the rule’s
promulgation indicate that maintaining
the 2015 Rule would produce
substantial uncertainty and confusion
among state and federal regulators and
enforcement officials, the regulated
public, and other interested
stakeholders. To provide for greater
regulatory certainty, the agencies
propose to repeal the 2015 Rule and
restore a longstanding regulatory
framework that is more familiar to and
better-understood by the agencies, our
co-regulators, and regulated entities,
until the agencies propose and finalize
a replacement definition.
a. Litigation to Date
As noted above, the 2015 Rule has
been challenged in legal actions across
multiple district courts, in which
plaintiffs have raised a number of
substantive and procedural claims
against the rule. Petitions for review
were also filed in multiple courts of
appeals and were consolidated in the
U.S. Court of Appeals for the Sixth
Circuit. To date, all three of the courts
that substantively have considered the
2015 Rule—the Sixth Circuit, the
District of North Dakota, and the
Southern District of Georgia—have
found that petitioners seeking to
overturn the rule are likely to succeed
on the merits of at least some of their
claims against the rule.
In the Sixth Circuit, the court granted
a nationwide stay of the 2015 Rule after
finding, among other factors, that the
petitioners showed a ‘‘substantial
possibility of success on the merits’’ of
their claims against the 2015 Rule,
including claims that the rule was
inconsistent with Justice Kennedy’s
opinion in Rapanos and that the rule’s
distance limitations were not
substantiated by specific scientific
support. In re EPA, 803 F.3d 804, 807
(6th Cir. 2015).
The District of North Dakota made
similar findings in issuing a preliminary
injunction against the 2015 Rule. There,
the court found that the plaintiff-States
are ‘‘likely to succeed on the merits of
their claim’’ that the rule violated the
congressional grant of authority to the
agencies under the CWA because the
rule ‘‘likely fails’’ to meet Justice
Kennedy’s significant nexus test. North
Dakota v. EPA, 127 F. Supp. 3d 1047,
1055–56 (D.N.D. 2015). The court also

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found that the plaintiff-States have a fair
chance of success on the merits of their
procedural claims that the agencies
failed to comply with APA requirements
in promulgating the rule. Id. at 1056–57.
The Southern District of Georgia also
preliminarily enjoined the 2015 Rule,
holding that the State plaintiffs had
demonstrated ‘‘a likelihood of success
on their claims that the [2015] WOTUS
Rule was promulgated in violation of
the CWA and the APA.’’ Georgia v.
Pruitt, No. 15–cv–79, 2018 U.S. Dist.
LEXIS 97223, at *14 (S.D. Ga. June 8,
2018) (‘‘Georgia’’) (granting preliminary
injunction). The court determined that
the 2015 Rule likely failed to meet the
standard expounded in SWANCC and
Rapanos, and that the rule was likely
fatally defective because it ‘‘allows the
Agencies to regulate waters that do not
bear any effect on the ‘chemical,
physical, and biological integrity’ of any
navigable-in-fact water.’’ Id. at *17–18.
The court also held that the plaintiffs
‘‘have demonstrated a likelihood of
success on both of their claims under
the APA’’ that the 2015 Rule ‘‘is
arbitrary and capricious’’ and ‘‘that the
final rule is not a logical outgrowth of
the proposed rule.’’ Id. at *18.
These rulings indicate that
substantive or procedural challenges to
the 2015 Rule are likely to be successful,
particularly claims that the rule is not
authorized under the CWA and was
promulgated in violation of the APA. A
successful challenge to the 2015 Rule
could result in a court order vacating
the rule in all or part, in all or part of
the country, and potentially resulting in
different regulatory regimes being in
effect in different parts of the country,
which would likely lead to substantial
regulatory confusion, uncertainty, and
inconsistency.
Notably, the agencies face an
increasing risk of a court order vacating
the 2015 Rule. The District of North
Dakota is proceeding to hear the merits
of the plaintiff-States’ claims against the
2015 Rule in that case, and the plaintiffStates in the Southern District of
Georgia have requested a similar meritsbriefing schedule. See Scheduling
Order, North Dakota v. EPA, No. 15–cv–
59 (D.N.D. May 2, 2018); Response to
Defendants’ Updated Response to
Plaintiff States’ Motion for Preliminary
Injunction at 11–12, Georgia, No. 15–
cv–79 (S.D. Ga. May 29, 2018). Although
the applicability date rule ensures that
the 2015 Rule will not go into effect
until February 6, 2020, the prospect of
a court order vacating the 2015 Rule
creates additional regulatory
uncertainty.

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b. Stakeholder Confusion Regarding the
Scope of the 2015 Rule and Extent of
Federal CWA Jurisdiction
Statements made in the litigation
against the 2015 Rule and in comments
regarding the 2015 Rule indicate that
there has been substantial disagreement
and confusion as to the scope of the
2015 Rule and the extent of federal
CWA jurisdiction more broadly. In the
Sixth Circuit, for example, State
petitioners asserted that the 2015 Rule
covers waters outside the scope of the
CWA pursuant to SWANCC and
Rapanos and ‘‘extends jurisdiction to
virtually every potentially wet area of
the country.’’ 14 Industry petitioners
contended that the rule’s ‘‘uncertain
standards are impossible for the public
to understand or the agencies to apply
consistently.’’ 15 In contrast,
environmental petitioners found that
SWANCC and Rapanos led to
widespread confusion over the scope of
the CWA and that the pre-2015
regulatory regime could theoretically
apply to ‘‘almost all waters and
wetlands across the country.’’ 16 These
petitioners asserted that the 2015 Rule
violated the CWA by failing to cover
certain waters, including waters that
may possess a ‘‘significant nexus’’ to
traditional navigable waters.17 Whether
such comments are accurate or not, they
indicate continued widespread
disagreement and confusion over the
meaning of the 2015 Rule and extent of
jurisdiction it entails.
Some comments received on the July
27, 2017 NPRM also demonstrate
continued confusion over the scope and
various provisions of the 2015 Rule. For
example, one commenter found that the
rule’s definitions of ‘‘adjacent,’’
‘‘significant nexus’’ and other key terms
lack clarity and thus lead to regulatory
uncertainty.18 This same commenter
contended that the rule could raise
constitutional concerns related to the
appropriate scope of federal authority
and encouraged the agencies to
undertake a new rulemaking to more
clearly articulate the extent of federal
CWA authority. Another commenter
echoed these concerns, alleging that the
2015 Rule resulted in a ‘‘vague and
14 Opening Brief of State Petitioners at 15, 61, In
re EPA, No. 15–3751 (6th Cir. Nov. 1, 2016).
15 Opening Brief for the Business & Municipal
Petitioners, In re EPA, No. 15–3751 (6th Cir. Nov.
1, 2016).
16 Brief of Conservation Groups at 11, In re EPA,
No. 15–3751 (6th Cir. Nov. 1, 2016).
17 See, e.g., id. at 22, 43.
18 See comments submitted by Oregon
Cattlemen’s Association (July 27, 2017) (Docket ID:
EPA–HQ–OW–2017–0203–0039), available at
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indecipherable explanation’’ of the
definition of ‘‘waters of the United
States’’ that has caused confusion and
uncertainty as to the extent of
jurisdiction that can be asserted by
federal, state and local authorities.19
The agencies have received comments
from numerous other individuals and
entities expressing confusion and
concern about the extent of federal CWA
jurisdiction asserted under the 2015
Rule, and the agencies are continuing to
review and consider these comments.
c. Impact on State Programs
Like other commenters on the
proposal to the 2015 Rule, some States
expressed confusion regarding the scope
of the proposal and, uniquely, the
potential impacts of that uncertainty on
States’ ability to implement CWA
programs. Though some States have
stated that the 2015 Rule ‘‘more clearly
identifies what types of waters would be
considered jurisdictional,’’ 20 others
assert that the extent of CWA
jurisdiction under the rule remained
‘‘fuzzy’’ and unclear.21 Certain States
noted that this uncertainty could ‘‘create
time delays in obtaining permits which
previously were not required’’ 22 and
‘‘result in increased costs to the State
and other private and public interests,
along with decreased regulatory
efficiency.’’ 23 One State suggested that
even if the 2015 Rule established greater
regulatory clarity, the rule’s case-by-case
determinations could result in
permitting delays when a jurisdictional
determination is required.24
Similar concerns have been raised in
the litigation challenging the 2015 Rule.
19 See comments submitted by Skagit County
Dike, Drainage and Irrigation District No. 12 and
Skagit County Dike District No. 1 (Sept. 27, 2017)
(Docket ID: EPA–HQ–OW–2017–0203–11709),
available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2017-0203-11709.
20 See, e.g., comments submitted by State of
Washington, Department of Ecology (Nov. 13, 2014)
(Docket ID: EPA–HQ–OW–2011–0880–13957),
available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-13957.
21 See, e.g., comments submitted by State of
Oklahoma (Nov. 14, 2014) (Docket ID: EPA–HQ–
OW–2011–0880–14625), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-14625; see also comments submitted by
National Association of Counties (Nov. 14, 2014)
(Docket ID: EPA–HQ–OW–2011–0880–15081),
available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-15081.
22 See comments submitted by State of Utah,
Governor’s Office (Nov. 14, 2014) (Docket ID: EPA–
HQ–OW–2011–0880–16534), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-16534.
23 See comments submitted by Wyoming
Department of Environmental Quality (Nov. 14,
2014) (Docket ID: EPA–HQ–OW–2011–0880–
16393), available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-16393.
24 See comments submitted by State of
Washington, Department of Ecology, supra note 20.

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For example, in the Southern District of
Georgia, the State of Indiana has
asserted that the 2015 Rule’s definition
of ‘‘waters of the United States’’ is
‘‘vague’’ and that the rule ‘‘imposes . . .
unclear regulatory requirements that
will result in an inefficient use of
limited regulatory resources.’’ 25 In
particular, the State asserts concerns
that implementing the 2015 Rule will
divert resources by ‘‘[d]emanding the
time and attention of regulators to make
the now-difficult determination of when
and whether a feature is a WOTUS’’ and
‘‘[g]enerating unnecessary
administrative appeals and lawsuits to
resolve jurisdictional disputes.’’ 26
d. Agency Experience With the 1986
Regulations
The agencies have been implementing
the pre-2015 regulations (hereinafter
referred to as the ‘‘1986 regulations’’)
almost uninterruptedly since 1986.
Corps staff are trained on making
jurisdictional determinations in the
field and through national webinars and
classroom or field-based trainings. From
June 2007 through June 2018, the Corps
issued 241,857 27 approved
jurisdictional determinations (AJDs)
under their 1986 regulations, as
informed by applicable Supreme Court
precedent and the agencies’ guidance.
Through over 30 years of experience,
the agencies have developed significant
technical expertise with the 1986
regulations and have had the
opportunity to refine the application of
the rules through guidance and the
agencies’ experience and federal court
decisions. Indeed, the 1986 regulations
have been the subject of a wide body of
case law, including three significant
U.S. Supreme Court decisions 28 and
dozens of cases in federal district courts
and courts of appeals that have
addressed the scope of analysis
required. Since 1986, the agencies have
issued numerous memoranda, guidance,
and question-and-answer documents
explaining and clarifying these
regulations.29
Given the longstanding nature and
history of the 1986 regulations, this
25 Statement of Bruno L. Pigott, Georgia, No. 15–
cv–79 (S.D. Ga. July 21, 2015).
26 Id.
27 U.S. Army Corps of Engineers, OMBIL
Regulatory Module (June 5, 2018).
28 Riverside Bayview, 474 U.S. 121 (1985);
SWANCC, 531 U.S. 159 (2001); Rapanos, 547 U.S.
715 (2006).
29 The Corps maintains many of these documents
on its public website, available at https://
www.usace.army.mil/Missions/Civil-Works/
Regulatory-Program-and-Permits/RelatedResources/CWA-Guidance/. The EPA maintains
many of these documents as well; see also https://
www.epa.gov/wotus-rule/about-waters-unitedstates.

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regulatory regime is more familiar to the
agencies, co-regulators, and regulated
entities. For this reason, as between the
2015 Rule and the 1986 regulations, the
1986 regulations (as informed by
applicable Supreme Court precedent
and the agencies’ guidance) would
appear to provide for greater regulatory
predictability, consistency, and
certainty, and the agencies seek public
comment on this issue. Though the
agencies acknowledge that the 1986
regulations have posed certain
implementation difficulties and were
the subject of court decisions that had
the effect of narrowing their scope, the
longstanding nature of the regulatory
regime—coupled with the agencies’ and
others’ extensive experience with the
regulatory scheme—make it preferable
to the regulatory uncertainty posed by
the 2015 Rule.
2. The 2015 Rule May Exceed the
Agencies’ Authority Under the CWA
The agencies are concerned that the
2015 Rule exceeded EPA’s authority
under the CWA by adopting an
expansive interpretation of the
‘‘significant nexus’’ standard that covers
waters outside the scope of the Act and
stretches the significant nexus standard
so far as to be inconsistent with
important aspects of Justice Kennedy’s
opinion in Rapanos, even though this
opinion was identified as the basis for
the significant nexus standard
articulated in the 2015 Rule. In
particular, the agencies are concerned
that the 2015 Rule took an expansive
reading of Justice Kennedy’s significant
nexus test and exceeds the agencies’
authority under the Act.
As expounded in Rapanos, Justice
Kennedy’s significant nexus standard is
a test intended to limit federal
jurisdiction due to the breadth of the
Corps’ then-existing standard for
tributaries and in order to ‘‘prevent[ ]
problematic applications of the statute.’’
547 U.S. at 783. ‘‘Given the potential
overbreadth of the Corps’ [1986]
regulations,’’ Justice Kennedy found
that the showing of a significant nexus
‘‘is necessary to avoid unreasonable
applications of the statute.’’ Id. at 782.
The agencies are concerned, upon
further consideration of the 2015 Rule,
that the significant nexus standard
articulated in that rule could lead to
similar unreasonable applications of the
CWA.
Justice Kennedy wrote that adjacent
‘‘wetlands possess the requisite nexus,
and thus come within the statutory
phrase ‘navigable waters,’ if the
wetlands, either alone or in combination
with similarly situated lands in the
region, significantly affect the chemical,

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physical, and biological integrity of
other covered waters more readily
understood as ‘navigable.’ ’’ 547 U.S. at
780. The opinion did not expressly
define the relevant ‘‘region’’ or what
was meant by ‘‘similarly situated,’’ but
it is reasonable to presume that that the
Justice did not mean ‘‘similarly
situated’’ to be synonymous with ‘‘all’’
waters in a region. The agencies’
Rapanos Guidance, for example, had
interpreted the term ‘‘similarly situated’’
more narrowly to ‘‘include all wetlands
adjacent to the same tributary.’’ 30 ‘‘A
tributary . . . is the entire reach of the
stream that is of the same order (i.e.,
from the point of confluence, where two
lower order streams meet to form the
tributary, downstream to the point such
tributary enters a higher order
stream).’’ 31 Thus, under the agencies’
2008 guidance, ‘‘where evaluating
significant nexus for an adjacent
wetland, the agencies will consider the
flow characteristics and functions
performed by the tributary to which the
wetland is adjacent along with the
functions performed by the wetland and
all other wetlands adjacent to that
tributary. This approach reflects the
agencies’ interpretation of Justice
Kennedy’s term ‘similarly situated’ to
include all wetlands adjacent to the
same tributary. . . . Interpreting the
phrase ‘similarly situated’ to include all
wetlands adjacent to the same tributary
is reasonable because such wetlands are
physically located in a like manner (i.e.,
lying adjacent to the same tributary).’’ 32
The 2015 Rule departed from this
interpretation of ‘‘similarly situated’’
wetlands in a ‘‘region,’’ including
applying it to other waters, not only
wetlands, that were not already
categorically jurisdictional as tributaries
or adjacent waters. The proposed rule,
for example, stated that ‘‘[o]ther waters,
including wetlands, are similarly
situated when they perform similar
functions and are located sufficiently
close together or sufficiently close to a
‘water of the United States’ so that they
can be evaluated as a single landscape
unit with regard to their effect on the
chemical, physical, or biological
integrity of a [primary] water.’’ 79 FR
22263 (April 21, 2014). The 2015 Rule
took it a step further and stated that ‘‘the
downstream health of larger
downstream waters is directly related to
the aggregate health of waters located
upstream, including waters such as
wetlands that may not be hydrologically
connected but function together to
ameliorate the potential impacts of

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31 Id.

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32 Id.

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flooding and pollutant contamination
from affecting downstream waters.’’ 80
FR 37063. The 2015 Rule thus
concluded that ‘‘[a] water has a
significant nexus when any single
function or combination of functions
performed by the water, alone or
together with similarly situated waters
in the region, contributes significantly
to the chemical, physical, or biological
integrity of the nearest [primary] water.’’
Id. at 37106. The ‘‘term ‘in the region’
means the watershed that drains to the
nearest [primary] water.’’ Id.
An examination of all of the waters in
‘‘the watershed’’ of ‘‘the nearest
[primary] water’’ under the 2015 Rule
therefore may have materially
broadened the scope of aggregation that
determines jurisdiction in a ‘‘significant
nexus’’ inquiry for waters not
categorically jurisdictional from the
focus in the proposed rule on waters
‘‘located sufficiently close together or
sufficiently close to a ‘water of the
United States’ so that they can be
evaluated as a single landscape unit.’’
79 FR 22263. The agencies in finalizing
the rule viewed the scientific literature
through a broader lens as ‘‘the effect of
landscape position on the strength of
the connection to the nearest ‘water of
the United States,’ ’’ and that ‘‘relevant
factors influencing chemical
connectivity include hydrologic
connectivity . . . , surrounding land
use and land cover, the landscape
setting, and deposition of chemical
constituents (e.g., acidic deposition).’’
80 FR 37094. The agencies are
concerned that this important change in
the interpretation of ‘‘similarly situated
waters’’ from the proposed 2015 Rule
and the 2008 Rapanos Guidance may
not be explainable by the scientific
literature, including the Connectivity
Report 33 cited throughout the preamble
to the 2015 Rule, in light of the
agencies’ view at the time that ‘‘[t]he
scientific literature does not use the
term ‘significant’ as it is defined in a
legal context.’’ 80 FR 37062. The
agencies solicit comment on whether
the agencies’ justification for the 2015
Rule’s interpretation of ‘‘similarly
situated’’ with reference to an entire
watershed for purposes of waters not
categorically jurisdictional relied on the
scientific literature without due regard
for the restraints imposed by the statute
and case law, and whether this
interpretation of Justice Kennedy’s
significant nexus standard is a reason, at
a minimum because of the legal risk it
33 U.S. EPA. Connectivity of Streams and
Wetlands to Downstream Waters: A Review and
Synthesis of the Scientific Evidence (Jan. 2015)
(EPA/600/R–14/475F).

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creates, to repeal the 2015 Rule. As
discussed, the 2015 Rule included
distance-based limitations that were not
specified in the proposal. In light of
this, the agencies also solicit comment
on whether these distance-based
limitations mitigated or affected the
agencies’ change in interpretation of
similarly situated waters in the 2015
Rule.
The agencies are also concerned that
the 2015 Rule does not give sufficient
effect to the term ‘‘navigable’’ in the
CWA. See South Carolina v. Catawba
Indian Tribe, 476 U.S. 498, 510 n.22
(1986) (‘‘It is our duty to give effect, if
possible, to every clause and word of a
statute[.]’’ (quoting United States v.
Menasche, 348 U.S. 528, 538–39 (1955))
(internal quotation marks omitted)).
Justice Kennedy’s concurring opinion in
Rapanos, on which the 2015 Rule relied
heavily for its basis, recognized the term
‘‘navigable’’ must have ‘‘some
importance’’ and, if that word has any
meaning, the CWA cannot be
interpreted to ‘‘permit federal regulation
whenever wetlands lie along a ditch or
drain, however remote and
insubstantial, that eventually may flow
into traditional navigable waters.’’
Rapanos, 547 U.S. at 778–79 (Kennedy,
J., concurring in judgment). When
interpreting the Rapanos decision and
its application for determining the scope
of CWA jurisdiction in 2008, the
agencies wrote ‘‘[p]rincipal
considerations when evaluating
significant nexus include the volume,
duration, and frequency of the flow of
water in the tributary and the proximity
of the tributary to a traditional navigable
water.’’ 34 The agencies are considering
whether the 2015 Rule’s definitions of
‘‘tributary’’ and ‘‘adjacent’’ were so
broad as to eliminate consideration of
these factors in a manner consistent
with Justice Kennedy’s opinion and the
CWA.
The 2015 Rule stated that the agencies
assessed ‘‘the significance of the nexus’’
to navigable water ‘‘in terms of the
CWA’s objective to ‘restore and
maintain the chemical, physical, and
biological integrity of the Nation’s
waters.’ ’’ 80 FR 37056 (quoting 33
U.S.C. 1251(a)). Under the 2015 Rule, a
significant nexus may be established by
an individual water or by collectively
considering ‘‘similarly situated’’ waters
across a ‘‘region,’’ defined as ‘‘the
watershed that drains to the nearest
[primary] water identified.’’ Id. at
37106. The agencies are now concerned
that this broad reliance on biological
functions, such as the provision of life
cycle dependent aquatic habitat, may
34 Rapanos

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not comport with the CWA and Justice
Kennedy’s statement in Rapanos that
‘‘environmental concerns provide no
reason to disregard limits in the
statutory text.’’ See 547 U.S. at 778. In
particular, the agencies are mindful that
the Southern District of Georgia’s
preliminary injunction of the 2015 Rule
was based in part on the court’s holding
that the 2015 Rule likely is flawed for
the same reason as the Migratory Bird
Rule: ‘‘the WOTUS Rule asserts that,
standing alone, a significant ‘biological
effect’—including an effect on ‘life cycle
dependent aquatic habitat[s]’—would
place a water within the CWA’s
jurisdiction. Thus, this WOTUS Rule
will likely fail for the same reason that
the rule in SWANCC failed.’’ Georgia,
2018 U.S. Dist. LEXIS 97223, at *18
(quoting 33 CFR 328.3(c)(5)). The
agencies solicit comment on whether
the 2015 Rule is flawed in the same
manner as the Migratory Bird Rule,
including whether the 2015 Rule raises
significant constitutional questions
similar to the questions raised by the
Migratory Bird Rule as discussed by the
Supreme Court in SWANCC.
Moreover, the 2015 Rule relied on a
scientific literature review—the
Connectivity Report—to support
exerting federal jurisdiction over certain
waters based on nine enumerated
functions. See 80 FR 37065 (‘‘the
agencies interpret the scope of ‘waters of
the United States’ protected under the
CWA based on the information and
conclusions in the [Connectivity]
Report’’). The report notes that
connectivity ‘‘occur[s] on a continuum
or gradient from highly connected to
highly isolated,’’ and ‘‘[t]hese variations
in the degree of connectivity are a
critical consideration to the ecological
integrity and sustainability of
downstream waters.’’ Id. at 37057. In its
review of a draft version of the
Connectivity Report, EPA’s Science
Advisory Board (‘‘SAB’’) noted,
‘‘[s]patial proximity is one important
determinant of the magnitude,
frequency and duration of connections
between wetlands and streams that will
ultimately influence the fluxes of water,
materials and biota between wetlands
and downstream waters.’’ 35 ‘‘Wetlands
that are situated alongside rivers and
their tributaries are likely to be
connected to those waters through the
exchange of water, biota and chemicals.
As the distance between a wetland and
a flowing water system increases, these
connections become less obvious.’’ 36
35 Science Advisory Board, U.S. EPA. Review of
the EPA Water Body Connectivity Report at 60 (Oct.
17, 2014).
36 Id. at 55.

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The Connectivity Report also recognizes
that ‘‘areas that are closer to rivers and
streams have a higher probability of
being connected than areas farther
away.’’ Connectivity Report at ES–4.
Yet, the SAB observed that ‘‘[t]he
Report is a science, not policy,
document that was written to
summarize the current understanding of
connectivity or isolation of streams and
wetlands relative to large water bodies
such as rivers, lakes, estuaries, and
oceans.’’ 37 ‘‘The SAB also
recommended that the agencies clarify
in the preamble to the final rule that
‘significant nexus’ is a legal term, not a
scientific one.’’ 80 FR 37065. And in
issuing the 2015 Rule, the agencies
stated, ‘‘the science does not provide a
precise point along the continuum at
which waters provide only speculative
or insubstantial functions to
downstream waters.’’ Id. at 37090.
The agencies now believe that they
previously placed too much emphasis
on the information and conclusions of
the Connectivity Report when setting
jurisdictional lines in the 2015 Rule,
relying on its environmental
conclusions in place of interpreting the
statutory text and other indicia of
Congressional intent to ensure that the
agencies’ regulations comport with their
statutory authority to regulate. This is of
particular concern to the agencies today
with respect to the agencies’ broad
application of Justice Kennedy’s phrase
‘‘similarly situated lands. ’’ As
discussed previously, the agencies took
an expansive reading of this phrase, in
part based on ‘‘one of the main
conclusions of the [Connectivity Report]
. . . that the incremental contributions
of individual streams and wetlands are
cumulative across entire watersheds,
and their effects on downstream waters
should be evaluated within the context
of other streams and wetlands in that
watershed,’’ see 80 FR 37066. Yet,
Justice Kennedy observed in Rapanos
that what constitutes a ‘‘significant
nexus’’ to the waters of the United
States is not a solely scientific question
and that it cannot be determined by
environmental effects alone. See, e.g.,
547 U.S. at 777–78 (noting that although
‘‘[s]cientific evidence indicates that
wetlands play a critical role in
controlling and filtering runoff . . .
environmental concerns provide no
reason to disregard limits in the
statutory text’’ (citations omitted)). This
includes how Congress’ use of the term
‘‘navigable’’ in the CWA and how the
policies embodied in section 101(b)
should inform this analysis. Justice
Kennedy wrote that ‘‘the Corps deems a
37 Id.

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water a tributary if it feeds into a
traditional navigable water (or a
tributary thereof) and possesses an
ordinary high-water mark,’’ defined as a
‘‘line on the shore established by the
fluctuations of water and indicated by
[certain] physical characteristics.’’ Id. at
781. This ‘‘may well provide a
reasonable measure of whether specific
minor tributaries bear a sufficient nexus
with other regulated waters to constitute
‘navigable waters’ under the Act. Yet the
breadth of this standard—which seems
to leave wide room for regulation of
drains, ditches, and streams remote
from any navigable-in-fact water and
carrying only minor volumes toward
it—precludes its adoption as the
determinative measure of whether
adjacent wetlands are likely to play an
important role in the integrity of an
aquatic system comprising navigable
waters as traditionally understood.’’ Id.
(emphasis added).
The 2015 Rule, by contrast, asserts
jurisdiction categorically over any
tributary, including all ephemeral and
intermittent streams that meet the rule’s
tributary definition, as well as all
wetlands and other waters that are
within certain specified distances from
a broadly defined category of tributaries
(e.g., all waters located within the 100year floodplain of a category (1) through
(5) ‘‘jurisdictional by rule’’ water and
not more than 1,500 feet from the
ordinary high water mark of such
water). According to the rule, tributaries
are characterized by the presence of the
physical indicators of a bed and banks
and an ordinary high water mark and
eventually contribute flow (directly or
indirectly) to a traditional navigable
water, interstate water, or territorial sea
that may be a considerable distance
away. See 80 FR 37105. The 2015 Rule
defined ‘‘ordinary high water mark’’ as
‘‘that line on the shore established by
the fluctuations of water and indicated
by physical characteristics such as a
clear, natural line impressed on the
bank, shelving, changes in the character
of soil, destruction of terrestrial
vegetation, the presence of litter and
debris, or other appropriate means that
consider the characteristics of the
surrounding areas.’’ Id. at 37106. The
2015 Rule did not require any
assessment of flow, including volume,
duration, or frequency, when defining
the ‘‘waters of the United States.’’
Instead, the 2015 Rule concluded that it
was reasonable to presume that ‘‘[t]hese
physical indicators demonstrate there is
volume, frequency, and duration of flow
sufficient to create a bed and banks and
an ordinary high water mark, and thus
to qualify as a tributary.’’ Id. at 37105.

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The 2015 Rule thus covers ephemeral
washes that flow only in response to
infrequent precipitation events if they
meet the definition of tributary. These
results, particularly that adjacent
waters, broadly defined, are
categorically jurisdictional no matter
how small or frequently flowing the
tributary to which they are adjacent, is,
at a minimum, in significant tension
with Justice Kennedy’s understanding of
the term significant nexus as explained
in Rapanos. See id. at 781–82 (‘‘[I]n
many cases wetlands adjacent to
tributaries covered by [the Corps’ 1986
tributary] standard might appear little
more related to navigable-in-fact waters
than were the isolated ponds held to fall
beyond the Act’s scope in SWANCC.’’).
The agencies are mindful that courts
that have considered the merits of
challenges to the 2015 Rule have
similarly observed that the rule may
conflict with Justice Kennedy’s opinion
in Rapanos, particularly the rule’s
definition of ‘‘tributary.’’ The District of
North Dakota found that the definitions
in the 2015 Rule raise ‘‘precisely the
concern Justice Kennedy had in
Rapanos, and indeed the general
definition of tributary [in the 2015 Rule]
is strikingly similar’’ to the standard for
tributaries that concerned Justice
Kennedy in Rapanos. North Dakota, 127
F. Supp. 3d at 1056. The Southern
District of Georgia also found that the
2015 Rule’s definition of ‘‘tributary’’ ‘‘is
similar to the one’’ at issue in Rapanos,
and that ‘‘it carries with it the same
concern that Justice Kennedy had
there.’’ Georgia, 2018 U.S. Dist. LEXIS
97223, at *17. Likewise, the Sixth
Circuit stated in response to petitioners’
‘‘claim that the Rule’s treatment of
tributaries, ‘adjacent waters,’ and waters
having a ‘significant nexus’ to navigable
waters is at odds with the Supreme
Court’s ruling in Rapanos’’ that ‘‘[e]ven
assuming, for present purposes, as the
parties do, that Justice Kennedy’s
opinion in Rapanos represents the best
instruction on the permissible
parameters of ‘waters of the United
States’ as used in the Clean Water Act,
it is far from clear that the new Rule’s
distance limitations are harmonious
with the instruction.’’ In re EPA, 803
F.3d at 807 & n.3 (noting that ‘‘[t]here
are real questions regarding the
collective meaning of the [Supreme]
Court’s fragmented opinions in
Rapanos’’).
One example that illustrates this point
is the ‘‘seasonally ponded, abandoned
gravel mining depressions’’ specifically
at issue in SWANCC, 531 U.S. at 164,
which the Supreme Court determined
were ‘‘nonnavigable, isolated, intrastate
waters,’’ id. at 166–72, and not

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jurisdictional. These depressions are
located within 4,000 feet of Poplar
Creek, a tributary to the Fox River, and
may have the ability to store runoff or
contribute other ecological functions in
the watershed. Thus, they would be
subject to, and might satisfy, a
significant nexus determination under
the 2015 Rule’s case-specific analysis.
However, Justice Kennedy himself
stated in Rapanos, which informed the
significant nexus standard articulated in
the rule, that, ‘‘[b]ecause such a
[significant] nexus was lacking with
respect to isolated ponds, the
[SWANCC] Court held the plain text of
the statute did not permit’’ the Corps to
assert jurisdiction over them. 547 U.S. at
767. Other potential examples of the
breadth of the significant nexus
standard articulated in the 2015 Rule
are provided below in the next section.
3. Concerns Regarding the 2015 Rule’s
Effect on the Scope of CWA Jurisdiction
The agencies asserted in the preamble
to the 2015 Rule that ‘‘State, tribal, and
local governments have well-defined
and longstanding relationships with the
Federal government in implementing
CWA programs and these relationships
are not altered by the final rule.’’ 80 FR
37054. The agencies further noted that
‘‘[c]ompared to the current regulations
and historic practice of making
jurisdictional determinations, the scope
of jurisdictional waters will decrease’’
under the 2015 Rule. Id. at 37101. When
compared to more recent practice,
however, the agencies determined that
the 2015 Rule would result ‘‘in an
estimated increase between 2.84 and
4.65 percent in positive jurisdictional
determinations annually.’’ Id. The
agencies thus concluded that the 2015
Rule would ‘‘result in a small overall
increase in positive jurisdiction
determinations compared to those made
under the Rapanos Guidance’’ and that
the ‘‘net effect’’ of the regulatory
changes would ‘‘be marginal at most.’’
Brief for Respondents at 32–33 & n.6, In
re EPA, No. 15–3571 (6th Cir. Jan. 13,
2017). Since publication of the final
rule, the agencies have received
information about the impact of these
changes, including through filings in
litigation against the 2015 Rule and
comments received in response to the
July 27, 2017 NPRM. After further
analysis and reconsideration of how the
2015 Rule is likely to impact
jurisdictional determinations, including
how the data on those impacts relate to
the specific regulatory changes made in
the 2015 Rule, the agencies are now
considering whether the definitional
changes in the 2015 Rule would have a
more substantial impact on the scope of

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jurisdictional determinations made
pursuant to the CWA than
acknowledged in the analysis for the
rule and would thus impact the balance
between federal, state, tribal, and local
government in a way that gives
inadequate consideration to the
overarching Congressional policy to
‘‘recognize, preserve, and protect the
primary responsibilities and rights of
States to prevent, reduce, and eliminate
pollution’’ and ‘‘to plan the
development and use . . . of land and
water resources. . . .’’ 33 U.S.C.
1251(b).
Between the agencies’ ‘‘historic’’ (i.e.,
1986 regulations) and ‘‘recent’’ practices
of making jurisdictional determinations
under the Rapanos Guidance, the
Supreme Court held that the agencies’
application of the 1986 regulation was
overbroad in some important respects.
See SWANCC, 531 U.S. at 174 (reversing
and remanding the assertion of
jurisdiction); Rapanos, 547 U.S. at 715
(vacating and remanding, for further
analysis, the assertion of CWA
jurisdiction). Throughout the
rulemaking process for the 2015 Rule,
the agencies stressed in public
statements,38 fact sheets,39 blog posts,40
and before Congress 41 that the rule
would not significantly expand the
jurisdictional reach of the CWA. Some
commenters questioned the accuracy of
these statements during the rulemaking
process for the 2015 Rule and in
response to the July 27, 2017 NPRM.
The court in North Dakota questioned
the scope of waters subject to the 2015
Rule, and based its preliminary
injunction in principal part on those
doubts, stating, for example, that ‘‘the
definition of tributary’’ in the 2015 Rule
38 Addressing farmers in Missouri in July 2014,
then-EPA Administrator Gina McCarthy stated that
no additional CWA permits would be required
under the proposed 2015 Rule. See: http://
www.farmfutures.com/story-epas-mccarthy-ditchmyths-waters-rule-8-114845 (‘‘The bottom line with
this proposal is that if you weren’t supposed to get
a permit before, you don’t need to get one now.’’).
39 U.S. EPA. Facts About the Waters of the U.S.
Proposal at 4 (July 1, 2014), available at https://
www.regulations.gov/
contentStreamer?documentId=EPA-HQ-OW-20110880-16357&attachmentNumber=38&
contentType=pdf (‘‘The proposed rule does not
expand jurisdiction.’’).
40 U.S. EPA blog post entitled ‘‘Setting the Record
Straight on Waters of the US’’ (June 30, 2014),
available at https://blog.epa.gov/blog/2014/06/
setting-the-record-straight-on-wous/ (‘‘The proposed
rule does not expand jurisdiction.’’).
41 In a hearing before the House Committee on
Science, Space, and Technology entitled
‘‘Navigating the Clean Water Act: Is Water Wet?’’
(July 9, 2014), then-Deputy EPA Administrator Bob
Perciasepe told the Committee that the agencies are
not expanding the jurisdiction of the CWA. See
https://science.house.gov/legislation/hearings/fullcommittee-hearing-navigating-clean-water-actwater-wet.

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‘‘includes vast numbers of waters that
are unlikely to have a nexus to
navigable waters within any reasonable
understanding of the term.’’ 127 F.
Supp. 3d at 1056; see also In re EPA,
803 F.3d at 807 (finding that ‘‘it is far
from clear that the new Rule’s distance
limitations are harmonious’’ with
Justice Kennedy’s significant nexus test
in Rapanos); Georgia, 2018 U.S. Dist.
LEXIS 97223, at *17 (holding that the
2015 Rule’s ‘‘tributary’’ definition ‘‘is
similar to the one invalidated in
Rapanos, and it carries with it the same
concern that Justice Kennedy had
there’’).
Given the concerns raised by some
commenters and the federal courts, the
agencies have reviewed data previously
relied upon to conclude that the 2015
Rule would have no or ‘‘marginal at
most’’ impacts on jurisdictional
determinations, Brief for Respondents at
32 n.6, In re EPA, No. 15–3571 (6th Cir.
Jan. 13, 2017), and are reconsidering the
validity of this conclusion. The agencies
solicit comment on whether the
agencies appropriately characterized or
estimated the potential scope of CWA
jurisdiction that could change under the
2015 Rule, including whether the
documents supporting the 2015 Rule
appropriately considered the data
relevant to and were clear in that
assessment.
For example, the agencies relied upon
an examination of the documents
supporting the estimated 2.84 to 4.65
percent annual increase in positive
approved jurisdictional determinations
(AJDs) to conclude that the 2015 Rule
would only ‘‘result in a small overall
increase in positive jurisdictional
determinations compared to those made
under the Rapanos Guidance.’’ See Brief
for Respondents at 32, In re EPA, No.
15–3571 (6th Cir. Jan. 13, 2017).
However, others have raised concerns
that this information and other data
show the 2015 Rule may have expanded
jurisdiction more significantly,
particularly with respect to so-called
‘‘other waters’’ that are not adjacent to
navigable waters and their tributaries.
In developing the 2015 Rule, the
agencies examined records in the Corps’
Operation and Maintenance Business
Information Link, Regulatory Module
(ORM2) database that documents
jurisdictional determinations associated
with various aquatic resource types,
including an isolated waters category.
‘‘The isolated waters category is used in
the Corps’ ORM2 database to represent
intrastate, non-navigable waters;
including wetlands, lakes, ponds,
streams, and ditches, that lack a direct
surface connection to other waterways.
These waters are hereafter referred to as

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‘ORM2 other waters.’ ’’ 42 To examine
how assertion of jurisdiction could
change under the 2015 Rule, the
agencies reviewed ORM2 aquatic
resource records from Fiscal Year
(FY)13 and FY14 and placed them into
three groups: Streams (ORM2 categories
of traditionally navigable waters,
relatively permanent waters, and nonrelatively permanent waters), wetlands
adjacent to the stream category group,
and other waters. Of the 160,087 records
for FY13 and FY14, streams represented
65 percent of the total records available,
wetlands represented 29 percent, and
other waters represented 6 percent.
From this baseline, the agencies
assumed that 100 percent of the records
classified as streams would meet the
jurisdictional tests established in the
final rule, and 100 percent of the
records classified as adjacent wetlands
would meet the definition of adjacent in
the final rule. These assumptions
resulted in a relatively minor projected
increase in positive jurisdictional
determinations under the final rule for
these categories: 99.3 to 100 percent for
the streams category, and 98.9 to 100
percent for the wetlands category.
The agencies also performed a
detailed analysis of the other waters
category to determine whether
jurisdiction might change for those
waters under the final rule. In total,
‘‘these files represented over 782
individual waters in 32 states.’’ 43
Of the existing negative
determinations for other waters, the
agencies made the following estimates:
• 17.1 percent of the negative
jurisdictional determinations for other
waters would become positive under the
2015 Rule because the aquatic resources
would meet the new definition of
adjacent waters. See 80 FR 37105. These
waters fall within the 100-year
floodplain and are within 1,500 feet of
a stream included in the United States
Geological Survey’s (USGS) National
Hydrography Dataset (NHD).
• 15.7 percent of the other waters
could become jurisdictional under
category (7) of the 2015 Rule following
a significant nexus analysis. See id. at
37104–05.
• 1.7 percent of the other waters
could become jurisdictional under
category (8) of the 2015 Rule following
a significant nexus analysis. See id. at
37105.
In total, the agencies estimated that
34.5 percent of the other waters
represented in the FY13 and FY14
ORM2 database could become
jurisdictional under the 2015 Rule after
42 2015
43 2015

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having been declared not jurisdictional
under the existing regulations and
agency guidance. Thus, while the
agencies acknowledged in the 2015 Rule
Economic Analysis that ‘‘[f]ollowing the
Supreme Court decisions in SWANCC
(2001) and Rapanos (2006), the agencies
no longer asserted CWA jurisdiction
over isolated waters,’’ the agencies
estimated in the 2015 Rule Economic
Analysis that 34.5 percent of the other
waters category could become
jurisdictional under the 2015 Rule.44 By
way of comparison, a similar analysis of
this category of other waters performed
in support of the proposed rule in 2014
(using FY09 and FY10 data from the
ORM2 database) estimated that 17
percent of the negative jurisdictional for
other waters would become positive.45
While the Economic Analysis for the
2015 Rule estimated that 34.5 percent of
negative jurisdictional determinations
for other waters would become
positive,46 the agencies nevertheless
premised the 2015 Rule on assertions
that the ‘‘scope of jurisdiction in this
rule is narrower than that under the
existing regulation,’’ the scope of
jurisdiction in the rule would result ‘‘in
an estimated increase between 2.84 and
4.65 percent in positive jurisdictional
determinations annually’’ based on
existing practice, and that such impacts
would be ‘‘small overall’’ and ‘‘marginal
at most.’’ See 80 FR 37054, 37101; Brief
for Respondents at 32–33 & n.6, In re
EPA, No. 15–3571 (6th Cir. Jan. 13,
2017). The agencies are examining these
statements and how this data relates
specifically to the regulatory changes
made in the 2015 Rule (as opposed to
those provisions which already
subjected many streams and wetlands to
CWA jurisdiction). The agencies request
comment on whether the projected
increase for this category is most
relevant to measuring the impacts of the
2015 Rule, whether the public had
ample notice of the doubling of
projected positive jurisdiction over the
other waters category from the proposed
to final rule, and whether the final rule
could expand overall CWA positive
jurisdictional determinations by a
material amount inconsistent with the
findings and conclusions that justified
the 2015 Rule.
In particular, the agencies seek
comment on the conclusions that were
based on the method that estimated a
44 2015

Rule Economic Analysis at 5, 12.
EPA and U.S. Army Corps of Engineers.
Economic Analysis of Proposed Revised Definition
of Waters of the United States at 12, Exhibit 3 (Mar.
2014) (Docket ID: EPA–HQ–OW–2011–0880–0003),
available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-0003.
46 2015 Rule Economic Analysis at 13, Figure 2.
45 U.S.

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2.84 to 4.65 percent increase in overall
jurisdiction, including the use of a
method whereby the increase in
assertion of jurisdiction in a particular
category of waters (e.g., streams,
wetlands, and other waters) was
proportionally applied based on the raw
number of records in a category relative
to the total number of records across all
categories in the ORM2 database,
notwithstanding whether the regulatory
changes in the 2015 Rule did not
materially impact those other categories.
For example, of the 160,087 records in
the ORM2 database for FY13 and FY14,
103,591 were associated with the
streams category, 46,781 were
associated with the wetlands category,
and 9,715 were related to the other
waters category. Thus, although 34.5
percent of previously non-jurisdictional
‘‘other waters’’ would become
jurisdictional under the 2015 Rule, the
proportional method used in the 2015
Rule Economic Analysis resulted in
only an estimated 2.09 percent increase
in positive jurisdictional determinations
for ‘‘other waters’’ relative to the total
number of jurisdictional determinations
considered.47
In addition, the record for the 2015
Rule includes a 57-page document
entitled ‘‘Supporting Documentation:
Analysis of Jurisdictional
Determinations for Economic Analysis
47 The following summarizes the methodology
used to derive the low-end estimated increase in
jurisdiction of 2.84 percent: Streams account for
103,591 of the 160,087 total records (64.709 percent
of the total ORM2 records) and 100 percent of
streams are assumed to be jurisdictional under the
final rule compared to 99.3 percent under previous
practice (100 percent minus 99.3 percent = 0.7
percent). The relative contribution of streams to the
overall change in jurisdictional determinations is
thus 64.709 percent multiplied by 0.7 percent for
a total of 0.45 percent. Wetlands account for 46,781
of the 160,087 total records (29.222 percent of the
total ORM2 records) and 100 percent of wetlands
are assumed to be jurisdictional under the final rule
compared to 98.9 percent under previous practice
(100 percent minus 98.9 percent = 1.1 percent). The
relative contribution of wetlands to the overall
estimated change in jurisdictional determinations is
thus 29.222 percent multiplied by 1.1 percent for
a total of 0.32 percent. Other waters account for
9,715 of the 160,087 total records (6.069 percent of
the total ORM2 records) and 34.5 percent of other
waters are assumed to be jurisdictional under the
final rule compared to 0.0 percent under previous
practice (34.5 percent minus 0.0 percent = 34.5
percent). The relative contribution of other waters
to the overall estimated change in jurisdictional
determinations is thus 6.069 percent multiplied by
34.5 percent for a total of 2.09 percent. The agencies
then added the relative contribution to the overall
estimated change in jurisdictional determinations
for each category of waters (i.e., 0.45 percent for
streams, 0.32 percent for wetlands, and 2.09 percent
for other waters) to get a total projected change in
positive jurisdictional determinations of 2.86
percent. The differences between this calculation
and the reported 2.84 percent in the 2015 Rule
Economic Analysis may be the result of rounding
error.

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and Rule,’’ 48 along with an
accompanying 3,695 page document of
approved jurisdictional determination
(AJD) forms.49 This contains the
agencies’ assessment conducted in April
2015 of almost two hundred previously
performed AJDs to help the agencies
better understand how waters might
change jurisdictional status based on the
distance limitations included in the
final 2015 Rule for adjacent and casespecific waters (see 80 FR 37105),
including where they might no longer
be jurisdictional under the final rule.
Certain examples included in the
assessment suggest that the 2015 Rule
could modify CWA jurisdiction over
waters that were deemed not
jurisdictional under the 1986 regulatory
framework and Supreme Court
precedent. The agencies request
comment on whether the examples
illustrate the concerns expressed by the
recent court decisions discussed above
that the 2015 Rule may have exceeded
the significant nexus standard
articulated by Justice Kennedy in the
Rapanos opinion and concerns
expressed by certain commenters that
the 2015 Rule may have created
additional regulatory uncertainty over
waters that were previously thought
beyond the scope of CWA jurisdiction.
The examples are intended to be
illustrative, and are not intended to
attempt to quantify or reassess previous
estimates of CWA jurisdiction, as the
agencies are not aware of any map or
dataset that accurately or with any
precision portrays CWA jurisdiction at
any point in the history of this complex
regulatory program.
In the first example, a property in
Chesapeake, Virginia, was reviewed by
the Corps’ Norfolk District in early
January 2014 and again in March 2015
and was determined not to contain
jurisdictional wetlands because the
wetlands on the property lacked a
hydrological surface connection of any
duration, frequency, or volume of flow
to other jurisdictional waters. The Corps
noted that the wetlands ‘‘appear to be
dependent upon groundwater for
hydrology, and have no surface
connections’’ to nearby tributaries, the
closest one of which was approximately
80 feet from the wetland. The agencies
48 U.S. EPA. Supporting Documentation: Analysis
of Jurisdictional Determinations for Economic
Analysis and Rule (Docket ID: EPA–HQ–OW–2011–
0880–20877), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-20877.
49 U.S. EPA and U.S. Army Corps of Engineers.
Supporting Documentation: Jurisdictional
Determinations (Docket ID: EPA–HQ–OW–2011–
0880–20876), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-20876.

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later stated that the wetland features
‘‘would be jurisdictional under the new
rule’’ because they are ‘‘within 100-feet
of a tributary’’ and would thus meet the
rule’s definition of ‘‘neighboring’’ and,
in turn, ‘‘adjacent.’’ Further information
regarding this AJD and property has
been added to the docket for the NPRM
and is identified as ‘‘Case Study A—AJD
Number NAO–2014–2269’’ (see Support
Document).
In another example, the Corps’
Buffalo District reviewed a small
wetland approximately 583 feet away
from the Johlin Ditch near Toledo, Ohio,
which eventually leads north to Lake
Erie. After conducting a field
investigation in September 2014, the
Corps determined that the wetlands
were not jurisdictional because the
‘‘wetlands are isolated and there is no
surface water connections [sic] and the
only potential jurisdiction would be the
[Migratory Bird Rule],’’ noting that the
area previously would have been
regulated under the Migratory Bird Rule
prior to the Supreme Court’s SWANCC
decision. The agencies later stated that
the wetlands would be jurisdictional
under the 2015 Rule. Further
information regarding this AJD and
property has been added to the docket
for the NPRM and is identified as ‘‘Case
Study B—AJD Number 2004–001914’’
(see Support Document).
In another example, the Corps’
Memphis District reviewed a borrow pit
on a property in Mississippi County,
Missouri, and concluded that the
borrow pit did not contain jurisdictional
wetlands. The project area was
described in the AJD as follows:

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The borrow pit has been abandoned for
some time. Vegetation consists mainly of
black willow (Salix nigra) and poison ivy
(Toxicodendron radicans). A site visit was
conducted on 8 December 2014. The borrow
pit is bordered by agricultural land on three
sides and County Road K on the western
border. There are no surface water
connections to other waters of the U.S. A
sample was taken within the site and all
three parameters for a wetland are present.
The Soil Survey book for Cape Girardeau,
Mississippi and Scott Counties Missouri,
compiled in 1974 and 1975 from aerial
photography indicates no drainage into or
out of the project site. The area is an isolated
wetland approximately 7.6 acres in size.

The abandoned pit in this example
was 2,184 feet from the nearest
‘‘tributary,’’ a feature that itself appears
to be a ditch in an agricultural field. The
wetlands in the borrow pit were
determined by the Corps to be isolated
and non-jurisdictional ‘‘with no
substantial nexus to interstate (or
foreign) commerce’’ and on the basis
that ‘‘prior to . . .‘’SWANCC,’ the
review area would have been regulated

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based solely on the ‘Migratory Bird
Rule.’ ’’ A later review by the agencies,
however, stated that these wetlands
would be jurisdictional under the 2015
Rule. Further information regarding this
property and associated AJD has been
added to the docket for the NPRM and
is identified as ‘‘Case Study C—AJD
Number MVM–2014–460’’ (see Support
Document).
In another example, the Corps’ New
England District reviewed a ‘‘mowed
wet meadow within a mowed hayfield’’
in Greensboro, Vermont, in August 2012
and concluded the site did not contain
jurisdictional wetlands. The AJD
described the wetlands as ‘‘surrounded
on all sides by similar upland,’’ ‘‘500′–
985′ away’’ from the nearest
jurisdictional waters, and ‘‘isolated
intrastate waters with no outlet, no
hydrological connection to the Lamoille
River, no nexus to interstate commerce,
and no significant nexus to the Lamoille
River (located about 1.7–1.8 miles
southeast of the site).’’ A later review by
the agencies, however, stated the
wetlands would be jurisdictional under
the 2015 Rule. Further information
regarding this property and associated
AJD has been added to the docket for
the NPRM and is identified as ‘‘Case
Study D—AJD Number NAE–2012–
1813’’ (see Support Document).
In another example, the Corps’
Chicago District completed AJD number
LRC–2015–31 for wetlands in
agricultural fields in Kane County,
Illinois, in January 2015. AJD Number
LRC–2015–31 was completed using two
separate AJD forms: One form for the
features at the project site that were
determined to be jurisdictional
according to the Rapanos Guidance
(‘‘positive AJD form’’) and a second
form for the features at the site that the
Corps determined were not
jurisdictional under the Rapanos
Guidance (‘‘negative AJD form’’). Only
the positive AJD form was included in
the docket in Supporting
Documentation entitled, ‘‘Jurisdictional
Determinations—Redacted.’’ 50 The
negative AJD form is available on the
Chicago District website.51
Using a field determination and desk
determinations, the Corps found on the
AJD form that there were ‘‘no ‘waters of
the U.S.’ within Clean Water Act (CWA)
jurisdiction (as defined by 33 CFR part
328) in the review area.’’ The Corps
described the project area in the AJD
form as follows: ‘‘Wetland A is a 1.37
acre high quality closed depressional
at 2082–83.
at: http://www.lrc.usace.army.mil/
Portals/36/docs/regulatory/jd/lrcnjd02-2015.pdf
(page 1 and 2).

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51 Available

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isolated wetland. Wetlands B and C
(0.08 ac and 0.15 ac) are isolated
wetlands that formed over a failed drain
tile and are over 1,200 feet away from
the closest jurisdictional waterway.’’
The AJD also notes, ‘‘Weland [sic] A and
the area around Wetlands B and C were
previously determined to be isolated in
2008. Wetland C is mapped as Prior
Converted in a NRCS certified farmed
wetland determination—other areas are
mapped as not inventoried.’’ Upon later
reviewing the negative AJD, however,
the agencies determined the wetlands
would be ‘‘now Yes JD’’ under the 2015
Rule. Further information regarding this
property and associated positive and
negative AJDs has been added to the
docket for the NPRM and is identified
as ‘‘Case Study E—AJD Number LRC–
2015–31’’ (see Support Document).
In another example, the Corps’
Pittsburgh District visited a property in
Butler, Pennsylvania, in October 2014
and determined the site did not contain
waters of the United States because the
wetland was ‘‘completely isolated and
has no nexus to a TNW or interstate or
foreign commerce.’’ The Corps noted
that the wetland would have been
regulated based solely on the Migratory
Bird Rule prior to the decision in
SWANCC. Upon reviewing the AJD, the
agencies later stated the wetland is
‘‘[i]solated but would have flood storage
function.’’ The agencies’ review notes
that the wetland is 1,270 feet from the
nearest relatively permanent water
(RPW) or traditional navigable water
(TNW). Given the wetland is within
4,000 feet of a tributary and the agencies
have stated it possesses at least one of
the nine functions relevant to the
significant nexus evaluation, see 80 FR
37106 (i.e., retention and attenuation of
flood waters), the wetland would be
subject to a significant nexus evaluation
under the 2015 Rule. It is unclear,
however, whether the wetland and its
flood storage function would contribute
significantly to the chemical, physical,
or biological integrity of the nearest
category (1) through (3) water as
required by the 2015 Rule to satisfy the
significant nexus test. Further
information regarding this property and
associated AJD has been added to the
docket for the NPRM and is identified
as ‘‘Case Study F—AJD Number LRP
2014–855’’ (see Support Document).
In addition to the projected increase
in positive jurisdictional determinations
and the above examples of expected JD
changes, an examination of the
documents supporting the estimated
2.84 to 4.65 percent annual increase in
positive AJDs raises concerns that the
2015 Rule may have significantly
expanded jurisdiction over tributaries in

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certain States, particularly those in more
arid parts of the country.
As described previously, to assess
how assertion of jurisdiction may
change under the 2015 Rule, the
agencies reviewed ORM2 aquatic
resource records from FY13 and FY14
and placed the aquatic resources into
three groups: Streams, wetlands
adjacent to the stream category group,
and other waters. With respect to the
streams category, the agencies assumed
that ‘‘100 percent of the records
classified as streams will meet the
definition of tributary in the final
rule,’’ 52 resulting in a relatively minor
projected increase in positive
jurisdictional determinations under the
final rule for streams: 99.3 percent to
100 percent, or a 0.7 percent increase.
However, the agencies have
reexamined the 57-page ‘‘Supporting
Documentation: Analysis of
Jurisdictional Determinations for
Economic Analysis and Rule’’ and have
questions regarding the minor projected
increase in positive jurisdictional
determinations over streams in some
states. An untitled table on page 46 of
the supporting document lists an
analysis of a subset of streams and the
number of those streams estimated to be
non-jurisdictional by State in the FY13–
FY14 ORM2 records for the purpose of
estimating stream mitigation costs
associated with the 2015 Rule.53
Investigating the percent of streams
estimated to be non-jurisdictional on a
State-by-State basis coupled with the
2015 Rule Economic Analysis’s
assumption that 100 percent of the
stream jurisdictional determinations
will be positive under the 2015 Rule
could indicate that there may be a
significant expansion of jurisdiction
over tributaries in some States beyond
current practice. For example, in the
FY13–FY14 ORM2 records for Arizona,
the table identifies 709 of 1,070 total
streams (66.3 percent) were nonjurisdictional. For Arkansas, the table
identifies 116 of 213 total streams (54.5
percent) as non-jurisdictional. In South
Dakota, North Dakota, Nevada, New
Mexico, and Wyoming, 8.5 percent, 9.2
percent, 13.2 percent, 16.7 percent, and
57.1 percent of streams in the FY13–
FY14 ORM2 database, respectively,
were identified in the table as nonjurisdictional. The agencies are
concerned that because the 2015 Rule
may assert jurisdiction over 100 percent
of streams as the agencies assumed in
the 2015 Rule Economic Analysis,
certain States, particularly those in the
arid West, would see significant
52 2015
53 The

Rule Economic Analysis at 8.
table includes all states except Hawaii.

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expansions of federal jurisdiction over
streams. The agencies solicit comment
on whether such expansions conflict
with the assumptions underlying and
statements justifying the 2015 Rule, and
if such expansions were consistent with
the policy goals of section 101(b) of the
CWA.
Several questions were raised by
commenters regarding whether the 2015
Rule expanded CWA jurisdiction over
intermittent and ephemeral streams, and
whether the agencies accurately
identified that potential expansion in
the development of the 2015 Rule.
Several commenters, for example,
suggested that the amount of
jurisdictional river and stream miles in
the United States may increase from
approximately 3.5 million miles to more
than 8 million miles in response to the
per se jurisdictional treatment of
millions of miles of ephemeral and
intermittent streams under the tributary
definition.54 To frame their analysis,
those commenters compared river and
stream miles reported in recent CWA
section 305(b) reports submitted by
States to EPA, and transmitted by EPA
to Congress, to the river and stream
miles depicted in maps developed by
the agencies and the USGS prior to the
2015 Rule’s proposal.
Section 305(b)(1)(A) of the CWA
directs each state to ‘‘prepare and
submit to the Administrator . . .
biennially . . . a report which shall
include . . . a description of the water
quality of all navigable waters in such
State during the preceding year. . . .’’
33 U.S.C. 1315(b)(1)(A). Section
305(b)(2) additionally directs the
Administrator to ‘‘transmit such State
reports, together with an analysis
thereof, to Congress . . . .’’ Id. at
1315(b)(2). Over the years, those reports
to Congress have identified between 3.5
and 3.7 million river and stream miles
nationwide (see Support Document).
The agencies previously observed that
this analysis may not be precise,
because of concerns regarding the
baseline for comparison and
54 See comments submitted by Arizona
Department of Environmental Quality et al. (Nov.
14, 2014) (Docket ID: EPA–HQ–OW–2011–0880–
15096), available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-15096;
comments submitted by CropLife America (Nov. 14,
2014) (Docket ID: EPA–HQ–OW–2011–0880–
14630), available at https://www.regulations.gov/
document?D=EPA-HQ-OW-2011-0880-14630;
comments submitted by American Foundry Society
(Nov. 14, 2014) (Docket ID: EPA–HQ–OW–2011–
0880–15148), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-15148; comments submitted by U.S.
Chamber of Commerce et al. (Nov. 12, 2014) (Docket
ID: EPA–HQ–OW–2011–0880–14115), available at
https://www.regulations.gov/document?D=EPA-HQOW-2011-0880-14115.

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assumptions regarding which
intermittent and ephemeral streams may
be covered under the 2015 Rule.55
The agencies are not aware of any
national, regional, or state-level map
that identifies all ‘‘waters of the United
States’’ and acknowledge that there are
limitations associated with existing
datasets. The agencies, however,
developed a series of draft maps using
the NHD identifying ‘‘rivers and streams
and tributaries and other water bodies’’
in each State, which then-EPA
Administrator Gina McCarthy
mentioned at a March 27, 2014 hearing
before the U.S. House of Representatives
Appropriations Committee
Subcommittee on Interior, Environment,
and Related Agencies.56 The EPA
provided a copy of those draft maps to
Congress on July 28, 2014,57 and they
remain available to the public on the
U.S. House of Representatives
Committee on Science, Space and
Technology website.58 The draft maps
identify a total of 8,086,742 river and
stream miles across the 50 States (see
Support Document).
Given the significant differences
between the CWA section 305(b) reports
and the draft NHD maps submitted to
Congress, and the possibility that each
may represent potential estimates for
the relative jurisdictional scope of the
1986 regulations and practice compared
to the 2015 Rule, several States have
questioned whether the proposed
definition of ‘‘tributary’’ for the 2015
Rule would expand federal jurisdiction
over State water resources. Eight State
departments of environmental quality,
for example, stated in joint comments
that ‘‘comparing the ‘waters of the
United States’ reported by States to
recent USGS maps released by the EPA
shows a 131% increase in federal
waters.’’ 59 Comments filed by the State
55 See U.S. EPA and U.S. Army Corps of
Engineers. Clean Water Rule Response to
Comments—Topic 8: Tributaries at 88–89, available
at https://www.epa.gov/sites/production/files/201506/documents/cwr_response_to_comments_8_
tributaries.pdf.
56 EPA Administrator Gina McCarthy testimony
before the U.S. House of Representatives
Appropriations Committee Subcommittee on
Interior, Environment, and Related Agencies (March
27, 2014), available at https://www.c-span.org/
video/?318438-1/fy2015-epa-budget.
57 Letter from Nancy Stoner, Acting Asst.
Administrator, U.S. EPA Office of Water, to Rep.
Lamar Smith, Chairman, U.S. House of
Representatives Committee on Science, Space, and
Technology (July 28, 2014), available at https://
science.house.gov/sites/
republicans.science.house.gov/files/documents/
epa_releases_maps_letter.pdf.
58 EPA State and National Maps of Waters and
Wetlands, available at https://science.house.gov/
epa-state-and-national-maps-waters-and-wetlands.
59 See comments submitted by Alabama Dept. of
Environ. Mgmt., Arizona Dept. of Environ. Quality,

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of Kansas on the proposed rule raised
similar concerns and focused on the
inclusion of ephemeral streams in the
proposed definition of tributary: ‘‘In
Kansas we have identified
approximately 31,000 miles of perennial
and intermittent waters that have been
treated as WOTUS for several
decades. . . . As per the preamble to
the Rule and EPA/ACOE statements, the
additional 133,000 miles [of ephemeral
streams] would result in a 460%
increase in the number of Kansas waters
presumed to be jurisdictional under the
Rule.’’ 60 Kansas added that the State
does ‘‘not believe ephemeral waters
have always been considered de facto
tributaries for CWA jurisdictional
purposes.’’ 61 Referencing a statement
made by then-EPA Administrator
McCarthy in which she stated,
‘‘[u]nfortunately, 60 percent of our
nation’s streams and millions of acres of
wetlands currently lack clear protection
from pollution under the Clean Water
Act,’’ 62 Kansas noted that ‘‘if those 60
percent that ‘lack clear protection’ are
brought under the umbrella of the CWA,
[there will be] a significantly larger
expansion than estimated in the
economic analysis for the Rule.’’ 63
The agencies in 2015 suggested that a
feature that flows very infrequently
would not form the physical indicators
required to meet the 2015 Rule’s
definitions of ‘‘ordinary high water
mark’’ and ‘‘tributary.’’ 64 In response to
comments questioning the agencies’
characterization of the change in scope
of jurisdiction under the 2015 Rule, the
agencies stated that the 2015 Rule was
narrower in scope than the existing
regulations and historical practice, and
reiterated that an increase of
approximately 3 percent represented the
agencies’ estimate of the increased
positive jurisdictional determinations
Indiana Dept. of Environ. Mgmt., Kansas Dept. of
Health and Environ., Louisiana Dept. of Environ.
Quality, Mississippi Dept. of Environ. Quality,
Oklahoma Dept. of Environ. Quality, and Wyoming
Dept. of Environ. Quality (Nov. 14, 2014) (Docket
ID: EPA–HQ–OW–2011–0880–15096), available at
https://www.regulations.gov/document?D=EPA-HQOW-2011-0880-15096.
60 See comments submitted by the State of Kansas
at Appendix A (Oct. 23, 2014) (Docket ID: EPA–
HQ–OW–2011–0880–16636), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-16636.
61 Id. (emphasis in original).
62 See ‘‘Clean Water Drives Economic Growth’’ by
Gina McCarthy (Sept. 29, 2014), available at http://
www.huffingtonpost.com/gina-mccarthy/cleanwater-act_b_5900734.html.
63 See supra note 60.
64 See, e.g., U.S. EPA and U.S. Army Corps of
Engineers. Clean Water Rule Response to
Comments—Topic 11: Cost/Benefits (Volume 2) at
223, available at https://www.epa.gov/sites/
production/files/2015-06/documents/cwr_response_
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compared to recent practice.65 In the
administrative record for the 2015 Rule
and in a brief filed with the Sixth
Circuit (based on that record), the
agencies asserted that the definition of
‘‘waters of the United States’’
historically has included ephemeral
streams and that some federal court
decisions after SWANCC upheld
assertions of CWA jurisdiction over
surface waters that have a hydrologic
connection to and that form part of the
tributary system of a traditional
navigable water, including intermittent
or ephemeral streams. 80 FR 37079;
Brief for Respondents at 11, 62–64, In re
EPA, No. 15–3571 (6th Cir. Jan. 13,
2017).66 The agencies are requesting
comment on whether these responses to
these issues are adequate. While some
ephemeral streams may have been
jurisdictional after a case-specific
analysis pursuant to the Rapanos
Guidance,67 and while challenges to
some of those determinations have been
rejected by courts, the agencies are
requesting public comment on whether
these prior conclusions and assertions
were correct.
Given the concerns expressed by three
federal courts regarding the potential
scope of the 2015 Rule and comments
raised during the 2015 rulemaking and
submitted in response to the July 27,
2017 NPRM, the agencies are reevaluating the 2015 Rule and the
potential change in jurisdiction. While
the agencies are not aware of any data
that estimates with any reasonable
certainty or predictability the exact
baseline miles and area of waters
covered by the 1986 regulations and
preexisting agency practice or data that
accurately forecasts of the additional
waters subject to jurisdiction under the
2015 Rule, the agencies are examining
whether the data and estimates used to
support the 2015 Rule’s conclusions
that the rule would be narrower than
preexisting regulations may not have
supported those conclusions, and
instead the 2015 Rule may have had
more than a marginal impact on CWA
jurisdictional determinations and may
impact well-defined and longstanding
e.g., id. at 10–13, 17.
also U.S. EPA and Department of the Army.
Technical Support Document for the Clean Water
Rule: Definition of Waters of the United States at
28 (May 27, 2015), available at https://
www.epa.gov/sites/production/files/2015-05/
documents/technical_support_document_for_the_
clean_water_rule_1.pdf.
67 See Rapanos Guidance at 7 (‘‘ ‘[R]elatively
permanent’ waters do not include ephemeral
tributaries which flow only in response to
precipitation and intermittent streams which do not
typically flow year-round or have continuous flow
at least seasonally. However, CWA jurisdiction over
these waters will be evaluated under the significant
nexus standard.’’).

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66 See

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relationships between the federal and
State governments in implementing
CWA programs. The agencies seek
comment on this and other data that
may be relevant to a proposed finding,
and whether such a change in finding
would, either independently or in
conjunction with other factors, support
the agencies’ proposal to repeal the 2015
Rule.
4. Potential Impact on Federal-State
Balance
When promulgating the 2015 Rule,
the agencies concluded and
prominently stated that ‘‘State, tribal,
and local governments have welldefined and longstanding relationships
with the Federal government in
implementing CWA programs and these
relationships are not altered by the final
rule,’’ 80 FR 37054. Indeed, it was ‘‘the
policy of the Congress to recognize,
preserve, and protect the primary
responsibilities and rights of States to
prevent, reduce, and eliminate
pollution, to plan the development and
use (including restoration, preservation,
and enhancement) of land and water
resources, and to consult with the
Administrator in the exercise of his
authority under this Act.’’ 33 U.S.C.
1251(b).
In response to the agencies’ July 27,
2017 NPRM, some commenters have
suggested that the 2015 Rule—
including, inter alia, elements of the
final rule that commenters were not able
to address during the comment period—
may not effectively reflect the specific
policy that Congress articulated in CWA
section 101(b). The agencies are
considering whether and are proposing
to conclude that the 2015 Rule did not
draw the appropriate line, for purposes
of CWA jurisdiction, between waters
subject to federal and State regulation,
on the one hand, and waters subject to
state regulation only, on the other. In
comments submitted to the agencies in
response to the July 27, 2017 NPRM,
many States, representatives of entities
within many sectors of the regulated
community, and numerous other
commenters expressed concerns that the
2015 Rule permits federal encroachment
upon the States’ traditional and primary
authority over land and water resources.
Such commenters cite the Supreme
Court’s recognition that ‘‘Congress chose
to ‘recognize, preserve, and protect the
primary responsibilities and rights of
states . . . to plan the development and
use’ ’’ of those resources in enacting the
CWA rather than ‘‘readjust the federalstate balance,’’ SWANCC, 531 U.S. at
174 (quoting CWA section 101(b), 33
U.S.C. 1251(b)).

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Under the 2015 Rule, commenters
have observed that the agencies asserted
categorical jurisdiction over water
features that may be wholly intrastate
and physically remote from navigablein-fact waters. Such waters ‘‘adjacent’’
to jurisdictional waters are deemed to
meet the definition of ‘‘waters of the
United States’’ under the 2015 Rule, so
long as any portion of the water is
located within 100 feet of the ordinary
high water mark of a category (1)
through (5) ‘‘jurisdictional by rule’’
water; within the 100-year floodplain of
a category (1) through (5) ‘‘jurisdictional
by rule’’ water but not more than 1,500
feet from the ordinary high water mark
of such water; or within 1,500 feet of the
high tide line of a primary water or the
ordinary high water mark of the Great
Lakes. 80 FR 37085–86, 37105. The
agencies also established case-specific
jurisdiction over water features
generally at a greater distance, including
waters (including seasonal or ephemeral
waters) located within 4,000 feet of the
high tide line or ordinary high water
mark of a category (1) through (5) water.
See 80 FR 37105. For such waters, ‘‘the
entire water is a water of the United
States if a portion is located within the
100-year floodplain of a water identified
in paragraphs (a)(1) through (3) . . . or
within 4,000 feet of the high tide line or
ordinary high water mark’’ of a category
(1) through (5) water.’’ Id.
The agencies are considering whether
the 2015 Rule’s coverage of waters
based, in part, on their location within
the 100-year floodplain of a
jurisdictional water is consistent with
the policy articulated in CWA section
101(b) that States should maintain
primary responsibility over land and
water resources. The agencies received
many comments on the proposal to the
2015 Rule indicating that the potential
breadth of this standard could conflict
with other federal, State or local laws
that regulate development within
floodplains.68 In particular, certain local
governments expressed concern that the
floodplain element of the rule could
conflict with local floodplain
ordinances or otherwise complicate
local land use planning and
development.69 Though the agencies
added a distance-based threshold to
limit the use of the 100-year floodplain
68 See, e.g., comments submitted by City of
Chesapeake (Sept. 9, 2014) (Docket ID: EPA–HQ–
OW–2011–0880–9615), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-9615.
69 See, e.g., comments submitted by National
Association of Counties (Nov. 14, 2014) (Docket ID:
EPA–HQ–OW–2011–0880–15081), available at
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as a basis for categorical CWA
jurisdiction with respect to adjacent
waters, the agencies are concerned that
the Rule’s use of this standard,
including its use as a basis for requiring
a case-specific significant nexus
determination, could nonetheless
interfere with traditional state and local
police power, as suggested by some of
the comments received in 2014.70
Comments received in response to the
July 27, 2017 NPRM also raise concerns
about the use of the 100-year floodplain.
Specifically, commenters expressed
concern about the absence of suitable
maps and about the accuracy of existing
maps. Given these concerns, the
agencies request comment on whether
the 2015 Rule’s use of the 100-year
floodplain as a factor to establish
jurisdiction over adjacent waters and
case-specific waters interferes with
States’ primary responsibilities over the
planning and development of land and
water resources in conflict with CWA
section 101(b). The agencies also seek
comment on to what extent the 100-year
floodplain component of the 2015 Rule
conflicts with other federal regulatory
programs, and whether such a conflict
impacts State and local governments.
The agencies noted in 2015 ‘‘that the
vast majority of the nation’s water
features are located within 4,000 feet of
a covered tributary, traditional
navigable water, interstate water, or
territorial sea.’’ 71 The agencies’
broadening of certain key concepts and
terms relative to the prior regulatory
regime means that the agencies can
potentially review the ‘‘vast majority’’ of
water features in the country under the
2015 Rule, unless those features have
been excluded from the definition.
Similar concern was raised in response
to the July 27, 2017 NPRM, for example,
by the Missouri Department of Natural
Resources and Department of
Agriculture.72 The agencies seek
comment on that analysis and whether
the 2015 Rule readjusts the federal-state
70 See, e.g., comments submitted by Georgia
Municipal Association (Nov. 13, 2014) (Docket ID:
EPA–HQ–OW–2011–0880–14527), available at
https://www.regulations.gov/document?D=EPA-HQOW-2011-0880-14527; comments submitted by City
of St. Petersburg (Nov. 13, 2014) (Docket ID: EPA–
HQ–OW–2011–0880–18897), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2011-0880-18897.
71 2015 Rule Economic Analysis at 11.
72 See comments submitted by the Missouri
Department of Natural Resources and Department of
Agriculture (Sept. 26, 2017) (Docket ID: EPA–HQ–
OW–2017–0203–13869), available at https://
www.regulations.gov/document?D=EPA-HQ-OW2017-0203-13869 (‘‘The broad definition of tributary
and the inclusion of a three-quarter mile buffer
around every tributary and impoundment, would
have cast a very broad jurisdictional umbrella over
the state; requiring significant nexus determinations
on all but a very few number of waters.’’).

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balance in a manner contrary to the
congressionally determined policy in
CWA section 101(b). Indeed, when
issuing a preliminary injunction of the
2015 Rule, the Southern District of
Georgia held that ‘‘The [2015] WOTUS
Rule asserts jurisdiction over remote
and intermittent waters without
evidence that they have a nexus with
any navigable-in-fact waters.’’ Georgia,
2018 U.S. Dist. LEXIS 97223, at *19.
The agencies thus solicit comment on
whether the definitions in the 2015 Rule
would subject wholly intrastate or
physically remote waters or wetlands to
CWA jurisdiction, either categorically or
on a case-by-case basis, and request
information about the number and
scope of such waters of which
commenters may be aware.73
Further, the agencies solicit comment
about whether these, or any other,
aspects of the 2015 Rule as finalized
would, as either a de facto or de jure
matter, alter federal-state relationships
in the implementation of CWA
programs and State regulation of State
waters, and whether the 2015 Rule
appropriately implements the
Congressional policy of recognizing,
preserving, and protecting the primary
rights of states to plan the development
and use of land and water resources.
Because such findings would, if adopted
by the agencies, negate a key finding
underpinning the 2015 Rule, the
agencies request comment on whether
to repeal the 2015 Rule on this basis.
5. Additional Bases for Repealing the
2015 Rule That the Agencies Are
Considering
In addition to our proposed
conclusions that the 2015 Rule failed to
provide regulatory certainty and that it
exceeded the agencies’ authority under
the CWA, the agencies are also
considering several other supplemental
bases for repealing the 2015 Rule. These
are discussed below along with requests
for public comment.
Some commenters have suggested that
the 2015 Rule may exceed Congress’
power under the Commerce Clause. The
Supreme Court in SWANCC found that,
in enacting the CWA, Congress had in
mind as its authority ‘‘its traditional
jurisdiction over waters that were or had
been navigable in fact or which could
reasonably be so made.’’ 531 U.S. at 172.
The Court went on to construe the CWA
to avoid the significant constitutional
73 This includes whether the 2015 Rule is
supported by a ‘‘clear and manifest’’ statement
under the CWA to change the scope of traditional
state regulatory authority. See BFP v. Resolution
Trust Corp., 511 U.S. 531, 544 (1994); see also Bond
v. United States, 134 S. Ct. 2077, 2089–90 (2014);
SWANCC, 531 U.S. at 172–74.

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questions raised by the agencies’
assertion that the ‘‘ ‘Migratory Bird Rule’
falls within Congress’ power to regulate
intrastate activities that ‘substantially
affect’ interstate commerce.’’ Id. at 173.
The agencies are evaluating the
concerns, reflected in certain comments
received by the agencies, that many
features that are categorically
jurisdictional under the 2015 Rule, such
as wetlands that fall within the distance
thresholds of the definition of
‘‘neighboring,’’ test the limits of the
scope of the Commerce Clause because
they may not have the requisite effect on
the channels of interstate commerce.74
For example, according to certain
litigants challenging the 2015 Rule, the
‘‘seasonally ponded, abandoned gravel
mining depressions’’ specifically at
issue in SWANCC, 531 U.S. at 164,
which the Supreme Court determined
were ‘‘nonnavigable, isolated, intrastate
waters,’’ id. at 166–72, might be subject
to case-specific jurisdiction under the
2015 Rule. The depressions appear to be
located within 4,000 feet of Poplar
Creek, a tributary to the Fox River, and
may have the ability to store runoff or
contribute other ecological functions in
the watershed.
The agencies request comment,
including additional information, on
whether the water features at issue in
SWANCC or other similar water features
could be deemed jurisdictional under
the 2015 Rule, and whether such a
determination is consistent with or
otherwise well-within the agencies’
statutory authority, would be
unreasonable or go beyond the scope of
the CWA, and is consistent with Justice
Kennedy’s significant nexus test
expounded in Rapanos wherein he
stated, ‘‘[b]ecause such a [significant]
nexus was lacking with respect to
isolated ponds, the [SWANCC] Court
held that the plain text of the statute did
not permit’’ the Corps to assert
jurisdiction over them. See 547 U.S. at
767.
The examples identified in Section
II.C.3 above raise similar issues. The
abandoned borrow pit, for example,
discussed in Case Study C—AJD
Number MVM–2014–460, was
determined by the Corps in December
2014 to be an isolated water located
2,184 feet from a relatively permanent
body of water ‘‘with no substantial
nexus to interstate (or foreign)
commerce’’ (see Support Document), yet
74 Though the agencies have previously said that
the 2015 Rule is consistent with the Commerce
Clause and the CWA, the agencies are in the process
of considering whether it is more appropriate to
draw a jurisdictional line that ensures that the
agencies regulate well within our constitutional and
statutory bounds.

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the agencies later stated the feature
would be jurisdictional under the 2015
Rule. In addition, the wetlands at issue
in Case Study B—AJD Number 2004–
001914 (see Support Document)
described above in Section II.C.3 were
located 583 feet from the Johlin Ditch
outside Toledo, Ohio, situated east of an
existing medical building and west of an
agricultural area. The wetlands were
determined by the Corps to be isolated,
lacking a surface connection to a water
of the United States and a substantial
nexus to interstate commerce. Those
wetlands, however, were later stated by
the agencies to be subject to CWA
jurisdiction under the 2015 Rule. The
agencies therefore solicit comment on
whether the 2015 Rule would cover
such wetlands and, if so, whether that
would exceed the CWA’s statutory
limits. See, e.g., SWANCC, 531 U.S. at
171–72, 174 (‘‘[W]e find nothing
approaching a clear statement from
Congress that it intended § 404(a) to
reach an abandoned sand and gravel
pit’’ that is ‘‘isolated.’’).
Interested parties are encouraged to
provide comment on whether the 2015
Rule is consistent with the statutory text
of the CWA and relevant Supreme Court
precedent, the limits of federal power
under the Commerce Clause as
specifically exercised by Congress in
enacting the CWA, and any applicable
legal requirements that pertain to the
scope of the agencies’ authority to
define the term ‘‘waters of the United
States.’’ The agencies also solicit
comment on any other issues that may
be relevant to the agencies’
consideration of whether to repeal the
2015 Rule, such as whether any
potential procedural deficiencies
limited effective public participation in
the development of the 2015 Rule.75
D. The Agencies’ Next Steps
In defining the term ‘‘waters of the
United States’’ under the CWA,
Congress gave the agencies broad
discretion to articulate reasonable limits
on the meaning of that term, consistent
with the Act’s text and its policies as set
forth in CWA section 101. In light of the
substantial litigation risk regarding
waters covered under the 2015 Rule,
and based on the agencies’ experience
and expertise in applying the CWA, the
agencies propose to repeal the 2015
Rule and put in place the prior
regulation. This is based on the
concerns articulated above and the
agencies’ concern that there may be
significant disruption to the
implementation of the Act and to the
75 See, e.g., Small Refiner Lead Phase-Down Task
Force v. EPA, 705 F.2d 506, 549 (DC Cir. 1983).

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public, including regulated entities, if
the 2015 Rule were vacated in part. The
agencies therefore propose to exercise
their discretion and policy judgment by
repealing the 2015 Rule permanently
and in its entirety because the agencies
believe that this approach is the most
appropriate means to remedy the
deficiencies of the 2015 Rule identified
above, address the litigation risk
surrounding the 2015 Rule, and restore
a regulatory process that has been in
place for years.
The agencies have considered other
alternatives that could have the effect of
addressing some of the potential
deficiencies identified, including
proposing revisions to specific elements
of the 2015 Rule, issuing revised
implementation guidance and
implementation manuals, and proposing
a further change to the February 6, 2020
applicability date of the 2015 Rule. The
agencies are soliciting comments on
whether any of these alternative
approaches would fully address and
ameliorate potential deficiencies in and
litigation risk associated with the 2015
Rule. Consistent with the President’s
Executive Order, the agencies are also
evaluating options for revising the
definition of ‘‘waters of the United
States.’’
The agencies are proposing to
permanently repeal the 2015 Rule at this
time, and are taking comment on
whether this proposal is the best and
most efficient approach to address the
potential deficiencies identified in this
notice and to provide the predictability
and regulatory certainty that alternative
approaches may not provide.
E. Effect of Repeal
The 2015 Rule amended longstanding
regulations contained in portions of 33
CFR part 328 and 40 CFR parts 110, 112,
116, 117, 122, 230, 232, 300, 302, and
401 by revising, removing, and redesignating certain paragraphs and
definitions in those regulations. In this
action, the agencies would repeal the
2015 Rule and restore the regulations in
existence immediately prior to the 2015
Rule. As such, if the agencies finalize
this proposal and repeal the 2015 Rule
and thus repeal those amendments, the
regulatory definitions of ‘‘waters of the
United States’’ in effect would be those
portions of 33 CFR part 328 and 40 CFR
parts 110, 112, 116, 117, 122, 230, 232,
300, 302, and 401 as they existed
immediately prior to the 2015 Rule’s
amendments. See, e.g., API v. EPA, 883
F.3d 918, 923 (DC Cir. 2018) (regulatory
criterion in effect immediately before
enactment of criterion that was vacated
by the court ‘‘replaces the now-vacated’’
criterion). Thus, if the agencies

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determine that repeal of the 2015 Rule
is appropriate, the agencies
concurrently would recodify the prior
regulation in the CFR, which would not
have the effect of creating a regulatory
vacuum, and the agencies need not
consider the potential consequences of
such a regulatory vacuum in light of
this. If this proposed rule is finalized,
the agencies propose to apply the prior
definition until a new definition of
CWA jurisdiction is finalized.
The current regulatory scheme for
determining CWA jurisdiction is
‘‘familiar, if imperfect,’’ In re EPA, 803
F.3d at 808, and the agencies and
regulated public have significant
experience operating under the
longstanding regulations that were
replaced by the 2015 Rule. The agencies
would continue to implement those
regulations, as they have for many years,
consistent with Supreme Court
decisions and practice, other case law
interpreting the rule, and informed by
agency guidance documents. Apart from
a roughly six-week period when the
2015 Rule was in effect in 37 States, the
agencies have continued to implement
the preexisting regulatory definitions as
a result of the court orders discussed in
Section I.B. above, as well as the final
rule adding an applicability date to the
2015 Rule (83 FR 5200, Feb. 6, 2018).
While the agencies acknowledge that
the 1986 and 1988 regulations have
been criticized and their application has
been narrowed by various legal
decisions, including SWANCC and
Rapanos, the longstanding nature of the
regulatory framework and its track
record of implementation makes it
preferable until the agencies propose
and finalize a replacement definition.
The agencies believe that, until a new
definition is completed, it is important
to retain the status quo that has been
implemented for many years rather than
the 2015 Rule, which has been and
continues to be mired in litigation.
In other words, restoration of the prior
regulatory text in the CFR, interpreted
in a manner consistent with Supreme
Court decisions, and informed by
applicable agency guidance documents
and longstanding practice, will ensure
that the scope of CWA jurisdiction will
be administered in the same manner as
it is now; as it was during the Sixth
Circuit’s lengthy, nationwide stay of the
2015 Rule; and as it was for many years
prior to the promulgation of the 2015
Rule. To be clear, the agencies are not
proposing a new definition of ‘‘waters of
the United States’’ in this specific
rulemaking separate from the definition
that existed immediately prior to the
2015 Rule. The agencies also are not
proposing to take this action in order to

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fill a regulatory gap because no such gap
exists today. See 83 FR 5200, 5204.
Rather, the agencies are solely
proposing to repeal the 2015
amendments to the above-referenced
portions of the CFR and recodify the
prior regulatory text as it existed
immediately prior to the 2015 Rule’s
amendments.
III. Minimal Reliance Interests
Implicated by a Repeal of the 2015 Rule
More than 30,000 AJDs of individual
aquatic resources and other features
have been issued since August 28, 2015,
the effective date of the 2015 Rule.
However, less than two percent of the
AJDs of individual aquatic resources
were issued under the 2015 Rule
provisions in the six weeks the rule was
in effect in a portion of the country.76
The 2015 Rule was in effect in only 37
States for about six weeks between the
2015 Rule’s effective date and the Sixth
Circuit’s October 9, 2015 nationwide
stay order, see In re EPA, 803 F.3d 804
(6th Cir. 2015), and only 540 AJDs for
aquatic resources and other features
were issued during that short window of
time. The remainder of the AJDs issued
since August 28, 2015, were issued
under the regulations defining the term
‘‘waters of the United States’’ that were
in effect immediately before the
effective date of the 2015 Rule.
‘‘Sudden and unexplained change,
. . . or change that does not take
account of legitimate reliance on prior
[agency] interpretation, . . . may be
arbitrary, capricious [or] an abuse of
discretion[,] [b]ut if these pitfalls are
avoided, change is not invalidating[.]’’
Smiley v. Citibank (South Dakota), N.A.,
517 U.S. 735, 742 (1996) (internal
quotation marks and citations omitted).
Therefore, in proposing to repeal the
2015 Rule, the agencies are considering
any interests that may have developed
in reliance on the 2015 Rule, as well as
the potential harm to such reliance
interests from repealing the Rule against
the benefits. The agencies solicit
comment on whether the AJDs that were
issued under the 2015 Rule’s brief
tenure (and any ensuing reliance
interests that were developed) would be
adversely affected by the Rule’s repeal.
If the potential for such harm exists, the
agencies also solicit comment on
whether those harms outweigh the
potential benefits of repealing the 2015
Rule.
Clean Water Act Approved Jurisdictional
Determinations, available at https://
watersgeo.epa.gov/cwa/CWA-JDs, as of May 9, 2018.
The 2015 Rule was enjoined in 13 States by the U.S.
District Court for the District of North Dakota and
has never gone into effect in those States.

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In staying the 2015 Rule nationwide,
the Sixth Circuit found no indication
‘‘that the integrity of the nation’s waters
will suffer imminent injury if the [2015
Rule] is not immediately implemented
and enforced.’’ In re EPA, 803 F.3d at
808. The Sixth Circuit wrote that the
‘‘burden—potentially visited
nationwide on governmental bodies,
state and federal, as well as private
parties—and the impact on the public in
general, implicated by the Rule’s
effective redrawing of jurisdictional
lines over certain of the nation’s waters’’
was of ‘‘greater concern.’’ Id. As a result,
the Sixth Circuit held that ‘‘the sheer
breadth of the ripple effects caused by
the Rule’s definitional changes counsels
strongly in favor of maintaining the
status quo for the time being.’’ Id. For
the reasons expounded in this notice
and the NPRM, the agencies believe that
any potential adverse reliance interests
are outweighed by the benefits of the
agencies’ proposed action. The agencies
therefore propose to repeal the 2015
Rule and request comment on that
proposal.
IV. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review; Executive Order
13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action that was submitted to the Office
of Management and Budget (OMB) for
review prior to the NPRM and again
prior to issuance of the SNPRM. Any
changes made in response to OMB
recommendations have been
documented in the docket.
While economic analyses are
informative in the rulemaking context,
the agencies are not relying on the
economic analysis performed pursuant
to Executive Orders 12866 and 13563
and related procedural requirements as
a basis for this proposed action. See,
e.g., NAHB, 682 F.3d at 1039–40 (noting
that the quality of an agency’s economic
analysis can be tested under the APA if
the ‘‘agency decides to rely on a costbenefit analysis as part of its
rulemaking’’).
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Cost
This rule is expected to be an
Executive Order 13771 deregulatory
action. Details on the estimated cost
savings of this proposed rule can be
found in the economic analysis that was
published together with the NPRM.

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C. Paperwork Reduction Act

F. Executive Order 13132: Federalism

This proposed rule does not impose
any new information collection burdens
under the Paperwork Reduction Act.

Executive Order 13132 requires the
agencies to develop an accountable
process to ensure ‘‘meaningful and
timely input by state and local officials
in the development of regulatory
policies that have federalism
implications.’’ ‘‘Policies that have
federalism implication’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’ Under
Executive Order 13132, the agencies
may not issue a regulation that has
federalism implications, that imposes
substantial direct compliance costs, and
that is not required by statute, unless
the federal government provides the
funds necessary to pay the direct
compliance costs incurred by state and
local government, or the agencies
consult with state and local officials
early in the process of developing the
proposed regulation. The agencies also
may not issue a regulation that has
federalism implications and that
preempts state law unless the agencies
consult with state and local officials
early in the process of developing the
proposed regulation.
This proposed rule will not have
substantial direct effects on the states,
on the relationship between the national
government and states, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, because it
merely proposes to repeal a rule that
was in effect in only a portion of the
country for a short period of time, and
does not alter the relationship or the
distribution of power and
responsibilities established in the CWA.
The agencies are proposing to repeal the
2015 Rule in part because the 2015 Rule
may have impermissibly and materially
affected the states and the distribution
of power and responsibilities among the
various levels of government and
therefore likely should have been
characterized as having federalism
implications when promulgated in
2015. Thus, the requirements of section
6 of the Executive Order do not apply
to this proposed rule because it returns
the federal-state relationship to the
status quo.

D. Regulatory Flexibility Act
The Regulatory Flexibility Act
generally requires an agency to conduct
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements unless the
agency certifies that the rule will not
have a significant economic impact on
a substantial number of small entities.
Small entities include small businesses,
small not-for-profit enterprises, and
small governmental jurisdictions.
The proposed repeal of the 2015 Rule
is a deregulatory action that would
effectively maintain the status quo as
the agencies are currently implementing
it, and avoid the imposition of
potentially significant adverse economic
impacts on small entities in the future.
Details on the estimated cost savings of
this proposed rule can be found in the
economic analysis that was published
together with the NPRM. Accordingly,
after considering the potential economic
impacts of the proposed repeal action
on small entities, we certify that this
proposed action will not have a
significant economic impact on a
substantial number of small entities.

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E. Unfunded Mandates Reform Act
Under section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA),
signed into law on March 22, 1995, an
agency must prepare a budgetary impact
statement to accompany any proposed
or final rule that includes a federal
mandate that may result in estimated
cost to state, local, or tribal governments
in the aggregate, or to the private sector,
of $100 million or more. Under section
205 of the UMRA, the agency must
select the most cost-effective and least
burdensome alternative that achieves
the objectives of the rule and is
consistent with statutory requirements.
Section 203 requires the agency to
establish a plan for informing and
advising any small governments that
may be significantly or uniquely
impacted by the rule. This proposed
action does not contain any unfunded
mandate as described in the UMRA, and
does not significantly or uniquely affect
small governments. The definition of
‘‘waters of the United States’’ applies
broadly to CWA programs. The
proposed action imposes no enforceable
duty on any state, local, or tribal
governments, or the private sector, and
does not contain regulatory
requirements that significantly or
uniquely affect small governments.

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G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175, entitled
‘‘Consultation and Coordination with

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32251

Indian Tribal Governments’’ (65 FR
67249, Nov. 9, 2000), requires the
agencies to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ This proposed
rule does not have tribal implications,
as specified in Executive Order 13175.
This proposed rule will not have
substantial direct effects on tribal
governments, on the relationship
between the federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
federal government and Indian tribes,
because it merely preserves the status
quo currently in effect today and in
effect immediately before promulgation
of the 2015 Rule. Thus, Executive Order
13175 does not apply to this proposed
rule. Consistent with E.O. 13175,
however, the agencies have and will
continue to consult with tribal officials,
as appropriate, as part of any future
rulemaking to define ‘‘waters of the
United States.’’
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045, ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
Apr. 23, 1997), applies to any rule that:
(1) Is determined to be ‘‘economically
significant’’ as defined under Executive
Order 12866, and (2) concerns an
environmental health or safety risk that
an agency has reason to believe may
have a disproportionate effect on
children. If the regulatory action meets
both criteria, the agency must evaluate
the environmental health or safety
effects of the planned rule on children,
and explain why the planned regulation
is preferable to other potentially
effective and reasonably feasible
alternatives considered by the agency.
This proposed rule is not subject to
Executive Order 13045 because it does
not involve decisions intended to
mitigate environmental health or safety
risks.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This rule is not subject to Executive
Order 13211, ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001), because it is
not likely to have a significant adverse
effect on the supply, distribution, or use
of energy.

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J. National Technology Transfer and
Advancement Act
Section 12 of the National Technology
Transfer and Advancement Act of 1995
requires federal agencies to evaluate
existing technical standards when
developing a new regulation. The
proposed rule does not involve
technical standards.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This proposed rule maintains the
legal status quo. The agencies therefore
believe that this action does not have
disproportionately high and adverse
human health or environmental effects
on minority, low-income populations,
and/or indigenous peoples, as specified
in Executive Order 12898 (59 FR 7629,
Feb. 16, 1994).
List of Subjects
33 CFR Part 328
Environmental protection,
Administrative practice and procedure,
Navigation (water), Water pollution
control, Waterways.
40 CFR Part 110
Environmental protection, Oil
pollution, Reporting and recordkeeping
requirements.
40 CFR Part 112
Environmental protection, Oil
pollution, Penalties, Reporting and
recordkeeping requirements.

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40 CFR Part 116
Environmental protection, Hazardous
substances, Reporting and
recordkeeping requirements, Water
pollution control.

40 CFR Part 300
Environmental protection, Air
pollution control, Chemicals, Hazardous
substances, Hazardous waste,
Intergovernmental relations, Natural
resources, Occupational safety and
health, Oil pollution, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
40 CFR Part 302
Environmental protection, Air
pollution control, Chemicals, Hazardous
substances, Hazardous waste,
Intergovernmental relations, Natural
resources, Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
40 CFR Part 401
Environmental protection, Waste
treatment and disposal, Water pollution
control.
■ For the reasons stated herein, the
agencies propose to amend 33 CFR part
328 and 40 CFR parts 110, 112, 116,
117, 122, 230, 232, 300, 302, and 401 of
the Code of Federal Regulations to
repeal the amendments that were
promulgated in the 2015 Rule and
reestablish the regulatory text that was
in place immediately prior to
promulgation of the 2015 Rule.
Dated: June 29, 2018.
E. Scott Pruitt,
Administrator, Environmental Protection
Agency.
Dated: June 29, 2018.
R.D. James,
Assistant Secretary of the Army (Civil Works).
[FR Doc. 2018–14679 Filed 7–11–18; 8:45 am]
BILLING CODE 6560–50–P

40 CFR Part 117
Environmental protection, Hazardous
substances, Penalties, Reporting and
recordkeeping requirements, Water
pollution control.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

40 CFR Part 122
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous substances, Reporting and
recordkeeping requirements, Water
pollution control.

42 CFR Part 447

40 CFR Part 230
Environmental protection, Water
pollution control.
40 CFR Part 232
Environmental protection,
Intergovernmental relations, Water
pollution control.

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Centers for Medicare & Medicaid
Services

[CMS–2413–P]
RIN 0938–AT61

Medicaid Program; Reassignment of
Medicaid Provider Claims
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
ACTION: Proposed rule.
AGENCIES:

This proposed rule would
remove the regulatory text that allows a
state to make payments to third parties
on behalf of an individual provider for

SUMMARY:

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benefits such as health insurance, skills
training, and other benefits customary
for employees. We are concerned that
these provisions are overbroad, and
insufficiently linked to the exceptions
expressly permitted by the statute. As
we noted in our prior rulemaking,
section 1902(a)(32) of the Act provides
for a number of exceptions to the direct
payment requirement, but it does not
authorize the agency to create new
exceptions.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on August 13, 2018.
ADDRESSES: In commenting, please refer
to file code CMS–2413–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–2413–P, P.O. Box 8016, Baltimore,
MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–2413–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
FOR FURTHER INFORMATION CONTACT:
Christopher Thompson, (410) 786–4044.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: http://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
I. Background
The Medicaid program was
established by the Congress in 1965 to

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provide health care services for lowincome and disabled beneficiaries.
Section 1902(a)(32) of the Social
Security Act (the Act) requires direct
payment to providers who render
services to Medicaid beneficiaries. It
states that no payment under the plan
for care and services provided to an
individual shall be made to anyone
other than such individual or the person
or institution providing such care or
service, under an assignment or power
of attorney or otherwise.
We codified § 447.10 implementing
section 1902(a)(32) of the Act in the
‘‘Payment for Services’’ final rule
published on September 29, 1978 (43 FR
45253). The statute provides several
specific exceptions to the general
principle of requiring that direct
payment be made to the individual
provider. The regulations implementing
section 1902(a)(32) of the Act have
generally tracked the plain statutory
language and required direct payments
absent a statutory exception.
In 2012, we proposed a new
regulatory exception in the ‘‘Provider
Payment Reassignment, and Setting
Requirements for Community First
Choice’’ proposed rule published on
May 3, 2012 (77 FR 26361, 26406) for
‘‘a class of practitioners for which the
Medicaid program is the primary source
of service revenue’’ such as home health
care providers. We recognized in the
preamble to the proposed rule that
section 1902(a)(32) of the Act does not
authorize additional exceptions to the
direct payment requirement (See 77 FR
26382).
We received a total of 7 comments on
the proposed regulatory exception, all
generally supportive of the proposed
rule. This provision was finalized in the
‘‘Provider Payment Reassignment, and
Home and Community-Based Setting
Requirements for Community First
Choice and Home and CommunityBased Services (HCBS) Waivers’’ final
rule published on January 16, 2014 (79
FR 2947, 3001) and authorized a state to
make payments to third parties on
behalf of the individual provider ‘‘for
benefits such as health insurance, skills
training, and other benefits customary
for employees.’’
We are concerned that § 447.10(g)(4)
is overbroad, and insufficiently linked
to the exceptions expressly permitted by
the statute. As we noted in our prior
rulemaking, section 1902(a)(32) of the
Act provides for a number of exceptions
to the direct payment requirement, but
it does not authorize the agency to
create new exceptions. Therefore, the
regulatory provision grants permissions
that Congress has foreclosed, so we are

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proposing to remove the regulatory
exception at § 447.10(g)(4).
II. Provisions of the Proposed
Regulations
This proposal would remove
§ 447.10(g)(4), but leave in place the
other provisions in § 447.10 including
the exceptions at § 447.10(e), (f) and
(g)(1) through (3). We seek comments
regarding how we might provide further
clarification on the types of payment
arrangements that would be permissible
assignments of Medicaid payments,
such as arrangements where a state
government withholds payments under
a valid assignment. Specifically, we
invite comments with examples of
payment withholding arrangements
between states and providers that we
should address.
With regard to section 1915(c),
1915(i), 1915(j), and 1915(k) authority,
this proposed rule will not impact a
state’s ability to perform Financial
Management Services (FMS) or secure
FMS through a vendor arrangement.
However, we also request comments on
whether and how the proposed removal
of § 447.10(g)(4) would impact selfdirected service models, where the
Medicaid beneficiary takes
responsibility for retaining and
managing his or her own services, and,
in some cases, may be performing
payroll and other employer-related
duties. We are especially interested in
comments that describe the additional
flexibilities needed to support
beneficiaries opting for self-directed
service models, which may ensure
stable, high-quality care for those
beneficiaries.
III. Collection of Information
Requirements
To the extent a state changes its
payment as a result of this rule, the state
would be required to notify entities of
the pending change in payment and
update its payment system. We believe
the associated burden is exempt from
the Paperwork Reduction Act (PRA) in
accordance with 5 CFR 1320.3(b)(2). We
believe that the time, effort, and
financial resources necessary to comply
with the aforementioned requirement
would be incurred by the state during
the normal course of their activities and,
therefore, should be considered usual
and customary business practices.
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and

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32253

time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
We are concerned that § 447.10(g)(4)
is overbroad, and insufficiently linked
to the exceptions expressly permitted by
the statute. Therefore, the regulatory
provision grants permissions that
Congress has foreclosed. As we noted in
our prior rulemaking published on
January 16, 2014 (79 FR 2947, 3001),
section 1902(a)(32) of the Act provides
for a number of exceptions to the direct
payment requirement, but the language
does not explicitly authorize the agency
to create new exceptions. Therefore, we
are proposing to remove the regulatory
exception at § 447.10(g)(4). To the extent
a state increased reimbursement levels
to reassign portions of a provider’s
reimbursement to a third party,
implementation of this rule may affect
the rates that are set by the state in the
future.
B. Overall Impact
We have examined the impacts of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March
22, 1995; Pub. L. 104–4), Executive
Order 13132 on Federalism (August 4,
1999), and the Congressional Review
Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule that may: (1) Have an
annual effect on the economy of $100
million or more in any 1 year, or
adversely and materially affecting a
sector of the economy, productivity,
competition, jobs, the environment,
public health or safety, or state, local or
tribal governments or communities (also
referred to as ‘‘economically
significant’’); (2) create a serious

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inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially alter the
budgetary impacts of entitlement grants,
user fees, or loan programs or the rights
and obligations of recipients thereof; or
(4) raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). We
estimate that this proposed rule could
be ‘‘economically significant’’ as it may
have an annual effect on the economy
in excess of the $100 million threshold
of Executive Order 12866, and hence
that this proposed rule is also a major
rule under the Congressional Review
Act. However there is considerable
uncertainty around this estimate and the
Department invites public comments to
help refine this analysis.
As discussed above, in the ‘‘Provider
Payment Reassignment, and Home and
Community-Based Setting Requirements
for Community First Choice and Home
and Community-Based Services (HCBS)
Waivers’’ final rule published on
January 16, 2014 (79 FR 2947, 3001), we
authorized a state to make payments to
third parties on behalf of the individual
provider ‘‘for benefits such as health
insurance, skills training, and other
benefits customary for employees.’’ We
lack information with which to quantify
the potential impacts of this policy on
these types of payments as the
Department does not formally track the
amount of reimbursement that is being
reassigned to third parties by states. To
offer one example, one such potential
impact of the proposed rulemaking
would be that states stop reassigning
homecare workers’ dues to unions. We
estimate that unions may currently
collect as much as $71 million from
such assignments.1 While we have not
1 Dues payments potentially associated with
policies of the type being proposed for revision
have been reported to be $8 million in Pennsylvania
and $10 million in Illinois (https://
www.fairnesscenter.org/cases/detail/protecting-thevulnerable and https://
www.washingtonexaminer.com/illinois-politiciansforced-home-care-workers-into-union-that-donatesheavily-to-them/article/2547368). The total
population is approximately 26 million in these two
states and 102 million across the states that have
been reported by the State Policy Network to have
relevant third-party payment policies (California,
Connecticut, Illinois, Maryland, Massachusetts,
Minnesota, Missouri, New Jersey, Oregon, Vermont
and Washington) (https://www2.census.gov/
programs-surveys/popest/tables/2010-2017/state/
totals/nst-est2017-01.xlsx and https://spn.org/duesskimming-faqs/). Factoring the $18 million (= $8
million + $10 million) proportionately by
population yields a nationwide total of
approximately $71 million in union dues payments

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similarly quantified the amount of other
authorized reassignments, such as
health insurance, skills training, or
other benefits, we believe that the
amount of payments made to third
parties on behalf of individual providers
for the variety of benefits within the
scope of this rulemaking is likely in
excess of $100 million. We seek
comment on this estimate, and
particularly on the type and amount of
payments currently being reassigned
under the exceptions in § 447.10(g).
The potential direct financial impact
to providers of this policy change could
be affected by many factors, such as the
nature and amounts of the types of
payments currently being reassigned
and decisions made by homecare
providers after a final policy takes effect
about whether or not to resume
payments to third parties for these types
of benefits. The Department is unable to
quantify these direct financial impacts
in the absence of specific information
about the types and amount of payments
being reassigned. Even where it may be
possible to derive such estimates, such
as with the example of union dues, the
Department lacks information to reliably
estimate the proportion of homecare
providers likely to stop making
payments versus those likely to
continue making payments through
alternative means. We request
comments on the factors that might
influence the direct financial impacts to
providers and recipients of
reassignments of this policy change for
the varied types and amount of
payments currently being reassigned
under the exceptions in § 447.10(g).
Although states will no longer be able
to withhold portions of a provider’s
payment, states may elect to maintain
the same level of payment, thus
affording the provider the opportunity
to purchase the items that were
previously funded through the
reassignment of reimbursement.
Conversely, states may elect to decrease
payment levels because rescission of
§ 447.10(g)(4) will limit their ability to
reassign payment to third parties. In
other words, states may have previously
factored their ability to reassign
provider payments into their payment
rates and might choose to revise their
rates in response to this regulatory
change. We request comments,
particularly from states, on potential
potentially affected by this proposed rule. This
transfer estimate could be over- or understated if
other states pay home care workers different
average wages than Pennsylvania and Illinois, if
dues payments are collected at different rates, or if
participation in Medicaid home care programs is
not proportionate to total population.

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state behavior under the proposed
policy.
If a state elected to maintain the same
level of payment, and if homecare
providers opt to continue all voluntary
payments presently being reassigned,
then the rule may have no impacts.
However, if a state elected to reduce
payment levels and/or if homecare
providers opt to discontinue all
voluntary payments, then the impacts of
the rule may be close to the full amount
of current reassignments, thus making
the rule economically significant.
While it is difficult for us to conduct
a detailed quantitative analysis given
this considerable uncertainty and lack
of data, we believe that without this
proposed rulemaking, states may apply
the exceptions at § 447.10(g) in ways
that do not comport with section
1902(a)(32) of the Act and we welcome
comment with regard to the quantitative
impact of the elimination of states’
ability to reassign Medicaid payment for
items such as health insurance, skills
training and other benefits customary
for employees. We also seek comments
identifying impacts to states and the
federal government as a result of this
proposed rule, including on the
assumption that the time, effort and
financial resources necessary to comply
with the proposed requirement would
be incurred by states during the normal
course of their activities and, therefore,
does not impose incremental costs.
C. Anticipated Effects
The RFA requires agencies to analyze
options for regulatory relief of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $7.5 million to $38.5
million in any 1 year. Individuals and
states are not included in the definition
of a small entity. We are not preparing
an analysis for the RFA because we have
determined, and the Secretary proposes
to certify, that this proposed rule would
not have a significant economic impact
on a substantial number of small
entities.
In addition, section 1102(b) of the Act
requires us to prepare an RIA if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 603
of the RFA. For purposes of section
1102(b) of the Act, we define a small
rural hospital as a hospital that is
located outside of a Metropolitan
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regulations and has fewer than 100
beds. We are not preparing an analysis
for section 1102(b) of the Act because
we have determined, and the Secretary
proposes to certify, that this proposed
rule would not have a significant impact
on the operations of a substantial
number of small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2018, that threshold is approximately
$150 million. This rule will have no
consequential effect on state, local, or
tribal governments or on the private
sector.

Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on state or local governments,
the requirements of Executive Order
13132 are not applicable.
D. Alternatives Considered
We considered issuing guidance to
require states to formally document
consent to reassign portions of a
provider’s payment. We also considered
limiting the items for which provider
reassignment could be made. However,
we are concerned that § 447.10(g)(4)) is

overbroad, and insufficiently linked to
the exceptions expressly permitted by
the statute. Therefore, we believe
removing the regulatory exception is the
best course of action.
E. Accounting Statement
As required by OMB Circular A–4
under Executive Order 12866 (available
at https://www.whitehouse.gov/sites/
whitehouse.gov/files/omb/circulars/A4/
a-4.pdf) in Table 1, we have prepared an
accounting statement showing the
classification of transfers associated
with the provisions in this proposed
rule. The accounting statement is based
on estimates provided in this regulatory
impact analysis and omits categories of
impacts for which partial quantification
has not been possible.

TABLE 1—ACCOUNTING STATEMENT
Units
Category

Low estimate

High estimate
Year dollars

Transfers:
Annualized Monetized $ millions/year ..........................

0
0

From whom to whom? ..................................................

F. Regulatory Reform Analysis Under
E.O. 13771
Executive Order 13771, entitled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017 and requires that the
costs associated with significant new
regulations ‘‘shall, to the extent
permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations.’’
This proposed rule is not expected to be
subject to the requirements of E.O.
13771 because this proposed rule is
expected to result in no more than de
minimis costs.

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G. Conclusion
In accordance with the provisions of
Executive Order 12866, this proposed
rule was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 447
Accounting, Administrative practice
and procedure, Drugs, Grant programs—
health, Health facilities, Health
professions, Medicaid, Reporting and
recordkeeping requirements, Rural
areas.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:

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$71
71

Discount rate
(%)

2017
2017

Period
covered

3
7

From third parties to home health providers.

PART 447—PAYMENTS FOR
SERVICES

FEDERAL COMMUNICATIONS
COMMISSION

1. The authority citation for part 447
continues to read as follows:

47 CFR Part 73

■

Authority: Sec. 1102 of the Social Security
Act (42 U.S.C. 1302).
§ 447.10

[Amended]

2. Section 447.10 is amended by
removing paragraph (g)(4).

■

Dated: May 3, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: May 7, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2018–14786 Filed 7–10–18; 11:15 am]
BILLING CODE 4120–01–P

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[MB Docket No. 18–184; FCC 18–69]

New FM Radio Broadcast Class C4 and
To Modify the Requirements for
Designating Short-Spaced
Assignments
Federal Communications
Commission.
ACTION: Notice of inquiry.
AGENCY:

In this document, the
Commission adopted a Notice of Inquiry
(NOI), based on a petition for
rulemaking filed by SSR
Communications, Inc., in which the
Commission sought comment on a
proposal to create a new class of FM
radio stations, Class C4, and to establish
a procedure for designating certain FM
stations.
DATES: Comments may be filed on or
before August 13, 2018 and reply
comments may be filed on or before
September 10, 2018.
ADDRESSES: You may submit comments,
identified by MB Docket No. 18–184, by
any of the following methods:
• Federal Communications
Commission’s Website: http://
SUMMARY:

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www.fcc.gov/cgb/ecfs/. Follow the
instructions for submitting comments.
• Mail: Filings can be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• People With Disabilities: Contact
the FCC to request reasonable
accommodations (accessible format
documents, sign language interpreters,
CART, etc.) by email: [email protected]
or phone: (202) 418–0530 or TTY: (202)
418–0432. For detailed instructions for
submitting comments and additional
information on the rulemaking process,
see the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Albert Shuldiner, Chief, Media Bureau,
Audio Division, (202) 418–2721; James
Bradshaw, Deputy Division Chief,
Media Bureau, Audio Division, (202)
418–2739. Direct press inquiries to
Janice Wise at (202) 418–8165.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Notice of
Inquiry, FCC 18–69, adopted June 4,
2018, and released June 5, 2018. The
full text of this document is available
electronically via the FCC’s Electronic
Document Management System
(EDOCS) website at http://https://
www.fcc.gov/edocs or via the FCC’s
Electronic Comment Filing System
(ECFS) website at http://https://
www.fcc.gov/ecfs/. (Documents will be
available electronically in ASCII,
Microsoft Word, and/or Adobe Acrobat.)
This document is also available for
public inspection and copying during
regular business hours in the FCC
Reference Information Center, which is
located in Room CY–A257 at FCC
Headquarters, 445 12th Street SW,
Washington, DC 20554. The Reference
Information Center is open to the public
Monday through Thursday from 8:00
a.m. to 4:30 p.m. and Friday from 8:00
a.m. to 11:30 a.m. Alternative formats
are available for people with disabilities
(braille, large print, electronic files,
audio format), by sending an email to
[email protected] or calling the
Commission’s Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Synopsis of Notice of Inquiry
1. Introduction. In this Notice of
Inquiry (NOI), the Commission explores
the possibility of amending part 73 of
the Commission’s Rules to create an
intermediate class of FM broadcast

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stations in Zone II between Class A and
Class C3, to be designated Class C4.
Commission staff estimates that 127
Class C3 stations, or 14 percent of the
total number of Class C3 stations, are
operating with facilities that are less
than the proposed Class C3 minimums
and thus could be subject to
reclassification to Class C4. It also
explores the possibility of establishing a
procedure whereby an FM station in the
non-reserved band (Channels 221–300),
regardless of Zone or station class, could
be designated as a Section 73.215
facility, resulting in such station
receiving interference protection based
on its actual authorized operating
parameters rather than the maximum
permitted parameters for its station
class.
2. Class C4 proposal. This proceeding
was initiated by a petition for
rulemaking filed by SSR
Communications, Inc. (SSR). SSR
advocates the creation of a new Class C4
with an effective radiated power (ERP)
that must exceed 6 kilowatts, a
maximum ERP of 12 kilowatts, and a
reference HAAT of 100 meters. The ERP
that Class C3 stations must exceed
would increase from 6 kilowatts to 12
kilowatts, but the maximum ERP would
remain at 25 kilowatts. In addition,
under the current rules, a station can
operate below the minimum ERP for its
class provided its HAAT allows it to
exceed the class contour distance for the
next lower class (for example, a Class C3
station must exceed the Class A contour
distance of 28 kilometers). Under the
SSR proposal, the next lower class for
a Class C3 station would be Class C4,
with a contour distance of 33
kilometers. SSR proposes amending
Sections 73.207(b)(1), 73.210(a),
73.210(b), 73.211(a)(1), 73.211(b), and
73.215(e) of the Rules to implement
these changes. SSR argues that a new
Class C4 would provide upgrade
opportunities for Class A facilities,
particularly minority-owned stations,
and create consistent ERP intervals
between FM classes.
3. Affected stations and their
listeners. Would the creation of a Class
C4 materially benefit existing Class A
stations by providing them with an
opportunity to upgrade that is not
possible today based on the current
Class C3 parameters? Would Class A
stations and their listeners, particularly
in rural or underserved areas, benefit
from the new Class C4? Is there a
significant demand for the rule changes
proposed by SSR? How many stations
are likely to be affected by such a rule
change? As suggested by SSR, would the
creation of a Class C4 be particularly
beneficial for minority-owned Class A

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stations by providing them with an
opportunity to upgrade? Would this
action encourage diversity of ownership
in the FM broadcast industry? Would
there be a detrimental effect on existing
stations and/or their listeners generally,
either from increased interference or
reclassification (upgrade or downgrade)?
4. Secondary services. How would a
new Class C4 affect secondary services
(FM translators and LPFM stations), as
well as AM primary stations that
rebroadcast on FM translator stations?
Are there lawful ways to mitigate or
eliminate the impact of this proposal on
secondary services, and, if so, what
measures would be effective or
appropriate? To what extent, if any,
does the Local Community Radio Act of
2010 (LCRA) impact the Commission’s
ability to protect existing FM translator
and LPFM stations? In particular, would
such protections be consistent with the
LCRA directive that the ‘‘Federal
Communications Commission, when
licensing new FM translators, FM
booster stations, and low-power FM
stations . . . ensure . . . that . . . (3)
[these stations] remain equal in status
and secondary to existing and modified
full-service FM stations’’? In this
respect, the Commission notes that it
would be reluctant to adopt any
proposal in this area that would have a
significantly negative impact on FM
translators and LPFM stations.
5. Allocation goals. Given the
maturity of the FM service, would an
increased density of signals resulting
from Class A stations upgrading to Class
C4 provide improved FM service
coverage, or merely contribute to a
higher ‘‘noise floor’’ overall while only
modestly benefiting individual stations?
Would upgrades to Class C4 increase the
overall number of radio stations
available to listeners or create
interference that would degrade
reception for stations in areas where
there is currently a listenable signal,
resulting in fewer listening choices for
listeners? More generally, is there a
‘‘tipping point’’ at which increasingly
granular station classifications are no
longer conducive to efficient signal
coverage and, if so, has that point been
reached?
6. Implementation procedures. What
is the appropriate balance of interests
between the anticipated benefit of
creating a new class of FM stations and
the disruption entailed in the
reclassification of existing stations? If a
new class is created, should the
Commission implement a blanket
reclassification process, as it did in 1983
and 1989, by requiring existing Class C3
stations to file for modification to meet
the proposed revised minimum facility

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requirements for Class C3 stations
within a set time frame or be reclassified
based on their actual operating
facilities? Should the mere filing for a
modification be sufficient to avoid
reclassification or should the
Commission also require construction to
be completed by a date certain? If a date
certain is set for filing a modification or
completing construction, what would be
a reasonable amount of time for
licensees to comply? Would a blanket
reclassification provide more reliable
and timely opportunities for upgrade
than the show cause procedure outlined
in the next paragraph?
7. Alternatively, should the
Commission adopt a show cause
procedure similar to that currently in
use for Class C0, whereby a Class C3
station operating below the proposed
revised minimum facility requirements
for Class C3 stations would be
reclassified only after the filing of a
‘‘triggering’’ application that requires it
to be reclassified to Class C4? Should
the affected Class C3 station have the
opportunity to preserve its Class C3
status by filing a construction permit
application to upgrade its facility to
meet Class C3 minimums? The
Commission notes that the
Commission’s licensing staff has found
that the Class C0 show cause procedure
appears to incentivize delay and
contention between the parties. Have
licensees experienced delay or other
difficulties using the Class C0 show
cause procedure? Is the blanket
reclassification process described in the
preceding paragraph preferable for that
reason? Are there other implementation
approaches the Commission should
consider that might address or avoid
problems identified with this show
cause procedure?
8. Other issues. To what extent, if any,
does the LCRA impact the
Commission’s creation of a new class of
FM stations or reclassification of
existing FM stations; in particular, the
provision that the Commission ‘‘shall
not amend its rules to reduce the
minimum co-channel and first- and
second-adjacent channel distance
separation requirements in effect on
[January 4, 2011] between—(A) lowpower FM stations; and (B) full-service
FM stations’’? Are there specific rule
changes that would be necessary or
advisable to implement any of the
foregoing proposals? The Commission
also invites commenters to make
suggestions as to how the Commission’s
forms and databases should be modified
to implement the above proposals.
9. Section 73.215 proposal. SSR
argues that, by providing interference
protection to a station’s contours based

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on maximum class facilities, as opposed
to the actual facilities, the Commission’s
rules overprotect stations operating with
facilities below their class maximum.
Accordingly, SSR proposes an
amendment to Section 73.3573 of the
Rules that would require such ‘‘submaximum’’ stations to be designated as
Section 73.215 facilities using a
procedure similar to the existing Class
C0 show cause and reclassification
procedure. Designation as a Section
73.215 facility would result in the submaximum station receiving interference
protection based on its actual
authorized operating parameters rather
than the maximum permitted
parameters for its station class. Under
SSR’s proposed procedure, stations not
already authorized under Section 73.215
that, for ten years prior to the filing of
a triggering application, have
continuously operated with a HAAT or
ERP below that of the class maximum
(or equivalent class maximum HAAT
and ERP combination in the case of
station operating with a HAAT
exceeding its reference HAAT) would be
given an opportunity to upgrade to
maximum class facilities or be subject to
designation as a Section 73.215 facility.
10. SSR recommends a show cause
procedure to implement its Section
73.215 proposal. Specifically, the
procedure would be initiated by the
filing of a ‘‘triggering’’ application that
specifies facilities that require the
designation of the affected submaximum station as a Section 73.215
facility. Triggering applications may
utilize Section 73.215 and must certify
that no alternative channel is available
for the proposed service. Copies of a
triggering application and related
pleadings would be required to be
served on the licensee of the affected
sub-maximum station. If the staff
concludes that a triggering application
is acceptable for filing, it would issue an
order to show cause why the affected
sub-maximum station should not be
designated as a Section 73.215 station.
The order to show cause would provide
the licensee of the sub-maximum station
30 days to express in writing an
intention to seek authority to modify its
technical facilities to its maximum class
HAAT and ERP (or equivalent
combination thereof) or to otherwise
challenge the triggering application. If
no such intention is expressed and the
triggering application is not challenged,
the affected sub-maximum station
would be designated as a Section 73.215
station and processing of the triggering
application would be completed. If such
intention is expressed within the 30-day
period, an additional 180-day period

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would be provided during which the
licensee of the sub-maximum station
would be required to file an acceptable
construction permit application to
increase HAAT and/or ERP to its class
maximum values (or equivalent
combination thereof). Upon grant of
such a construction permit application,
the triggering application would be
dismissed. As with Class C0
reclassifications, the licensee of the submaximum station would be required to
serve on triggering applicants copies of
any FAA submissions related to the
application grant process. If the
construction is not completed as
authorized, the affected sub-maximum
station would be automatically
designated as a Section 73.215 facility.
SSR’s proposal raises issues similar to
those posed by the Class C4 proposal,
and the Commission seeks comment
generally on the costs and benefits of
the proposal.
11. Affected stations and their
listeners. Would the proposed Section
73.215 mechanism materially benefit
stations seeking to upgrade and their
listeners? What is the demand for such
upgrades? Would there be a
corresponding detrimental effect on
listeners regarding loss of existing
interference-free service provided by
sub-maximum stations? The
Commission has explained that its
policy of protecting all stations as if
they are operating at maximum
permitted height or power for their
class, even if they are in fact operating
at or near the minimum permitted
height and power for their class,
‘‘permits stations to improve technical
facilities over time and provides a
certain degree of flexibility for
transmitter relocations.’’ To what extent
would adoption of the Section 73.215
proposal undermine this policy? Is this
policy still desirable in the mature FM
service? What are the relevant factors
that might affect the sub-maximum
station’s ability to upgrade to the class
maximums, and have those factors
changed due to technological or other
developments? If a station has operated
below maximum facilities for a
sufficient period of time, can the
Commission conclude that the station is
either unwilling or unable to operate at
maximum facilities, thereby justifying
protecting such station based on actual
operating parameters and allowing for
more efficient utilization of FM
spectrum? Is ten years of continuous
‘‘sub-maximum’’ operation the
appropriate period of time before a
station would be subject to involuntary
Section 73.215 designation, as suggested
by SSR, or is another period of time

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appropriate? To what extent should
transfers of control or assignments of
licensees impact the relevant time
period? That is, should the time period
apply per station or per licensee? For
example, if the relevant time period is
ten years and a station that has operated
below class maximums for nine years is
transferred or assigned to a third-party,
should the new licensee have ten
additional years to upgrade to class
maximums free from potential
designation as a Section 73.215 facility?
12. Secondary services. The
Commission seeks comment on the
likely impact of full service station
upgrades using the proposed Section
73.215 procedure on nearby secondary
services or AM primary stations that
rebroadcast on FM translator stations.
Are there lawful ways to mitigate or
eliminate the impact of this proposal on
secondary services, and, if so, what
measures would be effective or
appropriate?
13. Allocation goals. Would SSR’s
Section 73.215 proposal, if adopted,
result in increased interference levels in
the FM band? In particular, would the
increased density of signals resulting
from upgraded stations provide
improved FM service coverage, or
merely contribute to a higher ‘‘noise
floor’’ overall while only modestly
benefiting individual stations? Is this
proposal in tension with the original
purpose of Section 73.215 to afford
applicants greater flexibility in the
selection of transmitter sites? Should
the Commission significantly expand
the applicability of Section 73.215 as
proposed by SSR, and what would be
the policy and legal justifications for
doing so? Does the Commission’s long
history of licensing thousands of
stations in the reserved band—using a
contour methodology based on stations’
authorized facilities—show that
expanding eligibility for Section 73.215
processing would result in increased or
decreased services for listeners?
14. Implementation procedures. If the
Section 73.215 proposal is adopted,
should the Commission follow SSR’s
suggested procedures, which are based
on those currently in use for Class C0?
Should the triggering applicant be
required to certify that no alternative
channel is available for the proposed
service? Should the Commission use a
show cause procedure, and if so, what
deadlines would be appropriate?
15. Alternatively, should the
Commission adopt a more streamlined
procedure whereby all sub-maximum
stations would be provided a date
certain by which they must file an
upgrade application or automatically
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designation as a Section 73.215 facility
upon the filing of an acceptable
application from another licensee
seeking to upgrade its facilities? What
would be a reasonable amount of time
to allow sub-maximum stations to file
upgrade applications before becoming
subject to automatic designation as a
Section 73.215 facility? Would such a
procedure avoid unnecessary delays in
providing new FM service and
incentivize more stations to upgrade to
their class maximums? Would there be
any disadvantages with this approach?
Are there other streamlined
implementation approaches the
Commission should consider?
16. Other issues. The Commission
invites comment on other details of
SSR’s Section 73.215 proposal. Which
applicants should be permitted to use
the proposed Section 73.215 procedure?
Does ‘‘sub-maximum’’ include all
stations operating at less than class
maximums, or should the Commission
establish a cutoff whereby a station
would not be subject to designation as
a Section 73.215 facility if it operates at
a minimal distance below its class
maximum contour distance, such as two
kilometers? How would the proposal
affect stations that are short-spaced
under Section 73.213 of the Rules? Are
there specific rule changes that would
be necessary to implement the proposal?
The Commission also invites
commenters to make suggestions as to
how its forms and databases should be
modified to implement the Section
73.215 proposal.
17. Federal Rules that May Duplicate,
Overlap, or Conflict with the Proposed
Rule. None.
Ex Parte Rules
18. Permit But Disclose. The
proceeding this NOI initiates shall be
treated as a ‘‘permit-but-disclose’’
proceeding in accordance with the
Commission’s ex parte rules. Ex parte
presentations are permissible if
disclosed in accordance with
Commission rules, except during the
Sunshine Agenda period when
presentations, ex parte or otherwise, are
generally prohibited. Persons making ex
parte presentations must file a copy of
any written presentation or a
memorandum summarizing any oral
presentation within two business days
after the presentation (unless a different
deadline applicable to the Sunshine
period applies). Persons making oral ex
parte presentations are reminded that
memoranda summarizing the
presentation must (1) list all persons
attending or otherwise participating in
the meeting at which the ex parte
presentation was made, and (2)

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summarize all data presented and
arguments made during the
presentation. Memoranda must contain
a summary of the substance of the ex
parte presentation and not merely a
listing of the subjects discussed. More
than a one or two sentence description
of the views and arguments presented is
generally required. If the presentation
consisted in whole or in part of the
presentation of data or arguments
already reflected in the presenter’s
written comments, memoranda or other
filings in the proceeding, the presenter
may provide citations to such data or
arguments in his or her prior comments,
memoranda, or other filings (specifying
the relevant page and/or paragraph
numbers where such data or arguments
can be found) in lieu of summarizing
them in the memorandum. Documents
shown or given to Commission staff
during ex parte meetings are deemed to
be written ex parte presentations and
must be filed consistent with § 1.1206(b)
of the rules. In proceedings governed by
§ 1.49(f) of the rules or for which the
Commission has made available a
method of electronic filing, written ex
parte presentations and memoranda
summarizing oral ex parte
presentations, and all attachments
thereto, must be filed through the
electronic comment filing system
available for that proceeding, and must
be filed in their native format (e.g., .doc,
.xml, .ppt, searchable .pdf). Participants
in this proceeding should familiarize
themselves with the Commission’s ex
parte rules.
Filing Procedures
19. Pursuant to §§ 1.415 and 1.419 of
the Commission’s rules, 47 CFR 1.415,
1.419, interested parties may file
comments and reply comments on or
before the dates indicated on the first
page of this document. Comments may
be filed using the Commission’s
Electronic Comment Filing System
(ECFS). Electronic Filers: Comments
may be filed electronically using the
internet by accessing the ECFS: http://
apps.fcc.gov/ecfs/.
D Electronic Filers: Comments may be
filed electronically using the internet by
accessing the ECFS: http://apps.fcc.gov/
ecfs/.
D Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing. If more than one
docket or rulemaking number appears in
the caption of this proceeding, filers
must submit two additional copies for
each additional docket or rulemaking
number.
D Filings can be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or

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overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
D All hand-delivered or messengerdelivered paper filings for the
Commission’s Secretary must be
delivered to FCC Headquarters at 445
12th St. SW, Room TW–A325,
Washington, DC 20554. The filing hours
are 8:00 a.m. to 7:00 p.m. All hand
deliveries must be held together with
rubber bands or fasteners. Any
envelopes and boxes must be disposed
of before entering the building.

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D Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701.
D U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 445 12th Street SW,
Washington DC 20554.
D People with Disabilities: To request
materials in accessible formats for
people with disabilities (braille, large
print, electronic files, audio format),
send an email to [email protected] or call
the Consumer & Governmental Affairs
Bureau at 202–418–0530 (voice), 202–
418–0432 (tty).

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Ordering Clause
20. It is further ordered that, pursuant
to the authority contained in Sections 1,
4(i), 4(j), 301, 303, 307, 308, 309, 316,
and 319 of the Communications Act of
1934, as amended, 47 U.S.C. 151, 154(i),
154(j), 301, 303, 307, 308, 309, 316, and
319, this Notice of Inquiry is adopted.
Federal Communications Commission.
Marlene Dortch,
Secretary.
[FR Doc. 2018–14880 Filed 7–11–18; 8:45 am]
BILLING CODE 6712–01–P

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Notices

Federal Register
Vol. 83, No. 134
Thursday, July 12, 2018

This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2018–0032]

Notice of Request for Revision to and
Extension of Approval of an
Information Collection; Animal Welfare
Animal and Plant Health
Inspection Service, USDA.
ACTION: Revision to and extension of
approval of an information collection;
comment request.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request a revision to and extension of
approval of an information collection
associated with the Animal Welfare Act
regulations for the humane handling,
care, treatment, and transportation of
certain animals by dealers, research
facilities, exhibitors, carriers, and
intermediate handlers.
DATES: We will consider all comments
that we receive on or before September
10, 2018.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov/#!docket
Detail;D=APHIS-2018-0032.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2018–0032, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at http://
www.regulations.gov/#!docket
Detail;D=APHIS-2018-0032 or in our
reading room, which is located in Room
1141 of the USDA South Building, 14th
Street and Independence Avenue SW,
Washington, DC. Normal reading room

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hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 799–7039 before
coming.
FOR FURTHER INFORMATION CONTACT: For
information on the Animal Welfare Act
regulations, contact Dr. Kay CarterCorker, Director, National Policy Staff,
Animal Care, APHIS, 4700 River Road,
Unit 84, Riverdale, MD 20737; (301)
851–3748. For copies of more detailed
information on the information
collection, contact Ms. Kimberly Hardy,
APHIS’ Information Collection
Coordinator, at (301) 851–2483.
SUPPLEMENTARY INFORMATION:
Title: Animal Welfare.
OMB Control Number: 0579–0036.
Type of Request: Revision to and
extension of approval of an information
collection.
Abstract: Under the Animal Welfare
Act (AWA, 7 U.S.C. 2131 et seq.), the
Secretary of Agriculture is authorized to
promulgate standards and other
requirements governing the humane
handling, care, treatment, and
transportation of certain animals by
dealers, exhibitors, operators of auction
sales, research facilities, carriers and
intermediate handlers. The Secretary
has delegated responsibility for
administering the AWA to the U.S.
Department of Agriculture’s Animal and
Plant Health Inspection Service
(APHIS), Animal Care.
Definitions, regulations, and
standards established under the AWA
are contained in 9 CFR parts 1, 2, and
3 (referred to below as the regulations).
Part 1 contains definitions for terms
used in parts 2 and 3. Part 2 provides
administrative requirements and sets
forth institutional responsibilities for
regulated parties, including licensing
requirements for dealers, exhibitors, and
operators of auction sales. Dealers,
exhibitors, and operators of auction
sales are required to comply in all
respects with the regulations and
standards (9 CFR 2.100(a)) and to allow
APHIS officials access to their place of
business, facilities, animals, and records
to inspect for compliance (9 CFR 2.126).
Part 3 provides standards for the
humane handling, care, treatment, and
transportation of covered animals. Part
3 consists of subparts A through E,
which contain specific standards for
dogs and cats, guinea pigs and hamsters,
rabbits, nonhuman primates, and

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marine mammals, respectively, and
subpart F, which sets forth general
standards for warmblooded animals not
otherwise specified in part 3.
Administering the AWA requires the
use of several information collection
activities such as license applications
and renewals, which now include a
request to identify whether the business
mailing address is a personal residence
or not a personal residence; registration
applications and updates; annual
reports; acknowledgement of regulations
and standards; inspections; requests;
notifications; agreements; plans; written
program of veterinary care and health
records; itineraries; applications and
permits; records of acquisition,
disposition, or transport of animals;
official identification; variances;
protocols; health certificates;
complaints; marking requirements; and
recordkeeping.
These information collection activity
requirements provide APHIS with the
data necessary for the review and
evaluation of program compliance by
regulated facilities, and they provide a
workable enforcement system to carry
out the requirements of the AWA and
the intent of Congress without resorting
to more detailed and stringent
regulations and standards that could be
more burdensome to regulated facilities.
We are asking the Office of
Management and Budget (OMB) to
approve our use of these information
collection activities, as described, for an
additional 3 years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
Estimate of burden: The public
burden for this collection of information
is estimated to average 0.31 hours per
response.
Respondents: Individuals or
households; businesses or other forprofit entities; not-for-profit institutions;
farms; and State, local, and Tribal
governments.
Estimated annual number of
respondents: 9,112.
Estimated annual number of
responses per respondent: 128.
Estimated annual number of
responses: 1,164,553.
Estimated total annual burden on
respondents: 366,021 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 9th day of
July 2018.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2018–14945 Filed 7–11–18; 8:45 am]
BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE
Forest Service
Notice of New Fee Sites; Federal Lands
Recreation Enhancement Act
Bitterroot National Forest,
Forest Service, USDA.
ACTION: Notice of new fee sites.
AGENCY:

The Bitterroot National Forest
is proposing to implement new fees at
two campgrounds and one rental cabin.
These fees are only proposed and will
be determined upon further analysis
and public comment.
DATES: Send any comments about these
fee proposals by August 13, 2018 so
comments can be compiled, analyzed,
and shared with the Western Montana
Bureau of Land Management Resource
Advisory Committee. The effective date
of implementation of proposed new fees
will be no earlier than six months after
publication of this notice.
ADDRESSES: Julie King, Forest
Supervisor, Bitterroot National Forest,
1801 N First, Hamilton, MT 59840 or
Email to [email protected].
FOR FURTHER INFORMATION CONTACT:
Erica Strayer, Recreation Program
Manager, Darby Ranger District, at 406–
821–4252 or [email protected].
Information about proposed fee changes

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can also be found at www.fs.usda.gov/
goto/r1recfee.
The
Federal Recreation Lands Enhancement
Act (Title VII, Pub. L. 108–447) directed
the Secretary of Agriculture to publish
a six month advance notice in the
Federal Register whenever new
recreation fee areas are established.
These new fees will be reviewed by the
Western Montana Bureau of Land
Management Resource Advisory
Committee prior to a final decision and
implementation.
The Forest proposes a $50/night fee
for Lost Horse Guard Station, which
would open this site for public rental.
The Forest also proposes a $10/night fee
for both Slate Creek and Sam Billings
Memorial campgrounds. Lost Horse
Guard Station was built in 1935 and
listed on the National Register of
Historic Places in 1989. It lies at the
head of Lost Horse Creek, near the
Montana/Idaho divide. It is near a
variety of recreation opportunities such
as hiking, camping, horseback riding,
non-motorized water sports, hunting,
backcountry skiing, and snowmobiling
at Twin Lakes. The rustic guard station
can sleep up to eight people.
Slate Creek Campground also has a
new group gathering area and Sam
Billings Memorial Campground has new
horse camping sites. Reasonable fees,
paid by users of these sites and services,
will help ensure that the Forest can
continue maintaining and improving the
sites for future generations.
A business analysis of the proposed
new fee sites listed has shown that
people desire having a variety of
recreation opportunities and
experiences on the Bitterroot National
Forest, such as group camping, cabin
and lookout rentals and single family
camping. A market analysis of
surrounding recreation sites with
similar amenities indicates that the
proposed fees are comparable and
reasonable.
Advance reservations for the Lost
Horse Guard Station will be available
through www.recreation.gov or by
calling 1–877–444–6777. The National
Recreation Reservation Service charges
a $10 fee for reservations.

SUPPLEMENTARY INFORMATION:

Dated: May 17, 2018.
Glenn Casamassa,
Associate Deputy Chief, National Forest
System.
[FR Doc. 2018–14910 Filed 7–11–18; 8:45 am]
BILLING CODE 3411–15–P

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DEPARTMENT OF AGRICULTURE
Forest Service
Notice of Proposed New Fee Site;
Federal Lands Recreation
Enhancement Act
Flathead National Forest,
Forest Service, USDA.
ACTION: Notice of new fee site.
AGENCY:

The Flathead National Forest
is proposing to charge a new fee at the
Lindbergh Lake Campground. Funds
generated at the site will be used for the
operation and maintenance, upkeep of
facilities, and improvements as feasible.
This fee is only proposed and will be
determined upon further analysis and
public comment.
DATES: Send any comments about these
fee proposals by August 13, 2018 so
comments can be compiled, analyzed,
and shared with the Western Montana
Bureau Land Management (BLM)
Resource Advisory Council. The
effective date of implementation of this
fee would be no earlier than six months
after publication of this notice.
ADDRESSES: Chip Weber, Forest
Supervisor, Flathead National Forest,
650 Wolfpack Way, Kalispell, MT 59901
or Email to [email protected].
FOR FURTHER INFORMATION CONTACT:
Chris Prew, Recreation Program
Manager, Flathead National Forest, at
406–758–3538 or [email protected].
Information about proposed fee changes
can also be found at www.fs.usda.gov/
goto/r1recfee.
SUPPLEMENTARY INFORMATION: The
Federal Recreation Lands Enhancement
Act (Title VII, Pub. L. 108–447) directed
the Secretary of Agriculture to publish
a six month advance notice in the
Federal Register whenever new
recreation fee areas are established. This
new fee will be reviewed by the Western
Montana BLM Resource Advisory
Council prior to a final decision and
implementation.
The Flathead National Forest is
proposing to charge a $10 per night fee
at Lindbergh Lake Campground.
Lindbergh Lake Campground offers
breathtaking views of the Mission and
Swan Mountain Ranges and has a
concrete boat ramp for ease of lake
access and enjoyment. The lake offers
boating, swimming, and fishing
opportunities and is located in close
proximity to the Mission Mountains
Wilderness, which offers excellent
hiking opportunities. The campground
has 21 individual camp sites and
features a new toilet facility and other
site improvements.
SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

A business analysis of the proposed
new fee site has shown that people
desire having a variety of recreation
opportunities and experiences on the
Flathead National Forest, such as lakeorientated developed campgrounds. A
market analysis of surrounding
recreation sites with similar amenities
indicates that the proposed fee is
comparable and reasonable.
Dated: July 5, 2018.
Glenn Casamassa,
Associate Deputy Chief, National Forest
System.
[FR Doc. 2018–14911 Filed 7–11–18; 8:45 am]
BILLING CODE P

DEPARTMENT OF COMMERCE
Foreign-Trade Zones Board
[B–18–2018]

Production Activity Not Authorized;
Foreign-Trade Zone (FTZ) 26—Atlanta,
Georgia; PBR, Inc. d/b/a SKAPS
Industries (Non-Woven Geotextiles);
Athens, Georgia
On March 9, 2018, PBR, Inc. d/b/a
SKAPS Industries (SKAPS) submitted a
notification of proposed production
activity to the FTZ Board for its facility
within FTZ 26—Site 29, in Athens,
Georgia.
The notification was processed in
accordance with the regulations of the
FTZ Board (15 CFR part 400), including
notice in the Federal Register inviting
public comment (83 FR 13473, March
29, 2018). On July 9, 2018 the applicant
was notified of the FTZ Board’s decision
that further review of the activity is
warranted. The production activity
described in the notification was not
authorized. If the applicant wishes to
seek authorization for this activity, it
will need to submit an application for
production authority, pursuant to
Section 400.23.
Dated: July 9, 2018.
Elizabeth Whiteman,
Acting Executive Secretary.
[FR Doc. 2018–14928 Filed 7–11–18; 8:45 am]
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DEPARTMENT OF COMMERCE
International Trade Administration
[C–122–854]

Supercalendered Paper From Canada:
Notice of Rescission of Countervailing
Duty Administrative Review; 2015 and
2016
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(Commerce) is rescinding the
administrative reviews of the
countervailing duty (CVD) order on
supercalendared paper (SC paper) from
Canada for the period of review August
3, 2015, through December 31, 2015,
and the period of review January 1,
2016, through December 31, 2016.
DATES: Applicable July 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Emily Halle or Nicholas Czajkowski,
AD/CVD Operations, Office I,
Enforcement and Compliance,
International Trade Administration,
U.S. Department of Commerce, 1401
Constitution Avenue NW, Washington,
DC 20230; telephone (202) 482–0176 or
(202) 482–1395, respectively.
SUPPLEMENTARY INFORMATION:
AGENCY:

Background
On December 1, 2016, Commerce
published in the Federal Register a
notice of opportunity to request an
administrative review of the CVD order
on SC paper from Canada for the period
of review (POR) of August 3, 2015,
through December 31, 2015.1 Commerce
received timely-filed requests from
Verso Corporation (Verso); Catalyst
Paper Corporation, Catalyst Pulp and
Paper Sales Inc., and Catalyst Paper
(USA) Inc. (collectively, Catalyst); Irving
Paper Limited (Irving); Port Hawkesbury
Paper LP (PHP); and Resolute FP
Canada Inc and Resolute FP US Inc.
(collectively, Resolute), in accordance
with section 751(a) of the Tariff Act of
1930, as amended (the Act), to conduct
an administrative review of the CVD
order.2 Based upon this request, on
1 See Antidumping or Countervailing Duty Order,
Finding, or Suspended Investigation; Opportunity
To Request Administrative Review, 81 FR 86694
(December 1, 2016).
2 See Letter from Verso, ‘‘Supercalendered Paper
from Canada: Request for Administrative Review,’’
January 3, 2017; see Letter from Catalyst,
‘‘Supercalendered Paper from Canada: Request for
Administrative Review,’’ December 9, 2016; see
Letter from Irving, ‘‘Supercalendered Paper from
Canada, Inv. No. C–122–854—Request for
Administrative Review and Request for Expansion
of Review Period,’’ December 23, 2016; see Letter
from PHP, ‘‘Supercalendered Paper from Canada:
Request for Administrative Review,’’ December 9,

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February 13, 2017, in accordance with
section 751(a) of the Act, Commerce
published a notice of initiation.3
On December 4, 2017, Commerce
published in the Federal Register a
notice of opportunity to request an
administrative review of the CVD order
on SC paper from Canada for the period
of review (POR) of January 1, 2016,
through December 31, 2016.4 Commerce
received timely-filed requests from
Verso Corporation, Irving Paper
Limited, Port Hawkesbury Paper LP,
and Resolute FP Canada Inc and
Resolute FP US Inc., in accordance with
section 751(a) of the Act, to conduct an
administrative review of the CVD
order.5 Based upon this request, on
February 23, 2018, in accordance with
section 751(a) of the Act, Commerce
published a notice of initiation.6
On July 5, 2018, Commerce revoked
the CVD order on SC paper.7
Rescission of Administrative Reviews
Pursuant to 19 CFR 351.222(g),
Commerce revoked the CVD order on SC
paper from Canada. The effective date of
the revocation of the CVD order is
August 3, 2015. As a result of the
revocation, we instructed U.S. Customs
and Border Protection (CBP) to
discontinue the suspension of
liquidation and the collection of cash
deposits of estimated countervailing
duties, to liquidate all unliquidated
entries that were entered on or after
August 3, 2015, without regard to
countervailing duties, and to refund all
CVD cash deposits on all such
merchandise, with applicable interest.
These administrative reviews cover the
period August 3, 2015 through
December 31, 2015, and the period
January 1, 2016 through December 31,
2016; see Letter from Resolute, ‘‘Supercalendered
Paper from Canada: Request for Administrative
Review (8/3/15–12/31/15),’’ December 19, 2016.
3 See Initiation of Antidumping and
Countervailing Duty Administrative Reviews, 82 FR
10457 (February 13, 2017).
4 See Antidumping or Countervailing Duty Order,
Finding, or Suspended Investigation; Opportunity
To Request Administrative Review, 83 FR 57219
(December 4, 2017).
5 See Letter from Verso, ‘‘Supercalendered Paper
from Canada: Request for Administrative Review,’’
December 29, 2017; see Letter from Irving,
‘‘Supercalendered Paper from Canada, Inv. No.
C–122–854—Request for Administrative Review,’’
December 15, 2017; see Letter from PHP,
‘‘Supercalendered Paper from Canada: Request for
Administrative Review,’’ December 20, 2017; see
Letter from Resolute, ‘‘Supercalendered Paper from
Canada: Request for Administrative Review
(1/1/2016–12/31/2016),’’ December 21, 2017.
6 See Initiation of Antidumping and
Countervailing Duty Administrative Reviews, 83 FR
8058 (February 23, 2018).
7 See Supercalendered Paper from Canada: Final
Results of Changed Circumstances Review and
Revocation of Countervailing Duty Order, signed
July 5, 2018.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
2016. Because the revocation is
retroactive to August 3, 2015, the
periods covered by these ongoing
administrative reviews are no longer
subject to the CVD order, and there is no
basis for conducting the administrative
review. Therefore, Commerce is
rescinding these administrative reviews.
Assessment
Because we ordered the liquidation of
the entries subject to these
administrative reviews, as a result of the
revocation of the CVD order, there is no
need to issue additional instructions to
CBP.
Notification Regarding Administrative
Protective Orders
This notice serves as a reminder to
parties subject to administrative
protective order (APO) of their
responsibility concerning the return or
destruction of proprietary information
disclosed under APO in accordance
with 19 CFR 351.305. Timely written
notification of the return/destruction of
APO materials or conversion to judicial
protective order is hereby requested.
Failure to comply with the regulations
and terms of an APO is a violation
which is subject to sanction.
This notice is issued and published in
accordance with section 751 of the Act
and 19 CFR 351.213(d)(4).
Dated: July 5, 2018.
Gary Taverman,
Deputy Assistant Secretary for Antidumping
and Countervailing Duty Operations,
performing the non-exclusive functions and
duties of the Assistant Secretary for
Enforcement and Compliance.
[FR Doc. 2018–14922 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
International Trade Administration
[A–570–601]

Tapered Roller Bearings and Parts
Thereof, Finished and Unfinished,
From the People’s Republic of China:
Preliminary Results and Intent To
Rescind the Review in Part; 2016–2017
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(Commerce) is conducting an
administrative review (AR) of the
antidumping duty order on tapered
roller bearings and parts thereof,
finished and unfinished (TRBs), from
the People’s Republic of China (China).
The AR covers 20 exporters, of which
Commerce selected two exporters for

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AGENCY:

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individual examination (i.e., GGB
Bearing Technology (Suzhou) Co., Ltd.
(GGB); and Luoyang Bearing
Corporation (Group) (Luoyang)). The
period of review (POR) is June 1, 2016,
through May 31, 2017. We preliminarily
determine that sales of subject
merchandise have been made below
normal value (NV). Interested parties are
invited to comment on these
preliminary results.
DATES: Applicable July 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Andrew Medley, Enforcement and
Compliance, International Trade
Administration, U.S. Department of
Commerce, 1401 Constitution Avenue
NW, Washington, DC 20230; telephone:
(202) 482–4987.
SUPPLEMENTARY INFORMATION:
Scope of the Order
The merchandise covered by the order
includes tapered roller bearings and
parts thereof. The subject merchandise
is currently classifiable under
Harmonized Tariff Schedule of the
United States (HTSUS) subheadings:
8482.20.00, 8482.91.00.50, 8482.99.15,
8482.99.45, 8483.20.40, 8483.20.80,
8483.30.80, 8483.90.20, 8483.90.30,
8483.90.80, 8708.70.6060, 8708.99.2300,
8708.99.4850, 8708.99.6890,
8708.99.8115, and 8708.99.8180. The
HTSUS subheadings are provided for
convenience and customs purposes
only; the written description of the
scope of the order is dispositive.1
Methodology
Commerce is conducting this review
in accordance with section 751(a)(1)(B)
of the Act. For GGB, we calculated
export prices in accordance with section
772 of the Act. Because China is a nonmarket economy (NME) within the
meaning of section 771(18) of the Act,
for GGB, NV was calculated in
accordance with section 773(c) of the
Act. We preliminary find that Luoyang
is ineligible for a separate rate and is
part of the China-wide entity.
For a full description of the
methodology underlying our
conclusions, see the Preliminary
Decision Memorandum. The
Preliminary Decision Memorandum is a
public document and is on file
electronically via Enforcement and
Compliance’s Antidumping and
1 For a complete description of the scope of the
order, see Memorandum, ‘‘Decision Memorandum
for the Preliminary Results of the 2016–2017
Antidumping Duty Administrative Review of
Tapered Roller Bearings and Parts Thereof,
Finished and Unfinished, from the People’s
Republic of China’’ (Preliminary Decision
Memorandum), issued concurrently with and
hereby adopted by this notice.

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32263

Countervailing Duty Centralized
Electronic Service System (ACCESS).
ACCESS is available to registered users
at https://access.trade.gov, and to all
parties in the Central Records Unit,
room B8024 of the main Department of
Commerce building. In addition, a
complete version of the Preliminary
Decision Memorandum can be found at
http://enforcement.trade.gov/frn/. The
signed Preliminary Decision
Memorandum and the electronic
version of the Preliminary Decision
Memorandum are identical in content.
A list of the topics discussed in the
Preliminary Decision Memorandum is
attached as the Appendix to this notice.
Rate for Non-Examined Companies
Which Are Eligible for a Separate Rate
As indicated in the ‘‘Preliminary
Results of Review’’ section below, we
preliminarily determine that a
weighted-average dumping margin of
6.87 percent applies to the six firms not
selected for individual review which are
eligible for a separate rate. For further
information, see the Preliminary
Decision Memorandum at ‘‘Separate
Rate Assigned to Non-Selected
Companies.’’
Preliminary Results of Review
Twelve companies involved in the
administrative review did not
demonstrate that they are entitled to a
separate rate.2 Therefore, we
preliminarily finds these companies to
be part of the China-wide entity.3 The
rate previously established for the
China-wide entity is 92.84 percent. One
additional company, Hangzhou
Xiaoshan Dingli Machinery Co., Ltd.
(Dingli), could not demonstrate that it
had a suspended entry during the POR;
2 These companies are: (1) Apex Maritime
Shanghai Co., Ltd.; (2) Crossroads Global Trading
Co., Ltd.; (3) Honour Lane Shipping Ltd.; (4)
Kinetsu World Express China Co., Ltd.; (5) Luoyang;
(6) Pacific Link Intl Freight Forwarding Co., Ltd.; (7)
Shanghai Dizhao Industrial Trading Co., Ltd.; (8)
Thi Group Shanghai Ltd.; (9) Weifang HaoxinConmet Mechanical Products Co., Ltd.; (10) Yantai
Huilong Machinery Parts Co.; Ltd.; (11) Zhejiang
Machinery Import & Export Corp.; and (12) Zhejiang
Zhaofeng Mechanical & Electronic Co., Ltd.
3 See Preliminary Decision Memorandum, at 8.
Pursuant to Commerce’s change in practice,
Commerce no longer considers the NME entity as
an exporter conditionally subject to administrative
reviews. See Antidumping Proceedings:
Announcement of Change in Department Practice
for Respondent Selection in Antidumping Duty
Proceedings and Conditional Review of the
Nonmarket Economy Entity in NME Antidumping
Duty Proceedings, 78 FR 65963, 65970 (November
4, 2013). Under this practice, the NME entity will
not be under review unless a party specifically
requests, or Commerce self-initiates, a review of the
entity. Because no party requested a review of the
entity, the entity is not under review and the
entity’s rate is not subject to change.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

thus, we intend to rescind the review
with respect to Dingli.

We preliminarily determine that the
following weighted-average dumping

margins exist for the period June 1,
2016, through May 31, 2017:
Weightedaverage
dumping
margin
(percent)

Exporter

GGB Bearing Technology (Suzhou) Co., Ltd ......................................................................................................................................
CNH Industrial Italia SpA * ...................................................................................................................................................................
GSP Automotive Group Wenzhou Co. Ltd * ........................................................................................................................................
Hangzhou Hanji Auto Parts Co., Ltd * .................................................................................................................................................
Hangzhou Radical Energy-Saving Technology Co., Ltd * ...................................................................................................................
Ningbo Xinglun Bearings Import & Export Co., Ltd * ..........................................................................................................................
Zhejiang Sihe Machine Co., Ltd * ........................................................................................................................................................

6.87
6.87
6.87
6.87
6.87
6.87
6.87

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* This company was not selected as a mandatory respondent but is subject to this administrative review and demonstrated that it qualified for a
separate rate during the POR.

Disclosure and Public Comment
Commerce will disclose calculations
performed for these preliminary results
to the parties within five days of the
date of publication of this notice in
accordance with 19 CFR 351.224(b).
Interested parties may submit case briefs
no later than 30 days after the date of
publication of these preliminary results
of review.4 Rebuttals to case briefs may
be filed no later than five days after case
briefs are filed and all rebuttal briefs
must be limited to comments raised in
the case briefs.5 Parties who submit
comments are requested to submit with
the argument: (1) A statement of the
issue; (2) a brief summary of the
argument; and (3) a table of authorities.6
Any interested party may request a
hearing within 30 days of publication of
this notice.7 Hearing requests should
contain the following information: (1)
The party’s name, address, and
telephone number; (2) the number of
participants; and (3) a list of the issues
to be discussed. Oral presentations will
be limited to issues raised in the briefs.8
If a request for a hearing is made, parties
will be notified of the time and date for
the hearing to be held at the U.S.
Department of Commerce, 1401
Constitution Avenue NW, Washington,
DC 20230.9
All submissions, with limited
exceptions, must be filed electronically
using ACCESS. An electronically filed
document must be received successfully
in its entirety by 5 p.m. Eastern Time
(ET) on the due date.10 Documents
excepted from the electronic submission
requirements must be filed manually
(i.e., in paper form) with the APO/
Dockets Unit in Room 18022 and
4 See

19 CFR 351.309(c)(1)(ii).
19 CFR 351.309(d).
6 See 19 CFR 351.309(c)(2).
7 See 19 CFR 351.310(c).
8 Id.
9 See 19 CFR 351.310(d).
10 See 19 CFR 351.103(c).
5 See

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stamped with the date and time of
receipt by 5 p.m. ET on the due date.11
Unless otherwise extended,
Commerce intends to issue the final
results of this administrative review,
which will include the results of its
analysis of all issues raised in the case
briefs, within 120 days of publication of
these preliminary results, pursuant to
section 751(a)(3)(A) of the Act.
Assessment Rates
Upon issuance of the final results of
the administrative review, Commerce
will determine, and CBP shall assess,
antidumping duties on all appropriate
entries covered by this review.12 For
each examined respondent which is
eligible for a separate rate and which
has a weighted-average dumping margin
which is not zero or de minimis (i.e.,
less than 0.5 percent), we will calculate
importer-specific ad valorem duty
assessment rates based on the ratio of
the total amount of dumping calculated
for the importer’s examined sales to the
total entered value of those sales, in
accordance with 19 CFR 351.212(b)(1).
Pursuant to Commerce’s assessment
practice, for entries that were not
reported in the U.S. sales data submitted
by an examined respondent, we will
instruct CBP to liquidate such entries at
the China-wide rate. Additionally, if we
determine that an exporter had no
shipments of the subject merchandise,
any suspended entries that entered
under that exporter’s case number (i.e.,
at that exporter’s cash deposit rate) will
be liquidated at the China-wide rate.13
11 See 19 CFR 351.303(b) and ‘‘ACCESS
Handbook on Electronic Filing Procedures
Enforcement and Compliance International Trade
Administration U.S. Department of Commerce,’’
dated October 24, 2017, available at https://
access.trade.gov/help/Handbook_on_Electronic_
Filing_Procedures.pdf.
12 See 19 CFR 351.212(b)(1).
13 See Non-Market Economy Antidumping
Proceedings: Assessment of Antidumping Duties, 76
FR 65694 (October 24, 2011).

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For the respondents which were not
selected for individual examination in
this administrative review and which
qualified for a separate rate, the
assessment rate will be equal to the
weighted-average dumping margin
determined for the non-examined
respondents in the final results of this
administrative review. For the final
results, if we continue to treat the 12
exporters preliminarily found not to
qualify for separate rates as part of the
China-wide entity, we will instruct CBP
to apply an ad valorem assessment rate
of 92.84 percent, the current rate
established for the China-wide entity, to
all entries of subject merchandise
during the POR which were exported by
those companies. In addition, if
Commerce continues to find that Dingli
had no suspended entries during the
POR, we will rescind the review for that
company.14
We intend to issue assessment
instructions to CBP 15 days after the
publication of the final results of these
reviews.
Cash Deposit Requirements
The following cash deposit
requirements will be effective upon
publication of the final results of this
administrative review for all shipments
of the subject merchandise entered, or
withdrawn from warehouse, for
consumption on or after the publication
date, as provided for by section
751(a)(2)(C) of the Act: (1) For the
exporters listed above which have a
separate rate, the cash deposit rate will
be equal to the weighted-average
dumping margin established in the final
results of this review (except, if the rate
is zero or de minimis, then a cash
deposit rate of zero will be established
for that company); (2) for previously
14 For a full discussion of this practice, see NonMarket Economy Antidumping Proceedings:
Assessment of Antidumping Duties, 76 FR 65694
(October 24, 2011).

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
investigated or reviewed Chinese and
non-Chinese exporters not listed above
that have separate rates, the cash
deposit rate will continue to be equal to
the exporter-specific weighted-average
dumping margin published for the most
recently completed segment of this
proceeding; (3) for all Chinese exporters
of subject merchandise that have not
been found to be entitled to a separate
rate, the cash deposit rate will be the
cash deposit rate established for the
China-wide entity, 92.84 percent; and
(4) for all exporters of subject
merchandise which are not located in
China and which are not eligible for a
separate rate, the cash deposit rate will
be the rate applicable to the Chinese
exporter(s) that supplied that nonChinese exporter. These deposit
requirements, when imposed, shall
remain in effect until further notice.
Notification to Importers
This notice also serves as a
preliminary reminder to importers of
their responsibility under 19 CFR
351.402(f) to file a certificate regarding
the reimbursement of antidumping
duties prior to liquidation of the
relevant entries during this review
period. Failure to comply with this
requirement could result in the
Secretary’s presumption that
reimbursement of antidumping duties
occurred and the subsequent assessment
of double antidumping duties.
Notification to Interested Parties
We are issuing and publishing these
preliminary results of review in
accordance with sections 751(a)(l),
751(a)(2)(B) and 777(i)(l) of the Act, and
19 CFR 351.221(b)(4).
Dated: July 3, 2018.
Gary Taverman,
Deputy Assistant Secretary for Antidumping
and Countervailing Duty Operations,
performing the non-exclusive functions and
duties of the Assistant Secretary for
Enforcement and Compliance.

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Appendix—List of Topics Discussed in
the Preliminary Decision Memorandum
1. Summary
2. Background
3. Scope of the Order
4. Discussion of the Methodology
a. Non-Market Economy Country Status
b. Separate Rates
i. Separate Rates Applicants with No
Evidence of Suspended Entries
ii. Separate Rate Recipients
1. Wholly Foreign-Owned Companies
2. Wholly China-Owned Companies and
Joint Ventures
a. Absence of De Jure Control
b. Absence of De Facto Control
3. Companies Not Receiving a Separate
Rate

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c. Separate Rate Assigned to Non-Selected
Companies
d. The China-Wide Entity
e. Application of Facts Available and Use
of Adverse Interferences
f. Application of Partial AFA for GGB
g. Surrogate Country
h. Date of Sale
i. Normal Value Comparisons
j. Determination of Comparison Method
k. Constructed Export Price
i. Irrecoverable Value-Added Tax (VAT)
ii. GGB
l. Normal Value
i. Factor Valuations
ii. Currency Conversion
5. Recommendation
[FR Doc. 2018–14924 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
International Trade Administration
[A–580–874]

Certain Steel Nails From the Republic
of Korea: Preliminary Results of
Antidumping Duty Administrative
Review and Partial Rescission of
Antidumping Duty Administrative
Review; 2016–2017
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.

AGENCY:

The Department of Commerce
(Commerce) preliminarily determines
that Daejin Steel Co. (Daejin), Koram
Inc. (Koram), and Korea Wire Co., Ltd.
(Kowire), producers/exporters of
merchandise subject to this
administrative review, made sales of
subject merchandise at less than normal
value. The period of review (POR) is
July 1, 2016, through June 30, 2017.

SUMMARY:

DATES:

Applicable July 12, 2018.

32265

from Korea.1 On July 31, 2017, Daejin 2
and Kowire 3 each requested an
administrative review, and Mid
Continent Steel & Wire, Inc.4 (the
petitioner) requested an administrative
review of 206 producers and/or
exporters, including Daejin, Koram,
Koram Steel Co. Ltd., and Kowire. On
September 28, 2017, the petitioner
withdrew its administrative review
request with respect to 202 of the 206
companies identified as producers/
exporters in the petitioner’s July 31,
2017 letter. The petitioner maintained
its administrative review request with
respect to: Daejin, Koram, Koram Steel
Co. Ltd., and Kowire. As such,
Commerce issued its AD questionnaire
to these companies on October 10,
2017.5
Partial Rescission of Administrative
Review
Commerce received timely requests to
conduct an administrative review of
certain exporters covering the POR.
Because the petitioner timely withdrew
its request for review of all of the
companies listed in the Initiation
Notice, with the exception of Daejin,
Koram, Koram Steel Co. Ltd., and
Kowire, we are rescinding this
administrative review with respect to
the remaining companies on which we
initiated a review pursuant to 19 CFR
351.213(d)(1). For a list of the
companies for which we are rescinding
this review, see Appendix II to this
notice.
As discussed in the Preliminary
Decision Memorandum, we
preliminarily determine that Koram is
the successor-in-interest to Koram Steel
Co. Ltd.; therefore, we will not calculate
a separate dumping margin for Koram
Steel Co., Ltd.6 Accordingly, the three
companies subject to the instant review
are: Daejin, Koram, and Kowire.

FOR FURTHER INFORMATION CONTACT:

Robert Galantucci (Kowire), Maliha
Khan (Daejin), or Trisha Tran (Koram),
AD/CVD Operations, Office IV,
Enforcement and Compliance,
International Trade Administration,
U.S. Department of Commerce, 1401
Constitution Avenue NW, Washington,
DC 20230; telephone: (202) 482–2923,
(202) 482–0895, or (202) 482–4852,
respectively.
SUPPLEMENTARY INFORMATION:

Background
On July 3, 2017, Commerce published
in the Federal Register a notice of
opportunity to request an administrative
review of the antidumping duty (AD)
order on certain steel nails (steel nails)

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1 See Antidumping or Countervailing Duty Order,
Finding, or Suspended Investigation; Opportunity
to Request Administrative Review, 82 FR 30833
(July 3, 2017).
2 See Letter from Daejin, ‘‘Administrative Review
of the Antidumping Duty Order on Certain Steel
Nails from Korea—Request for Review,’’ dated July
31, 2017.
3 See Letter from Kowire, ‘‘Steel Nails from the
Republic of Korea—Request for Administrative
Review,’’ dated July 31, 2017.
4 See Letter from the petitioner, ‘‘Certain Steel
Nails from Korea: Request for Administrative
Reviews,’’ dated July 31, 2017.
5 See Commerce’s Letter, ‘‘Administrative Review
of Certain Steel Nails from Korea: Antidumping
Duty Questionnaire,’’ dated October 10, 2017.
6 See Memorandum, ‘‘Decision Memorandum for
Preliminary Results of the 2016–2017 Antidumping
Duty Administrative Review of Certain Steel Nails
from the Republic of Korea,’’ dated concurrently
with, and hereby adopted by this notice
(Preliminary Decision Memorandum) at 2.

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The Preliminary Decision
Memorandum is a public document and
is on file electronically via Enforcement
and Compliance’s Antidumping and
Countervailing Duty Centralized
Electronic Service System (ACCESS).
ACCESS is available to registered users
at http://access.trade.gov and available
to all parties in the Central Records
Unit, room B8024 of the main
Department of Commerce building. In
addition, a complete version of the
Preliminary Decision Memorandum can
be accessed directly on the internet at
http://enforcement.trade.gov/frn/. The
signed and electronic versions of the
Preliminary Decision Memorandum are
identical in content.

amozie on DSK3GDR082PROD with NOTICES1

Scope of the Order
The merchandise covered by this
order is certain steel nails having a
nominal shaft length not exceeding 12
inches.7 Merchandise covered by the
order is currently classified under the
Harmonized Tariff Schedule of the
United States (HTSUS) subheadings
7317.00.55.02, 7317.00.55.03,
7317.00.55.05, 7317.00.55.07,
7317.00.55.08, 7317.00.55.11,
7317.00.55.18, 7317.00.55.19,
7317.00.55.20, 7317.00.55.30,
7317.00.55.40, 7317.00.55.50,
7317.00.55.60, 7317.00.55.70,
7317.00.55.80, 7317.00.55.90,
7317.00.65.30, 7317.00.65.60 and
7317.00.75.00. Certain steel nails subject
to this order also may be classified
under HTSUS subheadings
7907.00.60.00, 8206.00.00.00 or other
HTSUS subheadings. While the HTSUS
subheadings are provided for
convenience and customs purposes, the
written description of the scope of this
order is dispositive. For a full
description of the scope of the order, see
the Preliminary Decision
Memorandum.8
Methodology
Commerce is conducting this review
in accordance with section 751(a) of the
Tariff Act of 1930, as amended (the Act).
Export price is calculated in accordance
with section 772 of the Act. Normal
value is calculated in accordance with
section 773 of the Act.
For a full description of the
methodology underlying our
conclusions, see the Preliminary
Decision Memorandum.9 A list of topics
included in the Preliminary Decision
7 The shaft length of certain steel nails with flat
heads or parallel shoulders under the head shall be
measured from under the head or shoulder to the
tip of the point. The shaft length of all other certain
steel nails shall be measured overall.
8 See Preliminary Decision Memorandum.
9 Id.

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liquidate the appropriate entries
without regard to antidumping duties.
For the 202 companies for which this
Preliminary Results of Review
review is rescinded, antidumping duties
will be assessed at rates equal to the
As a result of this review, we
cash deposit of estimated antidumping
preliminarily determine the following
duties in effect at the time of entry, or
weighted-average dumping margins for
the period July 1, 2016, through June 30, withdrawal from warehouse, for
consumption, in accordance with 19
2017:
CFR 351.212(c)(1)(i). Commerce intends
Weighted- to issue appropriate assessment
average
instructions directly to CBP 15 days
Exporter and/or producer
dumping
after publication of this notice. The final
margin
results of this review shall be the basis
(percent)
for the assessment of antidumping
Daejin Steel Co ..........................
3.02 duties on entries of merchandise
Koram Inc ...................................
10.59 covered by the final results of this
Korea Wire Co., Ltd ....................
1.10 review and for future deposits of
estimated duties, where applicable.
Assessment Rates
Cash Deposit Requirement
Upon completion of the
The following deposit requirements
administrative review, Commerce shall
will be effective upon publication of the
determine, and U.S. Customs and
notice of the final results of
Border Protection (CBP) shall assess,
administrative review for all shipments
antidumping duties on all appropriate
of steel nails from Korea entered, or
entries. Commerce intends to issue
withdrawn from warehouse, for
assessment instructions to CBP 15 days
consumption on or after the date of
after the date of publication of the final
publication of the final results of this
results of this review.
administrative review, as provided by
For any individually examined
section 751(a)(2)(C) of the Act: (1) The
respondents whose weighted-average
cash deposit rate for the companies
dumping margin is above de minimis
under review will be the rate
(i.e., 0.50 percent), we will calculate
established in the final results of this
importer-specific ad valorem duty
review (except, if the rate is zero or de
assessment rates based on the ratio of
minimis, no cash deposit will be
the total amount of dumping calculated
required); (2) for merchandise exported
for the importer’s examined sales to the
by manufacturers or exporters not
total entered value of those same sales
covered in this review but covered in a
in accordance with 19 CFR
prior segment of the proceeding, the
351.212(b)(1).10 For entries of subject
cash deposit rate will continue to be the
merchandise during the POR produced
company-specific rate published for the
by each respondent for which it did not most recently completed segment of this
know its merchandise was destined for
proceeding in which the manufacturer
the United States, we will instruct CBP
or exporter participated; (3) if the
to liquidate un-reviewed entries at the
exporter is not a firm covered in this
all-others rate if there is no rate for the
review, a prior review, or the less-thanintermediate company involved in the
fair-value investigation, but the
transaction.11 We will instruct CBP to
manufacturer is, the cash deposit rate
assess antidumping duties on all
will be the rate established for the most
appropriate entries covered by this
recently completed segment of the
review when the importer-specific
proceeding for the manufacturer of the
assessment rate calculated in the final
merchandise; and (4) the cash deposit
results of this review is above de
rate for all other manufacturers or
minimis. Where either the respondent’s
exporters will continue to be 11.80
weighted-average dumping margin is
percent ad valorem, the all-others rate
zero or de minimis, or an importerestablished in the less-than-fair value
specific assessment rate is zero or de
investigation.12
minimis, we will instruct CBP to
Disclosure and Public Comment
Commerce intends to disclose the
10 In these preliminary results, Commerce applied
calculations used in our analysis to
the assessment rate calculation methodology
adopted in Antidumping Proceedings: Calculation
interested parties in this review within
of the Weighted-Average Dumping Margin and
five days of the date of publication of
Assessment Rate in Certain Antidumping
this notice in accordance with 19 CFR
Proceedings: Final Modification, 77 FR 8101
Memorandum is included as Appendix
I to this notice.

(February 14, 2012).
11 See Antidumping and Countervailing Duty
Proceedings: Assessment of Antidumping Duties, 68
FR 23954 (May 6, 2003).

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12 See Certain Steel Nails from the Republic of
Korea: Final Determination of Sales at Less Than
Fair Value, 80 FR 28955 (May 20, 2015).

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
351.224(b). Interested parties are invited
to comment on the preliminary results
of this review. Pursuant to 19 CFR
351.309(c)(1)(ii), interested parties may
submit case briefs no later than 30 days
after the date of publication of this
notice. Rebuttal briefs, limited to issues
raised in the case briefs, may be filed no
later than five days after the time limit
for filing case briefs.13 Parties who
submit case briefs or rebuttal briefs in
this proceeding are requested to submit
with each brief: (1) A statement of the
issues, (2) a brief summary of the
argument, and (3) a table of
authorities.14 Executive summaries
should be limited to five pages total,
including footnotes.15 Case and rebuttal
briefs should be filed using ACCESS.16
Pursuant to 19 CFR 351.310(c), any
interested party may request a hearing
within 30 days of the publication of this
notice in the Federal Register. If a
hearing is requested, Commerce will
notify interested parties of the hearing
schedule. Interested parties who wish to
request a hearing, or to participate if one
is requested, must submit a written
request to the Assistant Secretary for
Enforcement and Compliance, filed
electronically via ACCESS within 30
days after the date of publication of this
notice. Requests should contain: (1) The
party’s name, address, and telephone
number; (2) the number of participants;
and (3) a list of the issues to be
discussed. Issues raised in the hearing
will be limited to those raised in the
respective case and rebuttal briefs.
We intend to issue the final results of
this administrative review, including
the results of our analysis of issues
raised by the parties in the written
comments, within 120 days of
publication of these preliminary results
in the Federal Register, unless
otherwise extended.17

amozie on DSK3GDR082PROD with NOTICES1

Notification to Importers
This notice also serves as a
preliminary reminder to importers of
their responsibility under 19 CFR
351.402(f) to file a certificate regarding
the reimbursement of antidumping
duties prior to liquidation of the
relevant entries during this review
period. Failure to comply with this
requirement could result in Commerce’s
presumption that reimbursement of
antidumping duties occurred and the
subsequent assessment of double
antidumping duties.
13 See
14 See

19 CFR 351.309(d)(1).
19 CFR 351.309(c)(2) and (d)(2).

15 Id.
16 See
17 See

19 CFR 351.303.
section 751(a)(3)(A) of the Act.

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Notification to Interested Parties
We are issuing and publishing this
notice in accordance with sections
751(a)(1) and 777(i)(1) of the Act and 19
CFR 351.221(b)(4).
Dated: July 5, 2018.
Gary Taverman,
Deputy Assistant Secretary for Antidumping
and Countervailing Duty Operations,
performing the non-exclusive functions and
duties of the Assistant Secretary for
Enforcement and Compliance.

Appendix I—List of Topics Discussed in
the Preliminary Decision Memorandum
I. Summary
II. Background
III. Scope of the Order
IV. Rescission of Review, In Part
V. Affiliation
VI. Duty Absorption Inquiry
VII. Discussion of the Methodology
A. Comparisons to Normal Value
B. Product Comparisons
C. Date of Sale
D. Level of Trade
E. Export Price
F. Normal Value
G. Successor-In-Interest Determination—
Koram
VIII. Currency Conversions
IX. Recommendation

Appendix II
Airlift Trans Oceanic Pvt. Ltd.
Aironware Enterprise (China) Ltd.
AM Global Shipping Lines
Ansing Rich Tech & Trade Co. Ltd.
Apex Maritime Co., Ltd.
Apex Shipping Co. Ltd.
Astrotech Steels Private Limited
Baoding Jieboshun Trading Corp. Ltd.
Beijing Jin Heung Co. Ltd.
Beijing Kang Jie Kong Int’l Cargo Co. Ltd.
Beijing Qin Li Jeff Trading Co., Ltd.
Bestbond International Limited
Bipex Co., Ltd.
Bollore Logistics Co. Ltd.
Bolung International Trading Co., Ltd.
Bon Voyage Logistics Inc.
Bonuts Hardware Logistics Co. Ltd.
Brilliant Group Logistics Corp.
C&D International Freight Forwarding
C.H. Robinson Freight Services Ltd.
Caesar International Logistics Co. Ltd.
Cana (Rizhao) Hardware Co. Ltd.
Cangzhou Xinqiao Int’l Trade Co. Ltd.
Capital Freight Management Inc.
Cargo Services Co. Ltd.
Caribbean International Co. Ltd.
Casia Global Logistics Co Ltd
China Container Line Northern Ltd.
China Dinghao Co., Ltd.
China International Freight Co., Ltd.
China Staple Enterprise Co. Ltd
Chinatrans International Limited
Chongqing Welluck Trading Co. Ltd.
Chosun Shipping Co. Ltd.
CJ Korea Express Corp.
CKX Co. Ltd.
Cohesion Freight (HK) Ltd.
Consolidated Shipping Services L.L.C.
Crelux International Co. Ltd.

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32267

Dahnay Logistics Private Ltd.
Dalian Sunny International Logistics
DCS Dah Star Logistics Co., Ltd.
De Well Container Shipping Inc.
Dezhou Hualude Hardware Products Co., Ltd.
Dong E Fuqiang Metal Products Co. Ltd.
DT Logistics Hong Kong Ltd
Duo-Fast Korea Co., Ltd.
Dynamic Network Container Line Limited
E&E Transport International Co., Ltd.
ECI Taiwan Co., Ltd.
Eco Steel Co., Ltd.
Ejem Brothers Limited
Eumex Line Shenzhen Limited
Eunsan Shipping & Aircargo Co., Ltd.
Euroline Global Co., Ltd.
Expeditors Korea Ltd.
Faithful Engineering Products Co. Ltd.
Fastgrow International Co.
Fastic Transportation Co., Ltd.
Flyjac Logistics Pvt. Ltd.
G Link Express Logistics (Korea) Ltd
GCL Logistics Co., Ltd.
Global Container Line, Inc.
Globelink Weststar Shipping
Glovis America
Grandee Logistics Ltd.
Hanbit Logistics Co., Ltd.
Hanjin Logistics India Private Ltd.
Hanmi Staple Co., Ltd.
Hanon Systems
Hebei Minmetals Co., Ltd.
Hebei Tuohua Metal Products Co., Ltd.
Hecny Shipping Ltd.
Hecny Transportation Ltd.
Hengtuo Metal Products Co Ltd
High Link Line Inc.
Hong Kong Hong Xing Da Trading Co. Ltd.
Hongyi Hardware Products Co., Ltd.
Honour Lane Logistics Company
Honour Lane Shipping Limited
Huanghua Yingjin Hardware Products Co.,
Ltd.
Hyundai Logistics Co. Ltd.
Inmax Industries Sdn. Bhd.
Integral Building Products Inc.
International Maritime and Aviation LLC
JAS Forwarding Co. Ltd.
Je-il Wire Production Co., Ltd.
Jeil Tacker Co. Ltd.
Jiangsu Soho Honry Import Export Co. Ltd.
Jiaxing Slk Import & Export Co., Ltd.
Jinhai Hardware Co., Ltd.
Jinheung Steel Corporation
Jinkaiyi International Industry Co.
Jinsco International Corp.
Joo Sung Sea Air Co., Ltd.
K Logistics Corp.
K Logistics Inc.
Kasy Logistics (Tianjin) Co., Ltd.
King Shipping Company
Korchina International Logistics Co. Ltd.
Korea Total Logistics Co. Ltd.
Kousa International Logistics Co. Ltd.
Kuehne Nagel Ltd.
LF Logistics Co. Ltd.
Linyi Flying Arrow Imp. & Exp. Ltd.
MR Forwarding China Ltd.
Maxspeed International Transport Co. Ltd.
Mingguang Ruifeng Hardware Products Co.,
Ltd.
Nailtech Co. Ltd.
Nanjing Caiqing Hardware Co., Ltd.
Nauri Logistics Co. Ltd.
NCL Container Lines Co. Ltd.
Neo Gls

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Neptune Shipping Limited
Nexen L&C Corp.
OEC Freight Worldwide Korea Co. Ltd.
OEC Logistics Co., Ltd.
OEC World Wide Korea Co. Ltd.
Oman Fasteners LLC
Orient Express Container Co., Ltd.
Oriental Power Logistics Co. Ltd.
Overseas Distribution Services Inc.
Overseas International Steel Industry
Panalpina World Transport (PRC) Ltd.
Paslode Fasteners (Shanghai) Co. Ltd.
Promising Way (Hong Kong) Limited
Pudong Prime International Logistics, Inc.
Qingdao Chesire Trading Co. Ltd.
Qingdao D&L Group Ltd.
Qingdao Hongyuan Nail Industry Co. Ltd.
Qingdao Master Metal Products Co. Ltd.
Qingdao Meijialucky Industry and Commerce
Co., Ltd.
Qingdao Mst Industry and Commerce Co.,
Ltd.
Qingdao Tiger Hardware Co., Ltd.
Ramses Logistics Company Limited
Regency Global Logistics Co., Ltd.
Ricoh Logistics System Co., Ltd.
Rise Time Industrial Co. Ltd.
Sam Un Co. Ltd.
Scanwell Container Line Ltd.
Schenker
Schenker & CO AG
SDC International Australia PTY Ltd
Seamaster Global Forwarding
Seamaster Logistics Sdn Bhd
Sejung (China) Sea & Air Co., Ltd.
Shandong Dinglong Imp. & Exp. Co. Ltd.
Shandong Liaocheng Minghua Metal PR
Shandong Oriental Cherry Hardware Group
Co. Ltd.
Shanghai Haoray International Trade Co. Ltd.
Shanghai Jade Shuttle Hardware Tools Co.,
Ltd.
Shanghai Line Feng Int’l Transportation Co.
Ltd.
Shanghai Pinnacle International Trading Co.,
Ltd.
Shanghai Pudong International
Transportation
Shanxi Pioneer Hardware Industry Co., Ltd.
Shanxi Tianli Industries Co., Ltd.
Shijiazhuang Shuangjian Tools Co. Ltd.
Shipping Imperial Co., Ltd.
Sino Connections Logistics Inc.
S-Mart (Tianjin) Technology Development
Co., Ltd.
Sparx Logistics China Limited
Speedmark International Ltd.
Suntec Industries Co., Ltd.
Swift Freight (India) Pvt Ltd.
T.H.I. Group Ltd.
The Stanley Works (Langfang) Fastening
System Co., Ltd.
Tianjin Bluekin Industries Limited
Tianjin Coways Metal Products Co.
Tianjin Free Trade Service Co. Ltd.
Tianjin Fulida Supply Co. Ltd.
Tianjin Huixinshangmao Co. Ltd.
Tianijn Hweschun Fasteners Manufacturing
Co. Ltd.
Tianjin Jinchi Metal Products Co., Ltd.
Tianjin Long Sheng Tai
Tianjin M&C Electronics Co., Ltd.
Tianjin Wonderful International Trading
Tianjin Zehui Hardware Co. Ltd.
Tianjin Zhonglian Metals Ware Co. Ltd.
Tianjin Zhonglian Times Technology

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Toll Global Forwarding Ltd.
Top Logistics Korea Ltd.
Top Ocean Consolidated Service Ltd.
Toyo Boeki Co. Ltd.
Trans Knights, Inc.
Translink Shipping, Inc.
Transwell Logistics Co. Ltd.
Transworld Transportation Co. Ltd.
Trim International Inc.
TTI Freight Forwarder Co. Ltd.
Unicorn (Tianjin) Fasteners Co., Ltd.
UPS SCS (China) Limited
Vanguard Logistics Services
W&K Corporation Limited
Weida Freight System Co. Ltd.
Woowon Sea & Air Co. Ltd.
Xi’an Metals and Minerals Imp. Exp. Co.
Xinjiayuan International Trade Co.
Xinjiayuan Trading Co., Limited
Youngwoo Fasteners Co., Ltd.
You-One Fastening Systems
Yumark Enterprises Corp.
Zhaoqing Harvest Nails Co. Ltd.
[FR Doc. 2018–14920 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
International Trade Administration
[C–122–854]

Supercalendered Paper From Canada:
Final Results of Changed
Circumstances Review and Revocation
of Countervailing Duty Order
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(Commerce) is revoking the
countervailing duty (CVD) order on
supercalendered paper (SC paper) from
Canada.
DATES: Applicable August 3, 2015.
FOR FURTHER INFORMATION CONTACT:
Emily Halle or Nicholas Czajkowski,
AD/CVD Operations, Enforcement and
Compliance, International Trade
Administration, U.S. Department of
Commerce, 1401 Constitution Avenue
NW, Washington, DC 20230; telephone
(202) 482–0176 or (202) 482–1395,
respectively.
SUPPLEMENTARY INFORMATION:
AGENCY:

Background
On December 10, 2015, Commerce
published the CVD Order on SC paper
from Canada.1 On March 21, 2018,
Verso Corporation (Verso) (i.e., the
petitioner) requested that Commerce
conduct a changed circumstances
review (CCR), pursuant to section
782(h)(2) of the Tariff Act of 1930, as
amended (the Act) and 19 CFR
1 See Supercalendered Paper from Canada:
Countervailing Duty Order, 80 FR 76668 (December
10, 2015) (CVD Order).

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351.222(g)(l)(i). Verso expressed a lack
of interest in the enforcement or
existence of the CVD Order, and
requested the retroactive revocation of
the CVD Order, effective August 3,
2015.2 Commerce published the
initiation of this CCR on May 14, 2018.3
The parties to this proceeding provided
comments on May 21, 2018.4 On June
21, 2018, pursuant to 19 CFR
351.302(b), Commerce extended the
time limit for completing this CCR.5
Final Results of Changed
Circumstances Review, and Revocation
of the Order
Pursuant to section 751(d)(1) of the
Act, and 19 CFR 351.222(g), Commerce
may revoke an antidumping duty or
CVD order, in whole or in part, based on
a review under section 751(b) of the Act
(i.e., a CCR). Section 751(b)(1) of the Act
requires a CCR to be conducted upon
receipt of a request which shows
changed circumstances sufficient to
warrant a review. Section 782(h)(2) of
the Act gives Commerce the authority to
revoke an order if producers accounting
for substantially all of the production of
the domestic like product have
expressed a lack of interest in the order.
Section 351.222(g) of Commerce’s
regulations provides that Commerce
will conduct a CCR under 19 CFR
351.216, and may revoke an order (in
whole or in part), if it concludes that: (i)
Producers accounting for substantially
all of the production of the domestic
like product to which the order pertains
have expressed a lack of interest in the
relief provided by the order, in whole or
in part; or (ii) if other changed
circumstances sufficient to warrant
revocation exist. Both the Act and
Commerce’s regulations require that
‘‘substantially all’’ domestic producers
express a lack of interest in the order for
Commerce to revoke the order, in whole
or in part.6 Commerce has interpreted
‘‘substantially all’’ to represent
producers accounting for at least 85
percent of U.S. production of the
domestic like product.7 In the Initiation
2 See Letter from Verso, ‘‘Supercalendered Paper
from Canada/Request for Changed Circumstances
Review,’’ March 21, 2018 (Verso Request).
3 See Supercalendered Paper from Canada:
Initiation of Changed Circumstances Review, 83 FR
22249 (May 14, 2018) (Initiation Notice).
4 See Letter from Verso, et. al., ‘‘Supercalendered
Paper from Canada (C–122–854): Joint Comments
on Initiation of Changed Circumstances Review,’’
May 21, 2018.
5 See Letter to Verso Corporation, ‘‘Countervailing
Duty Order on Supercalendered Paper from Canada:
Changed Circumstances Review; Extension of
Deadline for Final Results,’’ dated June 21, 2018.
6 See section 782(h) of the Act and 19 CFR
351.222(g).
7 See Honey from Argentina; Antidumping and
Countervailing Duty Changed Circumstances

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amozie on DSK3GDR082PROD with NOTICES1

Notice, we stated that Verso’s request
indicated it accounts for at least 85
percent of domestic production.8 We
received no comments concerning
Verso’s claim regarding its production
or otherwise indicating a lack of
industry support with respect to this
CCR.
As noted in the Initiation Notice,
Verso requested the revocation of this
CVD Order because it is no longer
interested in maintaining the CVD Order
or in the imposition of duties on the
subject merchandise as of August 3,
2015.9 We conclude that producers
accounting for substantially all of the
production of the domestic like product,
to which this CVD Order pertains, lack
interest in the relief provided by the
CVD Order. We find that the petitioner’s
affirmative statement of no interest in
the CVD Order constitutes good cause
for the conduct of this review.
On May 21, 2018, Commerce received
comments from Verso, the Government
of Canada, the Government of New
Brunswick, the Government of Nova
Scotia, the Government of Ontario, the
Government of Quebec, Irving Paper
Limited, Port Hawkesbury Paper L.P.,
Resolute FP Canada Inc., and Resolute
FP US Inc. In a joint filing, these parties,
who represent all of the interested
parties to this proceeding, stated their
agreement with the outcome proposed
in the Initiation Notice. Moreover, the
parties cited to 19 CFR 351.216(e),
which provides that, when all parties
agree to the outcome, Commerce will
issue its final results of CCR within 45
days of the initiation.
Accordingly, we are notifying the
public that we are revoking the CVD
Order, in whole. Based on Verso’s
request that revocation be retroactive to
August 3, 2015, and because we have
not completed any administrative
reviews of the CVD Order, we will
instruct U.S. Customs and Border
Protection (CBP) to discontinue the
suspension of liquidation and the
collection of cash deposits of estimated
countervailing duties, to liquidate all
unliquidated entries that were entered
on or after August 3, 2015, without
regard to countervailing duties, and to
refund all CVD cash deposits on all such
merchandise, with applicable interest.
Reviews; Preliminary Intent to Revoke Antidumping
and Countervailing Duty Orders, 77 FR 67790,
67791 (November 14, 2012), unchanged in Honey
from Argentina; Final Results of Antidumping and
Countervailing Duty Changed Circumstances
Reviews; Revocation of Antidumping and
Countervailing Duty Orders, 77 FR 77029
(December 31, 2012).
8 See Initiation Notice, 83 FR at 22249.
9 Id.

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Scope of the Order
The product covered by the order is
SC paper. SC paper is uncoated paper
that has undergone a calendering
process in which the base sheet, made
of pulp and filler (typically, but not
limited to, clay, talc, or other mineral
additive), is processed through a set of
supercalenders, a supercalender, or a
soft nip calender operation.10
The scope of this order covers all SC
paper regardless of basis weight,
brightness, opacity, smoothness, or
grade, and whether in rolls or in sheets.
Further, the scope covers all SC paper
that meets the scope definition
regardless of the type of pulp fiber or
filler material used to produce the
paper.
Specifically excluded from the scope
are imports of paper printed with final
content of printed text or graphics.
Subject merchandise primarily enters
under Harmonized Tariff Schedule of
the United States (HTSUS) subheading
4802.61.3035, but may also enter under
subheadings 4802.61.3010,
4802.62.3000, 4802.62.6020, and
4802.69.3000. Although the HTSUS
subheadings are provided for
convenience and customs purposes, the
written description of the scope of the
order is dispositive.
Instructions to U.S. Customs and
Border Protection
Because we determine that there are
changed circumstances that warrant the
revocation of the CVD Order, in whole,
we will instruct CBP to discontinue the
suspension of liquidation and the
collection of cash deposits of estimated
countervailing duties, to liquidate all
unliquidated entries that were entered
on or after August 3, 2015, without
regard to countervailing duties, and to
refund all CVD cash deposits on all such
merchandise, with applicable interest.
Notification to Interested Parties
This notice serves as a reminder to
parties subject to an administrative
protective order (APO) of their
responsibility concerning the
disposition of proprietary information
disclosed under APO in accordance
with 19 CFR 351.305(a)(3). Timely
written notification of the return/
destruction of APO materials or
conversion to judicial protective order is
hereby requested. Failure to comply
10 Supercalendering and soft nip calendering
processing, in conjunction with the mineral filler
contained in the base paper, are performed to
enhance the surface characteristics of the paper by
imparting a smooth and glossy printing surface.
Supercalendering and soft nip calendering also
increase the density of the base paper.

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with the regulations and terms of an
APO is a sanctionable violation.
We are issuing and publishing these
final results and revocation, in whole,
and notice in accordance with sections
751(b) and 777(i) of the Act and 19 CFR
351.216, 19 CFR 351.221(c)(3), and 19
CFR 351.222.
Dated: July 5, 2018.
Gary Taverman,
Deputy Assistant Secretary for Antidumping
and Countervailing Duty Operations,
performing the non-exclusive functions and
duties of the Assistant Secretary for
Enforcement and Compliance.
[FR Doc. 2018–14921 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
International Trade Administration
[A–570–904]

Certain Activated Carbon From the
People’s Republic of China:
Continuation of Antidumping Duty
Order
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: As a result of the
determinations by the Department of
Commerce (Commerce) and the
International Trade Commission (ITC)
that revocation of the antidumping duty
order on certain activated carbon from
the People’s Republic of China (China)
would likely lead to a continuation or
recurrence of dumping and material
injury to an industry in the United
States, Commerce is publishing a notice
of continuation of the antidumping duty
order.
DATES: Applicable July 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Robert Palmer, AD/CVD Operations,
Office VIII, Enforcement and
Compliance, International Trade
Administration, U.S. Department of
Commerce, 1401 Constitution Avenue
NW, Washington, DC 20230; telephone:
(202) 482–9068.
SUPPLEMENTARY INFORMATION:
AGENCY:

Background
On April 27, 2007, Commerce
published in the Federal Register notice
of the antidumping duty order on
certain activated carbon from China.1
On February 1, 2018, Commerce
published the notice of initiation of the
second five-year (sunset) review of the
antidumping duty order on certain
1 See Notice of Antidumping Duty Order: Certain
Activated Carbon from the People’s Republic of
China, 72 FR 20988 (April 27, 2007).

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activated carbon from China, pursuant
to section 751(c) of the Tariff Act of
1930, as amended (the Act).2
Commerce conducted this sunset
review on an expedited basis, pursuant
to section 751(c)(3)(B) of the Act and 19
CFR 351.218(e)(1)(ii)(C)(2), because it
received a complete, timely, and
adequate response from a domestic
interested party but no substantive
responses from respondent interested
parties. As a result of its review,
Commerce determined in accordance
with section 751(c) of the Act that
revocation of the antidumping duty
order would likely lead to a
continuation or recurrence of dumping.3
Commerce, therefore, notified the ITC of
the magnitude of the margins likely to
prevail should the antidumping duty
order be revoked. On July 6, 2018, the
ITC published notice of its
determination, pursuant to section
751(c) of the Act, that revocation of the
antidumping duty order on certain
activated carbon from China would
likely lead to a continuation or
recurrence of material injury to an
industry in the United States within a
reasonably foreseeable time.4

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Scope of the Order
The merchandise subject to the order
is certain activated carbon. Certain
activated carbon is a powdered,
granular, or pelletized carbon product
obtained by ‘‘activating’’ with heat and
steam various materials containing
carbon, including but not limited to coal
(including bituminous, lignite, and
anthracite), wood, coconut shells, olive
stones, and peat. The thermal and steam
treatments remove organic materials and
create an internal pore structure in the
carbon material. The producer can also
use carbon dioxide gas (CO2) in place of
steam in this process. The vast majority
of the internal porosity developed
during the high temperature steam (or
CO2 gas) activated process is a direct
result of oxidation of a portion of the
solid carbon atoms in the raw material,
converting them into a gaseous form of
carbon.
The scope of the order covers all
forms of activated carbon that are
activated by steam or CO2, regardless of
2 See Initiation of Five-Year (Sunset) Reviews, 83
FR 4681 (February 1, 2018).
3 See Certain Activated Carbon from the People’s
Republic of China: Final Results of the Expedited
Second Sunset Review of the Antidumping Duty
Order, 83 FR 26949 (June 11, 2018) (Final Results)
and accompanying Issues and Decision
Memorandum.
4 See Certain Activated Carbon from China:
Investigation No. 731–TA–1103 (Second Review),
USITC Publication 4776 (June 2018); see also
Certain Activated Carbon from China:
Determination, 83 FR 31568 (July 6, 2018).

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the raw material, grade, mixture,
additives, further washing or postactivation chemical treatment (chemical
or water washing, chemical
impregnation or other treatment), or
product form. Unless specifically
excluded, the scope of the order covers
all physical forms of certain activated
carbon, including powdered activated
carbon (PAC), granular activated carbon
(GAC), and pelletized activated carbon.
Excluded from the scope of the order
are chemically activated carbons. The
carbon-based raw material used in the
chemical activation process is treated
with a strong chemical agent, including
but not limited to phosphoric acid, zinc
chloride, sulfuric acid, or potassium
hydroxide that dehydrates molecules in
the raw material, and results in the
formation of water that is removed from
the raw material by moderate heat
treatment. The activated carbon created
by chemical activation has internal
porosity developed primarily due to the
action of the chemical dehydration
agent. Chemically activated carbons are
typically used to activate raw materials
with a lignocellulosic component such
as cellulose, including wood, sawdust,
paper mill waste and peat.
To the extent that an imported
activated carbon product is a blend of
steam and chemically activated carbons,
products containing 50 percent or more
steam (or CO2 gas) activated carbons are
within the scope, and those containing
more than 50 percent chemically
activated carbons are outside the scope.
This exclusion language regarding
blended material applies only to
mixtures of steam and chemically
activated carbons.
Also excluded from the scope are
reactivated carbons. Reactivated carbons
are previously used activated carbons
that have had adsorbed materials
removed from their pore structure after
use through the application of heat,
steam and/or chemicals.
Also excluded from the scope is
activated carbon cloth. Activated carbon
cloth is a woven textile fabric made of
or containing activated carbon fibers. It
is used in masks and filters and clothing
of various types where a woven format
is required.
Any activated carbon meeting the
physical description of subject
merchandise provided above that is not
expressly excluded from the scope is
included within the scope. The
products subject to the order are
currently classifiable under the HTSUS
subheading 3802.10.00. Although the
HTSUS subheading is provided for
convenience and customs purposes, the
written description of the scope of the
order is dispositive.

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Continuation of the Order
As a result of the determinations by
Commerce and the ITC that revocation
of the antidumping duty order would
likely lead to a continuation or
recurrence of dumping and material
injury to an industry in the United
States, pursuant to section 751(d)(2) of
the Act and 19 CFR 351.218(a),
Commerce hereby orders the
continuation of the antidumping duty
order on certain activated carbon from
China. U.S. Customs and Border
Protection will continue to collect
antidumping duty cash deposits at the
rates in effect at the time of entry for all
imports of subject merchandise.
The effective date of the continuation
of the order will be the date of
publication in the Federal Register of
this notice of continuation. Pursuant to
section 751(c)(2) of the Act, Commerce
intends to initiate the next sunset
review of the order not later than 30
days prior to the fifth anniversary of the
effective date of continuation.
This sunset review and this notice are
in accordance with section 751(c) and
751(d)(2) of the Act and published
pursuant to section 777(i)(1) of the Act
and 19 CFR 351.218(f)(4).
Dated: July 6, 2018.
Gary Taverman,
Deputy Assistant Secretary for Antidumping
and Countervailing Duty Operations,
performing the non-exclusive functions and
duties of the Assistant Secretary for
Enforcement and Compliance.
[FR Doc. 2018–15014 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
International Trade Administration
Initiation of Antidumping and
Countervailing Duty Administrative
Reviews
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(Commerce) has received requests to
conduct administrative reviews of
various antidumping and countervailing
duty orders and findings with May
anniversary dates. In accordance with
Commerce’s regulations, we are
initiating those administrative reviews.
DATES: Applicable July 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Brenda E. Brown, Office of AD/CVD
Operations, Customs Liaison Unit,
Enforcement and Compliance,
International Trade Administration,
U.S. Department of Commerce, 1401
AGENCY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
Constitution Avenue NW, Washington,
DC 20230, telephone: (202) 482–4735.
SUPPLEMENTARY INFORMATION:
Background
Commerce has received timely
requests, in accordance with 19 CFR
351.213(b), for administrative reviews of
various antidumping and countervailing
duty orders and findings with May
anniversary dates.
All deadlines for the submission of
various types of information,
certifications, or comments or actions by
Commerce discussed below refer to the
number of calendar days from the
applicable starting time.
Notice of No Sales
If a producer or exporter named in
this notice of initiation had no exports,
sales, or entries during the period of
review (POR), it must notify Commerce
within 30 days of publication of this
notice in the Federal Register. All
submissions must be filed electronically
at http://access.trade.gov in accordance
with 19 CFR 351.303.1 Such
submissions are subject to verification
in accordance with section 782(i) of the
Tariff Act of 1930, as amended (the Act).
Further, in accordance with 19 CFR
351.303(f)(1)(i), a copy must be served
on every party on Commerce’s service
list.

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Respondent Selection
In the event Commerce limits the
number of respondents for individual
examination for administrative reviews
initiated pursuant to requests made for
the orders identified below, Commerce
intends to select respondents based on
U.S. Customs and Border Protection
(CBP) data for U.S. imports during the
period of review. We intend to place the
CBP data on the record within five days
of publication of the initiation notice
and to make our decision regarding
respondent selection within 30 days of
publication of the initiation Federal
Register notice. Comments regarding the
CBP data and respondent selection
should be submitted seven days after
the placement of the CBP data on the
record of this review. Parties wishing to
submit rebuttal comments should
submit those comments five days after
the deadline for the initial comments.
In the event Commerce decides it is
necessary to limit individual
examination of respondents and
conduct respondent selection under
section 777A(c)(2) of the Act:
1 See Antidumping and Countervailing Duty
Proceedings: Electronic Filing Procedures;
Administrative Protective Order Procedures, 76 FR
39263 (July 6, 2011).

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In general, Commerce has found that
determinations concerning whether
particular companies should be
‘‘collapsed’’ (e.g., treated as a single
entity for purposes of calculating
antidumping duty rates) require a
substantial amount of detailed
information and analysis, which often
require follow-up questions and
analysis. Accordingly, Commerce will
not conduct collapsing analyses at the
respondent selection phase of this
review and will not collapse companies
at the respondent selection phase unless
there has been a determination to
collapse certain companies in a
previous segment of this antidumping
proceeding (e.g., investigation,
administrative review, new shipper
review or changed circumstances
review). For any company subject to this
review, if Commerce determined, or
continued to treat, that company as
collapsed with others, Commerce will
assume that such companies continue to
operate in the same manner and will
collapse them for respondent selection
purposes. Otherwise, Commerce will
not collapse companies for purposes of
respondent selection. Parties are
requested to (a) identify which
companies subject to review previously
were collapsed, and (b) provide a
citation to the proceeding in which they
were collapsed. Further, if companies
are requested to complete the Quantity
and Value (Q&V) Questionnaire for
purposes of respondent selection, in
general each company must report
volume and value data separately for
itself. Parties should not include data
for any other party, even if they believe
they should be treated as a single entity
with that other party. If a company was
collapsed with another company or
companies in the most recently
completed segment of this proceeding
where Commerce considered collapsing
that entity, complete Q&V data for that
collapsed entity must be submitted.
Respondent Selection—Aluminum
Extrusions From the People’s Republic
of China
In the event Commerce limits the
number of respondents for individual
examination in the administrative
review of the antidumping duty order
on aluminum extrusions from the
People’s Republic of China (‘‘China’’),
Commerce intends to select respondents
based on volume data contained in
responses to Q&V questionnaires.
Further, Commerce intends to limit the
number of Q&V questionnaires issued in
the review based on CBP data for U.S.
imports of aluminum extrusions from
the China. The extremely wide variety
of individual types of aluminum

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extrusion products included in the
scope of the order on aluminum
extrusions would preclude meaningful
results in attempting to determine the
largest China exporters of subject
merchandise by volume. Therefore,
Commerce will limit the number of Q&V
questionnaires issued based on the
import values in CBP data which will
serve as a proxy for imported quantities.
Parties subject to the review to which
Commerce does not send a Q&V
questionnaire may file a response to the
Q&V questionnaire by the applicable
deadline if they desire to be included in
the pool of companies from which
Commerce will select mandatory
respondents. The Q&V questionnaire
will be available on Commerce’s website
at http://trade.gov/enforcement/
news.asp on the date of publication of
this notice in the Federal Register. The
responses to the Q&V questionnaire
must be received by Commerce within
14 days of publication of this notice.
Please be advised that due to the time
constraints imposed by the statutory
and regulatory deadlines for
antidumping duty administrative
reviews, Commerce does not intend to
grant any extensions for the submission
of responses to the Q&V questionnaire.
Parties will be given the opportunity to
comment on the CBP data used by
Commerce to limit the number of Q&V
questionnaires issued. We intend to
release the CBP data under APO to all
parties having an APO within seven
days of publication of this notice in the
Federal Register. Commerce invites
comments regarding CBP data and
respondent selection within five days of
placement of the CBP data on the
record.
Deadline for Withdrawal of Request for
Administrative Review
Pursuant to 19 CFR 351.213(d)(1), a
party that has requested a review may
withdraw that request within 90 days of
the date of publication of the notice of
initiation of the requested review. The
regulation provides that Commerce may
extend this time if it is reasonable to do
so. Determinations by Commerce to
extend the 90-day deadline will be
made on a case-by-case basis.
Separate Rates
In proceedings involving non-market
economy (NME) countries, Commerce
begins with a rebuttable presumption
that all companies within the country
are subject to government control and,
thus, should be assigned a single
antidumping duty deposit rate. It is
Commerce’s policy to assign all
exporters of merchandise subject to an
administrative review in an NME

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country this single rate unless an
exporter can demonstrate that it is
sufficiently independent so as to be
entitled to a separate rate.
To establish whether a firm is
sufficiently independent from
government control of its export
activities to be entitled to a separate
rate, Commerce analyzes each entity
exporting the subject merchandise. In
accordance with the separate rates
criteria, Commerce assigns separate
rates to companies in NME cases only
if respondents can demonstrate the
absence of both de jure and de facto
government control over export
activities.
All firms listed below that wish to
qualify for separate rate status in the
administrative reviews involving NME
countries must complete, as
appropriate, either a separate rate
application or certification, as described
below. For these administrative reviews,
in order to demonstrate separate rate
eligibility, Commerce requires entities
for whom a review was requested, that
were assigned a separate rate in the
most recent segment of this proceeding
in which they participated, to certify
that they continue to meet the criteria
for obtaining a separate rate. The
Separate Rate Certification form will be
available on Commerce’s website at
http://enforcement.trade.gov/nme/nme-

sep-rate.html on the date of publication
of this Federal Register notice. In
responding to the certification, please
follow the ‘‘Instructions for Filing the
Certification’’ in the Separate Rate
Certification. Separate Rate
Certifications are due to Commerce no
later than 30 calendar days after
publication of this Federal Register
notice. The deadline and requirement
for submitting a Certification applies
equally to NME-owned firms, wholly
foreign-owned firms, and foreign sellers
who purchase and export subject
merchandise to the United States.
Entities that currently do not have a
separate rate from a completed segment
of the proceeding 2 should timely file a
Separate Rate Application to
demonstrate eligibility for a separate
rate in this proceeding. In addition,
companies that received a separate rate
in a completed segment of the
proceeding that have subsequently
made changes, including, but not
limited to, changes to corporate
structure, acquisitions of new
companies or facilities, or changes to
their official company name,3 should
timely file a Separate Rate Application
to demonstrate eligibility for a separate
rate in this proceeding. The Separate
Rate Status Application will be
available on Commerce’s website at

http://enforcement.trade.gov/nme/nmesep-rate.html on the date of publication
of this Federal Register notice. In
responding to the Separate Rate Status
Application, refer to the instructions
contained in the application. Separate
Rate Status Applications are due to
Commerce no later than 30 calendar
days of publication of this Federal
Register notice. The deadline and
requirement for submitting a Separate
Rate Status Application applies equally
to NME-owned firms, wholly foreignowned firms, and foreign sellers that
purchase and export subject
merchandise to the United States.
For exporters and producers who
submit a separate-rate status application
or certification and subsequently are
selected as mandatory respondents,
these exporters and producers will no
longer be eligible for separate rate status
unless they respond to all parts of the
questionnaire as mandatory
respondents.
Initiation of Reviews
In accordance with 19 CFR
351.221(c)(1)(i), we are initiating
administrative reviews of the following
antidumping and countervailing duty
orders and findings. We intend to issue
the final results of these reviews not
later than May 31, 2019.

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Period to be reviewed
Antidumping Duty Proceedings
AUSTRIA: Carbon and Alloy Steel Cut-to-Length Plate, A–433–812 .................................................................................
Bohler Edelstahl GmbH & Co KG
Bohler Bleche GmbH & Co KG
BELGIUM: Carbon and Alloy Steel Cut-to-Length Plate, A–423–812 ................................................................................
Henegelhoef Concrete Joints NV
Industeel Belgium S.A.
NLMK Clabecq S.A./NLMK Plate Sales S.A./NLMK Sales Europe S.A./NLMK Manage Steel Center S.A./NLMK
La Louviere S.A.
Sarens NV
Thyssenkrupp Materials Belgium N.V.
Universal Eisen und Stahl GmbH
Valvan Baling Systems
Voestalpine Belgium NV.
CANADA: Citric Acid and Citrate Salt, A–122–853 ............................................................................................................
Jungbunzlauer Canada Inc.
CANADA: Polyethylene Terephthalate Resin, A–122–855 .................................................................................................
Compagnie Selenis Canada
FRANCE: Carbon and Alloy Steel Cut-To-Length Plate, A–427–828 ................................................................................
Industeel France S.A.S.
GERMANY: Carbon and Alloy Steel Cut-To-Length Plate, A–428–844 .............................................................................
AG der Dillinger Huttenwerke
Ilsendburger Grobblech GmbH
Perficon Steel GmbH
Reiner Brach GmbH & Co. KG
Rudolf Rafflenbeul Stahlwarenfabrik GmBH & Co.
Salzgitter Mannesmann Grobblech GmbH
Salaigitter Flachstahl GmbH
Salzgitter Mannesmann International GmbH
2 Such entities include entities that have not
participated in the proceeding, entities that were
preliminarily granted a separate rate in any
currently incomplete segment of the proceeding
(e.g., an ongoing administrative review, new

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shipper review, etc.) and entities that lost their
separate rate in the most recently completed
segment of the proceeding in which they
participated.

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11/14/16–4/30/18
11/14/16–4/30/18

5/1/17–4/30/18
5/1/17–4/30/18
11/14/16–4/30/18
11/14/16–4/30/18

3 Only changes to the official company name,
rather than trade names, need to be addressed via
a Separate Rate Application. Information regarding
new trade names may be submitted via a Separate
Rate Certification.

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32273

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Period to be reviewed
Tenova (TAKRAF GmbH Lauchhammer)
ThyssenKrupp Steel Europe AG
ThyssenKrupp Schulte GmbH
UPC Universal Piping GmbH
VETTER Umformtechnik GmbH
INDIA: Certain Frozen Warmwater Shrimp,4 A–533–840 ...................................................................................................
INDIA: Certain Welded Carbon Steel Standard Pipes and Tubes, A–533–502 .................................................................
Apl Apollo Tubes Ltd.
Asian Contec Ltd.
Bhandari Foils & Tubes Ltd.
Bhushan Steel Ltd.
Blue Moon Logistics Pvt. Ltd.
CH Robinson Worldwide
Ess-Kay Engineers, Manushi Enterprise & Nishi Boring Corporation
Fiber Tech Composite Pvt. Ltd.
Garg Tube Export LLP
GCL Private Limited
Goodluck India Ltd.
GVN Fuels Ltd.
Hydromatik
Jindal Quality Tubular Ltd.
KLT Automatic & Tubular Products Ltd.
Lloyds Line Pipes Ltd.
MARINEtrans India Private Ltd.
Patton International Ltd.
SAR Transport Systems Pvt. Ltd.
Surya Global Steel Tubes Ltd.
Surya Roshni Ltd.
Welspun India Ltd.
Zenith Birla (India) Ltd.
Zenith Birla Steels Private Ltd.
Zenith Dyeintermediates Ltd.
ITALY: Carbon and Alloy Steel Cut-To-Length Plate, A–475–834 .....................................................................................
Euroflex SpA
Evarz Palini e Bertoil SpA
Ilva SpA
Metalcam SpA
Modelleria di Modini Renato
NLMK Verona SpA
Officine Tecnosider srl
Ondulit Italiana SpA
Padana Tubi e Profilati Acciaio SpA
Riva Fire SpA
JAPAN: Diffusion-Annealed Nickel-Plated Flat-Rolled Steel Products, A–588–869 ..........................................................
Nippon Steel & Sumitomo Metals Corporation
Toyo Kohan Co., Ltd.
OMAN: Polyethylene Terephthalate Resin, A–523–810 .....................................................................................................
Octal Saoc FZC
REPUBLIC OF KOREA: Carbon and Alloy Steel Cut-To-Length Plate, A–580–887 .........................................................
Buma Ce Co., Ltd.
Dong Yang Steel Pipe Co., Ltd.
Dongkuk Steel Mill Co., Ltd.
Expeditors Korea Ltd.
Haem Co., Ltd.
Hyundai Glovis Co., Ltd.
Hyundia Steel Company
J.I. Sea & Air Express Co., Ltd.
Maxpeed Co., Ltd.
POSCO
POSCO Daewoo Corporation
POSCO Processing & Service Co., Ltd.
Rames Logistics Co., Ltd.
Sumitomo Corp. Korea Ltd.
REPUBLIC OF KOREA: Polyester Staple Fiber, A–580–839 ............................................................................................
Huvis Corporation
Toray Chemical Korea, Inc.
TAIWAN: Carbon and Alloy Steel Cut-To-Length Plate, A–583–858 .................................................................................
Broad Hand Enterprise Co., Ltd.
C.H. Robinson Freight Services
China Steel Corporation
Chun Chi Grating Co., Ltd.
Eci Taiwan Co., Ltd.
Locksure Inc.
Nan Hoang Traffic Instrument Co.

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2/1/17–1/31/18
5/1/17–4/30/18

11/14/16–4/30/18

5/1/17–4/30/18
5/1/17–4/30/18
11/14/16–4/30/18

5/1/17–4/30/18
11/14/16–4/30/18

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Period to be reviewed
New Marine Consolidator Co., Ltd.
North America Mining Group Co., Ltd..
Oriental Power Logistics Co., Ltd.
Product Depot International Corp.
Scanwell Logistics (Taiwan)
Shang Chen Steel Co., Ltd.
Shin Yang Steel Co., Ltd.
Shye Yao Steel Co., Ltd.
Speedmark Consolidation
Sumeeko Industries Co., Ltd.
Triple Merits Ltd.
UKI Enterprise Co., Ltd.
TAIWAN: Certain Circular Welded Carbon Steel Pipes and Tubes, A–583–008 ...............................................................
Chung Hung Steel Corp.
Far East Machinery Co., Ltd.
Far East Machinery Group
Fine Blanking & Tool Co., Ltd.
Hou Lih Co., Ltd.
Kao Hsing Chang Iron & Steel Corp.
Lang Hwang Corp.
Locksure Inc.
New Chance Products Co., Ltd.
Pat & Jeff Enterprise Co., Ltd.
Pin Tai Metal Inc.
Shang Jouch Industrial Co., Ltd.
Shengyu Steel Co., Ltd.
Shin Yang Steel Co., Ltd.
Shuan Hwa Industrial Co., Ltd.
Tension Steel Industries Co., Ltd.
Titan Fastech Ltd.
Yeong Shien Industrial Co., Ltd.
Yieh Hsing Enterprise Co., Ltd.
Yousing Precision Industry Co., Ltd.
TAIWAN: Stilbenic Optical Brightening Agents, A–583–848 ..............................................................................................
Teh Fong Min International Co., Ltd.
THE PEOPLE’S REPUBLIC OF CHINA: 1-Hydroxyethylidene-1,1-Diphoshonic Acid (Hedp), A–570–045 ......................
Henan Qingshuiyuan Technology Co., Ltd.
THE PEOPLE’S REPUBLIC OF CHINA: Aluminum Extrusions, A–570–967 ....................................................................
Acro Import and Export Co.
Activa International Inc.
Activa Leisure Inc.
Allied Maker Limited
Alnan Aluminum Co., Ltd.
Alnan Aluminum Ltd.
Aluminicaste Fundicion de Mexico
AMC Ltd.
AMC Limited
Anji Chang Hong Chain Manufacturing
Anshan Zhongjda Industry Co., Ltd.
Aoda Aluminium (Hong Kong) Co., Limited
AsiaAlum GroupAtlas Integrated Manufacturing Ltd.
Belton (Asia) Development Limited
Belton (Asia) Development Ltd.
Birchwoods (Lin’an) Leisure Products Co., Ltd.
Bolnar Hong Kong Ltd.
Bracalente Metal Products (Suzhou) Co., Ltd.
Brilliance General Equipment Co., Ltd.
Changshu Changshen Aluminum Products Co., Ltd.
Changshu Changsheng Aluminum Products Co., Ltd.
Changzhou Changzhen Evaporator Co., Ltd.
Changzhou Changzheng Evaporator Co., Ltd.
Changzhou Tenglong Auto Accessories Manufacturing Co. Ltd
Changzhou Tenglong Auto Parts Co., Ltd.
Changzhou Tenglong Auto Parts Co. Ltd.
China Square
China Square Industrial Co.
China Square Industrial Ltd.
China Zhongwang Holdings, Ltd.
Chiping One Stop Industrial & Trade Co., Ltd.
Classic & Contemporary Inc.
Clear Sky Inc.
Cosco (J.M.) Aluminum Co., Ltd.
Cosco (JM) Aluminum Development Co. Ltd.
Dalian Huacheng Aquatic Products

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Period to be reviewed
Dalian Liwang Trade Co., Ltd.
Danfoss Micro Channel Heat Exchanger (Jia Xing) Co., Ltd.
Daya Hardware Co. Ltd.
Dongguan Dazhan Metal Co., Ltd.
Dongguang Aoda Aluminum Co., Ltd.
Dongguan Golden Tiger Hardware Industrial Co., Ltd.
Dragonluxe Limited
Dynabright International Group (HK) Ltd.
Dynamic Technologies China
ETLA Technology (Wuxi) Co. Ltd.
Ever Extend Ent. Ltd.
Fenghua Metal Product Factory
First Union Property Limited
FookShing Metal & Plastic Co. Ltd.
Foreign Trade Co. of Suzhou New & High-Tech Industrial Development Zone
Foshan City Nanhai Hongjia Aluminum Alloy Co., Ltd.
Foshan Golden Source Aluminum Products Co., Ltd.
Foshan Guangcheng Aluminium Co., Ltd.
Foshan Jinlan Aluminum Co. Ltd.
Foshan JinLan Aluminum Co., Ltd.
Foshan JMA Aluminum Company Limited
Foshan Nanhai Niu Yuan Hardware Product Co., Ltd.
Foshan Shanshui Fenglu Aluminum Co., Ltd.
Foshan Shunde Aoneng Electrical Appliances Co., Ltd.
Foshan Yong Li Jian Aluminum Co., Ltd.
Fujian Sanchuan Aluminum Co., Ltd.
Fukang Aluminum & Plastic Import and Export Co., Ltd.
Fuzhou Sunmodo New Energy Equipment
Gaotang Xinhai Economy & Trade Co., Ltd.
Genimex Shanghai, Ltd.
Global Hi-Tek Precision Co. Ltd.
Global PMX Dongguan Co., Ltd.
Global Point Technology (Far East) Limited
Gold Mountain International Development, Ltd.
Golden Dragon Precise Copper Tube Group, Inc.
Gran Cabrio Capital Pte. Ltd.
Gree Electric Appliances
GT88 Capital Pte. Ltd.
Guang Ya Aluminium Industries Co. Ltd.
Guang Ya Aluminum Industries Company Ltd
Guang Ya Aluminium Industries (HK) Ltd.
Guangcheng Aluminum Co., Ltd.
Guangdong Hao Mei Aluminum Co., Ltd.
Guangdong Jianmei Aluminum Profile Company Limited
Guangdong JMA Aluminum Profile Factory (Group) Co., Ltd.
Guangdong Midea
Guangdong Midea Microwave and Electrical Appliances
Guangdong Nanhai Foodstuffs Imp. & Exp. Co., Ltd.
Guangdong Weiye Aluminum Factory Co., Ltd.
Guangdong Whirlpool Electrical Appliances Co., Ltd.
Guangdong Xingfa Aluminum Co., Ltd.
Guangdong Xin Wei Aluminum Products Co., Ltd.
Guangdong Yonglijian Aluminum Co., Ltd.
Guangdong Zhongya Aluminum Company Ltd.
Guangzhou Jangho Curtain Wall System Engineering Co., Ltd.
Guangzhou Mingcan Die-Casting Hardware Products Co., Ltd.
Hangzhou Xingyi Metal Products Co., Ltd.
Hanwood Enterprises Limited
Hanyung Alcoba Co., Ltd.
Hanyung Alcobis Co., Ltd.
Hanyung Metal (Suzhou) Co., Ltd.
Hao Mei Aluminum Co., Ltd.
Hao Mei Aluminum International Co., Ltd.
Hebei Xusen Wire Mesh Products Co., Ltd.
Henan New Kelong Electrical Appliances Co., Ltd.
Henan Zhongduo Aluminum Magnesium New Material Co, Ltd.
Hong Kong Gree Electric Appliances Sales Limited
Hong Kong Modern Non-Ferrous Metal
Honsense Development Company
Houztek Architectural Products Co., Ltd.
Hui Mei Gao Aluminum Foshan Co., Ltd.
Huixin Aluminum
IDEX Dinglee Technology (Tianjin) Co., Ltd.
IDEX Health

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Period to be reviewed
IDEX Technology Suzhou Co., Ltd.
Innovative Aluminum (Hong Kong) Limited
iSource Asia
Jackson Travel Products Co., Ltd.
Jangho Curtain Wall Hong Kong Ltd.
Jiangmen Jianghai District Foreign Economic Enterprise Corp. Ltd.
Jiangmen Jianghai Foreign Ent. Gen.
Jiangmen Qunxing Hardware Diecasting Co., Ltd.
Jiangsu Changfa Refrigeration Co.
Jiangyin Suncitygaylin
Jiangyin Trust International Inc.
Jiangyin Xinhong Doors and Windows Co., Ltd.
Jiaxing Jackson Travel Products Co., Ltd.
Jiaxing Taixin Metal Products Co., Ltd.
Jiuyan Co., Ltd.
JMA (HK) Company Limited
Johnson Precision Engineering (Suzhou) Co., Ltd.
Justhere Co., Ltd.
Kam Kiu Aluminum Products Sdn Bhd
Kanal Precision Aluminum Product Co., Ltd.
Karlton Aluminum Company Ltd.
Kong Ah International Company Limited
Kromet International Inc.
Kromet Intl Inc.
Kromet International
Kunshan Giant Light Metal Technology Co., Ltd.
Liaoning Zhong Da Industrial Aluminum Co., Ltd.
Liaoning Zhongwang Group Co., Ltd.
Liaoyang Zhongwang Aluminum Profile Co. Ltd.
Longkou Donghai Trade Co., Ltd.
Metal Tech Co. Ltd.
Metaltek Group Co., Ltd.
Metaltek Metal Industry Co., Ltd.
Midea Air Conditioning Equipment Co., Ltd.
Midea Electric Trading Co., Pte Ltd.
Midea International Trading Co., Ltd.
Midea International Training Co., Ltd.
Miland Luck Limited
Nanhai Textiles Import & Export Co., Ltd.
New Asia Aluminum & Stainless Steel Product Co., Ltd.
New Zhongya Aluminum Factory
Nidec Sankyo (Zhejang) Corporation
Nidec Sankyo Zhejiang Corporation
Nidec Sankyo Singapore Pte. Ltd.
Ningbo Coaster International Co., Ltd.
Ningbo Hi Tech Reliable Manufacturing Company
Ningbo Innopower Tengda Machinery
Ningbo Ivy Daily Commodity Co., Ltd.
Ningbo Yili Import and Export Co., Ltd.
North China Aluminum Co., Ltd.
North Fenghua Aluminum Ltd.
Northern States Metals
PanAsia Aluminum (China) Limited
Pengcheng Aluminum Enterprise Inc.
Permasteelisa Hong Kong Limited
Permasteelisa South China Factory
Pingguo Aluminum Company Limited
Pingguo Asia Aluminum Co., Ltd.
Popular Plastics Company Limited
Precision Metal Works Ltd.
Press Metal International Ltd.
Samuel, Son & Co., Ltd.
Sanchuan Aluminum Co., Ltd.
Sanhua (Hangzhou) Micro Channel Heat Exchanger Co., Ltd.
Shandong Fukang Aluminum & Plastic Co. LTD.
Shandong Huajian Aluminum Group
Shangdong Huasheng Pesticide Machinery Co.
Shangdong Nanshan Aluminum Co., Ltd.
Shanghai Automobile Air-Conditioner Accessories Co. Ltd.
Shanghai Automobile Air Conditioner Accessories Ltd.
Shanghai Canghai Aluminum Tube Packaging Co., Ltd.
Shanghai Dofiberone Composites Co. Ltd.
Shanghai Dongsheng Metal
Shanghai Shen Hang Imp & Exp Co., Ltd.

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Period to be reviewed
Shanghai Tongtai Precise Aluminum Alloy Manufacturing Co. Ltd.
Shanghai Top-Ranking Aluminum Products Co., LTD.
Shanghai Top-Ranking New Materials Co., Ltd.
Shenyang Yuanda Aluminum Industry Engineering Co. Ltd.
Shenzhen Hudson Technology Development Co.
Shenzhen Jiuyuan Co., Ltd.
Sihui Shi Guo Yao Aluminum Co., Ltd.
Sincere Profit Limited
Skyline Exhibit Systems (Shanghai) Co. Ltd.
Southwest Aluminum (Group) Co., Ltd.
Summit Heat Sinks Metal Co., Ltd.
Summit Plastics Nanjing Co. Ltd.
Suzhou JRP Import & Export Co., Ltd.
Suzhou New Hongji Precision Part Co.
Tai-Ao Aluminum (Taishan) Co. Ltd.
Taishan City Kam Kiu Aluminium Extrusion Co., Ltd.
Taizhou Lifeng Manufacturing Co., Ltd.
Taitoh Machinery Shanghai Co. Ltd.
Taizhou United Imp. & Exp. Co., Ltd.
tenKsolar (Shanghai) Co., Ltd.
Tianjin Ganglv Nonferrous Metal Materials Co., Ltd.
Tianjin Jinmao Import & Export Corp., Ltd.
Tianjin Ruxin Electric Heat Transmission Technology Co., Ltd.
Tianjin Xiandai Plastic & Aluminum Products Co., Ltd.
Tiazhou Lifeng Manufacturing Corporation
Top-Wok Metal Co., Ltd.
Traffic Brick Network, LLC
Union Aluminum (SIP) Co.
Union Industry (Asia) Co., Ltd.
USA Worldwide Door Components (Pinghu) Co., Ltd.
Wenzhou Shengbo Decoration & Hardware
Wenzhou Yongtai Electric Co., Ltd.
Whirlpool (Guangdong)
Whirlpool Canada L.P.
Whirlpool Microwave Products Development Ltd.
Worldwide Door Components, Inc.
WTI Building Products, Ltd.
Wuxi Lutong Fiberglass Doors Co., Ltd,
Xin Wei Aluminum Co.
Xin Wei Aluminum Company Limited
Xinya Aluminum & Stainless Steel Product Co., Ltd.
Yuyao Haoshen Import & Export
Yuyao Fanshun Import & Export Co., Ltd.
Zahoqing China Square Industry Limited
Zhaoqing Asia Aluminum Factory Company Ltd.
Zhaoqing China Square Industry Limited
Zhaoqing China Square Industrial Ltd.
Zhaoqing New Zhongya Aluminum Co., Ltd.
Zhejiang Anji Xinxiang Aluminum Co., Ltd.
Zhejiang Lilies Industrial and Commercial Co.
Zhejiang Yili Automobile Air Condition Co., Ltd.
Zhejiang Yongkang Listar Aluminum Industry Co., Ltd.
Zhejiang Zhengte Group Co., Ltd.
Zhenjiang Xinlong Group Co., Ltd.
Zhongshan Daya Hardware Co., Ltd.
Zhongshan Gold Mountain Aluminum Factory Ltd.
Zhongya Shaped Aluminum (HK) Holding Limited
Zhuhai Runxingtai Electrical Equipment Co., Ltd.
THE PEOPLE’S REPUBLIC OF CHINA: Oil Country Tubular Goods, A–570–943 ...........................................................
Baoshan Iron & Steel
Hengyang Steel Tube Group International Trading Inc.
Hubei Xinyegang Steel Co., Ltd.
Hubei Xin Yegang Special Tube
THE PEOPLE’S REPUBLIC OF CHINA: Pure Magnesium, A–570–832 ...........................................................................
Tianjin Magnesium International Co., Ltd.
Tianjin Magnesium Metal Co., Ltd.
TURKEY: Circular Welded Carbon Steel Pipes and Tubes, A–489–501 ...........................................................................
Borusan Birlesik Boru Fabrikalari San ve Tic.
Borusan Gemlik Boru Tesisleri A.S.
Borusan Holding
Borusan Ihracat Ithalat ve Dagitim A.S.
Borusan Istikbal Ticaret T.A.S.
Borusan Ithicat ve Dagitim A.S.
Borusan Mannesmann Boru Sanayi ve Ticaret A.S.

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Period to be reviewed

amozie on DSK3GDR082PROD with NOTICES1

Borusan Mannesmann Yatirim Holding
Cayirova Boru Sanayi ve Ticaret A.S.
Cinar Boru Profil San. Ve Tic. As
Erbosan Erciyas Boru Sanayi ve Ticaret A.S.
Kale Baglanti Teknolojileri San. ve Tic.
Noksel Celik Boru Sanayi A.S.
Toscelik Metal Ticaret A.S.
Toscelik Profil ve Sac Endustrisi A.S.
Tosyali Dis Ticaret A.S.
Tubeco Pipe and Steel Corporation
Yucel Boru ve Profil Endustrisi A.S.
Yucelboru Ihracat Ithalat ve Pazarlama A.S.
TURKEY: Light-Walled Rectangular Pipe and Tube, A–489–815 ......................................................................................
Noksel Celik Boru Sanayi A.S.
Countervailing Duty Proceedings
REPUBLIC OF KOREA: Carbon and Alloy Steel Cut-To-Length Plate, C–580–888 .........................................................
BDP International
Blue Track Equipment
Boxco
Bukook Steel Co., Ltd.
Buma CE Co., Ltd.
Daelim Industrial Co., Ltd.
Daesam Industrial Co., Ltd.
Daesin Lighting Co., Ltd.
Daewoo International Corp.
Dong Yang Steel Pipe
Dongkuk Industries Co., Ltd.
Dongkuk Steel Mill Co., Ltd.
Dongbu Steel Co., Ltd.
EAE Automotive Equipment
EEW KHPC Co., Ltd.
Eplus Expo Inc.
GS Global Corp.
Haem Co., Ltd.
Han Young Industries
Hyosung Corp.
Hyundai Steel Co.
Jinmyung Frictech Co., Ltd.
Korean Iron and Steel Co., Ltd.
Kyoungil Precision Co., Ltd.
POSCO
Samsun C&T Corp.
SK Netwoks Co., Ltd.
Steel N People Ltd.
Summit Industry
Sungjin Co., Ltd.
Young Sun Steel
THE PEOPLE’S REPUBLIC OF CHINA: 1-Hydroxyethylidene-1,1-Diphoshonic Acid (Hedp), C–570–046 ......................
Changzhou Kewei Fine Chemicals Co., Ltd.
Changzhou Yao’s Tongde Chemical Co., Ltd.
Hebei Longke Water Treatment Co., Ltd.
Henan Qinshuiyuan Technology Co., Ltd.
Jinghai Environmental Protection Co., Ltd. (Jianghai)
Nanjing University of Chemical Technology Changzhou Wujin Water Quality
Stabilizer Factory
Nantong Uniphos Chemicals Co., Ltd.
Shandong Huayou Chemistry Co., Ltd.
Shandong Taihe Chemicals Co., Ltd.
Shandong Taihe Water Treatment Technologies Co., Ltd.
Shandong Xintai Water Treatment Technology
Wujin Fine Chemical Factory Co., Ltd.
Zaozhuang Fuxing Water Treatment Technology
Zaozhuang YouBang Chemicals Co., Ltd.
Zouping Dongfang Chemical Industry Co., Ltd.
THE PEOPLE’S REPUBLIC OF CHINA: Aluminum Extrusions, C–570–968 ....................................................................
Acro Import and Export Co.
Activa International Inc.
Activa Leisure Inc.
Allied Maker Limited
Alnan Aluminum Co., Ltd.
Alnan Aluminum Ltd.
Aluminicaste Fundicion de Mexico
AMC Ltd.

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Period to be reviewed
AMC Limited
Anji Chang Hong Chain Manufacturing
Anshan Zhongjda Industry Co., Ltd.
Aoda Aluminium (Hong Kong) Co., Limited
AsiaAlum Group
Atlas Integrated Manufacturing Ltd.
Belton (Asia) Development Limited
Belton (Asia) Development Ltd.
Birchwoods (Lin’an) Leisure Products Co., Ltd.
Bolnar Hong Kong Ltd.
Bracalente Metal Products (Suzhou) Co., Ltd.
Brilliance General Equipment Co., Ltd.
Changshu Changshen Aluminum Products Co., Ltd.
Changshu Changsheng Aluminum Products Co., Ltd.
Changzhou Changzhen Evaporator Co., Ltd.
Changzhou Changzheng Evaporator Co., Ltd.
Changzhou Tenglong Auto Accessories Manufacturing Co. Ltd
Changzhou Tenglong Auto Parts Co., Ltd.
Changzhou Tenglong Auto Parts Co Ltd
China Square
China Square Industrial Co.
China Square Industrial Ltd.
China Zhongwang Holdings, Ltd.
Chiping One Stop Industrial & Trade Co., Ltd.
Classic & Contemporary Inc.
Clear Sky Inc.
Cosco (J.M.) Aluminum Co., Ltd.
Cosco (JM) Aluminum Development Co. Ltd
Dalian Huacheng Aquatic Products
Dalian Liwang Trade Co., Ltd.
Danfoss Micro Channel Heat Exchanger (Jia Xing) Co., Ltd.
Daya Hardware Co. Ltd.
Dongguan Dazhan Metal Co., Ltd.
Dongguang Aoda Aluminum Co., Ltd.
Dongguan Golden Tiger Hardware Industrial Co., Ltd.
Dragonluxe Limited
Dynabright International Group (HK) Ltd.
Dynamic Technologies China
ETLA Technology (Wuxi) Co. Ltd.
Ever Extend Ent. Ltd.
Fenghua Metal Product Factory
First Union Property Limited
FookShing Metal & Plastic Co. Ltd.
Foreign Trade Co. of Suzhou New & High-Tech Industrial Development Zone
Foshan City Nanhai Hongjia Aluminum Alloy Co., Ltd.
Foshan Golden Source Aluminum Products Co., Ltd.
Foshan Guangcheng Aluminium Co., Ltd
Foshan Jinlan Aluminum Co. Ltd.
Foshan JinLan Aluminum Co., Ltd.
Foshan JMA Aluminum Company Limited
Foshan Nanhai Niu Yuan Hardware Product Co., Ltd.
Foshan Shanshui Fenglu Aluminum Co., Ltd.
Foshan Shunde Aoneng Electrical Appliances Co., Ltd
Foshan Yong Li Jian Aluminum Co., Ltd.
Fujian Sanchuan Aluminum Co., Ltd.
Fukang Aluminum & Plastic Import and Export Co., Ltd.
Fuzhou Sunmodo New Energy Equipment
Gaotang Xinhai Economy & Trade Co., Ltd.
Genimex Shanghai, Ltd.
Global Hi-Tek Precision Co. Ltd
Global PMX Dongguan Co., Ltd.
Global Point Technology (Far East) Limited
Gold Mountain International Development, Ltd.
Golden Dragon Precise Copper Tube Group, Inc.
Gran Cabrio Capital Pte. Ltd.
Gree Electric Appliances
GT88 Capital Pte. Ltd.
Guang Ya Aluminium Industries Co. Ltd.
Guang Ya Aluminum Industries Company Ltd
Guang Ya Aluminium Industries (HK) Ltd.
Guangcheng Aluminum Co., Ltd.
Guangdong Hao Mei Aluminum Co., Ltd.
Guangdong Jianmei Aluminum Profile Company Limited
Guangdong JMA Aluminum Profile Factory (Group) Co., Ltd.

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Period to be reviewed
Guangdong Midea
Guangdong Midea Microwave and Electrical Appliances
Guangdong Nanhai Foodstuffs Imp. & Exp. Co., Ltd.
Guangdong Weiye Aluminum Factory Co., Ltd.
Guangdong Whirlpool Electrical Appliances Co., Ltd.
Guangdong Xingfa Aluminum Co., Ltd.
Guangdong Xin Wei Aluminum Products Co., Ltd.
Guangdong Yonglijian Aluminum Co., Ltd.
Guangdong Zhongya Aluminum Company Ltd.
Guangzhou Jangho Curtain Wall System Engineering Co., Ltd.
Guangzhou Mingcan Die-Casting Hardware Products Co., Ltd.
Hangzhou Xingyi Metal Products Co., Ltd.
Hanwood Enterprises Limited
Hanyung Alcoba Co., Ltd.
Hanyung Alcobis Co., Ltd.
Hanyung Metal (Suzhou) Co., Ltd.
Hao Mei Aluminum Co., Ltd.
Hao Mei Aluminum International Co., Ltd.
Hebei Xusen Wire Mesh Products Co., Ltd.
Henan New Kelong Electrical Appliances Co., Ltd.
Henan Zhongduo Aluminum Magnesium New Material Co., Ltd.
Hong Kong Gree Electric Appliances Sales Limited
Hong Kong Modern Non-Ferrous Metal
Honsense Development Company
Houztek Architectural Products Co., Ltd.
Hui Mei Gao Aluminum Foshan Co., Ltd.
Huixin Aluminum
IDEX Dinglee Technology (Tianjin) Co., Ltd.
IDEX Health
IDEX Technology Suzhou Co., Ltd.
Innovative Aluminum (Hong Kong) Limited
iSource Asia
Jackson Travel Products Co., Ltd.
Jangho Curtain Wall Hong Kong Ltd.
Jiangmen Jianghai District Foreign Economic Enterprise Corp. Ltd.
Jiangmen Jianghai Foreign Ent. Gen.
Jiangmen Qunxing Hardware Diecasting Co., Ltd.
Jiangsu Changfa Refrigeration Co.
Jiangyin Suncitygaylin
Jiangyin Trust International Inc.
Jiangyin Xinhong Doors and Windows Co., Ltd.
Jiaxing Jackson Travel Products Co., Ltd.
Jiaxing Taixin Metal Products Co., Ltd.
Jiuyan Co., Ltd.
JMA (HK) Company Limited
Johnson Precision Engineering (Suzhou) Co., Ltd.
Justhere Co., Ltd.
Kam Kiu Aluminum Products Sdn Bhd
Kanal Precision Aluminum Product Co., Ltd.
Karlton Aluminum Company Ltd.
Kong Ah International Company Limited
Kromet International Inc.
Kromet Intl Inc.
Kromet International
Kunshan Giant Light Metal Technology Co., Ltd.
Liaoning Zhong Da Industrial Aluminum Co., Ltd.
Liaoning Zhongwang Group Co., Ltd.
Liaoyang Zhongwang Aluminum Profile Co. Ltd.
Longkou Donghai Trade Co., Ltd.
Metal Tech Co Ltd.
Metaltek Group Co., Ltd.
Metaltek Metal Industry Co., Ltd.
Midea Air Conditioning Equipment Co., Ltd.
Midea Electric Trading Co., Pte Ltd.
Midea International Trading Co., Ltd.
Midea International Training Co., Ltd.
Miland Luck Limited
Nanhai Textiles Import & Export Co., Ltd.
New Asia Aluminum & Stainless Steel Product Co., Ltd.
New Zhongya Aluminum Factory
Nidec Sankyo (Zhejang) Corporation
Nidec Sankyo Zhejiang Corporation
Nidec Sankyo Singapore Pte. Ltd.
Ningbo Coaster International Co., Ltd.

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Period to be reviewed
Ningbo Hi Tech Reliable Manufacturing Company
Ningbo Innopower Tengda Machinery
Ningbo Ivy Daily Commodity Co., Ltd.
Ningbo Yili Import and Export Co., Ltd.
North China Aluminum Co., Ltd.
North Fenghua Aluminum Ltd.
Northern States Metals
PanAsia Aluminum (China) Limited
Pengcheng Aluminum Enterprise Inc.
Permasteelisa Hong Kong Limited
Permasteelisa South China Factory
Pingguo Aluminum Company Limited
Pingguo Asia Aluminum Co., Ltd.
Popular Plastics Company Limited
Precision Metal Works Ltd.
Press Metal International Ltd.
Samuel, Son & Co., Ltd.
Sanchuan Aluminum Co., Ltd.
Sanhua (Hangzhou) Micro Channel Heat Exchanger Co., Ltd.
Shandong Fukang Aluminum & Plastic Co. LTD.
Shandong Huajian Aluminum Group
Shangdong Huasheng Pesticide Machinery Co.
Shangdong Nanshan Aluminum Co., Ltd.
Shanghai Automobile Air-Conditioner Accessories Co Ltd.
Shanghai Automobile Air Conditioner Accessories Ltd.
Shanghai Canghai Aluminum Tube Packaging Co., Ltd.
Shanghai Dofiberone Composites Co. Ltd.
Shanghai Dongsheng Metal
Shanghai Shen Hang Imp & Exp Co., Ltd.
Shanghai Tongtai Precise Aluminum Alloy Manufacturing Co. Ltd.
Shanghai Top-Ranking Aluminum Products Co., LTD.
Shanghai Top-Ranking New Materials Co., Ltd.
Shenyang Yuanda Aluminum Industry Engineering Co. Ltd.
Shenzhen Hudson Technology Development Co.
Shenzhen Jiuyuan Co., Ltd.
Sihui Shi Guo Yao Aluminum Co., Ltd.
Sincere Profit Limited
Skyline Exhibit Systems (Shanghai) Co. Ltd.
Southwest Aluminum (Group) Co., Ltd.
Summit Heat Sinks Metal Co., Ltd.
Summit Plastics Nanjing Co. Ltd.
Suzhou JRP Import & Export Co., Ltd.
Suzhou New Hongji Precision Part Co.
Tai-Ao Aluminum (Taishan) Co. Ltd.
Taishan City Kam Kiu Aluminium Extrusion Co., Ltd.
Taitoh Machinery Shanghai Co. Ltd.
Taizhou Lifeng Manufacturing Co., Ltd.
Tiazhou Lifeng Manufacturing Corporation
Taizhou United Imp. & Exp. Co., Ltd.
tenKsolar (Shanghai) Co., Ltd.
Tianjin Ganglv Nonferrous Metal Materials Co., Ltd.
Tianjin Jinmao Import & Export Corp., Ltd.
Tianjin Ruxin Electric Heat Transmission Technology Co., Ltd.
Tianjin Xiandai Plastic & Aluminum Products Co., Ltd.
Top-Wok Metal Co., Ltd.
Traffic Brick Network, LLC
Union Aluminum (SIP) Co.
Union Industry (Asia) Co., Ltd.
USA Worldwide Door Components (Pinghu) Co., Ltd.
Wenzhou Shengbo Decoration & Hardware
Wenzhou Yongtai Electric Co., Ltd.
Whirlpool (Guangdong)
Whirlpool Canada L.P.
Whirlpool Microwave Products Development Ltd.
Worldwide Door Components, Inc.
WTI Building Products, Ltd.
Wuxi Lutong Fiberglass Doors Co., Ltd.
Xin Wei Aluminum Co.
Xin Wei Aluminum Company Limited
Xinya Aluminum & Stainless Steel Product Co., Ltd.
Yuyao Fanshun Import & Export Co., Ltd.
Yuyao Haoshen Import & Export
Zahoqing China Square Industry Limited
Zhaoqing Asia Aluminum Factory Company Ltd.

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Period to be reviewed

Zhaoqing China Square Industrial Ltd.
Zhaoqing China Square Industry Limited
Zhaoqing New Zhongya Aluminum Co., Ltd.
Zhejiang Anji Xinxiang Aluminum Co., Ltd.
Zhejiang Lilies Industrial and Commercial Co.
Zhejiang Yili Automobile Air Condition Co., Ltd.
Zhejiang Yongkang Listar Aluminum Industry Co., Ltd.
Zhejiang Zhengte Group Co., Ltd.
Zhenjiang Xinlong Group Co., Ltd.
Zhongshan Daya Hardware Co., Ltd.
Zhongshan Gold Mountain Aluminum Factory Ltd.
Zhongya Shaped Aluminum (HK) Holding Limited
Zhuhai Runxingtai Electrical Equipment Co., Ltd.

Gap Period Liquidation

Suspension Agreements
None.
Duty Absorption Reviews

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During any administrative review
covering all or part of a period falling
between the first and second or third
and fourth anniversary of the
publication of an antidumping duty
order under 19 CFR 351.211 or a
determination under 19 CFR
351.218(f)(4) to continue an order or
suspended investigation (after sunset
review), the Secretary, if requested by a
domestic interested party within 30
days of the date of publication of the
notice of initiation of the review, will
determine whether antidumping duties
have been absorbed by an exporter or
producer subject to the review if the
subject merchandise is sold in the
United States through an importer that
is affiliated with such exporter or
producer. The request must include the
name(s) of the exporter or producer for
which the inquiry is requested.
4 On April 16, 2018, Commerce initiated the
2017–2018 administrative review of Certain Frozen
Warmwater Shrimp from India. See Initiation of
Antidumping and Countervailing Duty
Administrative Reviews, 83 FR 16298, 16300–
16304. In the notice of initiation, Commerce
inadvertently made the following errors: (1) We
included Premier Marine Products Private Limited
twice; (2) we made typographical errors in the
names of two companies (i.e., Triveni Fisheries P
Ltd. and U & Company Marine Exports, listed as
Triveni Fisheries P Ltd.U & Company Marine
Exports); and (3) we failed to limit the review for
Devi Sea Foods to shrimp produced in India where
Devi Sea Foods acted as either the manufacturer or
exporter (but not both), because shrimp produced
and exported by this company is not covered by the
antidumping duty order. See Certain Frozen
Warmwater Shrimp from India: Final Results of
Antidumping Duty Administrative Review, Partial
Rescission of Review, and Notice of Revocation of
Order in Part, 75 FR 41813, 41814 (July 19, 2010).
Accordingly, we are initiating this administrative
review for: (1) Premier Marine Products Private
Limited only once; (2) Triveni Fisheries P Ltd. and
U & Company Marine Exports (instead of Triveni
Fisheries P Ltd.U & Company Marine Exports); and
(3) Devi Sea Foods, but only with respect to shrimp
for which Devi Sea Foods is either the manufacturer
or exporter, but not both.

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For the first administrative review of
any order, there will be no assessment
of antidumping or countervailing duties
on entries of subject merchandise
entered, or withdrawn from warehouse,
for consumption during the relevant
provisional-measures ‘‘gap’’ period, of
the order, if such a gap period is
applicable to the POR.
Administrative Protective Orders and
Letters of Appearance
Interested parties must submit
applications for disclosure under
administrative protective orders in
accordance with the procedures
outlined in Commerce’s regulations at
19 CFR 351.305. Those procedures
apply to administrative reviews
included in this notice of initiation.
Parties wishing to participate in any of
these administrative reviews should
ensure that they meet the requirements
of these procedures (e.g., the filing of
separate letters of appearance as
discussed at 19 CFR 351.103(d)).
Factual Information Requirements
Commerce’s regulations identify five
categories of factual information in 19
CFR 351.102(b)(21), which are
summarized as follows: (i) Evidence
submitted in response to questionnaires;
(ii) evidence submitted in support of
allegations; (iii) publicly available
information to value factors under 19
CFR 351.408(c) or to measure the
adequacy of remuneration under 19 CFR
351.511(a)(2); (iv) evidence placed on
the record by Commerce; and (v)
evidence other than factual information
described in (i)–(iv). These regulations
require any party, when submitting
factual information, to specify under
which subsection of 19 CFR
351.102(b)(21) the information is being
submitted and, if the information is
submitted to rebut, clarify, or correct
factual information already on the
record, to provide an explanation
identifying the information already on

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the record that the factual information
seeks to rebut, clarify, or correct. The
regulations, at 19 CFR 351.301, also
provide specific time limits for such
factual submissions based on the type of
factual information being submitted.
Please review the final rule, available at
http://enforcement.trade.gov/frn/2013/
1304frn/2013-08227.txt, prior to
submitting factual information in this
segment.
Any party submitting factual
information in an antidumping duty or
countervailing duty proceeding must
certify to the accuracy and completeness
of that information.5 Parties are hereby
reminded that revised certification
requirements are in effect for company/
government officials as well as their
representatives. All segments of any
antidumping duty or countervailing
duty proceedings initiated on or after
August 16, 2013, should use the formats
for the revised certifications provided at
the end of the Final Rule.6 Commerce
intends to reject factual submissions in
any proceeding segments if the
submitting party does not comply with
applicable revised certification
requirements.
Extension of Time Limits Regulation
Parties may request an extension of
time limits before a time limit
established under Part 351 expires, or as
otherwise specified by the Secretary.
See 19 CFR 351.302. In general, an
extension request will be considered
untimely if it is filed after the time limit
established under Part 351 expires. For
submissions which are due from
multiple parties simultaneously, an
extension request will be considered
untimely if it is filed after 10:00 a.m. on
the due date. Examples include, but are
5 See

section 782(b) of the Act.
Certification of Factual Information To
Import Administration During Antidumping and
Countervailing Duty Proceedings, 78 FR 42678 (July
17, 2013) (Final Rule); see also the frequently asked
questions regarding the Final Rule, available at
http://enforcement.trade.gov/tlei/notices/factual_
info_final_rule_FAQ_07172013.pdf.
6 See

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not limited to: (1) Case and rebuttal
briefs, filed pursuant to 19 CFR 351.309;
(2) factual information to value factors
under 19 CFR 351.408(c), or to measure
the adequacy of remuneration under 19
CFR 351.511(a)(2), filed pursuant to 19
CFR 351.301(c)(3) and rebuttal,
clarification and correction filed
pursuant to 19 CFR 351.301(c)(3)(iv); (3)
comments concerning the selection of a
surrogate country and surrogate values
and rebuttal; (4) comments concerning
U.S. Customs and Border Protection
data; and (5) quantity and value
questionnaires. Under certain
circumstances, Commerce may elect to
specify a different time limit by which
extension requests will be considered
untimely for submissions which are due
from multiple parties simultaneously. In
such a case, Commerce will inform
parties in the letter or memorandum
setting forth the deadline (including a
specified time) by which extension
requests must be filed to be considered
timely. This modification also requires
that an extension request must be made
in a separate, stand-alone submission,
and clarifies the circumstances under
which Commerce will grant untimelyfiled requests for the extension of time
limits. These modifications are effective
for all segments initiated on or after
October 21, 2013. Please review the
final rule, available at http://
www.gpo.gov/fdsys/pkg/FR-2013-09-20/
html/2013-22853.htm, prior to
submitting factual information in these
segments.
These initiations and this notice are
in accordance with section 751(a) of the
Act (19 U.S.C. 1675(a)) and 19 CFR
351.221(c)(1)(i).
Dated: July 6, 2018.
Wendy J. Frankel,
Director, Customs and Border Protection
Liaison Unit, Antidumping and
Countervailing Duty Operations, Enforcement
and Compliance.
[FR Doc. 2018–14923 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration

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RIN 0648–XG310

Endangered and Threatened Species;
Take of Anadromous Fish
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Notice of final determination
and discussion of underlying biological
AGENCY:

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and environmental analyses; notice of
availability of Finding of No Significant
Impact.
NMFS has evaluated the joint
resource management plan (RMP)
submitted to NMFS by the Sauk-Suiattle
Indian Tribe, Swinomish Indian Tribal
Community, Upper Skagit Indian Tribe,
the Skagit River System Cooperative,
and the Washington Department of Fish
and Wildlife, pursuant to the limitation
on take prohibitions for actions
conducted under Limit 6 of the 4(d)
Rule for salmon and steelhead
promulgated under the Endangered
Species Act (ESA). The RMP specifies
harvest of ESA-listed, Skagit River
steelhead in Treaty Indian fisheries and
non-treaty recreational fisheries in the
Skagit River terminal area of
Washington State. This document serves
to notify the public that NMFS, by
delegated authority from the Secretary
of Commerce, had determined pursuant
to Limit 6 of the 4(d) rule for salmon
and steelhead that implementing and
enforcing the RMP will not appreciably
reduce the likelihood of survival and
recovery of Puget Sound steelhead. In
compliance with the National
Environmental Policy Act (NEPA),
NMFS also announces the availability of
its Finding of No Significant Impact for
the Skagit River steelhead fisheries
determination.
DATES: The final determination of take
prohibition limitation under the ESA
was made on April 12, 2018. The
Finding of No Significant Impact was
signed on April 12, 2018.
ADDRESSES: Requests for copies of the
decision documents or any of the other
associated documents should be
directed to NOAA’s National Marine
Fisheries Service, West Coast Region,
Sustainable Fisheries Division, 510
Desmond Drive, Suite 103, Lacey, WA
98503. The documents are also available
online at www.westcoast.fisheries.
noaa.gov.
FOR FURTHER INFORMATION CONTACT:
James Dixon at (360) 534–9329 or by
email at [email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

ESA-Listed Species Covered in This
Notice
Steelhead (Oncorhynchus mykiss):
threatened, naturally produced and
artificially propagated Puget Sound.
Chinook salmon (O. tshawytscha):
threatened, naturally produced and
artificially propagated Puget Sound.
Background
The Sauk-Suiattle Indian Tribe,
Swinomish Indian Tribal Community,

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Upper Skagit Indian Tribe, and the
Skagit River System Cooperative and the
Washington Department of Fish and
Wildlife have jointly submitted a
steelhead fishery RMP to NMFS
pursuant to the limitation on take
prohibitions for actions conducted
under Limit 6 of the 4(d) Rule for
salmon and steelhead promulgated
under the Endangered Species Act
(ESA). The plan was submitted in
November of 2016, pursuant to limit 6
of the 4(d) Rule for ESA-listed salmon
and steelhead. The RMP would manage
the harvest of Skagit River natural-origin
steelhead in the Skagit River and in the
terminal marine area of the Skagit River.
As required, NMFS took public
comments on its recommended
determination for how the plans address
the criteria in § 223.203(b)(5) prior to
making its final determination.
Discussion of the Biological Analysis
Underlying the Determination
The goal of the Skagit RMP is to
provide steelhead fishing opportunities
for the Skagit River Treaty Tribes and
for recreational fishers, in a manner that
is conservative at higher run sizes and
increasingly so at lower run sizes. For
a period of five years, the Skagit RMP
will implement annual steelhead
fisheries in the Skagit terminal
management area consistent with the
impact limits, management framework,
enforcement, and monitoring
requirements, as described in the RMP.
The Skagit RMP utilizes an abundancebased, stepped harvest regime to
determine annual harvest rates, based
on the annual forecasted run size. These
stepped harvest rates range from a 4
percent total allowable harvest rate at
low run sizes (<4,001 adults) to 25
percent for runs greater than 8,001
adults.
NMFS has analyzed the Skagit RMP’s
proposed abundance-based, stepped
harvest regime, along with the
conservation measures proposed in the
plan. We have concluded that the Skagit
RMP would provide effective protection
to the Skagit River steelhead
populations based on parameters
defining a viable salmonid population;
in terms of overall abundance and
productivity, as well as the diversity
and spatial structure of the individual
populations within the Skagit River
basin. The Skagit RMP will provide for
the proposed harvest opportunities
while not appreciably slowing the
population’s achievement of viable
function.
NMFS’ determination on the Skagit
RMP depends upon implementation of
all of the monitoring, evaluation,
reporting tasks or assignments, and

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

enforcement activities included in the
RMP. Reporting and inclusion of new
information derived from research,
monitoring, and evaluation activities
described in the plan provide assurance
that performance standards will be
achieved in future seasons.
Summary of Comments Received in the
Response to the Proposed Evaluation
and Pending Determination
NMFS published notice of its
Proposed Evaluation and Pending
Determination (PEPD) on the plan for
public review and comment on
December 7, 2017 (82 FR 57729). The
PEPD was available for public review
and comment for 30 days.
During the public comment period,
121 comments were received, all by
email. These came in the form of:
Individual, unique comments;
individuals who submitted form-letter
communications, some with added
comments; and letters from fish
conservation organizations. NMFS
thoroughly reviewed and considered all
of the substantive comments received
from the public and the additional
literature and studies submitted. This
review of new information and data
informed NMFS’ subsequent analysis, in
its biological opinion, but did not lead
to any changes to the Skagit RMP, as
submitted, or to NMFS’ determination
that the plan adequately addresses the
4(d), Limit 6 criteria. A section
summarizing and responding to the
substantive comments received during
the public comment period on the PEPD
is included as part of the final
evaluation document, available on the
West Coast Region website. Based on its
evaluation and recommended
determination and taking into account
the public comments, NMFS issued its
final determination on the joint statetribal plan.

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Authority
Under section 4 of the ESA, the
Secretary of Commerce is required to
adopt such regulations as he deems
necessary and advisable for the
conservation of species listed as
threatened. The ESA salmon and
steelhead 4(d) rule (50 CFR 223.203(b))
specifies categories of activities that
contribute to the conservation of listed
salmonids and sets out the criteria for
such activities. The rule further
provides that the prohibitions of
paragraph (a) of the rule do not apply to
actions undertaken in compliance with
a plan developed jointly by a state and
a tribe and determined by NMFS to be
in accordance with the salmon and

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steelhead 4(d) rule (65 FR 42422, July
10, 2000).
Angela Somma,
Chief, Endangered Species Division, Office
of Protected Resources, National Marine
Fisheries Service.
[FR Doc. 2018–14950 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–22–P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Submission for OMB Review;
Comment Request
The Department of Commerce will
submit to the Office of Management and
Budget (OMB) for clearance the
following proposal for collection of
information under the provisions of the
Paperwork Reduction Act (44 U.S.C.
Chapter 35).
Agency: National Oceanic and
Atmospheric Administration (NOAA).
Title: National Oceanic and
Atmospheric Administration’s
Papahanaumokuakea Marine National
Monument and University of Hawaii
Research Internship Program.
OMB Control Number: 0648–0719.
Form Number(s): None.
Type of Request: Regular (extension of
a currently approved information
collection).
Number of Respondents: 80.
Average Hours per Response: 1 hour
or less, for each application, reference
letter and support letter.
Burden Hours: 80.
Needs and Uses: This request is for
extension of a currently approved
information collection.
The National Oceanic and
Atmospheric Administration’s
(NOAA’s) Papaha¯naumokua¯kea Marine
National Monument (PMNM) would
like to collect student data and
information for the purposes of selecting
candidates for its research internship
program in partnership with the
University of Hawaii. The application
package would contain: (1) A form
requesting information on academic
background and professional
experiences, (2) reference forms in
support of the internship application by
two educational or professional
references, and (3) a support letter from
one academic professor or advisor.
Affected Public: Individuals or
households.
Frequency: One time.
Respondent’s Obligation: Voluntary.
This information collection request
may be viewed at reginfo.gov. Follow
the instructions to view Department of

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Commerce collections currently under
review by OMB.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to OIRA_Submission@
omb.eop.gov or fax to (202) 395–5806.
Dated: July 8, 2018.
Sarah Brabson,
NOAA PRA Clearance Officer.
[FR Doc. 2018–14889 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–NK–P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Submission for OMB Review;
Comment Request
The Department of Commerce will
submit to the Office of Management and
Budget (OMB) for clearance the
following proposal for collection of
information under the provisions of the
Paperwork Reduction Act (44 U.S.C.
chapter 35).
Agency: National Oceanic and
Atmospheric Administration (NOAA).
Title: NOAA Marine Debris Program
Performance Progress Report and Data
Collection Form.
OMB Control Number: 0648–0718.
Form Number(s): None.
Type of Request: Regular (revision
and extension of a currently approved
information collection).
Number of Respondents: 70.
Average Hours per Response: 2.
Burden Hours: 1,400.
Needs and Uses: This request is for
revision and extension of an existing
information collection.
The NOAA Marine Debris Program
(MDP) supports national and
international efforts to research,
prevent, and reduce the impacts of
marine debris. The MDP is a centralized
office within NOAA that coordinates
and supports activities, both within the
bureau and with other federal agencies,
which address marine debris and its
impacts. In addition to inter-agency
coordination, the MDP uses
partnerships with state and local
agencies, tribes, non-governmental
organizations, academia, and industry to
investigate and solve the problems that
stem from marine debris through
research, prevention, and reduction
activities, in order to protect and
conserve our nation’s marine
environment and ensure navigation
safety.
The Marine Debris Research,
Prevention, and Reduction Act (33

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
U.S.C. 1951 et seq.) as amended by the
Marine Debris Act Amendments of 2012
(Pub. L. 112–213, Title VI, Sec. 603, 126
Stat. 1576, December 20, 2012) outlines
three central program components for
the MDP to undertake: (1) Mapping,
identification, impact assessment,
removal, and prevention; (2) reducing
and preventing fishing gear loss; and (3)
outreach to stakeholders and the general
public. To address these components,
the Marine Debris Act authorized the
MDP to establish several competitive
grant programs on marine debris
research, prevention and removal that
provide federal funding to non-federal
applicants throughout the coastal
United States and territories.
The terms and conditions of the
financial assistance awarded through
these grant programs require regular
progress reporting and communication
of project accomplishments to MDP.
Progress reports contain information
related to, among other things, the
overall short and long-term goals of the
project, project methods and monitoring
techniques, actual accomplishments
(such as pounds of debris removed from
an ecosystem, numbers of volunteers
participating in a cleanup project, etc.),
status of approved activities, challenges
or potential roadblocks to future
progress, and lessons learned. This
information collection enables MDP to
monitor and evaluate the activities
supported by federal funds to ensure
accountability to the public and to
ensure that funds are used consistent
with the purpose for which they were
appropriated. It also ensures that
reported information is standardized in
such a way that allows for it to be
meaningfully synthesized across a
diverse set of projects and project types.
MDP uses the information collected in
a variety of ways to communicate with
federal and non-federal partners and
stakeholders on individual project and
general program accomplishments.
Revision: A section has been added to
the report form, but there is no change
to burden.
Affected Public: Not-for-profit
institutions; business or other for-profit
organizations; state, local or tribal
government.
Frequency: Semiannual.
Respondent’s Obligation: Required to
obtain or retain benefits.
This information collection request
may be viewed at reginfo.gov. Follow
the instructions to view Department of
Commerce collections currently under
review by OMB.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this

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notice to OIRA_Submission@
omb.eop.gov or fax to (202) 395–5806.
Dated: July 8, 2018.
Sarah Brabson,
NOAA PRA Clearance Officer.
[FR Doc. 2018–14888 Filed 7–11–18; 8:45 am]
BILLING CODE 3510–JE–P

DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Submission for OMB Review;
Comment Request
The Department of Commerce will
submit to the Office of Management and
Budget (OMB) for clearance the
following proposal for collection of
information under the provisions of the
Paperwork Reduction Act (44 U.S.C.
chapter 35).
Agency: National Oceanic and
Atmospheric Administration (NOAA).
Title: Highly Migratory Species
Dealer, Importer, and Exporter
Reporting Family of Forms.
OMB Control Number: 0648–0040.
Form Number(s): None.
Type of Request: Regular (revision
and extension of a currently approved
information collection).
Number of Respondents: 10,391.
Average Hours per Response: 15
minutes for catch document/statistical
document/re-export certificate
validation by government official; 120
minutes for authorization of nongovernmental catch document/statistical
document/re-export certificate
validation; 2 minutes for daily Atlantic
bluefin tuna landing reports; 3 minutes
for daily Atlantic bluefin tuna landing
reports from pelagic longline and purse
seine vessels; 1 minute for Atlantic
bluefin tuna tagging; 15 minutes for
biweekly Atlantic bluefin tuna dealer
landing reports; 15 minutes for HMS
international trade biweekly reports; 15
minutes for weekly electronic HMS
dealer landing reports (e-dealer); 5
minutes for negative weekly electronic
HMS dealer landing reports (e-dealer);
15 minutes for voluntary fishing vessel
and catch forms; 2 minutes for provision
of HMS dealer email address.
Burden Hours: 18,552.
Needs and Uses: This request is for
revision and extension of a currently
approved information collection.
Under the provisions of the
Magnuson-Stevens Fishery
Conservation and Management Act (16
U.S.C. 1801 et seq.), the National Marine
Fisheries Service (NMFS) is responsible
for management of the Nation’s marine
fisheries. NMFS must also promulgate

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regulations, as necessary and
appropriate, to carry out obligations the
United States (U.S.) undertakes
internationally regarding tuna
management through the Atlantic Tunas
Convention Act (ATCA, 16 U.S.C. 971 et
seq.).
This collection serves as a family of
forms for Atlantic highly migratory
species (HMS) dealer reporting,
including purchases of HMS from
domestic fishermen, and the import,
export, and/or re-export of HMS,
including federally managed tunas,
sharks, and swordfish.
Transactions covered under this
collection include purchases of Atlantic
HMS from domestic fishermen; and the
import/export of all bluefin tuna, frozen
bigeye tuna, southern bluefin tuna or
swordfish under the HMS International
Trade Program, regardless of geographic
area of origin. This information is used
to monitor the harvest of domestic
fisheries, and/or track international
trade of internationally managed
species.
The domestic dealer reporting
covered by this collection includes
weekly electronic landing reports and
negative reports (i.e., reports of no
activity) of Atlantic swordfish, sharks,
bigeye tuna, albacore, yellowfin, and
skipjack tunas (collectively referred to
as BAYS tunas), and biweekly and
electronic daily landing reports for
bluefin tuna, including tagging of
individual fish. Because of the recent
development of an individual bluefin
quota (IBQ) management system (RIN
0648–BC09), electronic entry of IBQrelated landing data is required for
Atlantic bluefin tuna purchased from
Longline and Purse seine category
vessels. NMFS intends to consider
integrating the electronic dealer
reporting for bluefin tuna and electronic
reporting for the IBQ system; however,
at this time, dealers must submit limited
bluefin tuna landings data to both
NMFS systems for purse seine and
pelagic longline vessels.
International trade tracking programs
are required by both the International
Commission for the Conservation of
Atlantic Tunas (ICCAT) and the InterAmerican Tropical Tuna Commission
(IATTC) to account for all international
trade of covered species. The U.S. is a
member of ICCAT and IATTC and
required by ATCA and the Tunas
Convention Act (16 U.S.C. 951 et. seq.,
consecutively) to promulgate
regulations as necessary and appropriate
to implement ICCAT and IATTC
recommendations. These programs
require that a statistical document or
catch document accompany each export
from and import to a member nation,

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

and that a re-export certificate
accompany each re-export. The
international trade reporting
requirements covered by this collection
include implementation of catch
document, statistical document, and reexport certificate trade tracking
programs for bluefin tuna, frozen bigeye
tuna, and swordfish. An electronic catch
document program for bluefin tuna
(EBCD) was recommended by ICCAT
and implemented by the United States
in 2016 (0648–BF17). U.S. regulations
implementing ICCAT statistical
document and catch document
programs require statistical documents
and catch documents for international
transactions of the covered species from
all ocean areas, so Pacific imports and
exports must also be accompanied by
statistical documents and catch
documents. Since there are statistical
document programs in place under
other international conventions (e.g., the
Indian Ocean Tuna Commission), a
statistical document or catch document
from another program may be used to
satisfy the statistical document
requirement for imports into the United
States. Revision: These statistical and
catch documents are now covered under
OMB Control No. 0648–0732, but their
validation is still part of this
information collection.
Dealers who internationally trade
Southern bluefin tuna are required to
participate in a trade tracking program
to ensure that imported Atlantic and
Pacific bluefin tuna will not be
intentionally mislabeled as ‘‘southern
bluefin’’ to circumvent reporting
requirements. This action is authorized
under ATCA, which provides for the
promulgation of regulations as may be
necessary and appropriate to carry out
ICCAT recommendations.
In addition to statistical document,
catch document, and re-export
certificate requirements, this collection
includes biweekly reports to
complement trade tracking statistical
documents by summarizing statistical
document data and collecting additional
economic information.
Affected Public: Business or other forprofit organizations.
Frequency: Weekly and biweekly.
Respondent’s Obligation: Mandatory.
This information collection request
may be viewed at reginfo.gov. Follow
the instructions to view Department of
Commerce collections currently under
review by OMB.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to OIRA_Submission@
omb.eop.gov or fax to (202) 395–5806.

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Dated: July 8, 2018.
Sarah Brabson,
NOAA PRA Clearance Officer.

personal identifiers or contact
information.

BILLING CODE 3510–22–P

DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DOD–2018–OS–0043]

Proposed Collection; Comment
Request
Office of the Under Secretary of
Defense for Personnel and Readiness,
DoD.
ACTION: Information collection notice.
AGENCY:

In compliance with the
Paperwork Reduction Act of 1995, the
Office of the Deputy Assistant Secretary
of Defense for Military Personnel Policy
announces a proposed public
information collection and seeks public
comment on the provisions thereof.
Comments are invited on: Whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; the accuracy of the
agency’s estimate of the burden of the
proposed information collection; ways
to enhance the quality, utility, and
clarity of the information to be
collected; and ways to minimize the
burden of the information collection on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
DATES: Consideration will be given to all
comments received by September 10,
2018.
SUMMARY:

You may submit comments,
identified by docket number and title,
by any of the following methods:
Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Department of Defense, Office of
the Chief Management Officer,
Directorate for Oversight and
Compliance, 4800 Mark Center Drive,
Mailbox #24, Suite 08D09, Alexandria,
VA 22350–1700.
Instructions: All submissions received
must include the agency name, docket
number and title for this Federal
Register document. The general policy
for comments and other submissions
from members of the public is to make
these submissions available for public
viewing on the internet at http://
www.regulations.gov as they are
received without change, including any

ADDRESSES:

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To
request more information on this
proposed information collection or to
obtain a copy of the proposal and
associated collection instruments,
please write to the Office of the Deputy
Assistant Secretary of Defense for
Military Personnel Policy, ATTN:
Accession Policy (3D1066), 1500
Defense Pentagon, Washington, DC
20301–1500, or call 703–695–5525.
SUPPLEMENTARY INFORMATION:
Title; Associated Form; and OMB
Number: Police Records Check; DD
Form 369; OMB Control Number 0704–
0007.
Needs and Uses: The information
collection requirement is necessary, per
Sections 504, 505 Title 10 U.S.C, to
identify persons who may be
undesirable for military service.
Applicants for enlistment must be
screened to identify any discreditable
involvement with police or other law
enforcement agencies. The DD Form
369, ‘‘Police Records Check,’’ is
forwarded to law enforcement agencies
to identify if an applicant has a criminal
record.
Affected Public: State, Local or Tribal
Government.
Annual Burden Hours: 78,750.
Number of Respondents: 175,000.
Responses per Respondent: 1.
Annual Responses: 175,000.
Average Burden per Response: 27
minutes.
Frequency: On occasion.
FOR FURTHER INFORMATION CONTACT:

[FR Doc. 2018–14887 Filed 7–11–18; 8:45 am]

Dated: July 9, 2018.
Shelly E. Finke,
Alternate OSD Federal Register, Liaison
Officer, Department of Defense.
[FR Doc. 2018–14933 Filed 7–11–18; 8:45 am]
BILLING CODE 5001–06–P

DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID: DOD–2018–OS–0041]

Notice of Availability of an
Environmental Assessment
Addressing Hazardous Materials
Warehouses and Gas Cylinder Sheds
at Naval Station Norfolk and Naval
Support Activity Norfolk Naval
Shipyard, Virginia
Defense Logistics Agency
(DLA), Department of Defense.
ACTION: Notice of availability (NOA).
AGENCY:

DLA announces the
availability of an Environmental
Assessment (EA) documenting the

SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
potential environmental effects
associated with the proposed action to
construct and operate hazardous
materials warehouses and gas cylinder
sheds at Naval Station Norfolk and
Naval Support Activity Norfolk Naval
Shipyard, Virginia. The EA has been
prepared as required under the National
Environmental Policy Act (NEPA) and
DLA Regulation, Environmental
Considerations in Defense Logistics
Agency Actions.
DATES: The public comment period will
end on August 13, 2018.
ADDRESSES: You may submit comments,
identified by DOD–2018–OS–0041, to
one of the following:
Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Department of Defense, Office of
the Deputy Chief Management Officer,
Directorate for Oversight and
Compliance, Regulatory and Advisory
Committee Division, 4800 Mark Center
Drive, Mailbox #24, Suite 08D09,
Alexandria, VA 22350–1700.
FOR FURTHER INFORMATION CONTACT: Ira
Silverberg at 571–767–0705 during
normal business hours Monday through
Friday, from 8:00 a.m. to 4:30 p.m.
(EDT) or by email: ira.silverberg@
dla.mil.
Dated: July 9, 2018.
Shelly E. Finke,
Alternate OSD Federal Register, Liaison
Officer, Department of Defense.

You may submit comments,
identified by DOD–2018–OS–0042, to
one of the following:
Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Mail: Department of Defense, Office of
the Deputy Chief Management Officer,
Directorate for Oversight and
Compliance, Regulatory and Advisory
Committee Division, 4800 Mark Center
Drive, Mailbox #24, Suite 08D09,
Alexandria, VA 22350–1700.
FOR FURTHER INFORMATION CONTACT: Ira
Silverberg at 571–767–0705 during
normal business hours Monday through
Friday, from 8:00 a.m. to 4:30 p.m.
(EDT) or by email: ira.silverberg@
dla.mil.
ADDRESSES:

The EA
has been prepared as required under the
National Environmental Policy Act
(NEPA) and DLA Regulation 1000.22,
Environmental Considerations in
Defense Logistics Agency Actions.
The EA posted to the docket provides
additional information about the
proposed action.
The EA is available in hardcopy at the
Tracy Branch Library, 20 East Eaton
Avenue, Tracy, CA 95376.

SUPPLEMENTARY INFORMATION:

Dated: July 9, 2018.
Shelly E. Finke,
Alternate OSD Federal Register, Liaison
Officer, Department of Defense.
[FR Doc. 2018–14927 Filed 7–11–18; 8:45 am]
BILLING CODE 5001–06–P

[FR Doc. 2018–14926 Filed 7–11–18; 8:45 am]
BILLING CODE 5001–06–P

FEDERAL COMMUNICATIONS
COMMISSION

DEPARTMENT OF DEFENSE

[OMB 3060–1048]

Office of the Secretary
[Docket ID: DOD–2018–OS–0042]

Notice of Availability for an
Environmental Assessment
Addressing Upgrade of the Main Gate
Access Control Point at Defense
Distribution Depot, San Joaquin,
California, and Surrounding Area
Defense Logistics Agency
(DLA), Department of Defense.
ACTION: Notice of availability (NOA).
AGENCY:

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Federal Communications
Commission.
ACTION: Notice and request for
comments.
AGENCY:

As part of its continuing effort
to reduce paperwork burdens, and as
required by the Paperwork Reduction
Act of 1995 (PRA), the Federal
Communications Commission (FCC or
Commission) invites the general public
and other Federal agencies to take this
opportunity to comment on the
following information collections.
Comments are requested concerning:
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the

SUMMARY:

DLA announces the
availability of an Environmental
Assessment (EA) documenting the
potential environmental effects
associated with the proposed action to
upgrade the main gate access control
point at Defense Distribution Depot, San
Joaquin, California, and surrounding
area.
DATES: The public comment period will
end on August 13, 2018.
SUMMARY:

Information Collection Being Reviewed
by the Federal Communications
Commission Under Delegated
Authority

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32287

information shall have practical utility;
the accuracy of the Commission’s
burden estimate; ways to enhance the
quality, utility, and clarity of the
information collected; ways to minimize
the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology; and ways to
further reduce the information
collection burden on small business
concerns with fewer than 25 employees.
The FCC may not conduct or sponsor
a collection of information unless it
displays a currently valid Office of
Management and Budget (OMB) control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
PRA that does not display a valid OMB
control number.
DATES: Written PRA comments should
be submitted on or before September 10,
2018. If you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all PRA comments to
Cathy Williams, FCC, via email to PRA@
fcc.gov and to [email protected].
FOR FURTHER INFORMATION CONTACT: For
additional information about the
information collection, contact Cathy
Williams at (202) 418–2918.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–1048.
Title: Section 1.929(c)(1), Composite
Interference Contour (CIC).
Form Number: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities, not-for-profit institutions
and state, local or tribal government.
Number of Respondents and
Responses: 50 respondents; 50
responses.
Estimated Time per Response: 2
hours.
Frequency of Response: On occasion
reporting requirement.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
is contained in 47 U.S.C. 309(j).
Total Annual Burden: 100 hours.
Total Annual Cost: No cost.
Privacy Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Needs and Uses: The Commission
will submit this expiring information
collection to the Office of Management

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and Budget (OMB) for approval of an
extension request.
Under 47 CFR 1.929(c)(1) of the
Commission’s rules, any increase in the
composite interference contour (CIC) of
a site-based licensee in the Paging and
Radiotelephone Service, Rural
Radiotelephone Service, or 800 MHz
Specialized Mobile Radio Service is a
major modification of a license that
requires prior Commission approval.
However, in February 2005, the
Commission adopted and released final
rules which amended section 1.929(c)(1)
to specify that expansion of a composite
interference contour (CIC) of a sitebased licensee in the Paging and
Radiotelephone Service—as well as the
Rural Radiotelephone Service and 800
MHz Specialized Mobile Radio
Service—over water on a secondary,
non-interference basis should be
classified as a minor (rather than major)
modification of a license. Such
reclassification has eliminated the filing
requirements associated with these
license modifications, but requires sitebased licensees to provide the
geographic area licensee (on the same
frequency) with the technical and
engineering information necessary to
evaluate the site-based licensee’s
operations over water.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2018–14860 Filed 7–11–18; 8:45 am]
BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS
COMMISSION
[OMB 3060–0009, OMB 3060–0594, OMB
3060–0601 and OMB 3060–0609]

Information Collections Being
Reviewed by the Federal
Communications Commission Under
Delegated Authority
Federal Communications
Commission.
ACTION: Notice and request for
comments.
AGENCY:

As part of its continuing effort
to reduce paperwork burdens, and as
required by the Paperwork Reduction
Act of 1995 (PRA), the Federal
Communications Commission (FCC or
Commission) invites the general public
and other Federal agencies to take this
opportunity to comment on the
following information collections.
Comments are requested concerning:
whether the proposed collection of
information is necessary for the proper
performance of the functions of the

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SUMMARY:

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Commission, including whether the
information shall have practical utility;
the accuracy of the Commission’s
burden estimate; ways to enhance the
quality, utility, and clarity of the
information collected; ways to minimize
the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology; and ways to
further reduce the information
collection burden on small business
concerns with fewer than 25 employees.
The FCC may not conduct or sponsor
a collection of information unless it
displays a currently valid Office of
Management and Budget (OMB) control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
PRA that does not display a valid OMB
control number.
DATES: Written PRA comments should
be submitted on or before August 13,
2018. If you anticipate that you will be
submitting comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all PRA comments to
Cathy Williams, FCC, via email to PRA@
fcc.gov and to [email protected].
FOR FURTHER INFORMATION CONTACT: For
additional information about the
information collection, contact Cathy
Williams at (202) 418–2918.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–0009.
Title: Application for Consent to
Assignment of Broadcast Station
Construction Permit or License or
Transfer of Control of Corporation
Holding Broadcast Station Construction
Permit or License, FCC Form 316.
Form Number: FCC Form 316.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities; Not-for-profit
institutions; State, local or tribal
government.
Number of Respondents and
Responses: 750 respondents, 750
responses.
Estimated Time per Response: 1.5–4.5
hours.
Frequency of Response: On occasion
reporting requirement.
Obligation To Respond: Required to
obtain benefits. Statutory authority for
this collection of information is
contained in Sections 154(i) and 310(d)
of the Communications Act of 1934, as
amended.
Total Annual Burden: 1,231 hours.
Total Annual Cost: $711,150.

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Privacy Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
Confidentiality is not required with this
collection of information.
Needs and Uses: FCC Form 316 is
required when applying for authority for
assignment of a broadcast station
construction permit or license, or for
consent to transfer control of a
corporation holding a broadcast station
construction permit or license where
there is little change in the relative
interest or disposition of its interests;
where transfer of interest is not a
controlling one; there is no substantial
change in the beneficial ownership of
the corporation; where the assignment is
less than a controlling interest in a
partnership; where there is an
appointment of an entity qualified to
succeed to the interest of a deceased or
legally incapacitated individual
permittee, licensee or controlling
stockholder; and, in the case of LPFM
stations, where there is a voluntary
transfer of a controlling interest in the
licensee or permittee entity. In addition,
the applicant must notify the
Commission when an approved transfer
of control of a broadcast station
construction permit or license has been
consummated.
OMB Control Number: 3060–0594.
Title: Cost of Service Filing for
Regulated Cable Services, FCC Form
1220.
Form Number: FCC Form 1220.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities; State, Local, or Tribal
Government.
Number of Respondents and
Responses: 20 respondents; 10
responses.
Estimated Hours per Response: 4–80
hours.
Frequency of Response: On occasion
and annual reporting requirements;
Third party disclosure requirement.
Total Annual Burden: 1,220 hours.
Total Annual Cost: $100,000.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this collection is contained
is Sections 154(i) and 623 of the
Communications Act of 1934, as
amended.
Nature and Extent Confidentiality:
There is no need for confidentiality with
this collection of information.
Privacy Impact Assessment: No
impact(s).
Needs and Uses: The Cable Television
Consumer Protection and Competition
Act of 1992 required the Commission to
prescribe rules and regulations for

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determining reasonable rates for basic
tier cable service and to establish
criteria for identifying unreasonable
rates for cable programming services
and associated equipment.
OMB Control Number: 3060–0601.
Title: Setting Maximum Initiated
Permitted Rates for Regulated Cable
Services, FCC Form 1200.
Form Number: FCC Form 1200.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities; State, Local, or Tribal
Government.
Number of Respondents and
Responses: 100 respondents; 50
responses.
Estimated Hours per Response: 2–10
hours.
Frequency of Response: One time and
annual reporting requirements; Third
party disclosure requirement.
Total Annual Burden: 800 hours.
Total Annual Cost: $62,500.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this collection is contained
in Section 623 of the Communications
Act of 1934, as amended.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.
Privacy Impact Assessment: No
impact(s).
Needs and Uses: Cable operators and
local franchise authorities file FCC Form

1200 to justify the reasonableness of
rates in effect on or after May 15, 1994.
The FCC uses the data to evaluate cable
rates the first time they are reviewed on
or after May 15, 1994, so that maximum
permitted rates for regulated cable
service can be determined.
OMB Control Number: 3060–0609.
Title: Section 76.934(e), Petitions for
Extension of Time.
Form Number: Not applicable.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities; and State, local, or tribal
governments.
Number of Respondents and
Responses: 20 respondents; 10
responses.
Frequency of Response: On occasion
reporting requirement; Third party
disclosure requirement.
Estimated Time per Response: 4
hours.
Total Annual Burden: 80 hours.
Total Annual Cost: None.
Privacy Impact Assessment: No
impact(s).
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority is contained in Sections 4(i)
and 623 of the Communications Act of
1934, as amended.
Nature and Extent of Confidentiality:
There is no need for confidentiality with
this collection of information.

32289

Needs and Uses: The information
collection requirements contained
under 47 CFR 76.934(e) states that small
cable systems may obtain an extension
of time to establish compliance with
rate regulations provided that they can
demonstrate that timely compliance
would result in severe economic
hardship. Requests for the extension of
time should be addressed to the local
franchising authorities (‘‘LFAs’’)
concerning rates for basic service tiers.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2018–14858 Filed 7–11–18; 8:45 am]
BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS
COMMISSION
Open Commission Meeting, Thursday,
July 12, 2018
July 5, 2018.

The Federal Communications
Commission will hold an Open Meeting
on the subjects listed below on
Thursday, July 12, 2018 which is
scheduled to commence at 10:30a.m. in
Room TW–C305, at 445 12th Street SW,
Washington, DC.

Item No.

Bureau

Subject

1 ......................

WIRELESS TELE-COMMUNICATIONS,
INTERNATIONAL AND OFFICE OF
ENGINEERING & TECHNOLOGY.

2 ......................

WIRELESS TELE-COMMUNICATIONS ..

Title: Expanding Flexible Use of the 3.7 to 4.2 GHz Band (GN Docket No. 18–
122); Expanding Flexible Use in Mid-Band Spectrum Between 3.7 and 24 GHz
(GN Docket No. 17–183); Petition for Rulemaking to Amend and Modernize
Parts 25 and 101 of the Commission’s Rules to Authorize and Facilitate the Deployment of Licensed Point-to-Multipoint Fixed Wireless Broadband Service in
the 3.7–4.2 GHz Band (RM–11791); Fixed Wireless Communications Coalition,
Inc., Request for Modified Coordination Procedures in Band Shared Between the
Fixed Service and the Fixed Satellite Service (RM–11778)
Summary: The Commission will consider an Order and Notice of Proposed Rulemaking that would continue the Commission’s efforts to make mid-band spectrum in the 3.7–4.2 GHz band available for expanded flexible use, primarily by
seeking comment on mechanisms for clearing for mobile use and whether to
allow point-to-multipoint use on a shared basis in portions of the band. To inform
the Commission’s decision-making on the future of the band, it would also collect information about FSS earth stations and space stations to provide a clear
understanding of the operations of current users.
Title: Amendment of Parts 1 and 22 of the Commission’s Rules with Regard to the
Cellular Service, Including Changes in Licensing of Unserved Area (WT Docket
No. 12–40); Amendment of the Commission’s Rules with Regard to Relocation
of Part 24 to Part 27; Interim Restrictions and Procedures for Cellular Service
Applications (RM–11510); Amendment of Parts 0, 1, and 22 of the Commission’s Rules with Regard to Frequency Coordination for the Cellular Service;
Amendment of Part 22 of the Commission’s Rules Regarding Certain Administrative and Filing Requirements; Amendment of the Commission’s Rules Governing Radiated Power Limits for the Cellular Service (RM–11660); Amendment
of Parts 1, 22, 24, 27, 74, 80, 90, 95, and 101 to Establish Uniform License Renewal, Discontinuance of Operation, and Geographic Partitioning and Spectrum
Disaggregation Rules and Policies for Certain Wireless Radio Services (WT
Docket No. 10–112); 2016 Biennial Review of Telecommunications Regulations
(WT Docket No. 16–138)
Summary:The Commission will consider a Report and Order eliminating unnecessary rules that apply to cellular service and other licensees.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Item No.

Bureau

Subject

3 ......................

MEDIA ......................................................

4 ......................

PUBLIC SAFETY & HOMELAND SECURITY.

5 ......................

WIRELINE COMPETITION ......................

6 ......................

ENFORCEMENT ......................................

Title: Children’s Television Programming Rules (MB Docket No. 18–202); Modernization of Media Regulation Initiative (MB Docket No. 17–105)
Summary: The Commission will consider a Notice of Proposed Rulemaking seeking comment on proposed revisions to the children’s television programming
rules to provide broadcasters greater flexibility in meeting their children’s programming obligations.
Title: Amendment of Part 11 of the Commission’s Rules Regarding the Emergency
Alert System (PS Docket No. 15–94); Wireless Emergency Alerts (PS Docket
No. 15–91)
Summary: The Commission will consider a Report and Order and Further Notice of
Proposed Rulemaking to improve emergency alerting, including facilitating more
effective EAS tests and preventing false alerts.
Title: Nationwide Number Portability (WC Docket No. 17–244); Numbering Policies
for Modern Communications (WC Docket No. 13–97)
Summary: The Commission will consider a Report and Order that forbears from
legacy requirements and amends rules to facilitate the move toward complete
nationwide number portability to promote competition between all service providers and increase network routing efficiencies.
Title: Amendment of Procedural Rules Governing Formal Complaint Proceedings
Delegated to the Enforcement Bureau (EB Docket No. 17–245)
Summary: The Commission will consider a Report and Order that consolidates and
streamlines the rules governing formal complaint proceedings delegated to the
Enforcement Bureau.

*

*
*
*
*
The meeting site is fully accessible to
people using wheelchairs or other
mobility aids. Sign language
interpreters, open captioning, and
assistive listening devices will be
provided on site. Other reasonable
accommodations for people with
disabilities are available upon request.
In your request, include a description of
the accommodation you will need and
a way we can contact you if we need
more information. Last minute requests
will be accepted, but may be impossible
to fill. Send an email to: [email protected]
or call the Consumer & Governmental
Affairs Bureau at 202–418–0530 (voice),
202–418–0432 (TTY).
Additional information concerning
this meeting may be obtained from the
Office of Media Relations, (202) 418–
0500; TTY 1–888–835–5322. Audio/
Video coverage of the meeting will be
broadcast live with open captioning
over the internet from the FCC Live web
page at www.fcc.gov/live.
For a fee this meeting can be viewed
live over George Mason University’s
Capitol Connection. The Capitol
Connection also will carry the meeting
live via the internet. To purchase these
services, call (703) 993–3100 or go to
www.capitolconnection.gmu.edu.

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Federal Communications Commission.
Marlene Dortch,
Secretary.
[FR Doc. 2018–14861 Filed 7–11–18; 8:45 am]
BILLING CODE 6712–01–P

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FEDERAL DEPOSIT INSURANCE
CORPORATION
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request (OMB No.
3064–0109; 0124; and 0162)
Federal Deposit Insurance
Corporation (FDIC).

AGENCY:
ACTION:

Notice and request for comment.

The FDIC, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on the renewal of existing
information collections, as required by
the Paperwork Reduction Act of 1995.
The FDIC published notices of its intent
to renew the information collections
described below in the Federal Register
and requested comment for 60 days. No
comments were received. The FDIC
hereby gives notice of its plan to submit
to OMB a request to approve the
renewal of these collections, and again
invites comment on the renewal.

SUMMARY:

Comments must be submitted on
or before August 13, 2018.

DATES:

Interested parties are
invited to submit written comments to
the FDIC by any of the following
methods:
• https://www.FDIC.gov/regulations/
laws/federal.

ADDRESSES:

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• Email: [email protected]. Include
the name and number of the collection
in the subject line of the message.
• Mail: Manny Cabeza, Counsel,
Room MB–3007, Federal Deposit
Insurance Corporation, 550 17th Street
NW, Washington, DC 20429.
• Hand Delivery: Comments may be
hand-delivered to the guard station at
the rear of the 17th Street Building
(located on F Street), on business days
between 7:00 a.m. and 5:00 p.m.
All comments should refer to the
relevant OMB control number. A copy
of the comments may also be submitted
to the OMB desk officer for the FDIC:
Office of Information and Regulatory
Affairs, Office of Management and
Budget, New Executive Office Building,
Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT:

Manny Cabeza, Counsel, 202–898–3767,
[email protected], MB–3007, Federal
Deposit Insurance Corporation, 550 17th
Street NW, Washington, DC 20429.
SUPPLEMENTARY INFORMATION:

Proposal to renew the following
currently approved collections of
information:
1. Title: Notice of Branch Closure.
OMB Number: 3064–0109.
Form Number: None.
Affected Public: Insured depository
institutions.
Burden Estimate:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
SUMMARY OF ANNUAL BURDEN
Estimated
time per
response
(hours)

Estimated
number of
respondents

Type of burden

Adoption of Closure Policy ...............................................
Notice of Closure ..............................................................

Recordkeeping .....
Disclosure .............

Mandatory ............
Mandatory ............

23
683

8
2

One time ...............
On occasion .........

184
1,366

Total Estimated Annual Burden ................................

...............................

...............................

....................

....................

...............................

1,550

General Description of Collection:
Section 42 of the Federal Deposit
Insurance Act mandates that an insured
depository institution closing a branch
notify its primary federal regulator not
later than 90 days prior to the closing.
The statute also provides that a notice
be posted on the premises of the branch
for the 30-day period immediately prior
to the closing and that the customers be
notified in a mailing at least 90 days
prior to the closing. Each insured
depository institution that has one or
more branches is required to adopt a
written policy for branch closings.
Burden Estimate Methodology and
Assumptions:
There are no changes in the
methodology or substance of this
information collection. FDIC believes
that the existing estimate of the time
required to develop a written branch
closure policy and to provide the

required branch closure notices is
accurate. The number of branch closure
notifications is closely related to the
number of branches closed, while the
number of closure policy adoptions
equals the number newly chartered
branch banking institutions and the
number of existing banking institutions
that transition from having no branches
to having at least one branch. To derive
an estimate of average annual branch
closure notifications, FDIC Risk
Management Supervision (RMS) staff
counted the number of full-service
standalone and in-store branches that
closed between 2015 and 2017. In
addition, FDIC staff count the number of
newly chartered branch banking
institutions and the number of
institutions that transitioned from
having no branches to having at least
one branch. To derive an estimate of
average annual branch closure

Frequency
of response

Average
total
annual
estimated
burden
(hours)

Obligation
to respond

notifications, FDIC Risk Management
Supervision (RMS) staff counted the
number of full-service standalone and
in-store branches that closed between
2015 and 2017. In addition, FDIC staff
counted the number of newly chartered
branch banking institutions and the
number of institutions that transitioned
from having no branches to having at
least one branch. FDIC records reflect
that there were 683 branch closures, on
average, each year between 2015 and
2017. FDIC estimates that an average of
23 institutions each year will transition
from having no branches to having at
least one branch.
2. Title: Notification of Change of
Insured Status.
OMB Number: 3064–0124.
Form Number: None.
Affected Public: Insured depository
institutions.
Burden Estimate:

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SUMMARY OF ANNUAL BURDEN
Estimated
time per
response
(hours)

Estimated
number of
respondents

Type of burden

Certification .......................................................................
Notification ........................................................................

Reporting ..............
Disclosure .............

Mandatory ............
Mandatory ............

150
2

.25
1

On Occasion ........
On Occasion ........

37.5
2

Total Estimated Annual Burden ................................

...............................

...............................

....................

....................

...............................

39.5

General Description of Collection:
This information collection consists
of two parts: (1) A certification that
insured depository institutions provide
the FDIC when all deposit liabilities
from one insured depository institution
are assumed from another insured
depository institution, with the latter
institution responsible for providing the
certification, and (2) a notification that
an insured depository institution
provides to its depositors when it seeks
to voluntarily terminate its insured
status. The certification is necessary to
implement the provisions of section 8(q)
of the Federal Deposit Insurance Act, 12
U.S.C. 1818(q), regarding termination of
the insured status of the transferring
institution and termination of the
separate deposit insurance coverage

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provided on deposit accounts assumed
by the assuming institution. The
depositor notification is required by
section 8(a) (6) of the Federal Deposit
Insurance Act, 12 U.S.C. 1818(a) (6).
This provision ensures that the
institution’s depositors receive
appropriate information regarding the
institution’s intent to terminate its
insured status and that, prior to the
termination of the institution’s insured
status, depositors receive appropriate
information concerning federal deposit
insurance coverage of their accounts
once the institution’s insured status is
terminated.
There is no change in the
methodology or substance of this
information collection. The number of
certifications submitted under this

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Frequency
of response

Average
total
annual
estimated
burden
(hours)

Obligation
to respond

information collection is closely related
to the number of insured depository
institutions that are acquired by another
depository institution through mergers
or as a result of the closing of the
institution by its chartering authority.
The number of depositor notifications is
driven by the number of institutions
that elect to voluntarily terminate its
insured status without having its
deposits assumed by another insured
depository institution. The change in
burden is due to economic fluctuation
reflected in a lower number of
certifications following mergers or
closures and a reduction in the number
of notifications due to voluntary
terminations of insured status.
3. Title: Large Bank Deposit Insurance
Program.

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OMB Number: 3064–0162.
Form Number: None.
Affected Public: Insured depository
institutions having at least $2 billion in

deposits and at least either: (a) 250,000
Deposit accounts; or (b) $20 billion in
total assets, regardless of the number of

deposit accounts (a ‘‘covered
institution’’).
Burden Estimate:

SUMMARY OF ANNUAL BURDEN
Obligation to
respond

Type of burden

Average
estimated
number of
respondents

Estimated
time per
response
(hours)

Frequency of
response

Average
total annual
estimated
burden
(hours)

Implementation
Posting and removing provisional holds—360.9(c)(1)
and (2).
Providing standard data format for deposit account and
customer information—360.9(d)(1).
Notification of identity of person responsible for producing standard data downloads—360.9(c)(3).
Request for exemption from provisional hold requirements—360.9(c)(9).
Provide deposit account and customer information in required standard format—360.9(d)(3).
Request for extension of compliance deadline—
360.9(e)(7).
Request for exemption—360.9(f) .....................................

Recordkeeping .....

Mandatory ............

8

150

One time ...............

1,200

Recordkeeping .....

Mandatory ............

8

110

One time ...............

880

Reporting ..............

Mandatory ............

8

8

One time ...............

64

Reporting ..............

Voluntary ..............

1

20

On occasion .........

20

Reporting ..............

Mandatory ............

8

40

On occasion .........

320

Reporting ..............

Voluntary ..............

1

20

On occasion .........

20

Reporting ..............

Voluntary ..............

1

20

On occasion .........

20

Total Implementation Burden ....................................

...............................

...............................

....................

....................

...............................

2,524

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Ongoing
Notification of identity of person responsible for producing standard data downloads—360.9(c)(3).
Request for exemption from provisional hold requirements—360.9(c)(9).
Request for exemption—360.9(f) .....................................
Test compliance with 360.9(c)–(d) pursuant to 360.9(h)

Reporting ..............

Mandatory ............

153

8

On occasion .........

1,224

Reporting ..............

Voluntary ..............

1

20

On occasion .........

20

Reporting ..............
Reporting ..............

Voluntary ..............
Mandatory ............

1
81

20
80

On occasion .........
On occasion .........

20
6,480

Total Ongoing Burden ...............................................

...............................

...............................

....................

....................

...............................

7,744

Total Estimated Annual Burden .........................

...............................

...............................

....................

....................

...............................

10,268

General Description of Collection:
Upon the failure of an FDIC-insured
depository institution, the FDIC is
required to pay insured deposits as soon
as possible.1 To do so, the FDIC must be
able to quickly determine the total
insured amount for each depositor. To
make this determination, the FDIC must
ascertain the balances of all deposit
accounts owned by the same depositor
in the same ownership capacity at a
failed institution as of the day of failure.
The FDIC issued a regulation (12 CFR
360.9) to modernize the process of
determining the insurance status of each
depositor in the event of failure of a
covered institution. The regulation
requires covered institutions to adopt
mechanisms that would, in the event of
the institution’s failure (1) provide the
FDIC with standard deposit account and
other customer information, and (2)
allow the placement and release of
holds on liability accounts, including
deposits. The regulation applies only to
covered institutions and imposes the
1 The FDIC can meet its obligation to pay insured
deposits either by payment in cash or by making
available to each depositor a transferred deposit in
a another insured depository institution. 12 U.S.C
§ 1821(f)(1).

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following recordkeeping and reporting
requirements:
Recordkeeping
360.9(c)(1) and (2)—Posting and
Removing Provisional Holds. Covered
institutions must have an automatic
process for placing a provisional hold
on deposit accounts within timeframes
specified in FDIC regulations.
360.9(d)(1) and (2)—Providing
Standard Data Format for Deposit
Account and Customer Information.
Covered institutions must produce
information in the specified standard
data format.
Reporting
360.9(c)(3)—Covered institutions
must notify the FDIC of the person(s)
responsible for producing required
standard data downloads and for
administering provisional holds.
360.9(c)(9)—A covered institution
may request an exemption from the
provisional hold requirements for
certain account systems servicing a
relatively small number of accounts
where manual application of
provisional holds is feasible.

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360.9(d)(3)—Upon request by the
FDIC, a covered institution must submit
the data required by 360.9(d)(1) .
360.9(e)(7)—A covered institution
may request an extension of the
deadline to comply with provisional
hold and standard data format
requirements.
360.9(f)—A covered institution may
request an exemption from the
provisional hold and standard data
format requirements due to high
concentration of deposits incidental to
credit card operations.
360.9(h)—A covered institution’s
compliance with the recordkeeping and
reporting requirements set forth in the
rule will be tested by the FDIC.
Burden Estimate Methodology and
Assumptions:
The FDIC is revising its burden
estimate because the number of covered
institutions has decreased due to
economic fluctuations and most covered
institutions have already implemented
the requirements of the regulation and
will only face reduced ongoing
compliance burdens. Based on FDIC
Call Report data,2 the regulation
currently applies to 145 institutions.
2 FDIC

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The FDIC has determined that in the
past, between 1 and 3 new institutions
per quarter have become covered under
the regulation. FDIC estimates that on

average, 2 new institutions per quarter
(8 new institutions per year) will
become covered and be subject to initial
implementation burden. The following

table reflects the FDCI’s estimate of the
breakdown of covered institutions
facing implementation and ongoing
burden during the next three years:

NUMBER OF INSTITUTIONS
Year 1

Year 3

Average

Implementation ................................................................................................................
Ongoing ...........................................................................................................................

8
145

8
153

8
161

8
153

Total ..........................................................................................................................

153

161

169

161

All covered institutions will be
required to comply with the
requirements of 360.9(h). FDIC
estimates that half of the covered
institutions will be tested for
compliance each year. As a result, it is
estimated that an average of 81 covered
institutions will be affected by this
reporting burden annually. No
institutions have requested an extension
under section 360.9(e)(7), or exemptions
under sections 360.9(c)(9) or 360.9(f).
The ‘‘Summary of Annual Burden’’ table
above lists a respondent count of 1 for
these requests as placeholders to
preserve the burden estimates for these
activities.
Request for Comment: Comments are
invited on: (a) Whether the collection of
information is necessary for the proper
performance of the FDIC’s functions,
including whether the information has
practical utility; (b) the accuracy of the
estimates of the burden of the
information collection, including the
validity of the methodology and
assumptions used; (c) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
All comments will become a matter of
public record.
Dated at Washington, DC, on July 6, 2018.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2018–14864 Filed 7–11–18; 8:45 am]
BILLING CODE 6714–01–P

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Year 2

FEDERAL ELECTION COMMISSION
Sunshine Act Meeting
Tuesday, July 17, 2018
at 10:00 a.m.
PLACE: 1050 First Street NE,
Washington, DC.
TIME AND DATE:

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This meeting will be closed to
the public.
MATTERS TO BE CONSIDERED: Compliance
matters pursuant to 52 U.S.C. 30109.
Matters concerning participation in
civil actions or proceedings or
arbitration.
*
*
*
*
*
Contact Person for More Information:
Judith Ingram, Press Officer, Telephone:
(202) 694–1220.
STATUS:

Laura E. Sinram,
Deputy Secretary of the Commission.
[FR Doc. 2018–15024 Filed 7–10–18; 4:15 pm]
BILLING CODE 6715–01–P

FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.

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Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than August 6, 2018.
A. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. Platte Valley Financial Service
Companies, Inc., Scottsbluff, Nebraska;
to acquire 100 percent of the voting
shares of The American Bank of Sidney,
Sidney, Nebraska.
Board of Governors of the Federal Reserve
System, July 9, 2018.
Ann Misback,
Secretary of the Board.
[FR Doc. 2018–14931 Filed 7–11–18; 8:45 am]
BILLING CODE P

FEDERAL TRADE COMMISSION
[File No. 182 3100]

ReadyTech Corporation; Analysis To
Aid Public Comment
Federal Trade Commission.
Proposed consent agreement.

AGENCY:
ACTION:

The consent agreement in this
matter settles alleged violations of
federal law prohibiting unfair or
deceptive acts or practices. The attached
Analysis to Aid Public Comment
describes both the allegations in the
complaint and the terms of the consent
order—embodied in the consent
agreement—that would settle these
allegations.

SUMMARY:

Comments must be received on
or before August 1, 2018.
ADDRESSES: Interested parties may file a
comment online or on paper, by
following the instructions in the
Request for Comment part of the
SUPPLEMENTARY INFORMATION section
below. Write: ‘‘ReadyTech Corporation’’
on your comment, and file your
comment online at https://
ftcpublic.commentworks.com/ftc/
readytechconsent by following the
DATES:

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instructions on the web-based form. If
you prefer to file your comment on
paper, write ‘‘ReadyTech; File No.
1823100’’ on your comment and on the
envelope, and mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex D), Washington, DC
20580; or deliver your comment to:
Federal Trade Commission, Office of the
Secretary, Constitution Center, 400 7th
Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT:
Monique Einhorn (202–326–2575),
Bureau of Consumer Protection, 600
Pennsylvania Avenue NW, Washington,
DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 6(f) of the Federal Trade
Commission Act, 15 U.S.C. 46(f), and
FTC Rule 2.34, 16 CFR 2.34, notice is
hereby given that the above-captioned
consent agreement containing a consent
order to cease and desist, having been
filed with and accepted, subject to final
approval, by the Commission, has been
placed on the public record for a period
of thirty (30) days. The following
Analysis to Aid Public Comment
describes the terms of the consent
agreement, and the allegations in the
complaint. An electronic copy of the
full text of the consent agreement
package can be obtained from the FTC
Home Page (for July 2, 2018), on the
World Wide Web, at https://
www.ftc.gov/news-events/commissionactions.
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before August 1, 2018. Write
‘‘ReadyTech; File No. 1823100’’ on your
comment. Your comment—including
your name and your state—will be
placed on the public record of this
proceeding, including, to the extent
practicable, on the public Commission
website, at https://www.ftc.gov/policy/
public-comments.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
readytechconsent by following the
instructions on the web-based form. If
this Notice appears at http://
www.regulations.gov/#!home, you also
may file a comment through that
website.
If you prefer to file your comment on
paper, write ‘‘ReadyTech; File No.

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17:21 Jul 11, 2018

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1823100’’ on your comment and on the
envelope, and mail your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite
CC–5610 (Annex D), Washington, DC
20580; or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex D),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible FTC website
at https://www.ftc.gov, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
website—as legally required by FTC
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, unless you submit a
confidentiality request that meets the

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requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
Visit the FTC website at http://
www.ftc.gov to read this Notice and the
news release describing it. The FTC Act
and other laws that the Commission
administers permit the collection of
public comments to consider and use in
this proceeding, as appropriate. The
Commission will consider all timely
and responsive public comments that it
receives on or before August 1, 2018.
For information on the Commission’s
privacy policy, including routine uses
permitted by the Privacy Act, see
https://www.ftc.gov/site-information/
privacy-policy.
Analysis of Proposed Consent Order To
Aid Public Comment
The Federal Trade Commission
(‘‘FTC’’ or ‘‘Commission’’) has accepted,
subject to final approval, a consent
agreement applicable to ReadyTech
Corporation (‘‘ReadyTech’’).
The proposed consent order has been
placed on the public record for thirty
(30) days for receipt of comments by
interested persons. Comments received
during this period will become part of
the public record. After thirty days, the
Commission will again review the
agreement and the comments received,
and will decide whether it should
withdraw from the agreement and take
appropriate action or make final the
agreement’s proposed order.
This matter concerns alleged false or
misleading representations that
ReadyTech made to consumers
concerning its participation in the
Privacy Shield framework agreed upon
by the U.S. and the European Union
(‘‘EU’’). The Privacy Shield framework
allows U.S. companies to transfer data
outside the EU consistent with EU law.
To join the EU-U.S. Privacy Shield
framework, a company must self-certify
to the U.S. Department of Commerce
(‘‘Commerce’’) that it complies with a
set of principles and related
requirements that have been deemed by
the European Commission as providing
‘‘adequate’’ privacy protection. These
principles include notice; choice;
accountability for onward transfer;
security; data integrity and purpose
limitation; access; and recourse,
enforcement, and liability. Commerce
maintains a public website, https://
www.privacyshield.gov/list, where it
posts the names of companies that have
self-certified to the EU-U.S. Privacy
Shield framework. The listing of
companies indicates whether their selfcertification is current. Companies are
required to re-certify every year in order
to retain their status as current members

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
of the EU-U.S. Privacy Shield
framework.
ReadyTech provides online and
instructor-led training. According to the
Commission’s complaint, ReadyTech
has set forth on its website,
www.readytech.com/policies/privacypolicy/, privacy policies and statements
about its practices, including statements
related to the status of its participation
in the EU-U.S. Privacy Shield
framework.
The Commission’s complaint alleges
that ReadyTech deceptively represented
that it was actively in the process of
certifying compliance with the EU-U.S.
Privacy Shield framework when, in fact,
ReadyTech never completed the
necessary steps to finalize its
application, and was not certified to
participate in the EU-U.S. Privacy
Shield framework.
Part I of the proposed order prohibits
ReadyTech from making
misrepresentations about its
membership in any privacy or security
program sponsored by the government
or any other self-regulatory or standardsetting organization, including, but not
limited to, the EU-U.S. Privacy Shield
framework and the Swiss-U.S. Privacy
Shield framework.
Parts II through VI of the proposed
order are reporting and compliance
provisions. Part II requires
acknowledgement of the order and
dissemination of the order now and in
the future to persons with
responsibilities relating to the subject
matter of the order. Part III ensures
notification to the FTC of changes in
corporate status and mandates that
ReadyTech submit an initial compliance
report to the FTC. Part IV requires
ReadyTech to retain documents relating
to its compliance with the order for a
five-year period.
Part V mandates that ReadyTech make
available to the FTC information or
subsequent compliance reports, as
requested. Part VI is a provision
‘‘sunsetting’’ the order after twenty (20)
years, with certain exceptions.
The purpose of this analysis is to
facilitate public comment on the
proposed order. It is not intended to
constitute an official interpretation of
the proposed complaint or order or to
modify the order’s terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–14865 Filed 7–11–18; 8:45 am]
BILLING CODE 6750–01–P

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GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0080: Docket No.
2018–0001; Sequence No. 3]

Submission for OMB Review; General
Services Administration Acquisition
Regulation; Contract Financing Final
Payment (GSA Form 1142 Release of
Claims)
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Notice of request for public
comments regarding an extension to an
existing OMB clearance.
AGENCY:

Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement and the
reinstatement of GSA Form 1142,
Release of Claims, regarding final
payment under construction and
building services contract. GSA
Contracting Officers have used this form
to achieve uniformity and consistency
in the release of claims process.
DATES: Submit comments on or before:
August 13, 2018.
FOR FURTHER INFORMATION CONTACT:
Leah Price, Procurement Analyst,
General Services Acquisition Policy
Division, GSA, by phone at 202–714–
9482 or by email at [email protected].
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
Additionally submit a copy to GSA by
any of the following methods:
• Regulations.gov: http://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for Information Collection
3090–0080. Select the link ‘‘Comment
Now’’ that corresponds with
‘‘Information Collection 3090–0080,
Contract Financing Final Payment; GSA
Form 1142, Release of Claims’’. Follow
the instructions on the screen. Please
include your name, company name (if
any), and ‘‘Information Collection 3090–
0080, Contract Financing Final
Payment; GSA Form 1142, Release of
Claims’’ on your attached document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
SUMMARY:

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Mandell/IC 3090–0080, Contract
Financing Final Payment; GSA Form
1142, Release of Claims.
Instructions: Comments received
generally will be posted without change
to http://www.regulations.gov, including
any personal and/or business
confidential information provided. To
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two-to-three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
SUPPLEMENTARY INFORMATION:
A. Purpose
The General Services Administration
Acquisition Regulation (GSAR) clause
552.232–72 requires construction and
building services contractors to submit
a release of claims before final payment
is made to ensure contractors are paid
in accordance with their contract
requirements and for work performed.
GSA Form 1142, Release of Claims is
used to achieve uniformity and
consistency in the release of claims
process.
B. Annual Reporting Burden
Respondents: 7,500.
Responses per Respondent: 1.
Annual Responses: 7,500.
Hours per Response: .10.
Total Burden Hours: 750.
C. Public Comments
A notice published in the Federal
Register at 83 FR 13280 on March 28,
2018. No comments were received.
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate and
based on valid assumptions and
methodology; and ways to enhance the
quality, utility, and clarity of the
information to be collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 3090–0080,
Contract Financing Final Payment; GSA
Form 1142, Release of Claims, in all
correspondence.
Dated: July 2, 2018.
Jeffrey A. Koses,
Director, Office of Acquisition Policy, Office
of Government-wide Policy.
[FR Doc. 2018–14885 Filed 7–11–18; 8:45 am]
BILLING CODE 6820–61–P

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0205; Docket No.
2018–0001; Sequence No. 12]

General Services Administration
Acquisition Regulation (GSAR);
Information Collection; Environmental
Conservation, Occupational Safety,
and Drug-Free Workplace
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Notice of request for comments
regarding the extension of a previously
existing OMB clearance.
AGENCY:

Under the provisions of the
Paperwork Reduction Act, the General
Services Administration will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement regarding
Environmental Conservation,
Occupational Safety, and Drug-Free
Workplace.

SUMMARY:

Submit comments on or before:
September 10, 2018.
ADDRESSES: Submit comments
identified by Information Collection
3090–0205 by any of the following
methods:
• Regulations.gov: http://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching the OMB control number.
Select the link ‘‘Comment Now’’ that
corresponds with ‘‘Information
Collection 3090–0205, Environmental
Conservation, Occupational Safety, and
Drug-Free Workplace’’. Follow the
instructions provided on the screen.
Please include your name, company
name (if any), and ‘‘Information
Collection 3090–0205, Environmental
Conservation, Occupational Safety, and
Drug-Free Workplace’’ on your attached
document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 3090–0205, Environmental
Conservation, Occupational Safety, and
Drug-Free Workplace.
Instructions: Please submit comments
only and cite Information Collection
3090–0205, Environmental
Conservation, Occupational Safety, and
Drug-Free Workplace, in all
correspondence related to this
collection. Comments received generally
will be posted without change to
regulations.gov, including any personal
and/or business confidential
information provided. To confirm

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DATES:

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receipt of your comment(s), please
check regulations.gov, approximately
two-to-three business days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Ms.
Johnnie McDowell, Procurement
Analyst, General Services Acquisition
Policy Division, GSA, at telephone 202–
718–6112, or via email to
[email protected].
SUPPLEMENTARY INFORMATION:
A. Purpose
The Federal Hazardous Substance Act
and Hazardous Material Transportation
Act prescribe standards for packaging of
hazardous substances. To meet the
requirements of the Acts, the General
Services Administration Regulation
prescribes provision 552.223–72,
Hazardous Material Information, to be
inserted in solicitations and contracts
that provides for delivery of hazardous
materials on a Free On Board (FOB)
origin basis.
This information collection will be
accomplished by means of the provision
which requires the contractor to identify
for each National Stock Number (NSN),
the DOT Shipping Name, Department of
Transportation (DOT) Hazards Class,
and whether the item requires a DOT
label. Contracting Officers and technical
personnel use the information to
monitor and ensure contract
requirements based on law and
regulation.
Properly identified and labeled items
of hazardous material allows for
appropriate handling of such items
throughout GSA’s supply chain system.
The information is used by GSA, stored
in an NSN database and provided to
GSA customers. Non-Collection and/or
a less frequently conducted collection of
the information resulting from GSAR
provision 552.223–72 would prevent the
Government from being properly
notified. Government activities may be
hindered from apprising their
employees of; (1) All hazards to which
they may be exposed; (2) Relative
symptoms and appropriate emergency
treatment; and (3) Proper conditions and
precautions for safe use and exposure.
B. Annual Reporting Burden
Respondents: 563.
Responses per Respondent: 3.
Total Responses: 1689.
Hours per Response: .67.
Total Burden Hours: 1111.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary, whether it will

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have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division, 1800 F
Street NW, Washington, DC 20405,
telephone 202–501–4755. Please cite
OMB Control No. 3090–0205,
Environmental Conservation,
Occupational Safety, and Drug-Free
Workplace, in all correspondence.
Dated: July 9, 2018.
Jeffrey Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2018–14937 Filed 7–11–18; 8:45 am]
BILLING CODE 6820–61–P

GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0287; Docket No.
2018–0001; Sequence No. 10]

Information Collection; Background
Investigations for Child Care Workers
Office of Mission Assurance,
General Services Administration (GSA).
ACTION: Notice of request for comments
regarding an existing OMB information
collection.
AGENCY:

Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve a previously approved
information collection requirement
regarding the collection of personal data
for background investigations for child
care workers accessing GSA owned and
leased controlled facilities
DATES: Submit comments on or before:
September 10, 2018.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
SUMMARY:

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Additionally, submit a copy to GSA by
any of the following methods:
• Regulations.gov: http://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching the OMB control number.
Select the link ‘‘Submit a Comment’’
that corresponds with ‘‘Information
Collection 3090–0287, Background
Investigations for Child Care Workers’’.
Follow the instructions provided at the
‘‘Submit a Comment’’ screen. Please
include your name, company name (if
any), and ‘‘Information Collection 3090–
0287, Background Investigations for
Child Care Workers’’ on your attached
document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 3090–0287, Background
Investigations for Child Care Workers.
Instructions: Please submit comments
only and cite Information Collection
3090–0287, Background Investigations
for Child Care Workers, in all
correspondence related to this
collection. Comments received generally
will be posted without change to http://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Mr.
Phil Ahn, Security Officer, Office of
Mission Assurance, GSA, by telephone
at XXX–XXX–XXXX or email
[email protected].
SUPPLEMENTARY INFORMATION:

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A. Purpose
Homeland Security Presidential
Directive (HSPD) 12 ‘‘Policy for a
Common Identification Standard for
Federal Employees and Contractors’’
requires the implementation of a
governmentwide standard for secure
and reliable forms of identification for
Federal employees and contractors.
OMB’s implementing instructions
requires all contract employees
requiring routine access to federally
controlled facilities for greater than six
(6) months to receive a background
investigation. The minimum
background investigation is Tier 1 and
the Office of Personnel Management
offers a Tier 1C for child care.
However, there is no requirement in
the law or HSPD–12 that requires child
care employees to be subject to the Tier
1C since employees of child care

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providers are neither government
employees nor government contractors.
The child care providers are required to
complete the criminal history
background checks mandated in the
Crime Control Act of 1990, Public Law
101–647, dated November 29, 1990, as
amended by Public Law 102–190, dated
December 5, 1991. These statutes
require that each employee of a child
care center located in a Federal building
or in leased space must undergo a
background check.
According to GSA policy, child care
workers (as described above) will need
to submit the following:
1. An original signed copy of a Basic
National Agency Check Criminal
History, GSA Form 176; and
2. Two sets of fingerprints on FBI
Fingerprint Cards, for SF–87 and/or
electronic prints from an enrollment
center.
3. Electronically submit the e-qip
(SF85) application for completion of the
Tier 1C.
This is not a request to collect new
information; this is a request to change
the form that is currently being used to
collect this information.
B. Annual Reporting Burden
Respondents: 1,200.
Responses per Respondent: 1.
Hours per Response: 1.
Total Burden Hours: 1,200.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755. Please
cite Background Investigations for Child
Care Workers, in all correspondence.
Dated: July 2, 2018.
David A. Shive,
Chief Information Officer.
[FR Doc. 2018–14882 Filed 7–11–18; 8:45 am]
BILLING CODE 6820–23–P

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32297

GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0007; Docket No.
2018–0001; Sequence No. 1]

Submission for OMB Review; General
Services Administration Acquisition
Regulation; Contractor’s Qualifications
and Financial Information (GSA Form
527)
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Notice of request for comments
regarding an extension to an existing
OMB clearance.
AGENCY:

Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement regarding
Contractor’s Qualifications and
Financial Information (GSA Form 527).
DATES: Submit comments on or before:
August 13, 2018.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC, 20503.
Additionally submit a copy to GSA by
any of the following methods:
• Regulations.gov: http://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal
searching Information Collection 3090–
0007. Select the link ‘‘Comment Now’’
that corresponds with ‘‘Information
Collection 3090–0007, Contractor’s
Qualifications and Financial
Information’’. Follow the instructions
provided on the screen. Please include
your name, company name (if any), and
‘‘Information Collection 3090–0007,
Contractor’s Qualifications and
Financial Information’’ on your attached
document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 3090–0007, Contractor’s
Qualifications and Financial
Information.
Instructions: Please submit comments
only and cite Information Collection
3090–0007, Contractor’s Qualifications
and Financial Information, in all
correspondence related to this
collection. Comments received generally
will be posted without change to
SUMMARY:

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regulations.gov, including any personal
and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check regulations.gov, approximately
two-to-three business days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT:
Johnnie McDowell, Policy Analyst,
Office of Governmentwide Policy, at
202–718–6112, or via email at
[email protected].
SUPPLEMENTARY INFORMATION:
A. Purpose
The General Services Administration
will be requesting that OMB extend
information collection 3090–0007,
concerning GSA Form 527, Contractor’s
Qualifications and Financial
Information. This form is used to
determine the financial capability of
prospective contractors as to whether
they meet the financial responsibility
standards in accordance with the
Federal Acquisition Regulation (FAR)
9.103(a) and 9.104–1 and also the
General Services Administration
Acquisition Manual (GSAM) 509.105–
1(a).

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B. Annual Reporting Burden
Respondents: 2,542.
Responses per Respondent: 1.2.
Total Responses: 3,050.
Hours per Response: 1.5.
Total Burden Hours: 4,575.
The estimated annual burden has
decreased since GSA’s 2014 submission
from 5,292 to 4,575 burden hours to
reflect the continued use of the
widespread option for potential
contractors to submit financial
statements and balance sheets in lieu of
completing the applicable fields on GSA
Form 527. The alternate submission of
financial statements and balance sheets
significantly reduces the burden on
prospective contractors, as these
documents are generally readily
available. The average estimated hours
to complete a response remained at the
optimal rate of 1.5 hours.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected. A request
for public comments was issued in the
Federal Register at 83 FR 7184, on

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February 20, 2018. No comments were
received.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405, telephone 202–501–4755.
Please cite OMB Control No. 3090–
0007, Contractor’s Qualifications and
Financial Information (GSA Form 527),
in all correspondence.
Dated: July 2, 2018.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
[FR Doc. 2018–14879 Filed 7–11–18; 8:45 am]
BILLING CODE 6820–61–P

GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–XXXX; Docket No.
2018–0001; Sequence No. 17]

Information Collection; CDP Supply
Chain Climate Change Information
Request
Office of Government-Wide
Policy (OGP), General Services
Administration.
ACTION: Notice of request for comments
regarding a new request for an Office of
Management and Budget (OMB)
clearance.
AGENCY:

The Office of Governmentwide Policy, General Services
Administration (GSA) will submit a
request to the Office of Management and
Budget (OMB) for review and clearance
for the CDP Supply Chain Climate
Change Information Request. As
required by the Paperwork Reduction
Act of 1995.
DATES: Submit comments on or before
September 10, 2018.
ADDRESSES: Submit comments
identified by Information Collection
3090–XXXX; CDP Supply Chain Climate
Change Information Request, by any of
the following methods:
ADDRESSES: Submit comments on this
collection by any of the following
methods:
• Regulations.gov: http://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for ‘‘Information Collection
3090–XXXX; CDP Supply Chain Climate
Change Information Request.’’ Select the
link ‘‘Submit a Comment’’ that
corresponds with ‘‘Information
Collection 3090–XXXX; CDP Supply
Chain Climate Change Information
SUMMARY:

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Request.’’ Follow the instructions
provided at the ‘‘Submit a Comment’’
screen. Please include your name,
company name (if any), and
‘‘Information Collection 3090–XXXX;
CDP Supply Chain Climate Change
Information Request’’ on your attached
document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
Washington, DC 20405. ATTN: Ms.
Mandell/IC 3090–XXXX; CDP Supply
Chain Climate Change Information
Request.
Instructions: Please submit comments
only and cite Information Collection
3090–XXXX; CDP Supply Chain Climate
Change Information Request, in all
correspondence related to this
collection. Comments received generally
will be posted without change to http://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
SUPPLEMENTARY INFORMATION:
A. Purpose
The CDP Supply Chain Climate
Change Information Request is an
electronic questionnaire designed to
collect information pertinent to
organizations’ exposure to energy
market and environmental risks. The
questionnaire is administered by CDP
North America, Inc., a 501(c)(3)
nonprofit organization (‘‘CDP’’). CDP
administers the questionnaire annually
to companies on behalf of over 650
institutional investors and over 100
major purchasing corporations and
governmental purchasing organizations.
In accordance with 31 U.S. Code
§ 3512(c)(1)(b), GSA will use the
information collected via this
questionnaire to inform and develop
purchasing policies and contract
requirements necessary to safeguard
Federal assets against waste, loss, and
misappropriation resulting from
unmitigated exposure to energy market
and environmental risks.
B. Annual Burden Hours
Frequency: Annual.
Affected Public: Federal contractors.
Number of Respondents: 250.
Responses per Respondent: 1.
Total Annual Responses: 250.
Estimated Time per Respondent: 4.8
hrs.
Total Burden Hours: 1,210.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary, whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Dated: July 2, 2018.
David A. Shive,
Chief Information Officer.
[FR Doc. 2018–14884 Filed 7–11–18; 8:45 am]
BILLING CODE 6820–61–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Board on Radiation and
Worker Health (ABRWH or the
Advisory Board), National Institute for
Occupational Safety and Health
(NIOSH)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC, announces the following meeting
of the Advisory Board on Radiation and
Worker Health (ABRWH). This meeting
is open to the public, limited only by
the space available. The meeting space
accommodates approximately 150
people and the audio conference line
has 150 ports for callers. The public is
welcome to submit written comments in
advance of the meeting, to the contact
person below. Written comments
received in advance of the meeting will
be included in the official record of the
meeting. The public is also welcome to
listen to the meeting by joining the
teleconference (information below).
DATES: The meeting will be held on
August 22, 2018 from 8:30 a.m. to 5:00
p.m., EDT, and August 23, 2018, 8:30
a.m. to 12:00 p.m., EDT. A public
comment session will be held on August
22, 2018 at 5:00 p.m. and conclude at
6:00 p.m. or following the final call for
public comment, whichever comes first.

amozie on DSK3GDR082PROD with NOTICES1

SUMMARY:

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Hilton Providence, 21
Atwells Avenue, Providence, RI 02903;
Phone: (401)–831–3900, Fax: (401)–274–
1562 and audio conference call via FTS
Conferencing. The USA toll-free dial-in
number is 1–866–659–0537; the pass
code is 9933701. Web conference by
Skype: meeting CONNECTION: https://
webconf.cdc.gov/zab6/yzdq02pl?sl=1.

ADDRESSES:

Jkt 244001

FOR FURTHER INFORMATION CONTACT:

Theodore Katz, MPA, Designated
Federal Officer, NIOSH, CDC, 1600
Clifton Road, Mailstop E–20, Atlanta,
Georgia 30333, Telephone (513) 533–
6800, Toll Free 1 (800) CDC–INFO,
Email [email protected].
SUPPLEMENTARY INFORMATION:

Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines
which have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule, advice on
methods of dose reconstruction which
have also been promulgated by HHS as
a final rule, advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program, and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC). In
December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS,
which subsequently delegated this
authority to the CDC. NIOSH
implements this responsibility for CDC.
The charter was issued on August 3,
2001, renewed at appropriate intervals,
rechartered under Executive Order
13811 on February 12, 2018, and will
terminate on September 30, 2019.
Purpose: This Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary
on whether there is a class of employees
at any Department of Energy facility
who were exposed to radiation but for
whom it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such

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radiation doses may have endangered
the health of members of this class.
Matters to be Considered: The agenda
will include discussions on the
following: NIOSH Program Update;
Department of Labor Program Update;
Department of Energy Program Update;
SEC Petitions Update; possible
discussion of a site profile review (dose
reconstruction methods for Feed
Materials Production Center (Fernald,
Ohio); SEC Petitions for: Sandia
National Laboratory (Albuquerque, New
Mexico), Metals and Controls
Corporation (Attleboro, Massachusetts,
Idaho National Laboratory (Scoville,
Idaho), and DeSoto Facility (Los
Angeles, California); continued review
of dose reconstruction methods
associated with estimating skin doses;
and a Board Work Session. Agenda
items are subject to change as priorities
dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–14929 Filed 7–11–18; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Healthcare Infection Control
Practices Advisory Committee
(HICPAC). This meeting is open to the
public, limited only by audio phone
lines available. The public is also
welcome to listen to the meeting by
dialing 888–790–3409, passcode:
3250534. A total of 200 lines will be
available. To register for this call, please
go to www.cdc.gov/hicpac.
DATES: The meeting will be held on
August 29, 2018, 3:00 p.m. to 5:00 p.m.,
EDT.
SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Teleconference Number: 1–
888–790–3409, passcode: 3250534.
FOR FURTHER INFORMATION CONTACT: Erin
Stone, M.A., HICPAC, Division of
Healthcare Quality Promotion, NCEZID,
CDC, 1600 Clifton Road NE, Mailstop
A–31, Atlanta, Georgia 30333;
Telephone (404) 639–4045, Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Purpose: The Committee is charged
with providing advice and guidance to
the Director, Division of Healthcare
Quality Promotion (DHQP), the Director,
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
the Director, CDC, the Secretary, Health
and Human Services regarding (1) the
practice of healthcare infection
prevention and control; (2) strategies for
surveillance, prevention, and control of
infections, antimicrobial resistance, and
related events in settings where
healthcare is provided; and (3) periodic
updating of CDC guidelines and other
policy statements regarding prevention
of healthcare-associated infections and
healthcare-related conditions.
Matters to be Considered: The agenda
will include discussions on updates
from the guidelines for infection
prevention in healthcare personnel
workgroup and the guidelines for
infection prevention in patients of
neonatal intensive care units
workgroup. Agenda items are subject to
change as priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
ADDRESSES:

Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–14930 Filed 7–11–18; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

amozie on DSK3GDR082PROD with NOTICES1

Centers for Medicare & Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval Washington Medicaid
State Plan Amendment (SPA) 17–0027
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of hearing:
Reconsideration of disapproval.
AGENCY:

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This notice announces an
administrative hearing to be held on
August 9, 2018, at the Department of
Health and Human Services, Centers for
Medicare & Medicaid Services, Division
of Medicaid & Children’s Health, Seattle
Regional Office, 701 Fifth Avenue, Suite
1600, Seattle, WA 98104 to reconsider
CMS’ decision to disapprove
Washington’s Medicaid SPA 17–0027.
DATES: Closing Date: Requests to
participate in the hearing as a party
must be received by the presiding
officer by July 27, 2018.
FOR FURTHER INFORMATION CONTACT:
Benjamin R. Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite
L, Baltimore, Maryland 21244,
Telephone: (410) 786–3169.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Washington’s Medicaid state
plan amendment (SPA) 17–0027, which
was submitted to the Centers for
Medicare & Medicaid Services (CMS) on
August 22, 2017 and disapproved on
May 14, 2018. This SPA requested CMS
approval to add coverage and
reimbursement of services provided by
Dental Health Aide Therapists (DHATs)
under the Other Licensed Practitioner
(OLP) benefit. Specifically, SPA 17–
0027 proposed the coverage and
reimbursement of services provided by
DHATs only when furnished in a
practice setting within the boundaries of
a tribal reservation and only when
operated by an Indian health program,
and proposed to make coverage of
DHAT services available only to
members of a federally recognized tribe
or those otherwise eligible for services
under Indian Health Service criteria.
Washington would, therefore, not
permit Medicaid beneficiaries to receive
Medicaid coverage for DHAT services if
they are not members of a federally
recognized tribe or otherwise eligible for
services under Indian Health Service
criteria.
The issues to be considered at the
hearing are whether Washington SPA
17–0027 is inconsistent with the
requirements of:
• Section 1902(a)(23) of the Social
Security Act (the Act) because it would
restrict access to services provided by a
DHAT to a limited group of
beneficiaries, and it would also prevent
beneficiaries from receiving DHAT
services from similarly qualified dental
services providers that provide services
outside the boundaries of a tribal
reservation or that are not Indian health
programs.
• Section 1902(a)(10)(A) of the Act
because it was unclear whether DHATs
SUMMARY:

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must be supervised by a licensed
professional consistent with the
requirements of the OLP benefit, and
because CMS was therefore unable to
determine whether DHAT services are
‘‘medical assistance’’ consistent with
1902(a)(10)(A) and 1905 of the Act.
Section 1116 of the Act and federal
regulations at 42 CFR part 430 establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
state plan or plan amendment. CMS is
required to publish in the Federal
Register a copy of the notice to a state
Medicaid agency that informs the
agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the state
Medicaid agency of additional issues
that will be considered at the hearing,
we will also publish that notice in the
Federal Register.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to Washington announcing
an administrative hearing to reconsider
the disapproval of its SPA reads as
follows:
Ms. MaryAnne Lindeblad
Director
State of Washington, Health Care Authority
626 8th Avenue PO Box 45502
Olympia, WA 98504–5050
Dear Ms. Lindeblad:
I am responding to your June 8, 2018
request for reconsideration of the decision to
disapprove Washington’s State Plan
amendment (SPA) 17–0027. Washington SPA
17–0027 was submitted to the Centers for
Medicare & Medicaid Services (CMS) on
August 22, 2017, and disapproved on May
14, 2018. I am scheduling a hearing on your
request for reconsideration to be held on
August 9, 2018, at the Department of Health
and Human Services, Centers for Medicare &
Medicaid Services, Division of Medicaid &
Children’s Health, Seattle Regional Office,
701 Fifth Avenue, Suite 1600, Seattle, WA
98104.
I am designating Mr. Benjamin R. Cohen as
the presiding officer. If these arrangements
present any problems, please contact Mr.
Cohen at (410) 786–3169. In order to
facilitate any communication that may be
necessary between the parties prior to the
hearing, please notify the presiding officer to

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
indicate acceptability of the hearing date that
has been scheduled and provide names of the
individuals who will represent the State at
the hearing. If the hearing date is not
acceptable, Mr. Cohen can set another date
mutually agreeable to the parties. The
hearing will be governed by the procedures
prescribed by federal regulations at 42 CFR
Part 430.
This SPA requested CMS approval to add
coverage and reimbursement of services
provided by Dental Health Aide Therapists
(DHATs) under the Other Licensed
Practitioner (OLP) benefit. Specifically, SPA
17–0027 proposed the coverage and
reimbursement of services provided by
DHATs only when furnished in a practice
setting within the boundaries of a tribal
reservation and only when operated by an
Indian health program, and proposed to make
coverage of DHAT services available only to
members of a federally recognized tribe or
those otherwise eligible for services under
Indian Health Service criteria. Washington
would, therefore, not permit Medicaid
beneficiaries to receive Medicaid coverage for
DHAT services if they are not members of a
federally recognized tribe or otherwise
eligible for services under Indian Health
Service criteria.
The issues to be considered at the hearing
are whether Washington SPA 17–0027 is
inconsistent with the requirements of:
• Section 1902(a)(23) of the Social Security
Act (the Act) because it would restrict access
to services provided by a DHAT to a limited
group of beneficiaries, and it would also
prevent beneficiaries from receiving DHAT
services from similarly qualified dental
services providers that provide services
outside the boundaries of a tribal reservation
or that are not Indian health programs.
• Section 1902(a)(10)(A) of the Act because
it was unclear whether DHATs must be
supervised by a licensed professional
consistent with the requirements of the OLP
benefit, and because CMS was therefore
unable to determine whether DHAT services
are ‘‘medical assistance’’ consistent with
1902(a)(10)(A) and 1905 of the Act.
In the event that CMS and the State come
to agreement on resolution of the issues
which formed the basis for disapproval, this
SPA may be moved to approval prior to the
scheduled hearing.
Sincerely,
Seema Verma

amozie on DSK3GDR082PROD with NOTICES1

Administrator
Section 1116 of the Social Security Act (42
U.S.C. section 1316; 42 CFR section 430.18)
(Catalog of Federal Domestic Assistance
program No. 13.714. Medicaid Assistance
Program.)
Dated: July 6, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–14876 Filed 7–6–18; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2642]

Advisory Committee; Science Advisory
Board to the National Center for
Toxicological Research; Renewal
AGENCY:

Food and Drug Administration,

HHS.
Notice; renewal of advisory
committee.

ACTION:

The Food and Drug
Administration (FDA) is announcing the
renewal of the Science Advisory Board
(the Board) to the National Center for
Toxicological Research (NCTR) by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Board to the NCTR
for an additional 2 years beyond the
charter expiration date. The new charter
will be in effect until June 2, 2020.
DATES: Authority for the Board to the
NCTR expired on June 2, 2018;
however, the Commissioner formally
determined that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Donna L. Mendrick, National Center for
Toxicological Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2208, Silver Spring,
MD 20993–0002, 301–796–8892,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Board to the NCTR. The Board is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Board to the
NCTR advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
FDA has regulatory responsibility. The
Board advises the NCTR Director in
establishing, implementing, and
evaluating the research programs that
assist the Commissioner in fulfilling
regulatory responsibilities. The Board
provides an extra-agency review in
ensuring that the research programs at
NCTR are scientifically sound and
pertinent.
The Board shall consist of a core of
nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
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32301

designee from among authorities
knowledgeable in the fields of
toxicological research. Members will be
invited to serve for overlapping terms of
up to 4 years. Almost all non-Federal
members of this Board serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
ToxicologicalResearch/ucm148166.htm
or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14943 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2565]

Advisory Committee;
Psychopharmacologic Drugs Advisory
Committee; Renewal
AGENCY:

Food and Drug Administration,

HHS.
Notice; renewal of advisory
committee.

ACTION:

The Food and Drug
Administration (FDA) is announcing the
renewal of the Psychopharmacologic
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the
Psychopharmacologic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until June
4, 2020.

SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Authority for the
Psychopharmacologic Drugs Advisory
Committee will expire on June 4, 2020,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Psychopharmacologic Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the practice of psychiatry and
related fields and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
PsychopharmacologicDrugs

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DATES:

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Jkt 244001

AdvisoryCommittee/default.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14934 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2236]

Human Gene Therapy for Retinal
Disorders; Draft Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Human Gene
Therapy for Retinal Disorders; Draft
Guidance for Industry.’’ The draft
guidance provides recommendations to
stakeholders developing human gene
therapy (GT) products for retinal
disorders affecting adult and pediatric
patients. The draft guidance focuses on
issues specific to GT products for retinal
disorders and provides
recommendations related to product
development, preclinical testing, and
clinical trial design for such GT
products.

SUMMARY:

Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,

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including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–2236 for ‘‘Human Gene
Therapy for Retinal Disorders; Draft
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Angela Moy, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:

amozie on DSK3GDR082PROD with NOTICES1

I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Human Gene
Therapy for Retinal Disorders; Draft
Guidance for Industry.’’ The draft
guidance provides recommendations to
stakeholders developing GT products
for retinal disorders affecting adult and
pediatric patients. These disorders vary
in etiology, prevalence, diagnosis, and

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management, and include genetic as
well as age-related diseases. These
disorders manifest with central or
peripheral visual impairment and often
with progressive visual loss. The draft
guidance focuses on issues specific to
GT products for retinal disorders and
provides recommendations related to
product development, preclinical
testing, and clinical trial design for such
GT products.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of two other human gene
therapy draft guidance documents
entitled ‘‘Human Gene Therapy for
Hemophilia; Draft Guidance for
Industry’’ and ‘‘Human Gene Therapy
for Rare Diseases; Draft Guidance for
Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Human Gene Therapy for Retinal
Disorders.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 50 have been approved under OMB
control number 0910–0755; the
collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; the
collections of information in 21 CFR
part 211 have been approved under
OMB control number 0910–0139; the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in the
guidance entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ have been approved under
OMB control number 0910–0765; and
the collections of information in the
guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429.

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Frm 00044

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32303

III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14870 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2258]

Human Gene Therapy for Rare
Diseases; Draft Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Human Gene
Therapy for Rare Diseases; Draft
Guidance for Industry.’’ The draft
guidance document provides
recommendations to stakeholders
developing a human gene therapy (GT)
product intended to treat a rare disease
in adult and/or pediatric patients
regarding the manufacturing,
preclinical, and clinical trial design
issues for all phases of the clinical
development program. Such
information is intended to assist
sponsors in designing clinical
development programs for such
products, where there may be limited
study population size and potential
feasibility and safety issues as well as
issues relating to the interpretability of
bioactivity/efficacy outcomes that may
be unique to rare diseases or to the
nature of the GT product itself.
DATES: Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the

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32304

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

amozie on DSK3GDR082PROD with NOTICES1

instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment as
well as any attachments, except for
information submitted, marked, and
identified as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–2258 for ‘‘Human Gene
Therapy for Rare Diseases; Draft
Guidance for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies, total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the

VerDate Sep<11>2014

17:21 Jul 11, 2018

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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments, and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
The Orphan Drug Act of 1983 (Pub. L.
97–414) defines a rare disease as a
disease or condition that affects fewer
than 200,000 persons in the United
States. Since most rare diseases have no
approved therapies, there is a significant
unmet need for effective treatments.

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However, developing safe and effective
products to treat rare diseases can be
challenging. For example, it may be
more difficult to find and recruit such
patients into clinical trials, and many
rare diseases exhibit a number of
variations or subtypes. Consequently,
patients may have highly diverse
clinical manifestations and rates of
disease progression with unpredictable
clinical courses. Despite these
challenges, GT-related research and
development continue to grow at a rapid
rate, with several products advancing in
clinical development.
FDA is announcing the availability of
a document entitled ‘‘Human Gene
Therapy for Rare Diseases; Draft
Guidance for Industry.’’ The draft
guidance provides recommendations to
stakeholders developing a GT product
intended to treat a rare disease in adult
and/or pediatric patients regarding the
manufacturing, preclinical, and clinical
trial design issues for all phases of the
clinical development program. Such
information is intended to assist
sponsors in designing clinical
development programs for such
products, where there may be limited
study population size and potential
feasibility and safety issues as well as
issues relating to the interpretability of
bioactivity/efficacy outcomes that may
be unique to rare diseases or to the
nature of the GT product itself.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of two other human gene
therapy draft guidance documents
entitled ‘‘Human Gene Therapy for
Hemophilia; Draft Guidance for
Industry’’ and ‘‘Human Gene Therapy
for Retinal Disorders; Draft Guidance for
Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Human Gene Therapy for Rare
Diseases.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 50 have been approved under OMB
control number 0910–0755; the

E:\FR\FM\12JYN1.SGM

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in the
guidance entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ have been approved under
OMB control number 0910–0765; and
the collections of information in the
guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429.

Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.

III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.

ACTION:

BILLING CODE 4164–01–P

longer marketed and requested that the
approval of the applications be
withdrawn.
Approval is withdrawn as of
August 13, 2018.

DATES:

FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2180]

Concordia Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 29 New
Drug Applications
AGENCY:

Food and Drug Administration,

HHS.
Notice.

The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 29 new drug
applications (NDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no

SUMMARY:

Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.

SUPPLEMENTARY INFORMATION:

Application No.

Drug

Applicant

NDA 011287 .........

NDA 016211 .........

Kayexalate (sodium polystyrene sulfonate) Powder for Suspension,
453.6 gram (g)/bottle.
Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram
(mg), 10 mg, and 25 mg.
Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial ....

NDA 018674 .........
NDA 018852 .........

Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL) .............
Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg ......

NDA 018854 .........
NDA 018988 .........
NDA 019844 .........
NDA 019870 .........
NDA 019964 .........

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg ....
Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium)
Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%.
Isolyte H in Dextrose 5% in Plastic Container Injection .........................
Isolyte M in Dextrose 5% in Plastic Container Injection .........................
Terazol 3 (terconazole) Vaginal Cream, 0.8% ........................................

Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria
Dr., Lexington, KY 40504.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ
07936.
B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Novartis Pharmaceuticals Corp.

NDA 020000 .........
NDA 020393 .........

Dextrose 5% in Ringer’s in Plastic Container Injection ..........................
Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray ...............

NDA 020394 .........
NDA 021180 .........

Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray ...............
Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch,
0.035 mg/24 h; 0.15 mg/24 h.
Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg .....

NDA 012249 .........

NDA 021633 .........
NDA 022033 .........
NDA 022106 .........
NDA 022386 .........
NDA 050201 .........
NDA 050344 .........
NDA 050442 .........
NDA 050497 .........
amozie on DSK3GDR082PROD with NOTICES1

[FR Doc. 2018–14871 Filed 7–11–18; 8:45 am]

32305

NDA 050512 .........
NDA 050527 .........
NDA 050593 .........
NDA 050646 .........
NDA 050668 .........
NDA 050792 .........

VerDate Sep<11>2014

Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg
and 150 mg.
Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial ............
PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500
mg; 2 mg.
Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sulfate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g.
Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment,
EQ 3.5 mg base/g; 10,000 units/g.
Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial
and EQ 100 mg base/vial.
Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/
vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vial.
Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and
EQ 250 mg base.
Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125
mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.
Eryc Sprinkles (erythromycin) Capsules, 125 mg ...................................
Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/
vial.
Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg .....................
Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and
Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base.

17:21 Jul 11, 2018

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B. Braun Medical, Inc.
Do.
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd.,
Titusville, NJ 08560.
B. Braun Medical, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT 06877–0368.
Do.
Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300,
Raritan, NJ 08869–0602.
Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
2525 Dupont Dr., Irvine, CA 92612.
Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304.
Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932.
Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536.
Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd
St., New York, NY 10017.
Alcon Laboratories, Inc., 6201 South Freeway, TC–45, Fort Worth, TX
76134.
Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426.
Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866.
Do.
Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045.
GlaxoSmithKline.
King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
B. Braun Medical, Inc.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Application No.

Drug

NDA 050807 .........

Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vial ..............................

Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 13,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on August 13, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14935 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2018–D–2238]

Human Gene Therapy for Hemophilia;
Draft Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.

amozie on DSK3GDR082PROD with NOTICES1

ACTION:

Notice of availability.

Applicant
Hospira, Inc.

Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).

SUMMARY:

Written/Paper Submissions

Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the

Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment as
well as any attachments, except for
information submitted, marked, and
identified as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA 2018–
D–2238 for ‘‘Human Gene Therapy for
Hemophilia; Draft Guidance for
Industry.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Human Gene
Therapy for Hemophilia; Draft Guidance
for Industry.’’ The draft guidance
document provides recommendations to
stakeholders developing human gene
therapy (GT) products for the treatment
of hemophilia. The draft guidance
provides recommendations on the
clinical trial design and related
development of coagulation factor VIII
(hemophilia A) and IX (hemophilia B)
activity assays, including how to
address discrepancies in factor VIII and
factor IX activity assays. The draft
guidance also includes
recommendations regarding preclinical
considerations to support development
of GT products for the treatment of
hemophilia.

DATES:

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17:21 Jul 11, 2018

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PO 00000

Frm 00047

Fmt 4703

Sfmt 4703

a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies, total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments, and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:

Jessica Walker Udechukwu, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:

amozie on DSK3GDR082PROD with NOTICES1

I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Human Gene
Therapy for Hemophilia; Draft Guidance
for Industry.’’ The draft guidance
document provides recommendations to
stakeholders developing GT products
for the treatment of hemophilia. The
draft guidance provides
recommendations on the clinical trial
design and related development of
coagulation factor VIII (hemophilia A)
and IX (hemophilia B) activity assays,
including how to address discrepancies
in factor VIII and factor IX activity
assays. The draft guidance also includes
recommendations regarding preclinical
considerations to support development
of GT products for the treatment of
hemophilia. Hemophilia therapy in the
United States has progressed from
replacement therapies for on-demand
treatment of bleeding to prophylaxis to
reduce the frequency of bleeding. GT
products for hemophilia are being
developed as single-dose treatments that
may provide long-term expression of the
missing or abnormal coagulation factor
in the patient at steady levels to reduce
or eliminate the need for exogenous
factor replacement.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of two other human gene
therapy draft guidance documents
entitled ‘‘Human Gene Therapy for
Retinal Disorders; Draft Guidance for
Industry’’ and ‘‘Human Gene Therapy
for Rare Diseases; Draft Guidance for
Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Human Gene Therapy for
Hemophilia.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.

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II. Paperwork Reduction Act of 1995

32307

This draft guidance refers to
previously approved collections of
information subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; the
collections of information in 21 CFR
part 211 have been approved under
OMB control number 0910–0139; the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in the
guidance entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ have been approved under
OMB control number 0910–0765; and
the collections of information in the
guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429.

Applications (INDs); Draft Guidance for
Industry.’’ The draft guidance document
provides sponsors of a human gene
therapy IND with recommendations
regarding CMC information required to
assure product safety, identity, quality,
purity, and strength (including potency)
of the investigational product. The draft
guidance applies to human gene therapy
products and to combination products
that contain a human gene therapy in
combination with a drug or device.
The draft guidance, when finalized, is
intended to supersede the document
entitled ‘‘Guidance for FDA Reviewers
and Sponsors: Content and Review of
Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene
Therapy Investigational New Drug
Applications (INDs),’’ dated April 2008
(April 2008 guidance).
DATES: Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:

III. Electronic Access

Electronic Submissions

Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.

Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Since your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).

Dated: July 5, 2018.
Leslie Kux.
Associate Commissioner for Policy.
[FR Doc. 2018–14875 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0205]

Chemistry, Manufacturing, and Control
Information for Human Gene Therapy
Investigational New Drug Applications;
Draft Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene
Therapy Investigational New Drug

SUMMARY:

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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and

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Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment as
well as any attachments, except for
information submitted, marked, and
identified as confidential if submitted as
detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0205 for ‘‘Chemistry,
Manufacturing, and Control (CMC)
Information for Human Gene Therapy
Investigational New Drug Applications
(INDs); Draft Guidance for Industry.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies, total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments, and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://

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www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Gretchen Opper, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Chemistry,
Manufacturing, and Control (CMC)
Information for Human Gene Therapy
Investigational New Drug Applications
(INDs); Draft Guidance for Industry.’’
The draft guidance provides sponsors of
a human gene therapy IND with
recommendations regarding CMC
information required to assure product
safety, identity, quality, purity, and
strength (including potency) of the
investigational product (21 CFR
312.23(a)(7)(i)). The draft guidance
applies to human gene therapy products
and to combination products that
contain a human gene therapy in
combination with a drug or device. The
field of gene therapy has progressed
rapidly since FDA issued the April 2008
guidance. Therefore, FDA is updating
the guidance to provide current FDA
recommendations regarding the CMC
content of a gene therapy IND. In
addition, the draft guidance is organized
to follow the structure of the FDA
guidance on the Common Technical
Document.

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The draft guidance, when finalized, is
intended to supersede the April 2008
guidance. Elsewhere in this issue of the
Federal Register, FDA is announcing
the availability of two other draft
guidances. In a separate document, FDA
is announcing the availability of a draft
document entitled ‘‘Long Term FollowUp After Administration of Human
Gene Therapy Products; Draft Guidance
for Industry’’ and the availability of a
draft document entitled ‘‘Testing of
Retroviral Vector-Based Human Gene
Therapy Products for Replication
Competent Retrovirus During Product
Manufacture and Patient Follow-up;
Draft Guidance for Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on CMC information for human gene
therapy INDs. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR part 312 and
Form FDA 1571 have been approved
under OMB control number 0910–0014;
and the collections of information in 21
CFR part 1271 have been approved
under OMB control number 0910–0543.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14866 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

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You may submit comments
on any guidance at any time as follows:

ADDRESSES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–0081]

Testing of Retroviral Vector-Based
Human Gene Therapy Products for
Replication Competent Retrovirus
During Product Manufacture and
Patient Follow-up; Draft Guidance for
Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Testing of Retroviral
Vector-Based Human Gene Therapy
Products for Replication Competent
Retrovirus During Product Manufacture
and Patient Follow-up; Draft Guidance
for Industry.’’ The draft guidance
document provides sponsors of
retroviral vector-based human gene
therapy products recommendations
regarding the testing for replication
competent retrovirus (RCR) during the
manufacture of retroviral vector-based
products, and during follow-up
monitoring of patients who have
received retroviral vector-based
products. Recommendations include the
identification and amount of material to
be tested, and general testing methods.
In addition, recommendations are
provided on monitoring patients for
evidence of retroviral infection after
administration of retroviral vector-based
gene therapy products. The draft
guidance, when finalized, is intended to
supersede the document entitled
‘‘Guidance for Industry: Supplemental
Guidance on Testing for Replication
Competent Retrovirus in Retroviral
Vector Based Gene Therapy Products
and During Follow-up of Patients in
Clinical Trials Using Retroviral
Vectors,’’ dated November 2006. The
draft guidance, when finalized, is also
intended to supplement the documents
entitled ‘‘Long Term Follow-Up After
Administration of Human Gene Therapy
Products; Draft Guidance for Industry’’
and ‘‘Chemistry, Manufacturing, and
Control Information for Human Gene
Therapy Investigational New Drug
Applications; Draft Guidance for
Industry,’’ when these draft guidance
documents are finalized.
DATES: Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.

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SUMMARY:

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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
1999–D–0081 for ‘‘Testing of Retroviral
Vector-Based Human Gene Therapy
Products for Replication Competent
Retrovirus During Product Manufacture
and Patient Follow-up; Draft Guidance
for Industry.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your

PO 00000

Frm 00050

Fmt 4703

Sfmt 4703

32309

comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:

Melissa Segal, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,

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Silver Spring, MD 20993–0002, 240–
402–7911.

regulations. This guidance is not subject
to Executive Order 12866.

SUPPLEMENTARY INFORMATION:

II. Paperwork Reduction Act of 1995

I. Background

The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.

FDA is announcing the availability of
a draft document entitled ‘‘Testing of
Retroviral Vector-Based Human Gene
Therapy Products for Replication
Competent Retrovirus During Product
Manufacture and Patient Follow-up;
Draft Guidance for Industry.’’ The draft
guidance document provides sponsors
of retroviral vector-based human gene
therapy products recommendations
regarding the testing for RCR during the
manufacture of retroviral vector-based
products, and during follow-up
monitoring of patients who have
received retroviral vector-based
products. Recommendations are also
provided for RCR testing during
manufacture, including identification
and amount of material to be tested, and
general testing methods. In addition,
recommendations are provided on
monitoring patients for evidence of
retroviral infection after administration
of retroviral vector-based gene therapy
products. The draft guidance, when
finalized, is intended to supersede the
document entitled ‘‘Guidance for
Industry: Supplemental Guidance on
Testing for Replication Competent
Retrovirus in Retroviral Vector Based
Gene Therapy Products and During
Follow-up of Patients in Clinical Trials
Using Retroviral Vectors,’’ dated
November 2006. The draft guidance,
when finalized, is also intended to
supplement the ‘‘Long Term Follow-Up
After Administration of Human Gene
Therapy Products; Draft Guidance for
Industry’’ and ‘‘Chemistry,
Manufacturing, and Control Information
for Human Gene Therapy
Investigational New Drug Applications;
Draft Guidance for Industry,’’ when
these draft guidance documents are
finalized. Elsewhere in this issue of the
Federal Register, FDA is announcing
the availability of these other two draft
guidance documents.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on
testing of retroviral vector-based human
gene therapy products for replication
competent retrovirus during product
manufacture and patient follow-up. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and

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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14868 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2475]

Advisory Committee; Allergenic
Products Advisory Committee;
Renewal
AGENCY:

Food and Drug Administration,

HHS.
Notice; renewal of advisory
committee.

ACTION:

The Food and Drug
Administration (FDA) is announcing the
renewal of the Allergenic Products
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Allergenic
Products Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until July 9, 2020.
DATES: Authority for the Allergenic
Products Advisory Committee expired
on July 9, 2018; however, the
Commissioner formally determined that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of
SUMMARY:

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Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6338, Silver Spring,
MD 20993–0002; 240–402–5771,
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Allergenic Products Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and adequacy of labeling
of marketed and investigational
allergenic biological products or
materials that are administered to
humans for the diagnosis, prevention, or
treatment of allergies and allergic
disease, and makes appropriate
recommendations to the Commissioner
of its findings regarding the affirmation
or revocation of biological product
licenses; on the safety, effectiveness,
and labeling of the products; on clinical
and laboratory studies of such products;
on amendments or revisions to
regulations governing the manufacture,
testing, and licensing of allergenic
biological products; and on the quality
and relevance of FDA’s research
programs that provide the scientific
support for regulating these agents.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of allergy,
immunology, pediatrics, internal
medicine, biochemistry, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include

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one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
AllergenicProductsAdvisoryCommittee/
ucm129360.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14942 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2173]

Long Term Follow-Up After
Administration of Human Gene
Therapy Products; Draft Guidance for
Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Long Term FollowUp After Administration of Human
Gene Therapy Products; Draft Guidance
for Industry.’’ The draft guidance
provides sponsors, who are developing
a human gene therapy (GT) product,
recommendations regarding the design
of long term follow-up (LTFU)
observational studies for the collection
of data on delayed adverse events
following administration of a GT
product. The draft guidance, when
finalized, is intended to supersede the
document entitled ‘‘Guidance for
Industry: Gene Therapy Clinical
Trials—Observing Participants for
Delayed Adverse Events’’ dated
November 2006. This draft guidance,
when finalized, is also intended to
supplement the guidance entitled
‘‘Testing of Retroviral Vector-Based

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Human Gene Therapy Products for
Replication Competent Retrovirus
during Product Manufacture and Patient
Follow-up; Draft Guidance for
Industry.’’
Submit either electronic or
written comments on the draft guidance
by October 10, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–2173 for ‘‘Long Term FollowUp After Administration of Human
Gene Therapy Products; Draft Guidance
for Industry.’’ Received comments will
be placed in the docket and, except for

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those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See

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the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:

amozie on DSK3GDR082PROD with NOTICES1

I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Long Term
Follow-Up After Administration of
Human Gene Therapy Products; Draft
Guidance for Industry.’’ The draft
guidance provides a brief introduction
of the product characteristics, patientrelated factors, and the preclinical and
clinical data that should be considered
when assessing the need for LTFU
observations for your GT product. The
draft guidance also describes the
Agency’s current recommendations for
the conduct of LTFU studies,
specifically the information/data to
support a sponsor’s rationale for the
duration and design of a LTFU protocol
when clinical trials are initiated. Also
included in the draft guidance are GT
product-specific clinical considerations
for monitoring subjects under a LTFU
protocol and recommendations on
patient monitoring for licensed GT
products. The draft guidance, when
finalized, is intended to supersede the
guidance entitled ‘‘Guidance for
Industry: Gene Therapy Clinical
Trials—Observing Participants for
Delayed Adverse Events’’ dated
November 2006. The draft guidance,
when finalized, is also intended to
supplement the guidance entitled
‘‘Testing of Retroviral Vector-Based
Human Gene Therapy Products for
Replication Competent Retrovirus
during Product Manufacture and Patient
Follow-up; Draft Guidance for
Industry,’’ published elsewhere in this
issue of the Federal Register. Also,
elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of another draft guidance
entitled ‘‘Chemistry, Manufacturing,
and Control Information for Human
Gene Therapy Investigational New Drug
Applications; Draft Guidance for
Industry.’’
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on long term follow-up after
administration of human gene therapy
products. It does not establish any rights

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for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 50 and
56 have been approved under OMB
control number 0910–0755; the
collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; and the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14867 Filed 7–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Heritable Disorders in
Newborns and Children (ACHDNC) will
hold a public meeting.
DATES: Thursday, August 2, 2018, from
9:30 a.m. to 5:00 p.m. Eastern Time
(ET).
ADDRESSES: This meeting is a webinar
only and requires advanced registration.
Please register online at http://
www.achdncmeetings.org/ by 12:00 p.m.
ET on July 30, 2018.
SUMMARY:

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Ann
Ferrero, Maternal and Child Health
Bureau (MCHB), HRSA, in one of three
ways: (1) Send a request to the following
address: Ann Ferrero, MCHB, HRSA
5600 Fishers Lane, Room 18N100C,
Rockville, MD 20857; (2) call 301–443–
3999; or (3) send an email to AFerrero@
hrsa.gov.
SUPPLEMENTARY INFORMATION:
Background: The ACHDNC provides
advice and recommendations to the
Secretary of HHS on the development of
newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. In addition,
ACHDNC’s recommendations regarding
inclusion of additional conditions for
screening, following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA through the
Recommended Uniform Screening Panel
(RUSP) pursuant to section 2713 of the
Public Health Service Act (42 U.S.C.
300gg–13). Under this provision, nongrandfathered group health plans and
health insurance issuers offering group
or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
Agenda: During the August 2, 2018,
meeting, the ACHDNC will discuss
issues related to long-term follow-up,
timeliness, education and training, the
evidence-based review process, and risk
assessment in newborn screening.
Information about the ACHDNC, a roster
of members, and the meeting agenda, as
well as past meeting summaries, is
located on the ACHDNC website:
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
index.html.
Public Participation: Members of the
public will have the opportunity to
provide comments, which are part of the
official Committee record. To submit
written comments or request time
for an oral comment at the meeting,
please register online by 12:00 p.m. ET
on July 27, 2018, at http://
www.achdncmeetings.org. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Individuals associated
with groups or who plan to provide
comments on similar topics may be
asked to combine their comments and
FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
present them through a single
representative. No audiovisual
presentations are permitted. Written
comments should identify the
individual’s name, address, email,
telephone number, professional or
organization affiliation, background or
area of expertise (i.e., parent, family
member, researcher, clinician, public
health, etc.) and the topic/subject
matter.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–14908 Filed 7–11–18; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Meetings

amozie on DSK3GDR082PROD with NOTICES1

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Center for
Advancing Translational Sciences.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Cures Acceleration
Network Review Board.
Date: September 27, 2018.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: Report from the Institute Director.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, annn.ramseyewing@
nih.gov.

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Name of Committee: National Center for
Advancing Translational Sciences Advisory
Council.
Date: September 27, 2018.
Open: 8:30 a.m. to 3:00 p.m.
Agenda: Report from the Institute Director
and other staff.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Closed: 3:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Conference Room 6, 31 Center
Drive, Bethesda, MD 20892.
Contact Person: Anna L. Ramsey-Ewing,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1
Democracy Plaza, Room 1072, Bethesda, MD
20892, 301–435–0809, anna.ramseyewing@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: July 5, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–14873 Filed 7–11–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the ZAT1 PJ (02)
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel; Mechanisms of
Mind and Body Interventions (MMB).
Date: August 1, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy

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Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Pamela Eugenia Jeter,
Ph.D., Scientific Review Officer, Office of
Scientific Review, Division of Extramural
Activities, NCCIH, NIH, 6707 Democracy
Boulevard, Suite 401, Bethesda, MD 20892,
301–435–2591, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Integrative Health,
National Institutes of Health, HHS)
Dated: July 6, 2018.
Michelle D. Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–14874 Filed 7–11–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Accreditation and Approval of Saybolt
LP (Nederland, TX) as a Commercial
Gauger and Laboratory
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of Saybolt LP (Nederland, TX)
as a commercial gauger and laboratory.
AGENCY:

Notice is hereby given,
pursuant to CBP regulations, that
Saybolt LP (Nederland, TX) has been
approved to gauge petroleum and
certain petroleum products and
accredited to test petroleum and certain
petroleum products for customs
purposes for the next three years as of
August 8, 2017.
DATES: Saybolt LP (Nederland, TX) was
approved and accredited as a
commercial gauger and laboratory as of
August 8, 2017. The next triennial
inspection date will be scheduled for
August 2020.
FOR FURTHER INFORMATION CONTACT:
Christopher J. Mocella, Laboratories and
Scientific Services Directorate, U.S.
Customs and Border Protection, 1300
Pennsylvania Avenue NW, Suite 1500N,
Washington, DC 20229, tel. 202–344–
1060.
SUPPLEMENTARY INFORMATION: Notice is
hereby given pursuant to 19 CFR 151.12
and 19 CFR 151.13, that Saybolt LP,
4144 N Twin City Hwy., Nederland, TX
77627, has been approved to gauge
petroleum and certain petroleum
products and accredited to test
petroleum and certain petroleum
products for customs purposes, in
accordance with the provisions of 19
CFR 151.12 and 19 CFR 151.13. Saybolt
SUMMARY:

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LP (Nederland, TX) is approved for the
following gauging procedures for
petroleum and certain petroleum
products from the American Petroleum
Institute (API):

CBPL No.

API chapters
3 ...................
7 ...................
8 ...................
12 .................
17 .................

Title
Tank gauging.
Temperature determination.
Sampling.
Calculations.
Maritime measurement.

ASTM

Title

..............
..............
..............
..............

D4006
D4928
D473
D4294

27–48 ..............
Pending ...........

D4052
D4007

Standard Test Method for Water in Crude Oil by Distillation.
Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration.
Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method.
Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluorescence
Spectrometry.
Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter.
Standard Test Method for Water and Sediment in Crude Oil by the Centrifuge Method (Laboratory Procedure).

27–03
27–05
27–06
27–13

Anyone wishing to employ this entity
to conduct laboratory analyses and
gauger services should request and
receive written assurances from the
entity that it is accredited or approved
by the U.S. Customs and Border
Protection to conduct the specific test or
gauger service requested. Alternatively,
inquiries regarding the specific test or
gauger service this entity is accredited
or approved to perform may be directed
to the U.S. Customs and Border
Protection by calling (202) 344–1060.
The inquiry may also be sent to
[email protected]. Please
reference the website listed below for a
complete listing of CBP approved
gaugers and accredited laboratories.
http://www.cbp.gov/about/labsscientific/commercial-gaugers-andlaboratories.
Dated: July 2, 2018.
Dave Fluty,
Executive Director, Laboratories and
Scientific Services.

descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to claim this cultural item
should submit a written request to the
Berkshire Museum. If no additional
claimants come forward, transfer of
control of the cultural item to the lineal
descendants, Indian Tribes, or Native
Hawaiian organizations stated in this
notice may proceed.
Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
claim this cultural item should submit
a written request with information in
support of the claim to the Berkshire
Museum at the address in this notice by
August 13, 2018.

DATES:

Jason Vivori, Collections
Experience Manager, Berkshire
Museum, 39 South Street, Pittsfield, MA
01201, telephone (413) 443–7171 ext.
341, email jvivori@
berkshiremuseum.org.

ADDRESSES:

[FR Doc. 2018–14918 Filed 7–11–18; 8:45 am]
BILLING CODE 9111–14–P

Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3005, of the intent to repatriate a
cultural item under the control of the
Berkshire Museum, Pittsfield, MA, that
meets the definitions of sacred objects
and objects of cultural patrimony under
25 U.S.C. 3001.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American cultural items. The National
Park Service is not responsible for the
determinations in this notice.

SUPPLEMENTARY INFORMATION:

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025701;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Intent To Repatriate Cultural
Items: Berkshire Museum, Pittsfield,
MA
National Park Service, Interior.
Notice.

AGENCY:
ACTION:
amozie on DSK3GDR082PROD with NOTICES1

Saybolt LP (Nederland, TX) is
accredited for the following laboratory
analysis procedures and methods for
petroleum and certain petroleum
products set forth by the U.S. Customs
and Border Protection Laboratory
Methods (CBPL) and American Society
for Testing and Materials (ASTM):

The Berkshire Museum, in
consultation with the appropriate
Indian Tribes or Native Hawaiian
organizations, has determined that the
cultural item listed in this notice meets
the definition of sacred object and object
of cultural patrimony. Lineal

SUMMARY:

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History and Description of the Cultural
Item
In 1903, one cultural item was
removed from Pine Point in Becker
County, MN, by John K. West, an
entrepreneur from western
Massachusetts, who arrived in Detroit
Lakes in 1881 with his wife, Ms. Jessie
Campbell West. Both individuals spent
considerable time in Detroit Lakes and
other areas within Becker County and
acquired numerous objects from White
Earth Reservation. Shortly after Ms.
West’s death in January 1903, several
objects were sent to Massachusetts and
were acquired by the Berkshire
Museum. The one sacred object/object
of cultural patrimony is described as an
‘‘Ojibwa large drum’’ (#C1992.53)
otherwise referred to as a ‘‘Big Drum’’ or
‘‘Manidoo Dewe’igan’’ (meaning ‘‘Spirit
Drum’’).
The Pine Point community, where
this particular drum originated, is
within the boundaries of Becker County
on the White Earth Reservation. From
the creation of the White Earth
Reservation in 1867 through the mid1900s, the people of White Earth existed
often under great hardship due to
significant economic, cultural, and
religious oppression combined with
well-documented dispossession of land
and other resources. Historically, the
Big Drum served an important role in
maintaining peace between
communities and such drums continue
to hold a spiritual and healing role with
ceremonies that are still held on the
White Earth Reservation. In addition,
the ongoing historical and spiritual
importance of these drums is that they
are central to the White Earth people as
a whole and could never have been
alienated, appropriated, or conveyed by
any individual regardless of whether or
not the individual was a member of the
tribe. Thomas Vennum wrote in The
Ojibwa Dance Drum, ‘‘Because song and

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
dance are traditionally considered to be
sacred in origin they are for Native
Americans a form of prayer . . . and
because most song is accompanied by
percussion of some sort—drums more
often than not—the instruments
themselves become sacred through their
associations.’’ This feeling was
reaffirmed by the White Earth Band of
the Minnesota Chippewa Tribe during
consultation with the Berkshire
Museum. In a letter dated April 5, 2017,
the White Earth Band of the Minnesota
Chippewa Tribe requested the return of
the Big Drum due to its substantial
cultural and religious significance.
Determinations Made by the Berkshire
Museum
Officials of the Berkshire Museum
have determined that:
• Pursuant to 25 U.S.C. 3001(3)(C),
the one cultural item described above is
a specific ceremonial object needed by
traditional Native American religious
leaders for the practice of traditional
Native American religions by their
present-day adherents.
• Pursuant to 25 U.S.C. 3001(3)(D),
the one cultural item described above
has ongoing historical, traditional, or
cultural importance central to the
Native American group or culture itself,
rather than property owned by an
individual.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the sacred object and object of
cultural patrimony and the White Earth
Band of the Minnesota Chippewa Tribe.

amozie on DSK3GDR082PROD with NOTICES1

Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to claim these cultural items
should submit a written request with
information in support of the claim to
Jason Vivori, Collections Experience
Manager, Berkshire Museum, 39 South
Street, Pittsfield, MA 01201, telephone
(413) 443–7171 ext. 341, email jvivori@
berkshiremuseum.org, by August 13,
2018. After that date, if no additional
claimants have come forward, transfer
of control of the sacred object and object
of cultural patrimony to the White Earth
Band of the Minnesota Chippewa Tribe
may proceed.
The Berkshire Museum is responsible
for notifying the White Earth Band of
the Minnesota Chippewa Tribe that this
notice has been published.

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Dated: June 1, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14896 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025846;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion: State
Historic Preservation Office, Lansing,
MI
National Park Service, Interior.
ACTION: Notice.
AGENCY:

The State Historic
Preservation Office (SHPO), Michigan
State Housing Development Authority,
has completed an inventory of human
remains and associated funerary objects
in consultation with the appropriate
Indian Tribes or Native Hawaiian
organizations, and has determined that
there is a cultural affiliation between the
human remains and present-day Indian
Tribes or Native Hawaiian
organizations. Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request to the Michigan State Historic
Preservation Office. If no additional
requestors come forward, transfer of
control of the human remains and
associated funerary objects to the lineal
descendants, Indian Tribes, or Native
Hawaiian organizations stated in this
notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains and associated funerary
objects should submit a written request
with information in support of the
request to the State Historic
Preservation Office at the address in this
notice by August 13, 2018.
ADDRESSES: Dean L. Anderson, State
Historic Preservation Office, Michigan
State Housing Development Authority,
735 East Michigan Avenue, Lansing, MI
48909, telephone: (517) 373–1618, email
[email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains and associated
SUMMARY:

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32315

funerary objects under the control of the
State Historic Preservation Office,
Lansing, MI. The human remains and
associated funerary objects were
removed from a highway construction
project on US–12, Lenawee County, MI.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains. The National
Park Service is not responsible for the
determinations in this notice.
Consultation
A detailed assessment of the human
remains was made during 1993–1995 by
the former Office of the State
Archaeologist (OSA) professional staff
and by a physical anthropologist.
According to documents held by the
SHPO, in 1995 the OSA initiated
consultation on the human remains and
funerary objects with the Citizen
Potawatomi Nation, Oklahoma; Forest
County Potawatomi Community,
Wisconsin; Hannahville Indian
Community, Michigan; Pokagon Band of
Potawatomi Indians, Michigan and
Indiana; and Prairie Band Potawatomi
Nation (previously listed as the Prairie
Band of Potawatomi Nation, Kansas).
History and Description of the Remains
In the 1920s, human remains
representing nine individuals were
removed from a highway construction
project in Lenawee County, MI. In 1925,
the remains were re-interred on the
grounds of the Walker Tavern historic
site, located a few miles from the
highway construction project. The
Walker Tavern structure was built
around 1832, as a farmhouse, and then
became a tavern and inn along the
Detroit to Chicago stagecoach route. In
1921, Frederic Hewitt converted the
tavern into a museum, and in 1965, the
structure was sold to the Michigan
Department of Natural Resources. The
Parks and Recreation Division of the
Michigan Department of Conservation
operated the historic site until 1975,
when the Michigan Historical Museum,
which was part of the Michigan
Historical Center (MHC), took
responsibility for the Walker Tavern
museum and its collections.
In the mid-1990s, Barbara Mead,
Assistant State Archaeologist, did the
NAGPRA reporting for the Office of the
State Archaeologist (OSA) and for the
state museum. At that time, the state
museum turned over to Ms. Mead a
single cranium and associated funerary
objects that she determined had been

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part of the group of human remains that
was re-interred on the grounds of the
Walker Tavern site in 1925.
In 2009, the Department of History,
Arts, and Libraries, which included
both the OSA and the state museum,
was eliminated. The state museum was
moved into the Department of Natural
Resources, and the OSA was moved into
the Michigan State Housing
Development Authority. Soon after that,
the OSA was eliminated, and the
archaeology staff were moved into the
SHPO. Consequently, the archaeological
collections, including the Walker
Tavern materials, are now held by the
SHPO.
The human remains in the Walker
Tavern collection include a single
cranium with no teeth present and
lacking the mandible. The cranium was
examined by a physical anthropologist
who stated that the individual was
approximately 10–15 years of age, and
that no determination of sex or ethnic
identity of the individual could be
made. No known individuals were
identified.
When the state museum assumed
responsibility for the Walker Tavern
collection in 1975, the cranium was
recorded under Michigan Department of
Conservation accession number A1253.
The state museum assigned catalog
number FA–155–75 to the cranium.
The state museum also cataloged a
group of 18 funerary objects associated
with the human remains disinterred
during road construction in the 1920s.
The 18 associated funerary objects are:
One pewter spoon, one bottle, one oval
stone, one deer mandible, three loose
teeth, one lot of fur pieces with tassels
wrapped in porcupine quill, one silver
armband, one wooden bowl or toy
canoe, one lot of wool scraps, one lot of
linen scraps, one silver armband, one
copper or brass kettle fragment, one iron
knife blade, one lot of very small bone
chips, one lot of shell and glass beads
and one pewter bowl.
Based on the funerary objects, it is
estimated that the original interment of
the objects and the human remains took
place between approximately 1760 and
1810. A typescript in the MHC Walker
Tavern files identified as an article in
the Lenawee County Exponent dated
November 22, 1923, describes the
discovery of Indian graves and artifacts
during road construction work in the
Irish Hills area. The article mentions
some of the same funerary objects
described above and associated with the
cranium. This assemblage of funerary
objects, including trade silver and
beads, together with the cranium,
represent a Native American interment.

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The inventory that Assistant State
Archaeologist Barbara Mead compiled
in 1995 included the following
information on cultural affiliation:
Probably Potawatomi. Early in the
eighteenth century, the Potawatomi,
Miami, Ottawa, Huron/Wyandotte and
Kickapoo were present in southern
Michigan. Most of the reports for tribes
other than the Potawatomi are from the
pre-1720 era. By the 1760s, the
Potawatomi territory included Lenawee
County; no other tribes seemed to be
present, except perhaps as travelers or
temporary residents. (Cleland, Charles
E., 1992, Rites of Conquest, the
University of Michigan Press; Tanner,
Helen Hornbeck (ed.), 1987, Atlas of
Great Lakes Indian History, University
of Oklahoma Press; Trigger, Bruce G.
(ed.), 1978, Handbook of North
American Indians, Vol. 15: Northeast,
Smithsonian Institution).
Determinations Made by the State
Historic Preservation Office
Officials of the State Historic
Preservation Office have determined
that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A),
the 18 objects described in this notice
are reasonably believed to have been
placed with or near individual human
remains at the time of death or later as
part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the Native American human
remains and associated funerary objects
and the Citizen Potawatomi Nation,
Oklahoma; Forest County Potawatomi
Community, Wisconsin; Hannahville
Indian Community, Michigan; Pokagon
Band of Potawatomi Indians, Michigan
and Indiana; and Prairie Band
Potawatomi Nation (previously listed as
the Prairie Band of Potawatomi Nation,
Kansas).
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains and associated
funerary objects should submit a written
request with information in support of
the request to Dean L. Anderson, State
Historic Preservation Office, Michigan
State Housing Development Authority,
735 East Michigan Avenue, P.O. Box
30044, Lansing, MI 48909, telephone
(517) 373–1618, email andersond15@
michigan.gov, by August 13, 2018. After

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that date, if no additional requestors
have come forward, transfer of control
of the human remains and associated
funerary objects to the Citizen
Potawatomi Nation, Oklahoma; Forest
County Potawatomi Community,
Wisconsin; Hannahville Indian
Community, Michigan; Pokagon Band of
Potawatomi Indians, Michigan and
Indiana; and Prairie Band Potawatomi
Nation (previously listed as the Prairie
Band of Potawatomi Nation, Kansas)
may proceed.
The State Historic Preservation Office
is responsible for notifying the Citizen
Potawatomi Nation, Oklahoma; Forest
County Potawatomi Community,
Wisconsin; Hannahville Indian
Community, Michigan; Pokagon Band of
Potawatomi Indians, Michigan and
Indiana; and Prairie Band Potawatomi
Nation (previously listed as the Prairie
Band of Potawatomi Nation, Kansas)
that this notice has been published.
Dated: June 21, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14905 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025769;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion: St.
Joseph Museums, Inc., St. Joseph, MO
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The St. Joseph Museum has
completed an inventory of human
remains, in consultation with the
appropriate Indian Tribes or Native
Hawaiian organizations, and has
determined that there is a cultural
affiliation between the human remains
and present-day Indian Tribes or Native
Hawaiian organizations. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request to the St. Joseph
Museum. If no additional requestors
come forward, transfer of control of the
human remains to the lineal
descendants, Indian Tribes, or Native
Hawaiian organizations stated in this
notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
request transfer of control of these
human remains should submit a written
request with information in support of
the request to the St. Joseph Museum at
the address in this notice by August 13,
2018.
Trevor Tutt, Collections
Manager, St. Joseph Museums, Inc.,
St. Joseph, MO 64506, telephone (816)
232–8471, email trevor@
stjosephmuseum.org.

ADDRESSES:

Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the St. Joseph Museums, Inc., St. Joseph,
MO. The human remains were removed
from Kake, AK.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains. The National
Park Service is not responsible for the
determinations in this notice.

SUPPLEMENTARY INFORMATION:

Consultation
A detailed assessment of the human
remains was made by the St. Joseph
Museum professional staff in
consultation with representatives of the
Organized Village of Kake.

amozie on DSK3GDR082PROD with NOTICES1

History and Description of the Remains
Prior to 1910, human remains
representing, at minimum, one
individual were removed from Kake,
AK. Subsequently, William H. Case
transferred these human remains to
Harry L. George, who, in turn donated
them to the St. Joseph Museum. The
human remains—a jaw bone—belonged
to a Medicine Man who had died and
was buried in a grave house, in
accordance with Native custom. When a
sickness, attributed to evil spirits, fell
upon the village the Medicine Man’s
bones were thrown in salt water. A
white missionary from Kake was said to
have retrieved the jaw bone from the
Pacific Ocean several years later,
accounting for the barnacles found on
the teeth. As Russian missionaries first
arrived in Kake in the 1790s, the
retrieval of the jaw by a white
missionary would have occurred
between the 1790s and early 1910, when
Case photographed it and sent the
images to George. George had purchased
the jawbone along with a series of ivory
buttons and a jade axe head for $30.00
no later than July 14, 1911.

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The Harry George collection was
originally meant to be donated to the St.
Joseph Museum prior to George’s death
in 1923, but due to lack of storage space,
it was on loan to the Missouri State
Museum in Jefferson City until it
transferred to the St. Joseph Museum in
October 1944. The bulk of the collection
was stored in the basement of the St.
Joseph City Hall while select items were
displayed at the AJ August House, the
second location of the St. Joseph
Museum. After the St. Joseph Museum
received the Wyeth-Tootle Mansion as
their main display site in 1946, the vast
majority of the items went on display
there. That same year, funds were
provided for the St. Joseph Museum to
purchase the George Collection outright.
The human remains in the collection
have remained in storage since at least
the 1970s. When the St. Joseph
Museum, now the St. Joseph Museums,
Inc., moved to the Glore Psychiatric
Museum in 2004, much of the George
Collection was moved as well, including
the jaw bone. In 2017, it, and other
human remains were returned to storage
at the Wyeth-Tootle Mansion for
processing under NAGPRA.
Research into the Harry George
Collection, specifically the William H.
Case photographs, began around 2017.
Zachary Jones, Archivist at the Alaska
State Archives, assisted in identifying
objects in the collection and initiated
consultation with the Organized Village
of Kake. Frank Hughes, the NAGPRA
Coordinator for the Organized Village of
Kake, contacted Trevor Tutt, the
Collections Manager for the St. Joseph
Museums, Inc., and began
correspondence related to items of
cultural patrimony and remains related
to Kake, Alaska. Through
correspondence, the oral tradition of
human remains being thrown in salt
water in retaliation against a sickness in
the village was confirmed. As research
indicates that missionary activity in
Kake peaked during the 1890s–1910
period, the jaw might have been
removed during that two decade span.
Determinations Made by the St. Joseph
Museum
Officials of the St. Joseph Museum
have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the Native American human
remains and the Organized Village of
Kake.

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32317

Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request with information in
support of the request to Trevor Tutt,
Collections Manager, St. Joseph
Museums, Inc., St. Joseph, MO 64506,
telephone (816) 232–8471, email
[email protected], by August
13, 2018. After that date, if no
additional requestors have come
forward, transfer of control of the
human remains to the Organized Village
of Kake may proceed.
The St. Joseph Museum is responsible
for notifying the Organized Village of
Kake that this notice has been
published.
Dated: June 12, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14901 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025692;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion: U.S.
Department of Agriculture, Tongass
National Forest, Juneau Ranger
District, Juneau, AK
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The U.S. Department of
Agriculture, Tongass National Forest,
Juneau Ranger District, (Tongass
National Forest) has completed an
inventory of human remains and
associated funerary objects, in
consultation with the appropriate
Indian Tribes or Native Hawaiian
organizations, and has determined that
there is a cultural affiliation between the
human remains and associated funerary
objects and present-day Indian Tribes or
Native Hawaiian organizations. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of the human remains and associated
funerary objects should submit a written
request to the Tongass National Forest.
If no additional requestors come
forward, transfer of control of the
human remains and associated funerary
objects to the lineal descendants, Indian
Tribes, or Native Hawaiian

SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

organizations stated in this notice may
proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains and associated funerary
objects should submit a written request
with information in support of the
request to the Tongass National Forest at
the address in this notice by August 13,
2018.
ADDRESSES: M. Earl Stewart, Forest
Supervisor, Tongass National Forest,
648 Mission Street, Ketchikan, AK
99901–6591, telephone (907) 228–6281,
email [email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of the human remains and associated
funerary objects under the control of the
USDA Tongass National Forest, Juneau
Ranger District, Juneau, AK. The human
remains and associated funerary objects
were removed from Entrance Island,
near Hobart Bay, AK, on two separate
occasions by two separate collectors.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains and
associated funerary objects. The
National Park Service is not responsible
for the determinations in this notice.
Consultation
A detailed assessment of the human
remains was made by Tongass National
Forest archeologists in partnership with
the professional staff of the Alaska State
Museum and in consultation with
representatives of Douglas Indian
Association and the Organized Village
of Kake.

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History and Description of the Remains
In the summer of 1961, funerary
objects, in several pieces, were removed
from a small cave on Entrance Island
near Hobart Bay, AK. An individual
exploring the island reported that he
found a small cave that contained
human remains and portions of a
bentwood box, as well as some other
burial items believed to have been
placed there at the time of burial. He
collected a basket of a type that
reportedly was used to cradle a baby
and sometimes was used to bury the
deceased. Additional items collected

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include a piece of leather cordage, a
portion of a woven cedar mat, and a
piece of wood with evidence of a kerf
corner, all of which were connected
with either the basket or the bentwood
box. The human remains and the
bentwood box were not removed from
the cave at that time. The individual
returned the four burial items to the
Tongass National Forest in 2017.
Subsequently, it was determined that
these funerary objects are associated
with the below described human
remains and funerary object that were
separately collected by a different
individual.
In 1961, the desiccated remains of an
infant inside a bentwood box that had
been wrapped in a cedar mat were
removed from a small burial cave on
Entrance Island, near Hobart Bay. In
November 1961, these human remains
and funerary objects were sent to the
Alaska State Museum for curation.
Based on oral testimony, this burial site
and the above described burial cave are
determined to be one and the same. The
human remains consist of a single
individual, a mummified infant,
estimated to be between the ages of 6
and 9 months. Determination of sex or
affinity based on skeletal features was
not possible. The bentwood box
containing the infant’s remains was
painted and uncarved. It was recovered
from beneath the cedar bark mat. When
found, the infant had ermine skins tied
in its hair.
The human remains and associated
funerary objects are believed to be of
pre-contact or first contact date, as after
contact, the Christian burial practice of
underground internment became
widespread. The human remains are
reasonably believed to be associated
with the Ke´ex Kwa´an, who have
traditionally used and occupied the
island. The cultural affiliation of the
human remains was determined by
consulting Haa Aanı´ Our Land Tlingit
and Haida Land Rights and Use, by
Walter R. Goldschmidt and Theodore H.
Haas, edited by Thomas F. Thorton
(1998). Additional cultural affiliation
information was provided by the
Organized Village of Kake and the
Douglas Indian Association. The Ke´ex
Kwa´an continue to live in their
traditional territory and use the Hobart
Bay area. Their present-day descendants
are the Organized Village of Kake.
Determinations Made by the Tongass
National Forest
Officials of the Tongass National
Forest have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice

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represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A),
the seven objects described in this
notice are reasonably believed to have
been placed with or near individual
human remains at the time of death or
later as part of the death rite or
ceremony.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the human remains and
associated funerary objects and the
Organized Village of Kake.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains and associated
funerary objects should submit a written
request with information in support of
the request to M. Earl Stewart, Forest
Supervisor, Tongass National Forest,
648 Mission Street, Ketchikan, AK
99901–6591, telephone (907) 228–6281,
email [email protected], by August 13,
2018. After that date, if no additional
requestors have come forward, transfer
of control of the human remains and
associated funerary objects to the
Organized Village of Kake may proceed.
The Tongass National Forest is
responsible for notifying the Douglas
Indian Association and the Organized
Village of Kake that this notice has been
published.
Dated: May 31, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14903 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025756;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion:
University of San Diego, San Diego, CA
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The University of San Diego
has completed an inventory of human
remains in consultation with the
appropriate Indian Tribes or Native
Hawaiian organizations, and has
determined that there is no cultural
affiliation between the human remains
and any present-day Indian Tribes or
Native Hawaiian organizations.
Representatives of any Indian Tribe or
Native Hawaiian organization not

SUMMARY:

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amozie on DSK3GDR082PROD with NOTICES1

identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request to the University of San Diego.
If no additional requestors come
forward, transfer of control of the
human remains to the Indian Tribes or
Native Hawaiian organizations stated in
this notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request with information in support of
the request to the University of San
Diego, at the address in this notice by
August 13, 2018.
ADDRESSES: Derrick R. Cartwright,
Ph.D., University of San Diego, 5998
Alcala Park, San Diego, CA 92110,
telephone (619) 260–7632, email
[email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the University of San Diego, San Diego,
CA. The human remains were removed
from Squaw Point, near Dove Creek,
Delores County, CO.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3) and 43 CFR 10.11(d).
The determinations in this notice are
the sole responsibility of the museum,
institution, or Federal agency that has
control of the Native American human
remains. The National Park Service is
not responsible for the determinations
in this notice.
Consultation
A detailed assessment of the human
remains were made by the University of
San Diego professional staff in
consultation with representatives of the
Hopi Tribe of Arizona; Kewa Pueblo,
New Mexico (previously listed as the
Pueblo of Santo Domingo); Navajo
Nation, Arizona, New Mexico & Utah;
Ohkay Owingeh, New Mexico
(previously listed as the Pueblo of San
Juan); Pueblo of Acoma, New Mexico;
Pueblo of Cochiti, New Mexico; Pueblo
of Isleta, New Mexico; Pueblo of Jemez,
New Mexico; Pueblo of Laguna, New
Mexico; Pueblo of Nambe, New Mexico;
Pueblo of Picuris, New Mexico; Pueblo
of Pojoaque, New Mexico; Pueblo of San
Felipe, New Mexico; Pueblo of San
Ildefonso, New Mexico; Pueblo of
Sandia, New Mexico; Pueblo of Santa
Ana, New Mexico; Pueblo of Santa

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Clara, New Mexico; Pueblo of Taos,
New Mexico; Pueblo of Tesuque, New
Mexico; Pueblo of Zia, New Mexico;
Southern Ute Indian Tribe of the
Southern Ute Reservation, Colorado; Ute
Indian Tribe of the Uintah & Ouray
Reservation, Utah; Ute Mountain Ute
Tribe (previously listed as the Ute
Mountain Tribe of the Ute Mountain
Reservation, Colorado, New Mexico &
Utah);Ysleta del Sur Pueblo (previously
listed as the Ysleta Del Sur Pueblo of
Texas); and Zuni Tribe of the Zuni
Reservation, New Mexico (hereafter
referred to as ‘‘The Consulted Tribes’’).
History and Description of the Remains
At an unknown time, human remains
representing, at minimum, one
individual were removed from Squaw
Point, near Dove Creek, CO. No
information regarding the circumstances
surrounding the removal is known. Rose
Tyson, a physical anthropologist,
received the human remains from Dr.
Spencer L. Rogers, also a physical
anthropologist, and gave them to the
Anthropology Department at the
University of San Diego in 2002. The
human remains—one cranium and
mandible—belong to a male and have
been cradleboard flattened. Printed in
ink on the left side of the cranium is
‘‘PII 7/55 Squaw Point near Dove Creek
Colorado prop. S. L. Rogers.
Dimensions: maximum length 143 mm,
maximum width 168 mm.’’ No known
individual was identified. No associated
funerary objects are present.
Determinations Made by the University
of San Diego
Officials of the University of San
Diego have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), a
relationship of shared group identity
cannot be reasonably traced between the
Native American human remains and
any present-day Indian Tribe.
• Treaties, Acts of Congress, or
Executive Orders, indicate that the land
from which the Native American human
remain was removed is the aboriginal
land of the Southern Ute Indian Tribe of
the Southern Ute Reservation, Colorado;
Ute Indian Tribe of the Uintah & Ouray
Reservation, Utah; and the Ute
Mountain Ute Tribe (previously listed as
the Ute Mountain Tribe of the Ute
Mountain Reservation, Colorado, New
Mexico & Utah).
• Pursuant to 43 CFR 10.11(c)(1), the
disposition of the human remains may
be to the Southern Ute Indian Tribe of
the Southern Ute Reservation, Colorado;

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Ute Indian Tribe of the Uintah & Ouray
Reservation, Utah; and the Ute
Mountain Ute Tribe (previously listed as
the Ute Mountain Tribe of the Ute
Mountain Reservation, Colorado, New
Mexico & Utah).
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request with information in
support of the request to Dr. Derrick R.
Cartwright, University of San Diego,
5998 Alcala Park, San Diego, CA 92110,
telephone (619) 260–7632, email
[email protected] by August
13, 2018. After that date, if no
additional requestors have come
forward, transfer of control of the
human remain to the Southern Ute
Indian Tribe of the Southern Ute
Reservation, Colorado; Ute Indian Tribe
of the Uintah & Ouray Reservation,
Utah; and the Ute Mountain Ute Tribe
(previously listed as the Ute Mountain
Tribe of the Ute Mountain Reservation,
Colorado, New Mexico & Utah) may
proceed.
The University of San Diego is
responsible for notifying The Consulted
Tribes that this notice has been
published.
Dated: June 11, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14899 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025845;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion: Heard
Museum, Phoenix, AZ
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The Heard Museum has
completed an inventory of human
remains, in consultation with the
appropriate Indian Tribes or Native
Hawaiian organizations, and has
determined that there is a cultural
affiliation between the human remains
and present-day Indian Tribes or Native
Hawaiian organizations. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request to the Heard Museum.

SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

If no additional requestors come
forward, transfer of control of the
human remains to the lineal
descendants, Indian Tribes, or Native
Hawaiian organizations stated in this
notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request with information in support of
the request to the Heard Museum at the
address in this notice by August 13,
2018.
ADDRESSES: David Roche, Director/CEO,
Heard Museum, 2301 North Central
Avenue, Phoenix, AZ 85004, telephone
(602) 252–8840, email director@
heard.org.
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the Heard Museum, Phoenix, AZ. The
human remains were removed from
Camp Verde, Yavapai County, AZ.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains. The National
Park Service is not responsible for the
determinations in this notice.

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Consultation
A detailed assessment of the human
remains was made by the Heard
Museum professional staff in
consultation with representatives of
Cheyenne River Sioux Tribe of the
Cheyenne River Reservation, South
Dakota; Hopi Tribe of Arizona; Hualapai
Indian Tribe of the Hualapai Indian
Reservation, Arizona; Three Affiliated
Tribes of the Fort Berthold Reservation,
North Dakota; Yavapai-Apache Nation
of the Camp Verde Indian Reservation,
Arizona; Yavapai-Prescott Indian Tribe
(previously listed as the YavapaiPrescott Tribe of the Yavapai
Reservation, Arizona); and Zuni Tribe of
the Zuni Reservation, New Mexico.
History and Description of the Remains
Sometime prior to 1991, human
remains representing, at minimum, one
individual were removed from Camp
Verde in Yavapai County, AZ. The
circumstances surrounding the removal
are unknown. In 1991, the human
remains were in the collection of the

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Heard Museum and were assigned the
catalog number NA–SW–PR–T–1. The
human remains are those of an adult. No
known individuals were identified. No
associated funerary objects are present.
Based on consultation, the Camp
Verde provenience, the type of burial
(inhumation), and the presence of
copper oxide stains which are often
found on burials in the Tuzigoot area
(Caywood and Spicer 1935:99–100;
Wilcox 1987:128), the Heard Museum
has determined that these human
remains belong to the Sinagua culture.
The Sinagua period was from A.D. 600
to A.D. 1450. The following present-day
Indian Tribes descend from the Sinagua
culture: Ak-Chin Indian Community
(previously listed as the Ak Chin Indian
Community of the Maricopa (Ak Chin)
Indian Reservation, Arizona); Fort
McDowell Yavapai Nation, Arizona;
Gila River Indian Community of the Gila
River Indian Reservation, Arizona;
Havasupai Tribe of the Havasupai
Reservation, Arizona; Hopi Tribe of
Arizona; Hualapai Indian Tribe of the
Hualapai Indian Reservation, Arizona;
Salt River Pima-Maricopa Indian
Community of the Salt River
Reservation, Arizona; Tohono O’odham
Nation of Arizona; Yavapai-Apache
Nation of the Camp Verde Indian
Reservation, Arizona; Yavapai-Prescott
Indian Tribe (previously listed as the
Yavapai-Prescott Tribe of the Yavapai
Reservation, Arizona); and Zuni Tribe of
the Zuni Reservation, New Mexico
(hereafter referred to as ‘‘The Tribes’’).
Determinations Made by the Heard
Museum
Officials of the Heard Museum have
determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the Native American human
remains and The Tribes.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request with information in
support of the request to David Roche,
Director/CEO, Heard Museum, 2301
North Central Avenue, Phoenix, AZ
85004, telephone (602) 252–8840, email
[email protected], by August 13, 2018.
After that date, if no additional
requestors have come forward, transfer

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of control of the human remains to The
Tribes may proceed.
The Heard Museum is responsible for
notifying The Tribes that this notice has
been published.
Dated: June 21, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14904 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025827;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Intent To Repatriate Cultural
Items: U.S. Department of the Interior,
National Park Service, Grand Canyon
National Park, Grand Canyon, AZ
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The U.S. Department of the
Interior, National Park Service, Grand
Canyon National Park, in consultation
with the appropriate Indian Tribes or
Native Hawaiian organizations, has
determined that the cultural items listed
in this notice meet the definition of
unassociated funerary objects. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to claim these cultural items
should submit a written request to
Grand Canyon National Park. If no
additional claimants come forward,
transfer of control of the cultural items
to the lineal descendants, Indian Tribes,
or Native Hawaiian organizations stated
in this notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
claim these cultural items should
submit a written request with
information in support of the claim to
Grand Canyon National Park at the
address in this notice by August 13,
2018.
ADDRESSES: Christine Lehnertz,
Superintendent, Grand Canyon National
Park, P.O. Box 129, Grand Canyon, AZ
86023, telephone (928) 638–7945, email
[email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3005, of the intent to repatriate cultural
items under the control of Grand
Canyon National Park, Grand Canyon,
AZ, that meet the definition of
SUMMARY:

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unassociated funerary objects under 25
U.S.C. 3001.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the Superintendent, Grand Canyon
National Park.
History and Description of the Cultural
Items
In 1935, three cultural items were
removed from GC 62 in Coconino
County, AZ, during a vegetation project
by the Works Progress Administration
and the National Park Service. The three
objects were kept by Claude A. Wagner
Jr. until 1974 when he donated them to
Grand Canyon National Park. The three
unassociated funerary objects are one
copper bracelet and two metal bells.
GC 62 is described as a cremation site,
about six feet in diameter with evidence
of a large fire. No human remains were
collected from GC 62. The site is located
in an area traditionally used by the
Havasupai Tribe and cremation was a
Havasupai burial practice. The
Havasupai Tribal Council has identified
the items as likely coming from a tribal
cremation.

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Determinations Made by Grand Canyon
National Park
Officials of Grand Canyon National
Park have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B),
the three cultural items described above
are reasonably believed to have been
placed with or near individual human
remains at the time of death or later as
part of the death rite or ceremony and
are believed, by a preponderance of the
evidence, to have been removed from a
specific burial site of a Native American
individual.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the unassociated funerary
objects and the Havasupai Tribe of the
Havasupai Reservation, Arizona.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to claim these cultural items
should submit a written request with
information in support of the claim to
Christine Lehnertz, Superintendent,
Grand Canyon National Park, P.O. Box
129, Grand Canyon, AZ 86023,
telephone (928) 638–7945, email chris_
[email protected], by August 13, 2018.
After that date, if no additional
claimants have come forward, transfer
of control of the unassociated funerary

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objects to the Havasupai Tribe of the
Havasupai Reservation, Arizona may
proceed.
Grand Canyon National Park is
responsible for notifying the Havasupai
Tribe of the Havasupai Reservation,
Arizona that this notice has been
published.
Dated: June 18, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14902 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025702;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion:
University of Michigan, Ann Arbor, MI
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The University of Michigan
has completed an inventory of human
remains, in consultation with the
appropriate Indian Tribes or Native
Hawaiian organizations, and has
determined that there is a cultural
affiliation between the human remains
and present-day Indian Tribes or Native
Hawaiian organizations. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request to the University of
Michigan. If no additional requestors
come forward, transfer of control of the
human remains to the lineal
descendants, Indian Tribes, or Native
Hawaiian organizations stated in this
notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request with information in support of
the request to the University of
Michigan at the address in this notice by
August 13, 2018.
ADDRESSES: Dr. Ben Secunda, NAGPRA
Project Manager, University of
Michigan, Office of Research, 4080
Fleming Building, 503 South Thompson
Street, Ann Arbor, MI 48109–1340,
telephone (734) 647–9085, email
[email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
SUMMARY:

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Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the University of Michigan, Ann Arbor,
MI. The human remains were removed
from the Garry site (20AC19), Arenac
County, MI.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains. The National
Park Service is not responsible for the
determinations in this notice.
Consultation
A detailed assessment of the human
remains was made by the University of
Michigan Museum of Anthropological
Archaeology (UMMAA) professional
staff in consultation with
representatives of the Bay Mills Indian
Community, Michigan; Chippewa Cree
Indians of the Rocky Boy’s Reservation,
Montana (previously listed as the
Chippewa-Cree Indians of the Rocky
Boy’s Reservation, Montana); Minnesota
Chippewa Tribe, Minnesota (Six
component reservations: Bois Forte
Band (Nett Lake); Fond du Lac Band;
Grand Portage Band; Leech Lake Band;
Mille Lacs Band; White Earth Band);
Saginaw Chippewa Indian Tribe of
Michigan; Sault Ste. Marie Tribe of
Chippewa Indians, Michigan; and
Sokaogon Chippewa Community,
Wisconsin (hereafter referred to as ‘‘The
Consulted Tribes’’).
Requests for consultation were also
sent to the Bad River Band of the Lake
Superior Tribe of Chippewa Indians of
the Bad River Reservation, Wisconsin;
Grand Traverse Band of Ottawa and
Chippewa Indians, Michigan;
Keweenaw Bay Indian Community,
Michigan; Lac Courte Oreilles Band of
Lake Superior Chippewa Indians of
Wisconsin; Lac du Flambeau Band of
Lake Superior Chippewa Indians of the
Lac du Flambeau Reservation of
Wisconsin; Lac Vieux Desert Band of
Lake Superior Chippewa Indians of
Michigan; Red Cliff Band of Lake
Superior Chippewa Indians of
Wisconsin; Red Lake Band of Chippewa
Indians, Minnesota; St. Croix Chippewa
Indians of Wisconsin; and Turtle
Mountain Band of Chippewa Indians of
North Dakota (hereafter referred to as
‘‘The Tribes Invited to Consult’’).
History and Description of the Remains
In August of 1971, human remains
representing, at minimum, one
individual were removed from the Garry
site (20AC19) in Arenac County, MI.

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Workers contacted the Michigan State
Police after encountering human
remains while digging a trench for a
water main on private land. The human
remains were taken to the State Crime
Lab for analysis and subsequently
transferred to the UMMAA. After
analyzing the human remains,
archaeologists from the UMMAA and
Indiana State Museum returned to the
burial site to excavate the remaining
portion of the trench. The individual
had been buried in a semi-prone
position within a bell-shaped pit.
Several Post-Contact Period objects were
found in association with the burial but
were transferred to the Arenac County
Historical Society instead of the
UMMAA. The human remains are of
one adolescent, indeterminate sex, 17–
18 years old. Copper staining is present
on the right ulna and radius. Perimortem sharp force trauma, possibly
from a knife or blade, on some of the
human remains may be the cause of
death as there is no evidence of healing
from this trauma. No known individuals
were identified. There are no associated
funerary objects under the control of
UMMAA.
The human remains have been
determined to be Native American
based on burial treatment and
diagnostic artifacts. A relationship of
shared group identity can be reasonably
traced between the Native American
human remains from this site and the
Chippewa based on multiple lines of
evidence. The associated funerary
objects noted from the site are typical of
the types of goods traded in the region
from approximately A.D. 1760 to 1820.
Additionally, according to historical
records, when the burial occurred, the
Chippewa were the predominant tribe
in the area. This is further evinced by
a treaty creating two Chippewa
reservations in the vicinity of the Garry
site in 1837.
Determinations Made by the University
of Michigan
Officials of the University of Michigan
have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the Native American human
remains and The Consulted Tribes and
The Tribes Invited to Consult.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice

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that wish to request transfer of control
of these human remains should submit
a written request with information in
support of the request to Dr. Ben
Secunda, NAGPRA Project Manager,
University of Michigan, Office of
Research, 4080 Fleming Building, 503
South Thompson Street, Ann Arbor, MI
48109–1340, telephone (734) 647–9085,
email [email protected], by August
13, 2018. After that date, if no
additional requestors have come
forward, transfer of control of the
human remains to The Consulted Tribes
and The Tribes Invited to Consult may
proceed.
The University of Michigan is
responsible for notifying The Consulted
Tribes and The Tribes Invited to Consult
that this notice has been published.
Dated: June 1, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14897 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025758;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion:
Museum of Ojibwa Culture and
Marquette Mission Park, City of St.
Ignace, MI
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The Museum of Ojibwa
Culture and Marquette Mission Park,
City of St. Ignace, has completed an
inventory of human remains, in
consultation with the appropriate
Indian Tribes or Native Hawaiian
organizations, and has determined that
there is no cultural affiliation between
the human remains and any present-day
Indian Tribes or Native Hawaiian
organizations. Representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request to the Museum of
Ojibwa Culture and Marquette Mission
Park, City of St. Ignace. If no additional
requestors come forward, transfer of
control of the human remains to the
Indian Tribes or Native Hawaiian
organizations stated in this notice may
proceed.
DATES: Representatives of any Indian
Tribe or Native Hawaiian organization
not identified in this notice that wish to
request transfer of control of these
SUMMARY:

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human remains should submit a written
request with information in support of
the request to the Museum of Ojibwa
Culture and Marquette Mission Park,
City of St. Ignace at the address in this
notice by August 13, 2018.
ADDRESSES: Shirley Sorrels, Director,
Museum of Ojibwa Culture and
Marquette Mission Park, c/o Bernstein &
Associates, 1041 N Lafayette Street,
Denver, CO 80218, telephone (303) 894–
0648, email [email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the Museum of Ojibwa Culture and
Marquette Mission Park, City of St.
Ignace. The human remains were
removed from Marquette Mission Site
(20MK82), Mackinac County, MI.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3) and 43 CFR 10.11(d).
The determinations in this notice are
the sole responsibility of the museum,
institution, or Federal agency that has
control of the Native American human
remains. The National Park Service is
not responsible for the determinations
in this notice.
Consultation
A detailed assessment of the human
remains was made by the Museum of
Ojibwa Culture and Marquette Mission
Park, City of St. Ignace professional staff
in consultation with representatives of
the Forest County Potawatomi
Community, Wisconsin; Little Traverse
Bay Bands of Odawa Indians, Michigan;
Saginaw Chippewa Indian Tribe of
Michigan; and Sault Ste. Marie Tribe of
Chippewa Indians, Michigan.
History and Description of the Remains
In 1983, 1997, and 2001, (during
excavations by Michigan State
University archeologists), human
remains representing, at minimum,
three individuals were removed with
faunal remains from the Marquette
Mission site (20MK82) in St. Ignace,
Mackinac County, MI. After each
excavation season, the excavated
material were transported to the
Michigan State University Museum,
where they were curated. In early 2017,
during an examination of the faunal
remains, three human teeth were
identified: A child’s worn shovelshaped maxillary incisor (5810.005.02
box 8), an adult shovel-shaped incisor
(5810.169.91.01), and an adult molar
(5810.123.03.03). No known individuals

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were identified. No associated funerary
objects are present.
The archeological site is within
Marquette Mission Park. The Museum
of Ojibwa Culture and Marquette
Mission Park manages the Park. Both
the Park and the Museum are under the
auspices of the City of St. Ignace. Based
on the archaeological context, the
human remains date to A.D. 17th
century, when Native Americans
representing many different cultures,
including but not limited to, the Wendat
(Huron), Anishinaabek [Ojibwa/Ojibwe
(Chippewa), Odawa (Ottawa)],
Bode´wadmi (Potawatomi), and
Haudenosaunee (Iroquois), lived in
proximity to the Marquette Mission site.
Determinations Made by the Museum of
Ojibwa Culture and Marquette Mission
Park, City of St. Ignace
Officials of the Museum of Ojibwa
Culture and Marquette Mission Park,
City of St. Ignace have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
are Native American based on the
biological and archeological evidence.
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of three
individuals of Native American
ancestry.
• Pursuant to 25 U.S.C. 3001(2), a
relationship of shared group identity
cannot be reasonably traced between the
Native American human remains and
any present-day Indian tribe.
• According to final judgments of the
Indian Claims Commission or the Court
of Federal Claims, or Treaties, Acts of
Congress, or Executive Orders, the land
from which the Native American human
remains were removed is the aboriginal
land of the Absentee-Shawnee Tribe of
Indians of Oklahoma; Bad River Band of
the Lake Superior Tribe of Chippewa
Indians of the Bad River Reservation,
Wisconsin; Bay Mills Indian
Community, Michigan; Chippewa Cree
Indians of the Rocky Boy’s Reservation,
Montana (previously listed as the
Chippewa-Cree Indians of the Rocky
Boy’s Reservation, Montana); Citizen
Potawatomi Nation, Oklahoma;
Delaware Nation, Oklahoma; Delaware
Tribe of Indians; Eastern Shawnee Tribe
of Oklahoma; Forest County Potawatomi
Community, Wisconsin; Grand Traverse
Band of Ottawa and Chippewa Indians,
Michigan; Hannahville Indian
Community, Michigan; Keweenaw Bay
Indian Community, Michigan; Kickapoo
Traditional Tribe of Texas; Kickapoo
Tribe of Indians of the Kickapoo
Reservation in Kansas; Kickapoo Tribe
of Oklahoma; Lac Courte Oreilles Band
of Lake Superior Chippewa Indians of

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Wisconsin; Lac du Flambeau Band of
Lake Superior Chippewa Indians of the
Lac du Flambeau Reservation of
Wisconsin; Lac Vieux Desert Band of
Lake Superior Chippewa Indians of
Michigan; Little River Band of Ottawa
Indians, Michigan; Little Traverse Bay
Bands of Odawa Indians, Michigan;
Match-e-be-nash-she-wish Band of
Pottawatomi Indians of Michigan;
Miami Tribe of Oklahoma; Minnesota
Chippewa Tribe, Minnesota (Six
component reservations: Bois Forte
Band (Nett Lake); Fond du Lac Band;
Grand Portage Band; Leech Lake Band;
Mille Lacs Band; White Earth Band);
Nottawaseppi Huron Band of the
Potawatomi, Michigan (previously listed
as the Huron Potawatomi, Inc.); Ottawa
Tribe of Oklahoma; Peoria Tribe of
Indians of Oklahoma; Pokagon Band of
Potawatomi Indians, Michigan and
Indiana; Prairie Band Potawatomi
Nation (previously listed as the Prairie
Band of Potawatomi Nation, Kansas);
Red Cliff Band of Lake Superior
Chippewa Indians of Wisconsin; Red
Lake Band of Chippewa Indians,
Minnesota; Saginaw Chippewa Indian
Tribe of Michigan; Sault Ste. Marie
Tribe of Chippewa Indians, Michigan;
Shawnee Tribe, Oklahoma; Sokaogon
Chippewa Community, Wisconsin; St.
Croix Chippewa Indians of Wisconsin;
Stockbridge Munsee Community,
Wisconsin; Turtle Mountain Band of
Chippewa Indians of North Dakota; and
Wyandotte Nation (hereinafter referred
to as ‘‘The Tribes’’)
• Pursuant to 43 CFR 10.11(c)(1), the
disposition of the human remains may
be to The Tribes.
Additional Requestors and Disposition
Representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request with information in support of
the request to Shirley Sorrels, Director,
Museum of Ojibwa Culture and
Marquette Mission Park, c/o Bernstein &
Associates, 1041 N Lafayette Street,
Denver, CO 80218, telephone (303) 894–
0648, email [email protected], by August
13, 2018. After that date, if no
additional requestors have come
forward, transfer of control of the
human remains to The Tribes may
proceed.
The Museum of Ojibwa Culture and
Marquette Mission Park, City of St.
Ignace is responsible for notifying The
Tribes that this notice has been
published.

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32323

Dated: June 11, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14900 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
National Park Service
[NPS–WASO–NAGPRA–NPS0025755;
PPWOCRADN0–PCU00RP14.R50000]

Notice of Inventory Completion: San
Diego Museum of Man, San Diego, CA
National Park Service, Interior.
Notice.

AGENCY:
ACTION:

The San Diego Museum of
Man has completed an inventory of
human remains, in consultation with
the appropriate Indian Tribes or Native
Hawaiian organizations, and has
determined that there is a cultural
affiliation between the human remains
and present-day Indian Tribes or Native
Hawaiian organizations. Lineal
descendants or representatives of any
Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request to the San Diego
Museum of Man. If no additional
requestors come forward, transfer of
control of the human remains to the
lineal descendants, Indian Tribes, or
Native Hawaiian organizations stated in
this notice may proceed.
DATES: Lineal descendants or
representatives of any Indian Tribe or
Native Hawaiian organization not
identified in this notice that wish to
request transfer of control of these
human remains should submit a written
request with information in support of
the request to the San Diego Museum of
Man at the address in this notice by
August 13, 2018.
ADDRESSES: Ben Garcia, Deputy
Director, San Diego Museum of Man,
1350 El Prado, San Diego, CA 92101,
telephone (619) 239–2001 ext. 17, email
[email protected].
SUPPLEMENTARY INFORMATION: Notice is
here given in accordance with the
Native American Graves Protection and
Repatriation Act (NAGPRA), 25 U.S.C.
3003, of the completion of an inventory
of human remains under the control of
the San Diego Museum of Man, San
Diego, CA. The human remains were
removed from Kanaga Island, AK.
This notice is published as part of the
National Park Service’s administrative
responsibilities under NAGPRA, 25
U.S.C. 3003(d)(3). The determinations in
SUMMARY:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

this notice are the sole responsibility of
the museum, institution, or Federal
agency that has control of the Native
American human remains. The National
Park Service is not responsible for the
determinations in this notice.
Consultation
A detailed assessment of the human
remains was made by the San Diego
Museum of Man professional staff in
consultation with representatives of the
Aleut Corporation and the Native
Village of Atka.
History and Description of the Remains
At an unknown date, human remains
representing, at minimum, one
individual were removed from Kanaga
Island, part of the Andreanof Islands
group of the Aleutian Islands in Alaska.
These human remains lack conclusive
collection documentation regarding the
date of collection, collector, or specific
geographic location other than a general
association to Kanaga Island. The
human remains were donated to the San
Diego Museum of Man by Lieutenant M.
Nolan some time before 1950. No
known individuals were identified. No
associated funerary objects are present.
An examination of the human
remains by San Diego Museum of Man
physical anthropology professional staff
determined the individual to be Native
Alaskan. The Aleutian Islands are
known to be aboriginal lands of the
modern Aleut peoples. Based on
museum records, geographical location,
physical examination, and consultation,
the museum reasonably believes the
individual is culturally affiliated with
the Native Village of Atka.

amozie on DSK3GDR082PROD with NOTICES1

Determinations Made by the San Diego
Museum of Man
Officials of the San Diego Museum of
Man have determined that:
• Pursuant to 25 U.S.C. 3001(9), the
human remains described in this notice
represent the physical remains of one
individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there
is a relationship of shared group
identity that can be reasonably traced
between the Native American human
remains and the Native Village of Atka.
Additional Requestors and Disposition
Lineal descendants or representatives
of any Indian Tribe or Native Hawaiian
organization not identified in this notice
that wish to request transfer of control
of these human remains should submit
a written request with information in
support of the request to Ben Garcia,
Deputy Director, San Diego Museum of
Man, 1350 El Prado, San Diego, CA
92101, telephone (619) 239–2001 ext.

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17:21 Jul 11, 2018

Jkt 244001

17, email [email protected],
by August 13, 2018. After that date, if
no additional requestors have come
forward, transfer of control of the
human remains to the Native Village of
Atka may proceed.
The San Diego Museum of Man is
responsible for notifying the Native
Village of Atka that this notice has been
published.
Dated: June 11, 2018.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2018–14898 Filed 7–11–18; 8:45 am]
BILLING CODE 4312–52–P

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0098]

Agency Information Collection
Activities: Petition Process for
Designation of Federal Lands as
Unsuitable for All or Certain Types of
Surface Coal Mining Operations and
for Termination of Previous
Designations
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining
Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of
information that establishes the
minimum procedures and standards for
designating Federal lands unsuitable for
certain types of surface mining
operations and for terminating
designations pursuant to a petition. The
information requested will aid the
regulatory authority in the decision
making process to approve or
disapprove a request. This information
collection activity was previously
approved by the Office of Management
and Budget (OMB), and assigned control
number 1029–0098.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease, 1849 C
SUMMARY:

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Frm 00065

Fmt 4703

Sfmt 4703

Street NW; Mail Stop 4559, Washington,
DC 20240. Comments may also be
submitted electronically to jtrelease@
osmre.gov.
To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: 30 CFR part 769—
Petition process for designation of
Federal lands as unsuitable for all or
certain types of surface coal mining
operations and for termination of
previous designations.
OMB Control Number: 1029–0098.
Abstract: This part establishes the
minimum procedures and standards for
designating Federal lands unsuitable for
FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
certain types of surface mining
operations and for terminating
designations pursuant to a petition. The
information requested will aid the
regulatory authority in the decision
making process to approve or
disapprove a request.
Form Number: None.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: People
who may be adversely affected by
surface mining on Federal lands.
Total Estimated Number of Annual
Respondents: One every three years.
Total Estimated Number of Annual
Responses: One every three years.
Estimated Completion Time per
Response: 3,000 hours.
Total Estimated Number of Annual
Burden Hours: 1,000 hours annually.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Authority: The authorities for this action
are the Surface Mining Control and
Reclamation Act of 1977, as amended (30
U.S.C. 1201 et seq.), and the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14891 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0051]

Agency Information Collection
Activities: State Regulatory Authority:
Inspection and Enforcement
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.

amozie on DSK3GDR082PROD with NOTICES1

AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining
Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of

SUMMARY:

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17:21 Jul 11, 2018

Jkt 244001

information which requires that each
regulatory authority conduct periodic
inspections of coal mining activities,
and prepare and maintain inspection
reports and other related documents for
OSMRE and public review. This
information collection activity was
previously approved by the Office of
Management and Budget (OMB), and
assigned control number 1029–0051.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease,
1849 C Street NW, Mail Stop 4559,
Washington, DC 20240. Comments may
also be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may

PO 00000

Frm 00066

Fmt 4703

Sfmt 4703

32325

be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: 30 CFR part 840—
State Regulatory Authority: Inspection
and Enforcement.
OMB Control Number: 1029–0051.
Abstract: This provision requires the
regulatory authority to conduct periodic
inspections of coal mining activities,
and prepare and maintain inspection
reports and other related documents for
OSMRE and public review. This
information is necessary to meet the
requirements of the Surface Mining
Control and Reclamation Act of 1977
and its public participation provisions.
Public review assures the public that the
State is meeting the requirements of the
Act and approved State regulatory
program.
Form Number: None.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: State
Regulatory Authorities.
Total Estimated Number of Annual
Respondents: 24 States.
Total Estimated Number of Annual
Responses: 106,382.
Estimated Completion Time per
Response: From 4.7 hours to 1,081
hours per response depending on
activity.
Total Estimated Number of Annual
Burden Hours: 296,938 hours for States.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once,
annually, quarterly, and monthly.
Total Estimated Annual Nonhour
Burden Cost: $1,440.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Authority: The authorities for this
action are the Surface Mining Control
and Reclamation Act of 1977, as
amended (30 U.S.C. 1201 et seq.), and
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14892 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0094]

Agency Information Collection
Activities: General
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining
Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of
information establishes procedures and
requirements for terminating
jurisdiction of surface coal mining and
reclamation operations, petitions for
rulemaking, and citizen suits filed
under the Surface Mining Control and
Reclamation Act of 1977. This
information collection activity was
previously approved by the Office of
Management and Budget (OMB), and
assigned control number 1029–0094.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease, 1849
C Street NW, Mail Stop 4559,
Washington, DC 20240. Comments may
also be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.

amozie on DSK3GDR082PROD with NOTICES1

SUMMARY:

VerDate Sep<11>2014

17:21 Jul 11, 2018

Jkt 244001

We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: 30 CFR part 700—
General.
OMB Control Number: 1029–0094.
Abstract: The information requested
by this part establishes procedures and
requirements for terminating
jurisdiction of surface coal mining and
reclamation operations, petitions for
rulemaking, and citizen suits filed
under the Surface Mining Control and
Reclamation Act of 1977.
Form Number: None.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: State
and Tribal regulatory authorities,
private citizens and citizen groups, and
surface coal mining companies.
Total Estimated Number of Annual
Respondents: 23 respondents.
Total Estimated Number of Annual
Responses: 23 responses.
Estimated Completion Time per
Response: Varies from 1 to 50 hours.
Total Estimated Number of Annual
Burden Hours: 80 hours.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.

PO 00000

Frm 00067

Fmt 4703

Sfmt 4703

Authority:The authorities for this
action are the Surface Mining Control
and Reclamation Act of 1977, as
amended (30 U.S.C. 1201 et seq.), and
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14890 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0057]

Agency Information Collection
Activities: Reclamation on Private
Lands
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining
Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of
information which authorizes Federal,
State, and Tribal governments to reclaim
private lands and allows for the
establishment of procedures for the
recovery of the cost of reclamation
activities on privately owned lands.
This information collection activity was
previously approved by the Office of
Management and Budget (OMB), and
assigned control number 1029–0057.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease, 1849
C Street NW, Mail Stop 4559,
Washington, DC 20240. Comments may
also be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
SUMMARY:

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amozie on DSK3GDR082PROD with NOTICES1

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: 30 CFR part 882—
Reclamation on Private Lands.
OMB Control Number: 1029–0057.
Abstract: Public Law 95–87
authorizes Federal, State, and Tribal
governments to reclaim private lands
and allows for the establishment of
procedures for the recovery of the cost
of reclamation activities on privately
owned lands. These procedures are
intended to ensure that governments
have sufficient capability to file liens so
that certain landowners will not receive
a windfall from reclamation.
Form Number: None.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: State
governments and Indian Tribes.
Total Estimated Number of Annual
Respondents: 1 State or Tribe.
Total Estimated Number of Annual
Responses: 1.

VerDate Sep<11>2014

17:21 Jul 11, 2018

Jkt 244001

Estimated Completion Time per
Response: 120 hours.
Total Estimated Number of Annual
Burden Hours: 120 hours.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Authority:The authorities for this
action are the Surface Mining Control
and Reclamation Act of 1977, as
amended (30 U.S.C. 1201 et seq.), and
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14893 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0087]

Agency Information Collection
Activities: OSM–76—Abandoned Mine
Land Problem Area Description Form
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining
Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of
information which is used to update the
Office of Surface Mining Reclamation
and Enforcement’s electronic inventory
of abandoned mine lands (e-AMLIS).
From this inventory, the most serious
problem areas are selected for
reclamation through the apportionment
of funds to States and Indian tribes. This
information collection activity was
previously approved by the Office of
Management and Budget (OMB), and
assigned control number 1029–0087.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
SUMMARY:

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32327

Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease, 1849
C Street NW, Mail Stop 4559,
Washington, DC 20240. Comments may
also be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: Abandoned Mine
Land Problem Area Description Form.
OMB Control Number: 1029–0087.
Abstract: The problem area
description (PAD) form is used to
update the Office of Surface Mining
Reclamation and Enforcement’s

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

electronic inventory of abandoned mine
lands (e-AMLIS). From this inventory,
the most serious problem areas are
selected for reclamation through the
apportionment of funds to States and
Indian tribes.
Form Number: OSM–76.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: State
and Tribal governments.
Total Estimated Number of Annual
Respondents: 27 State and Tribal
governments.
Total Estimated Number of Annual
Responses: 1,888 responses.
Estimated Completion Time per
Response: An average of 8 hours per
new PAD and 1.5 hours for an updated
PAD.
Total Estimated Number of Annual
Burden Hours: 5,016 hours.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Authority: The authorities for this
action are the Surface Mining Control
and Reclamation Act of 1977, as
amended (30 U.S.C. 1201 et seq.), and
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14894 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
[S1D1S SS08011000 SX064A000
189S180110; S2D2S SS08011000
SX064A000 18XS501520; OMB Control
Number 1029–0120]

amozie on DSK3GDR082PROD with NOTICES1

Agency Information Collection
Activities: Nomination and Request for
Payment Form for OSMRE’s National
Technical Training Courses
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:

In accordance with the
Paperwork Reduction Act of 1995, we,
the Office of Surface Mining

SUMMARY:

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17:21 Jul 11, 2018

Jkt 244001

Reclamation and Enforcement (OSMRE),
are announcing our intention to request
renewed approval for the collection of
information which is used to identify
and evaluate the training courses
requested by students to enhance their
job performance, to calculate the
number of classes and instructors
needed to complete OSMRE’s technical
training mission, and to estimate costs
to the training program. This
information collection activity was
previously approved by the Office of
Management and Budget (OMB), and
assigned control number 1029–0120.
DATES: Interested persons are invited to
submit comments on or before
September 10, 2018.
ADDRESSES: Send your comments on
this information collection request (ICR)
by mail to: The Office of Surface Mining
Reclamation and Enforcement,
Information Collection Clearance
Officer, Attn: John Trelease, 1849
C Street NW, Mail Stop 4559,
Washington, DC 20240. Comments may
also be submitted electronically to
[email protected].
FOR FURTHER INFORMATION CONTACT: To
request additional information about
this ICR, contact John Trelease by email
at [email protected], or by telephone
at (202) 208–2783.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995, we provide the
general public and other Federal
agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
information. This helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand our information
collection requirements and provide the
requested data in the desired format.
We are soliciting comments on the
proposed ICR that is described below.
We are especially interested in public
comment addressing the following
issues: (1) Is the collection necessary to
the proper functions of the OSMRE; (2)
is the estimate of burden accurate; (3)
how might the OSMRE enhance the
quality, utility, and clarity of the
information to be collected; and (4) how
might the OSMRE minimize the burden
of this collection on the respondents,
including through the use of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include or
summarize each comment in our request
to OMB to approve this ICR. Before

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including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
This notice provides the public with
60 days in which to comment on the
following information collection
activity:
Title of Collection: Nomination and
Request for Payment Form for OSMRE’s
National Technical Training Courses.
OMB Control Number: 1029–0120.
Abstract: The form is used to identify
and evaluate the training courses
requested by students to enhance their
job performance, to calculate the
number of classes and instructors
needed to complete OSMRE’s technical
training mission, and to estimate costs
to the training program.
Form Number: OSM–105.
Type of Review: Extension of a
currently approved collection.
Respondents/Affected Public: State
and Tribal regulatory and reclamation
employees.
Total Estimated Number of Annual
Respondents: 944 respondents.
Total Estimated Number of Annual
Responses: 944 responses.
Estimated Completion Time per
Response: 120 hours.
Total Estimated Number of Annual
Burden Hours: 79 hours.
Respondent’s Obligation: Required to
obtain or retain a benefit.
Frequency of Collection: Once.
Total Estimated Annual Nonhour
Burden Cost: $0.
An agency may not conduct or
sponsor and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number.
Authority: The authorities for this
action are the Surface Mining Control
and Reclamation Act of 1977, as
amended (30 U.S.C. 1201 et seq.), and
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
John A. Trelease,
Acting Chief, Division of Regulatory Support.
[FR Doc. 2018–14895 Filed 7–11–18; 8:45 am]
BILLING CODE 4310–05–P

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
INTERNATIONAL TRADE
COMMISSION
[Investigation Nos. 701–TA–607 and 731–
TA–1417 and 1419 (Preliminary)]

Steel Propane Cylinders From China
and Thailand
Determinations
On the basis of the record 1 developed
in the subject investigations, the United
States International Trade Commission
(‘‘Commission’’) determines, pursuant
to the Tariff Act of 1930 (‘‘the Act’’),
that there is a reasonable indication that
an industry in the United States is
materially injured by reason of imports
of steel propane cylinders from China
and Thailand that are alleged to be sold
in the United States at less than fair
value (‘‘LTFV’’) and imports of steel
propane cylinders from China that are
allegedly subsidized by the government
of China.2 3 The products subject to
these investigations are provided for in
heading 7311.00.00 of the Harmonized
Tariff Schedule of the United States.

amozie on DSK3GDR082PROD with NOTICES1

Commencement of Final Phase
Investigations
Pursuant to section 207.18 of the
Commission’s rules, the Commission
also gives notice of the commencement
of the final phase of its investigations.
The Commission will issue a final phase
notice of scheduling, which will be
published in the Federal Register as
provided in section 207.21 of the
Commission’s rules, upon notice from
the U.S. Department of Commerce
(‘‘Commerce’’) of affirmative
preliminary determinations in the
investigations under sections 703(b) or
733(b) of the Act, or, if the preliminary
determinations are negative, upon
notice of affirmative final
determinations in those investigations
under sections 705(a) or 735(a) of the
Act. Parties that filed entries of
appearance in the preliminary phase of
the investigations need not enter a
separate appearance for the final phase
of the investigations. Industrial users,
and, if the merchandise under
investigation is sold at the retail level,
representative consumer organizations
have the right to appear as parties in
Commission antidumping and
countervailing duty investigations. The
1 The record is defined in sec. 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).
2 Steel Propane Cylinders from the People’s
Republic of China, Taiwan, and Thailand: Initiation
of Less-Than-Fair-Value Investigations, 83 FR
28189, June 18, 2018; Steel Propane Cylinders from
China: Initiation of Countervailing Duty
Investigation, 83 FR 28196, June 18, 2018.
3 Commissioner Jason Kearns not participating.

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17:21 Jul 11, 2018

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Secretary will prepare a public service
list containing the names and addresses
of all persons, or their representatives,
who are parties to the investigations.
Background
On May 22, 2018, Worthington
Industries Inc., Columbus, Ohio, and
Manchester Tank and Equipment,
Franklin, Tennessee, filed petitions with
the Commission and Commerce,
alleging that an industry in the United
States is materially injured or
threatened with material injury by
reason of subsidized imports of steel
propane cylinders from China and LTFV
imports of steel propane cylinders from
China, Taiwan, and Thailand.
Accordingly, effective May 22, 2018, the
Commission, pursuant to sections 703(a)
and 733(a) of the Act (19 U.S.C.
1671b(a) and 1673b(a)), instituted
countervailing duty investigation No.
701–TA–607 and antidumping duty
investigation Nos. 731–TA–1417–1419
(Preliminary). On June 14, 2018,
petitioners withdrew the antidumping
duty petition covering imports from
Taiwan and the investigation was
subsequently terminated.4
Notice of the institution of the
Commission’s investigations and of a
public conference to be held in
connection therewith was given by
posting copies of the notice in the Office
of the Secretary, U.S. International
Trade Commission, Washington, DC,
and by publishing the notice in the
Federal Register of May 29, 2018 (83 FR
24491). The conference was held in
Washington, DC, on June 12, 2018, and
all persons who requested the
opportunity were permitted to appear in
person or by counsel.
The Commission made these
determinations pursuant to sections
703(a) and 733(a) of the Act (19 U.S.C.
1671b(a) and 1673b(a)). It completed
and filed its determinations in these
investigations on July 6, 2018. The
views of the Commission are contained
in USITC Publication 4804 (July 2018),
entitled Steel Propane Cylinders from
China and Thailand: Investigation Nos.
701–TA–607 and 731–TA–1417 and
1419 (Preliminary).
By order of the Commission.
Issued: July 6, 2018.
Jessica Mullan,
Attorney-Advisor.

32329

INTERNATIONAL TRADE
COMMISSION
[Investigation No. 731–TA–894 (Third
Review)]

Ammonium Nitrate From Ukraine;
Termination of Five-Year Review
United States International
Trade Commission.
ACTION: Notice.
AGENCY:

The Commission instituted
the subject five-year review in May 2018
to determine whether revocation of the
antidumping duty order on Ammonium
Nitrate from Ukraine would be likely to
lead to continuation or recurrence of
material injury. On June 18, 2018, the
Department of Commerce published
notice that it was revoking the order
effective June 12, 2018, because no
domestic interested party filed a notice
of intent to participate. Accordingly, the
subject review is terminated.
DATES: June 29, 2018.
FOR FURTHER INFORMATION CONTACT:
Lawrence Jones (202–205–3358), Office
of Investigations, U.S. International
Trade Commission, 500 E Street SW,
Washington, DC 20436. Hearingimpaired individuals are advised that
information on this matter can be
obtained by contacting the
Commission’s TDD terminal on 202–
205–1810. Persons with mobility
impairments who will need special
assistance in gaining access to the
Commission should contact the Office
of the Secretary at 202–205–2000.
General information concerning the
Commission may also be obtained by
accessing its internet server (https://
www.usitc.gov).
Authority: This review is being
terminated under authority of title VII of
the Tariff Act of 1930 and pursuant to
section 751(c) of the Tariff Act of 1930
(19 U.S.C. 1675(c)). This notice is
published pursuant to section 207.69 of
the Commission’s rules (19 CFR 207.69).
SUMMARY:

By order of the Commission.
Issued: July 6, 2018.
Jessica Mullan,
Attorney-Advisor.
[FR Doc. 2018–14883 Filed 7–11–18; 8:45 am]
BILLING CODE 7020–02–P

DEPARTMENT OF JUSTICE

[FR Doc. 2018–14886 Filed 7–11–18; 8:45 am]
BILLING CODE 7020–02–P
4 Steel Propane Cylinders from Taiwan:
Termination of Less-Than-Fair-Value Investigation,
83 FR 29748, June 26, 2018; Steel Propane
Cylinders from Taiwan: Termination of
Investigation, 83 FR 31174, July 3, 2018.

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Notice of Lodging of Proposed
Consent Decree Under the Oil
Pollution Act
On July 5, 2018, the Department of
Justice lodged a proposed Consent
Decree with the United States District

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

Court for the Eastern District of
Louisiana in the lawsuit entitled United
States of America and Louisiana v.
Shell Offshore Inc., Civil Action No.
2:18–cv–6495. The United States is
acting at the request of the designated
federal trustees: National Oceanic and
Atmospheric Administration (‘‘NOAA’’)
and the United States Department of the
Interior (‘‘DOI’’) through the United
States Fish and Wildlife Service. The
State of Louisiana is acting through its
designated State trustees: The Louisiana
Oil Spill Coordinator’s Office,
Department of Public Safety (‘‘LOSCO’’),
Louisiana Department of Natural
Resources (‘‘LDNR’’), Louisiana
Department of Environmental Quality
(‘‘LDEQ’’), Louisiana Department of
Wildlife and Fisheries (‘‘LDWF’’), and
the Coastal Protection and Restoration
Authority (‘‘CPRA’’).
This is a civil action brought against
Defendant Shell Offshore Inc. (‘‘Shell’’)
for recovery of damages for injury to,
destruction of, loss of, or loss of use of
natural resources, under Section 1002 of
the Oil Pollution Act (‘‘OPA’’), 33 U.S.C.
2702, and Section 2480 of the Louisiana
Oil Spill Prevention and Response Act
(‘‘OSPRA’’), La. Rev. Stat. 30:2480. The
United States and Louisiana seek
damages in order to compensate for and
restore natural resources injured by
Shell’s crude oil spill that occurred at
Shell’s Green Canyon Block 248 subsea
oil production system in the Gulf of
Mexico beginning on or about May 11,
2016. The United States and the State
also seek to recover unreimbursed costs
of assessing such injuries.
The Complaint in this natural
resource damages case was filed against
Shell concurrently with the lodging of
the proposed Consent Decree. The
Complaint alleges that Shell is liable for
damages under OPA and OSPRA. The
Complaint alleges that Shell discharged
crude oil into the Gulf of Mexico in May
2016 and that natural resources were
injured as a result of the discharge.
Under the proposed Consent Decree,
Shell will pay a total of $3,871,169.54.
Of this total, Shell will pay $3.625
million to the trustees to restore,
replace, or acquire the equivalent of the
natural resources allegedly injured,
destroyed, or lost as a result of the oil
spill and $246,169.54 to reimburse the
trustees for all remaining unpaid
assessment costs.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Acting
Assistant Attorney General,
Environment and Natural Resources
Division, and should refer to United
States of America and Louisiana v.

VerDate Sep<11>2014

17:21 Jul 11, 2018

Jkt 244001

Shell Offshore Inc., D.J. Ref. No. 90–5–
1–1–11920. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted by either
email or by mail:
To submit
comments:

Send them to:

By email .......

pubcomment-ees.enrd@
usdoj.gov.
Acting Assistant Attorney
General, U.S. DOJ—ENRD,
P.O. Box 7611, Washington, DC 20044–7611.

By mail .........

During the public comment period,
the proposed Consent Decree may be
examined and downloaded at this
Justice Department website: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
proposed Consent Decree upon written
request and payment of reproduction
costs. Please mail your request and
payment to: Consent Decree Library,
U.S. DOJ—ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $7.50 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Thomas Carroll,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.

provide your name and organizational
affiliation. Visitors must report to the
NSF visitor’s desk in the building lobby
to receive a visitor’s badge.
STATUS: Some of these meetings will be
open to the public. Others will be closed
to the public. See full description
below.
MATTERS TO BE CONSIDERED:
Tuesday, July 17, 2018
Plenary Board Meeting
Open Session: 8:00–8:25 a.m.
• NSB Chair’s Opening Remarks
• NSF Director’s Remarks
• Summary of DC Meetings
Committee on Oversight (CO)
Open Session: 8:25–9:15 a.m.
• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• Summary of Merit Review Retreat
• Presentation on Enterprise Risk
Management
• Inspector General’s Update
• Chief Financial Officer’s Update
Committee on National Science and
Engineering Policy (SEP)
Open Session: 9:15–10:05 a.m.

[FR Doc. 2018–14907 Filed 7–11–18; 8:45 am]

• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• Update on Future Indicators Project

BILLING CODE 4410–15–P

Plenary Board
Open Session 10:15 a.m.–12:00 p.m.

NATIONAL SCIENCE FOUNDATION
Sunshine Act Meetings; National
Science Board
The National Science Board (NSB),
pursuant to NSF regulations (45 CFR
part 614), the National Science
Foundation Act, as amended, (42 U.S.C.
1862n–5), and the Government in the
Sunshine Act (5 U.S.C. 552b), hereby
gives notice of the scheduling of
meetings for the transaction of NSB
business as follows:
TIME AND DATE: Tuesday, July 17, 2018
from 8:00 a.m. to 4:45 p.m. and
Wednesday, July 18, 2018, from 8:00
a.m. to 2:15 p.m. EDT.
PLACE: These meetings will be held at
the NSF headquarters, 2415 Eisenhower
Avenue, Alexandria, VA 22314.
Meetings are held in the boardroom on
the 2nd floor. The public may observe
public meetings held in the boardroom.
All visitors must contact the Board
Office (call 703–292–7000 or send an
email to [email protected]) at
least 24 hours prior to the meeting and

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Presentation and Panel Discussion—
‘‘Being Smart About Artificial
Intelligence (AI)’’
• Chair’s Opening Remarks and
Introductions
• Presentation, Dr. Andrew Moore,
Carnegie Mellon University
• Panel Presentations and Discussion
• Dr. Michael Jordan, University of
California, Berkeley
• Dr. Daniela Rus, Massachusetts
Institute of Technology
• Dr. Charles Isbell, Georgia Institute
of Technology
• Dr. James Kurose, Assistant
Director, Computer & Information
Science & Engineering
Committee on Strategy (CS)
Open Session: 1:00–1:30 p.m.
• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• FY 2018 Appropriations and FY
2019 Budget Request Update
Committee on Awards and Facilities
(A&F)

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
Open Session: 1:30–2:00 p.m.
• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• CY 2018–2019 Schedule of Planned
Action and Information Items
• Update on the Status of Regional
Class Research Vessel Construction
• Discussion of the Information Item/
Action Item Sequence
Committee on Awards and Facilities
(A&F)
Closed Session: 2:00–4:45 p.m.

Committee on External Engagement (EE)
Open Session: 8:00–8:50 a.m.
• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• Listening Session Report
• NSB Alumni Network
• Congressional Engagement Plan
Task Force on the Skilled Technical
Workforce (STW)
Open Session: 8:50–9:30 a.m.
• Chair’s Opening Remarks
• Approval of Prior Minutes
• Update and Discussion on
Stakeholder Meetings
• Discussion of Focus Areas for the
Task Force
Committee on Strategy (CS)
Closed Session: 9:30–10:30 a.m.
amozie on DSK3GDR082PROD with NOTICES1

• Board Chair’s Opening Remarks
• Approval of Prior Minutes
• Director’s Remarks
Plenary Board
Open Session: 11:50 a.m.–2:15 p.m.
• Board Chair’s Opening Remarks
• Introduction of Presentation on the
National Academies and Board of
International Scientific Organizations
(Break for lunch from 12:20–1:15 p.m.)
• Board Chair’s Opening Remarks
• NSF Director’s Remarks
• Approval of Prior Minutes
• Vote: NSB Calendar for CY 2019
• Open Committee Reports
• NSF INCLUDES Presentation
• Board Chair’s Closing Remarks
Meeting Adjourns: 2:15 p.m.
MEETINGS THAT ARE OPEN TO THE PUBLIC:

Wednesday, July 18, 2018

• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• FY 2020 Budget Discussion
Plenary Board

Tuesday, July 17, 2018
8:00–8:25 a.m. Plenary NSB
Introduction
8:20–9:15 a.m. Committee on Oversight
(CO)
9:15–10:05 a.m. Committee on Science
& Engineering Policy (SEP)
10:15 a.m.– 12:00 p.m. Plenary Panel on
Artificial Intelligence
1:00–1:30 p.m. Committee on Strategy
(CS)
1:30–2:00 p.m. Committee on Awards &
Facilities (A&F)
Wednesday, July 18, 2018
8:00–8:50 a.m. Committee on External
Engagement (EE)
8:50–9:30 a.m. Task Force on Skilled
Technical Workforce (STW)
11:50 a.m.–2:15 p.m. Plenary (break for
lunch from 12:20–1:15 p.m.)
MEETINGS THAT ARE CLOSED TO THE
PUBLIC:

Tuesday, July 17, 2018
2:00–4:45 p.m. (A&F)
Wednesday, July 18, 2018

Closed Session: 10:45–11:35 a.m.
• Board Chair’s Opening Remarks
• Director’s Remarks

17:21 Jul 11, 2018

Plenary Board (Executive)
Closed Session: 11:35–11:50 a.m.

• Committee Chair’s Opening
Remarks
• Approval of Prior Minutes
• Action Item: Leadership-Class
Computing Phase I Acquisition
• Action Item: Seismological facility
for the Advancement of GEosciences
(SAGE) Operations & Maintenance
Award
• Action Item: Geodetic facility for
the Advancement of GEosciences
(GAGE) Operations & Maintenance
Award
• Action Item: Candidate MREFCfunded Upgrades of the ATLAS and
CMS Detectors at the Large Hadron
Collider
• Information Item: Astronomy
Facility Transitions
MATTERS TO BE DISCUSSED:

VerDate Sep<11>2014

• Approval of Prior Minutes
• Closed Committee Reports
• Midscale Research Infrastructure
Report
• Vote: ATLAS and CMS Upgrades
• Vote: GAGE O&M
• Vote: SAGE O&M
• Vote: Leadership-Class Computing
Phase I Acquisition
• Vote: Contract Services for Arctic
Research Support and Logistics

Jkt 244001

9:30–10:30 a.m. (CS)
10:45–11:35 a.m. Plenary
11:35–11:50 a.m. Plenary Executive

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32331

CONTACT PERSONS FOR MORE
INFORMATION: The NSB Office

contact is
Brad Gutierrez, [email protected], 703–
292–7000. The NSB Public Affairs
contact is Nadine Lymn, nlymn@
nsf.gov, 703–292–2490.
SUPPLEMENTAL INFORMATION: Public
meetings and public portions of
meetings held in the 2nd floor
boardroom will be webcast. To view
these meetings, go to: http://
www.tvworldwide.com/events/nsf/180
717 and follow the instructions. The
public may observe public meetings
held in the boardroom. The address is
2415 Eisenhower Avenue, Alexandria,
VA, 22314.
Please refer to the NSB website for
additional information. You will find
any updated meeting information and
schedule updates (time, place, subject
matter, or status of meeting) at https://
www.nsf.gov/nsb/meetings/notices.
jsp#sunshine.
The NSB will continue its program to
provide some flexibility around meeting
times. After the first meeting of each
day, actual meeting start and end times
will be allowed to vary by no more than
15 minutes in either direction. As an
example, if a 10:00 meeting finishes at
10:45, the meeting scheduled to begin at
11:00 may begin at 10:45 instead.
Similarly, the 10:00 meeting may be
allowed to run over by as much as 15
minutes if the Chair decides the extra
time is warranted. The next meeting
would start no later than 11:15. Arrive
at the NSB boardroom or check the
webcast 15 minutes before the
scheduled start time of the meeting you
wish to observe.
Chris Blair,
Executive Assistant to the National Science
Board Office.
[FR Doc. 2018–14984 Filed 7–10–18; 11:15 am]
BILLING CODE 7555–01–P

OCCUPATIONAL SAFETY AND
HEALTH REVIEW COMMISSION
Privacy Act of 1974; System of
Records
Occupational Safety and Health
Review Commission.
ACTION: Notice of a Modified System of
Records.
AGENCY:

In accordance with the
Privacy Act of 1974, as amended, the
Occupational Safety and Health Review
Commission (OSHRC) is revising the
notice for Privacy Act system-of-records
OSHRC–3.
DATES: Comments must be received by
OSHRC on or before August 13, 2018.
SUMMARY:

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The revised system of records will
become effective on that date, without
any further notice in the Federal
Register, unless comments or
government approval procedures
necessitate otherwise.
ADDRESSES: You may submit comments
by any of the following methods:
• Email: [email protected]. Include
‘‘PRIVACY ACT SYSTEM OF
RECORDS’’ in the subject line of the
message.
• Fax: (202) 606–5417.
• Mail: One Lafayette Centre, 1120
20th Street NW, Ninth Floor,
Washington, DC 20036–3457.
• Hand Delivery/Courier: Same as
mailing address.
Instructions: All submissions must
include your name, return address, and
email address, if applicable. Please
clearly label submissions as ‘‘PRIVACY
ACT SYSTEM OF RECORDS.’’
FOR FURTHER INFORMATION CONTACT: Ron
Bailey, Attorney-Advisor, Office of the
General Counsel, via telephone at (202)
606–5410, or via email at rbailey@
oshrc.gov.
The
Privacy Act of 1974, 5 U.S.C. 552a(e)(4),
requires federal agencies such as
OSHRC to publish in the Federal
Register notice of any new or modified
system of records. As detailed below,
OSHRC is revising Public
Transportation Benefit Program
Records, OSHRC–3, to revise the
system’s name; account for changes in
the names of the pertinent office and
positions within the agency; revise the
categories of records maintained; and
update the reference to the applicable
General Records Schedule for disposal
of records. In addition, OSHRC in the
past has relied on blanket routine uses
to describe the circumstances under
which records may be disclosed. Going
forward, as revised notices are
published for new and modified
systems of records, a full description of
the routine uses—rather than a reference
to blanket routine uses—will be
included in each notice. This is simply
a change in format, however, and has
not resulted in any substantive changes
to the routine uses for this system of
records.
The notice for OSHRC–3, provided
below in its entirety, is as follows.

amozie on DSK3GDR082PROD with NOTICES1

SUPPLEMENTARY INFORMATION:

SYSTEM NAME AND NUMBER

Transportation Subsidy Program
Records, OSHRC–3.
SECURITY CLASSIFICATION:

None.

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SYSTEM LOCATION:

Office of the Executive Director,
OSHRC, 1120 20th Street NW, Ninth
Floor, Washington, DC 20036–3457;
Atlanta Office, 100 Alabama Street,
Room 2R90, Atlanta, GA 30303–3104.
SYSTEM MANAGER(S):

Support Services Specialist, Office of
the Executive Director, OSHRC, 1120
20th Street NW, Ninth Floor,
Washington, DC 20036–3457; (202) 606–
5100. Lead Legal Assistant, Atlanta
Office, 100 Alabama Street, Room 2R90,
Atlanta, GA 30303–3104; (404) 562–
1640.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

29 U.S.C. 661; Executive Order 13150.
PURPOSE(S) OF THE SYSTEM:

This system of records is maintained
for the purpose of documenting an
employee’s participation in the
Transportation Subsidy Program.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:

This system of records covers all
current and former employees who are,
or were, enrolled in the Transportation
Subsidy Program.
CATEGORIES OF RECORDS IN THE SYSTEM:

This system of records includes
information submitted by current and
former participants via the OSHRC
Transportation Subsidy Program
Application. This form contains the
employee’s name and home address.
The system also contains a Pre-tax
Transportation Program Application
which includes the employee’s name
and the last four digits of his or her
social security number. Lastly, the
system includes a SmartTrip form with
the employee’s name.
RECORD SOURCE CATEGORIES:

Information in this system of records
comes from applicants to, and current
and former participants in, the
Transportation Subsidy Program.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:

In addition to disclosures generally
permitted under 5 U.S.C. 552a(b), all or
a portion of the records or information
contained in this system of records may
be disclosed as a routine use pursuant
to 5 U.S.C. 552a(b)(3) under the
circumstances or for the purposes
described below, to the extent such
disclosures are compatible with the
purposes for which the information was
collected:
(1) To the Department of Justice (DOJ),
or to a court or adjudicative body before

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which OSHRC is authorized to appear,
when any of the following entities or
individuals—(a) OSHRC, or any of its
components; (b) any employee of
OSHRC in his or her official capacity;
(c) any employee of OSHRC in his or her
individual capacity where DOJ (or
OSHRC where it is authorized to do so)
has agreed to represent the employee; or
(d) the United States, where OSHRC
determines that litigation is likely to
affect OSHRC or any of its
components—is a party to litigation or
has an interest in such litigation, and
OSHRC determines that the use of such
records by DOJ, or by a court or other
tribunal, or another party before such
tribunal, is relevant and necessary to the
litigation.
(2) To an appropriate agency, whether
federal, state, local, or foreign, charged
with investigating or prosecuting a
violation or enforcing or implementing
a law, rule, regulation, or order, when
a record, either on its face or in
conjunction with other information,
indicates a violation or potential
violation of law, which includes civil,
criminal or regulatory violations, and
such disclosure is proper and consistent
with the official duties of the person
making the disclosure.
(3) To a federal, state, or local agency
maintaining civil, criminal or other
relevant enforcement information, such
as current licenses, if necessary to
obtain information relevant to an
OSHRC decision concerning the hiring,
appointment, or retention of an
employee; the issuance, renewal,
suspension, or revocation of a security
clearance; the execution of a security or
suitability investigation; the letting of a
contract; or the issuance of a license,
grant or other benefit.
(4) To a federal, state, or local agency,
in response to that agency’s request for
a record, and only to the extent that the
information is relevant and necessary to
the requesting agency’s decision in the
matter, if the record is sought in
connection with the hiring,
appointment, or retention of an
employee; the issuance, renewal,
suspension, or revocation of a security
clearance; the execution of a security or
suitability investigation; the letting of a
contract; or the issuance of a license,
grant or other benefit by the requesting
agency.
(5) To an authorized appeal grievance
examiner, formal complaints manager,
equal employment opportunity
investigator, arbitrator, or other duly
authorized official engaged in
investigation or settlement of a
grievance, complaint, or appeal filed by
an employee, only to the extent that the

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information is relevant and necessary to
the case or matter.
(6) To OPM in accordance with the
agency’s responsibilities for evaluation
and oversight of federal personnel
management.
(7) To officers and employees of a
federal agency for the purpose of
conducting an audit, but only to the
extent that the record is relevant and
necessary to this purpose.
(8) To OMB in connection with the
review of private relief legislation at any
stage of the legislative coordination and
clearance process, as set forth in
Circular No. A–19.
(9) To a Member of Congress or to a
person on his or her staff acting on the
Member’s behalf when a written request
is made on behalf and at the behest of
the individual who is the subject of the
record.
(10) To the National Archives and
Records Administration (NARA) for
records management inspections and
such other purposes conducted under
the authority of 44 U.S.C. 2904 and
2906.
(11) To appropriate agencies, entities,
and persons when: (a) OSHRC suspects
or has confirmed that there has been a
breach of the system of records; (b)
OSHRC has determined that as a result
of the suspected or confirmed breach
there is a risk of harm to individuals,
OSHRC, the Federal Government, or
national security; and (c) the disclosure
made to such agencies, entities, and
persons is reasonably necessary to assist
in connection with OSHRC’s efforts to
respond to the suspected or confirmed
breach or to prevent, minimize, or
remedy such harm.
(12) To NARA, Office of Government
Information Services (OGIS), to the
extent necessary to fulfill its
responsibilities in 5 U.S.C. 552(h), to
review administrative agency policies,
procedures and compliance with FOIA,
and to facilitate OGIS’ offering of
mediation services to resolve disputes
between persons making FOIA requests
and administrative agencies.
(13) To another federal agency or
federal entity, when OSHRC determines
that information from this system of
records is reasonably necessary to assist
the recipient agency or entity in (a)
responding to a suspected or confirmed
breach or (b) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
Federal Government, or national
security, resulting from a suspected or
confirmed breach.
(14) To other federal agencies to effect
salary or administrative offsets, or for

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other purposes connected with the
collection of debts owed to the United
States, pursuant to sections 5 and 10 of
the Debt Collection Act of 1982, as
amended by the Debt Collection
Improvement Act of 1996.
(15) To other federal, state, local or
foreign agencies conducting computer
matching programs to help eliminate
fraud and abuse and to detect
unauthorized overpayments made to
individuals. When disclosures are made
as part of computer matching programs,
OSHRC will comply with the Computer
Matching and Privacy Protection Act of
1988, and the Computer Matching and
Privacy Protections Amendments of
1990.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:

32333

Street NW, Ninth Floor, Washington, DC
20036–3457. For an explanation on how
such requests should be drafted, refer to
29 CFR 2400.5 (notification), and 29
CFR 2400.6 (procedures for requesting
records).
EXEMPTIONS PROMULGATED FOR THE SYSTEM:

None.
HISTORY:

April 14, 2006, 71 FR 19556; August
4, 2008, 73 FR 45256; October 5, 2015,
80 FR 60182; and September 28, 2017,
82 FR 45324.
Dated: July 5, 2018.
Nadine N. Mancini,
General Counsel, Senior Agency Official for
Privacy.
[FR Doc. 2018–14878 Filed 7–11–18; 8:45 am]

Records are stored on paper in locked
file cabinets.

BILLING CODE 7600–01–P

POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:

POSTAL REGULATORY COMMISSION

Paper records can be retrieved
manually by name.

[Docket Nos. MC2018–190 and CP2018–264]

New Postal Product

POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:

AGENCY:

Records are retained and disposed of
in accordance with NARA’s General
Records Schedule 2.4, Items 130 and
131.

SUMMARY:

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:

Paper records are maintained in
locked file cabinets. Access to the
cabinets is limited to personnel having
a need for access to perform their
official functions.
RECORD ACCESS PROCEDURES:

Individuals who wish to gain access
to their records should notify: Privacy
Officer, OSHRC, 1120 20th Street NW,
Ninth Floor, Washington, DC 20036–
3457. For an explanation on how such
requests should be drafted, refer to 29
CFR 2400.6 (procedures for requesting
records).
CONTESTING RECORD PROCEDURES:

Individuals who wish to contest their
records should notify: Privacy Officer,
OSHRC, 1120 20th Street NW, Ninth
Floor, Washington, DC 20036–3457. For
an explanation on the specific
procedures for contesting the contents
of a record, refer to 29 CFR 2400.8
(Procedures for requesting amendment),
and 29 CFR 2400.9 (Procedures for
appealing).
NOTIFICATION PROCEDURES:

Individuals interested in inquiring
about their records should notify:
Privacy Officer, OSHRC, 1120 20th

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Frm 00074

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ACTION:

Postal Regulatory Commission.
Notice.

The Commission is noticing a
recent Postal Service filing for the
Commission’s consideration concerning
negotiated service agreements. This
notice informs the public of the filing,
invites public comment, and takes other
administrative steps.
DATES: Comments are due: July 13,
2018.
Submit comments
electronically via the Commission’s
Filing Online system at http://
www.prc.gov. Those who cannot submit
comments electronically should contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section by
telephone for advice on filing
alternatives.
ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

David A. Trissell, General Counsel, at
202–789–6820.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Docketed Proceeding(s)

I. Introduction
The Commission gives notice that the
Postal Service filed request(s) for the
Commission to consider matters related
to negotiated service agreement(s). The
request(s) may propose the addition or
removal of a negotiated service
agreement from the market dominant or
the competitive product list, or the

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices

modification of an existing product
currently appearing on the market
dominant or the competitive product
list.
Section II identifies the docket
number(s) associated with each Postal
Service request, the title of each Postal
Service request, the request’s acceptance
date, and the authority cited by the
Postal Service for each request. For each
request, the Commission appoints an
officer of the Commission to represent
the interests of the general public in the
proceeding, pursuant to 39 U.S.C. 505
(Public Representative). Section II also
establishes comment deadline(s)
pertaining to each request.
The public portions of the Postal
Service’s request(s) can be accessed via
the Commission’s website (http://
www.prc.gov). Non-public portions of
the Postal Service’s request(s), if any,
can be accessed through compliance
with the requirements of 39 CFR
3007.40.
The Commission invites comments on
whether the Postal Service’s request(s)
in the captioned docket(s) are consistent
with the policies of title 39. For
request(s) that the Postal Service states
concern market dominant product(s),
applicable statutory and regulatory
requirements include 39 U.S.C. 3622, 39
U.S.C. 3642, 39 CFR part 3010, and 39
CFR part 3020, subpart B. For request(s)
that the Postal Service states concern
competitive product(s), applicable
statutory and regulatory requirements
include 39 U.S.C. 3632, 39 U.S.C. 3633,
39 U.S.C. 3642, 39 CFR part 3015, and
39 CFR part 3020, subpart B. Comment
deadline(s) for each request appear in
section II.
II. Docketed Proceeding(s)

amozie on DSK3GDR082PROD with NOTICES1

1. Docket No(s).: MC2018–190 and
CP2018–264; Filing Title: USPS Request
to Add Priority Mail Express & Priority
Mail Contract 70 to Competitive Product
List and Notice of Filing Materials
Under Seal; Filing Acceptance Date:
July 5, 2018; Filing Authority: 39 U.S.C.
3642 and 39 CFR 3020.30 et seq.; Public
Representative: Christopher C. Mohr,
Comments Due: July 13, 2018.
This Notice will be published in the
Federal Register.
Ruth Ann Abrams,
Acting Secretary.
[FR Doc. 2018–14877 Filed 7–11–18; 8:45 am]
BILLING CODE 7710–FW–P

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SMALL BUSINESS ADMINISTRATION
[Disaster Declaration #15580 and #15581;
NEBRASKA Disaster Number NE–00070]

Presidential Declaration of a Major
Disaster for Public Assistance Only for
the State of Nebraska
U.S. Small Business
Administration.
ACTION: Notice.
AGENCY:

The number assigned to this disaster
for physical damage is 15580B and for
economic injury is 155810.
(Catalog of Federal Domestic Assistance
Number 59008)
Rafaela Monchek,
Acting Associate Administrator for Disaster
Assistance.
[FR Doc. 2018–14932 Filed 7–11–18; 8:45 am]
BILLING CODE 8025–01–P

This is a Notice of the
Presidential declaration of a major
disaster for Public Assistance Only for
the State of Nebraska (FEMA–4375–DR),
dated 06/29/2018.
Incident: Severe Winter Storm and
Straight-line Winds.
Incident Period: 04/13/2018 through
04/18/2018.
DATES: Issued on 06/29/2018.
Physical Loan Application Deadline
Date: 08/28/2018.
Economic Injury (EIDL) Loan
Application Deadline Date: 03/29/2019.
ADDRESSES: Submit completed loan
applications to: U.S. Small Business
Administration, Processing and
Disbursement Center, 14925 Kingsport
Road, Fort Worth, TX 76155.
FOR FURTHER INFORMATION CONTACT: A.
Escobar, Office of Disaster Assistance,
U.S. Small Business Administration,
409 3rd Street SW, Suite 6050,
Washington, DC 20416, (202) 205–6734.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that as a result of the
President’s major disaster declaration on
06/29/2018, Private Non-Profit
organizations that provide essential
services of a governmental nature may
file disaster loan applications at the
address listed above or other locally
announced locations.
The following areas have been
determined to be adversely affected by
the disaster:
Primary Counties: Antelope, Blaine,
Boone, Boyd, Cheyenne, Clay,
Custer, Deuel, Fillmore, Garfield,
Gosper, Greeley, Hall, Hamilton,
Holt, Howard, Keith, Knox, Logan,
Loup, Madison, Merrick, Nance,
Nuckolls, Pierce, Platte, Rock,
Sherman, Valley, Webster, Wheeler.
The Interest Rates are:
SUMMARY:

Percent
For Physical Damage:
Non-Profit Organizations With
Credit Available Elsewhere ...
Non-Profit Organizations Without Credit Available Elsewhere .....................................
For Economic Injury:
Non-Profit Organizations Without
Credit Available Elsewhere

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2.500
2.500
2.500

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
[Summary Notice No. 2018–38]

Petition for Exemption; Summary of
Petition Received; 3GLP, Inc. dba
Precision Flight Devices
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice.
AGENCY:

This notice contains a
summary of a petition seeking relief
from specified requirements of Title 14
of the Code of Federal Regulations. The
purpose of this notice is to improve the
public’s awareness of, and participation
in, the FAA’s exemption process.
Neither publication of this notice nor
the inclusion or omission of information
in the summary is intended to affect the
legal status of the petition or its final
disposition.

SUMMARY:

Comments on this petition must
identify the petition docket number and
must be received on or before August 1,
2018.
ADDRESSES: Send comments identified
by docket number FAA–2018–0325
using any of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov and follow
the online instructions for sending your
comments electronically.
• Mail: Send comments to Docket
Operations, M–30; U.S. Department of
Transportation (DOT), 1200 New Jersey
Avenue SE, Room W12–140, West
Building Ground Floor, Washington, DC
20590–0001.
• Hand Delivery or Courier: Take
comments to Docket Operations in
Room W12–140 of the West Building
Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
• Fax: Fax comments to Docket
Operations at 202–493–2251.
Privacy: In accordance with 5 U.S.C.
553(c), DOT solicits comments from the
public to better inform its rulemaking
process. DOT posts these comments,
DATES:

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
without edit, including any personal
information the commenter provides, to
http://www.regulations.gov, as
described in the system of records
notice (DOT/ALL–14 FDMS), which can
be reviewed at http://www.dot.gov/
privacy.
Docket: Background documents or
comments received may be read at
http://www.regulations.gov at any time.
Follow the online instructions for
accessing the docket or go to the Docket
Operations in Room W12–140 of the
West Building Ground Floor at 1200
New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
Jake
Troutman, (202) 683–7788, 800
Independence Avenue SW, Washington,
DC 20591.
This notice is published pursuant to
14 CFR 11.85.

FOR FURTHER INFORMATION CONTACT:

Lirio Liu,
Executive Director, Office of Rulemaking.

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Petition for Exemption
Docket No.: FAA–2018–0325.
Petitioner: 3GLP, Inc. dba Precision
Flight Devices.
Section(s) of 14 CFR Affected: Part 21,
subpart H; part 27; 45.23(b); 45.27(a);
61.113; 91.7(a); 91.9(b)(2); 91.9(c);
91.103; 91.109(a); 91.119; 91.121;
91.151(a); 91.203(a) & (b); 91.405(a);
91.407(a)(1); 91.409(a)(1) & (2); 91.417(a)
& (b).
Description of Relief Sought: The
petitioner is requesting relief to
commercially operate a CW–30, hybrid
fixed wing and vertical takeoff and land
multi-copter, unmanned aircraft (UA)
that weighs more than 55 pounds (lbs.).
The proposed operation would allow
the petitioner to conduct aerial data
collection to include remote sensing and
measuring by an instrument or
combination of instruments aboard the
UA. Specifically, Precision Flight
Devices intends to operate the UA at
less than 30 miles per hour with a
maximum takeoff weight of 75 lbs. The
operations would be conducted within
visual line of sight over a 15.56 square
mile area situated at and around Kiana
and Nulato airfields (8 square miles per
airport) in Western Alaska. The
collection of UA high resolution data
and images may require operations as
close as 200 feet from non-participating
persons.
[FR Doc. 2018–14913 Filed 7–11–18; 8:45 am]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
[Summary Notice No. PE–2018–57]

Petition for Exemption; Summary of
Petition Received; NextEra Energy, Inc.
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice.
AGENCY:

This notice contains a
summary of a petition seeking relief
from specified requirements of Title 14
of the Code of Federal Regulations. The
purpose of this notice is to improve the
public’s awareness of, and participation
in, the FAA’s exemption process.
Neither publication of this notice nor
the inclusion or omission of information
in the summary is intended to affect the
legal status of the petition or its final
disposition.

SUMMARY:

Comments on this petition must
identify the petition docket number and
must be received on or before August 1,
2018.
ADDRESSES: Send comments identified
by docket number FAA–2018–0225
using any of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov and follow
the online instructions for sending your
comments electronically.
• Mail: Send comments to Docket
Operations, M–30; U.S. Department of
Transportation (DOT), 1200 New Jersey
Avenue SE, Room W12–140, West
Building Ground Floor, Washington, DC
20590–0001.
• Hand Delivery or Courier: Take
comments to Docket Operations in
Room W12–140 of the West Building
Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
• Fax: Fax comments to Docket
Operations at 202–493–2251.
Privacy: In accordance with 5 U.S.C.
553(c), DOT solicits comments from the
public to better inform its rulemaking
process. DOT posts these comments,
without edit, including any personal
information the commenter provides, to
http://www.regulations.gov, as
described in the system of records
notice (DOT/ALL–14 FDMS), which can
be reviewed at http://www.dot.gov/
privacy.
Docket: Background documents or
comments received may be read at
http://www.regulations.gov at any time.
Follow the online instructions for
accessing the docket or go to the Docket
Operations in Room W12–140 of the
West Building Ground Floor at 1200
DATES:

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32335

New Jersey Avenue SE, Washington,
DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Jake
Troutman, (202) 683–7788, 800
Independence Avenue SW, Washington,
DC 20591.
This notice is published pursuant to
14 CFR 11.85.
Lirio Liu,
Executive Director, Office of Rulemaking.

Petition for Exemption
Docket No.: FAA–2018–0225.
Petitioner: NextEra Energy, Inc.
Section(s) of 14 CFR Affected:
§§ 61.23(a) & (c); 61.101(e)(4) & (5);
61.113(a); 61.315(a); 91.7(a),
91.105(a)(2), 91.119(c); 91.121;
91.151(a)(1); 91.403(b); 91.405(a);
91.407(a)(1); 91.409(a)(1) & (2); 91.417(a)
& (b).
Description of Relief Sought: The
petitioner proposes to operate
unmanned aircraft systems, weighing
more than 55 pounds, for aerial data
collection operations, including support
of storm response. The operations will
be within visual line of site of the pilot
or visual observer, under 400 feet, and
at speeds at or less than 100 miles an
hour.
[FR Doc. 2018–14912 Filed 7–11–18; 8:45 am]
BILLING CODE 4910–13–P

DEPARTMENT OF THE TREASURY
Office of the Comptroller of the
Currency
Agency Information Collection
Activities: Information Collection
Renewal; Submission for OMB Review;
Subordinated Debt Licensing
Requirements
Office of the Comptroller of the
Currency (OCC), Treasury.
ACTION: Notice and request for comment.
AGENCY:

The OCC, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other federal
agencies to take this opportunity to
comment on a continuing information
collection as required by the Paperwork
Reduction Act of 1995 (PRA).
In accordance with the requirements
of the PRA, the OCC may not conduct
or sponsor, and the respondent is not
required to respond to, an information
collection unless it displays a currently
valid Office of Management and Budget
(OMB) control number.
The OCC is soliciting comment
concerning the renewal of its

SUMMARY:

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information collection titled,
‘‘Subordinated Debt Licensing
Requirements.’’ The OCC also is giving
notice that it has sent the collection to
OMB for review.
DATES: Comments must be submitted on
or before August 13, 2018.
ADDRESSES: Commenters are encouraged
to submit comments by email, if
possible. You may submit comments by
any of the following methods:
• Email: [email protected].
• Mail: Legislative and Regulatory
Activities Division, Office of the
Comptroller of the Currency, Attention:
1557–0320, 400 7th Street SW, Suite
3E–218, Washington, DC 20219.
• Hand Delivery/Courier: 400 7th
Street SW, Suite 3E–218, Washington,
DC 20219.
• Fax: (571) 465–4326.
Instructions: You must include
‘‘OCC’’ as the agency name and ‘‘1557–
0320’’ in your comment. In general, the
OCC will publish your comment on
www.reginfo.gov without change,
including any business or personal
information that you provide, such as
name and address information, email
addresses, or phone numbers.
Comments received, including
attachments and other supporting
materials, are part of the public record
and subject to public disclosure. Do not
include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure.
Additionally, please send a copy of
your comments by mail to: OCC Desk
Officer, 1557–0320, U.S. Office of
Management and Budget, 725 17th
Street NW, #10235, Washington, DC
20503 or by email to oira_submission@
omb.eop.gov.
You may review comments and other
related materials that pertain to this
information collection 1 following the
close of the 30-day comment period for
this notice by any of the following
methods:
• Viewing Comments Electronically:
Go to www.reginfo.gov. Click on the
‘‘Information Collection Review’’ tab.
Underneath the ‘‘Currently under
Review’’ section heading, from the dropdown menu, select ‘‘Department of
Treasury’’ and then click ‘‘submit.’’ This
information collection can be located by
searching by OMB control number
‘‘1557–0320’’ or ‘‘Subordinated Debt
Licensing Requirements.’’ Upon finding
the appropriate information collection,
click on the related ‘‘ICR Reference
Number.’’ On the next screen, select
1 On April 3, 2018, the OCC published a 60-day
notice for this information collection; no public
comments were received.

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‘‘View Supporting Statement and Other
Documents’’ and then click on the link
to any comment listed at the bottom of
the screen.
• For assistance in navigating
www.reginfo.gov, please contact the
Regulatory Information Service Center
at (202) 482–7340.
• Viewing Comments Personally: You
may personally inspect comments at the
OCC, 400 7th Street SW, Washington,
DC. For security reasons, the OCC
requires that visitors make an
appointment to inspect comments. You
may do so by calling (202) 649–6700 or,
for persons who are deaf or hearing
impaired, TTY, (202) 649–5597. Upon
arrival, visitors will be required to
present valid government-issued photo
identification and submit to security
screening in order to inspect comments.
FOR FURTHER INFORMATION CONTACT: OCC
Clearance Officer, (202) 649–5490 or, for
persons who are deaf or hearing
impaired, TTY, (202) 649–5597,
Legislative and Regulatory Activities
Division, Office of the Comptroller of
the Currency, 400 7th Street SW, Suite
3E–218, Washington, DC 20219.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), federal
agencies must obtain approval from
OMB for each collection of information
they conduct or sponsor. ‘‘Collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) to include
agency requests or requirements that
members of the public submit reports,
keep records, or provide information to
a third party. The OCC asks OMB to
extend its approval of the following
collection.
Title: Subordinated Debt Licensing
Requirements.
OMB Control No.: 1557–0320.
Frequency of Response: On occasion.
Affected Public: Business or other forprofit.
Burden Estimates:
Prepayment of Subordinated Debt in
Form of Call Option: 184 Respondents;
1.30 burden hours per respondent; 239
total burden hours.
Authority to Limit Distributions: 42
Respondents; 0.5 hours per respondent;
21 total burden hours.
Total Burden: 260 hours.
Description: The scope of this
Information Collection Renewal is
limited to the following: (1) The 12 CFR
5.47(g) and 12 CFR 5.56(b) requirements
that national banks and federal savings
associations (collectively,
‘‘institutions’’) apply for OCC approval
prior to prepaying subordinated debt if
the prepayment is in the form of a call
option and (2) the 12 CFR 5.47(d)
requirement that national banks issuing

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subordinated debt disclose the OCC’s
authority under 12 CFR 3.11 to limit
distributions.
National banks must receive prior
OCC approval in order to prepay
subordinated debt that is included in
tier 2 capital, and certain banks must
receive prior approval to prepay
subordinated debt that is not included
in tier 2 capital. If the prepayment is in
the form of a call option, a national bank
must submit the information required
for general prepayment requests under
12 CFR 5.47(g)(1)(ii)(A) and also comply
with 12 CFR 5.47(g)(1)(ii)(B)(2), which
requires a national bank to submit
either: (1) A statement explaining why
the bank believes that following the
proposed prepayment the bank would
continue to hold an amount of capital
commensurate with its risk or (2) a
description of the replacement capital
instrument that meets the criteria for
tier 1 or tier 2 capital under 12 CFR
3.20, including the amount of such
instrument and the time frame for
issuance.
Federal savings associations must
receive OCC approval prior to prepaying
subordinated debt securities or
mandatorily redeemable preferred stock
included in tier 2 capital. If the
prepayment is in the form of a call
option, a federal savings association
must submit the information required
for general prepayment requests under
12 CFR 5.56(b)(2)(i) and also comply
with 12 CFR 5.56(b)(2)(ii)(A), which
requires a federal savings association to
submit either: (1) A statement
explaining why the federal savings
association believes that following the
proposed prepayment the savings
association would continue to hold an
amount of capital commensurate with
its risk or (2) a description of the
replacement capital instrument that
meets the criteria for tier 1 or tier 2
capital under 12 CFR 3.20, including the
amount of such instrument and the time
frame for issuance.
Pursuant to 12 CFR 5.47(d)(3)(ii)(C), a
national bank issuing subordinated debt
must disclose on the face of the note the
OCC’s authority under 12 CFR 3.11 to
limit distributions, including interest
payments on any tier 2 capital
instrument if the national bank has full
discretion to permanently or
temporarily suspend such payments
without triggering an event of default.
Comments submitted in response to
this notice will be summarized and
included in the request for OMB
approval. All comments will become a
matter of public record. Comments are
invited on:
(a) Whether the collections of
information are necessary for the proper

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices
performance of the OCC’s functions,
including whether the information has
practical utility;
(b) The accuracy of the OCC’s
estimates of the burden of the
information collections, including the
validity of the methodology and
assumptions used;
(c) Ways to enhance the quality,
utility, and clarity of the information to
be collected; and
(d) Ways to minimize the burden of
information collections on respondents,
including through the use of automated
collection techniques or other forms of
information technology.
Dated: July 6, 2018.
Karen Solomon,
Acting First Deputy Comptroller and Chief
Counsel.
[FR Doc. 2018–14941 Filed 7–11–18; 8:45 am]
BILLING CODE 4810–33–P

FOR FURTHER INFORMATION CONTACT:

Melissa Avstreih, Designated Federal
Officer, Office of Financial Research,
Department of the Treasury, 1500
Pennsylvania Avenue NW, Washington,
DC 20220, (202) 927–8032 (this is not a
toll-free number), or OFR_FRAC@
ofr.treasury.gov. Persons who have
difficulty hearing or speaking may
access this number via TTY by calling
the toll-free Federal Relay Service at
(800) 877–8339.
SUPPLEMENTARY INFORMATION: On July 2,
2018 (83 FR 31035), the OFR announced
the 12th meeting of the Financial
Research Advisory Committee. The OFR
has had to change the start time for the
meeting until 1:00 p.m. Eastern Time.
All other information in the notice is
unchanged, including the location and
tentative agenda/topics for discussion.
Dated: July 3, 2018.
Barbara Shycoff,
Chief of External Affairs.

DEPARTMENT OF THE TREASURY

[FR Doc. 2018–14949 Filed 7–11–18; 8:45 am]

Open Meeting of the Financial
Research Advisory Committee

BILLING CODE 4810–25–P

Office of Financial Research,
Department of the Treasury.
ACTION: Notice of open meeting; time
change.
AGENCY:

The Financial Research
Advisory Committee for the Treasury’s
Office of Financial Research (OFR)
previously announced its 12th meeting
to be held on Thursday, July 26, 2018,
in the Benjamin Strong Room, Federal
Reserve Bank of New York, 33 Liberty
Street, New York, New York, 10045,
beginning at 11:00 a.m. Eastern Time.
By this notice, the OFR is changing the
start time for the meeting to 1:00 p.m.
Eastern Time. The meeting will be open
to the public and limited seating will be
available.
DATES: The meeting will be held on
Thursday, July 26, 2018, beginning at
1:00 p.m. Eastern Time.
ADDRESSES: The meeting will be held in
the Benjamin Strong Room, Federal
Reserve Bank of New York, 33 Liberty
Street, New York, New York, 10045. The
meeting will be open to the public. A
limited number of seats will be available
for those interested in attending the
meeting, and those seats would be on a
first-come, first-served basis. Because
the meeting will be held in a secured
facility, members of the public who plan
to attend the meeting MUST contact the
OFR by email at OFR_FRAC@
ofr.treasury.gov by 5 p.m. ET on
Thursday, July 19, 2018, to inform the
OFR of their desire to attend the
meeting and receive further instructions
about building clearance.

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DEPARTMENT OF VETERANS
AFFAIRS
Creating Options for Veterans
Expedited Recovery (COVER)
Commission; Notice of Meeting
In accordance with the Federal
Advisory Committee Act, the Creating
Options for Veterans Expedited Recover
(COVER) Commission gives notice that
the first meeting will be held on July 24
and July 25, 2018 at the Capital Hilton,
1001 16th Street NW, Washington, DC.
The meeting will convene at 8:00 a.m.
and adjourn at 5:00 p.m. EST on July 24
and July 25. The meeting will be
partially closed to the public on July 24,
2018 and July 25, 2018. In accordance
with 5 U.S.C. 552b(c)(2) and (6), which
exempt a meeting from the requirement
to be open to the public, the meeting
will be closed on July 24 from 8:00 a.m.
to 12:00 p.m. because it is likely to
‘‘relate solely to the internal personnel
rules and practices of an agency’’ or
‘‘disclose . . . information of a personal
nature where disclosure would
constitute a clearly unwarranted
invasion of personal privacy.’’ On July
25, the meeting will be closed from
12:00 p.m. to 5:00 p.m. under section
552b(c)(9)(B) because it would reveal
information the disclosure of which
would, ‘‘in the case of an agency, be
likely to significantly frustrate
implementation of a proposed agency
action.’’ This closed session will
include discussion of ground rules,
decision making protocol, and strategy

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to establish ground rules. Any
precipitous release of those discussions
through an open session will frustrate
program implementation, to the
detriment of our Veterans who we
consider our greatest customer/
benefactor of the commission.
Open sessions will be held on both
days in Capital Hilton’s South American
AB room. The open session on Day 1
will focus current VHA Whole Health
Practices, VA’s Mental Health Services
and Resources. The open session Day 2
will include review and discussion of
the objectives of the Commission as
described in the Comprehensive
Addiction and Recovery Act (CARA) of
2016. A listening line will be available
to the public who prefer to call in rather
than attend the open sessions at the
Capital Hilton. This listening line
number will be activated 10 minutes
before each of the two open sessions.
The listening line number is 800–767–
1750; access code 48664#.
The purpose of the COVER
Commission is to examine the evidencebased therapy treatment model used by
the Department of Veterans Affairs (VA)
for treating mental health conditions of
Veterans and the potential benefits of
incorporating complementary and
integrative health approaches as
standard practice throughout the
Department. The Commission will: (1)
Examine the efficacy of the evidencebased therapy model used by VA to treat
mental health illnesses and identify
areas of improvement; (2) conduct a
patient-centered survey within each
VISN to examine: The experiences of
veterans with VA facilities regarding
mental health care, the experiences of
veterans with non-VA facilities
regarding mental health care, the
preferences of veterans regarding
available treatment for mental health
issues and which methods the veterans
believe to be most effective, the
experience, if any, of veterans with
respect to complementary and
integrative health approaches, the
prevalence of prescribing medication to
veterans seeking treatment for mental
health disorders through VA, and the
outreach efforts of VA regarding the
availability of benefits and treatments
for veterans for addressing mental
health issues; (3) examine available
research on complementary and
integrative health approaches for mental
health disorders in areas of therapy
including: Music therapy, equine
therapy, training and caring for service
dogs, yoga therapy, acupuncture
therapy, meditation therapy, outdoor
sports therapy, hyperbaric oxygen
therapy, accelerated resolution therapy,
art therapy, magnetic resonance therapy,

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and others; (4) study the sufficiency of
VA resources to deliver quality mental
health care; and (5) study the current
treatments and resources available
within VA and assess: The effectiveness
of such treatments and resources in
decreasing the number of suicides per
day by veterans, the number of veterans
who have been diagnosed with mental
health issues, the percentage of veterans
who have completed VA counseling
sessions, and the efforts of VA to
expand complementary and integrative

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health treatments viable to the recovery
of veterans with mental health issues as
determined by the Secretary to improve
the effectiveness of treatments offered
by VA.
Any member of the public seeking
additional information should email
COVER [email protected]. The
Designated Federal Officer for the
Commission is Ms. Sheila B. Hickman.
Ms. Hickman and the staff will be
monitoring and responding to questions
or comments sent to this email box. The

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Committee will also accept written
comments which may be sent to the
same email box. In the public’s
communications with the Committee,
the writers must identify themselves
and state the organizations, associations,
or persons they represent.
Dated: July 9, 2018.
Jelessa M. Burney,
Federal Advisory Committee Management
Officer.
[FR Doc. 2018–14936 Filed 7–11–18; 8:45 am]
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Vol. 83

Thursday,

No. 134

July 12, 2018

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services
42 CFR Parts 409, 424, 484, et al.
Medicare and Medicaid Programs; CY 2019 Home Health Prospective
Payment System Rate Update and CY 2020 Case-Mix Adjustment
Methodology Refinements; Home Health Value-Based Purchasing Model;
Home Health Quality Reporting Requirements; Home Infusion Therapy
Requirements; and Training Requirements for Surveyors of National
Accrediting Organizations; Proposed Rule

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 409, 424, 484, 486, and
488
[CMS–1689–P]
RIN 0938–AT29

Medicare and Medicaid Programs; CY
2019 Home Health Prospective
Payment System Rate Update and CY
2020 Case-Mix Adjustment
Methodology Refinements; Home
Health Value-Based Purchasing Model;
Home Health Quality Reporting
Requirements; Home Infusion Therapy
Requirements; and Training
Requirements for Surveyors of
National Accrediting Organizations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:

This proposed rule would
update the home health prospective
payment system (HH PPS) payment
rates, including the national,
standardized 60-day episode payment
rates, the national per-visit rates, and
the non-routine medical supply (NRS)
conversion factor, effective for home
health episodes of care ending on or
after January 1, 2019. It also proposes
updates to the HH PPS case-mix weights
for calendar year (CY) 2019 using the
most current, complete data available at
the time of rulemaking; discusses our
efforts to monitor the potential impacts
of the rebasing adjustments that were
implemented in CYs 2014 through 2017;
proposes a rebasing of the HH market
basket (which includes a decrease in the
labor-related share); proposes the
methodology used to determine rural
add-on payments for CYs 2019 through
2022, as required by section 50208 of
the Bipartisan Budget Act of 2018
hereinafter referred to as the ‘‘BBA of
2018’’; proposes regulations text
changes regarding certifying and
recertifying patient eligibility for
Medicare home health services; and
proposes to define ‘‘remote patient
monitoring’’ and recognize the cost
associated as an allowable
administrative cost. Additionally, it
proposes case-mix methodology
refinements to be implemented for
home health services beginning on or
after January 1, 2020, including a
change in the unit of payment from 60day episodes of care to 30-day periods
of care, as required by section 51001 of
the BBA of 2018; includes information

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on the implementation of temporary
transitional payments for home infusion
therapy services for CYs 2019 and 2020,
as required by section 50401 of the BBA
of 2018; solicits comments regarding
payment for home infusion therapy
services for CY 2021 and subsequent
years; proposes health and safety
standards for home infusion therapy;
and proposes an accreditation and
oversight process for home infusion
therapy suppliers. This rule proposes
changes to the Home Health ValueBased Purchasing (HHVBP) Model to
remove two OASIS-based measures,
replace three OASIS-based measures
with two new proposed composite
measures, rescore the maximum number
of improvement points, and reweight
the measures in the applicable measures
set. Also, the Home Health Quality
Reporting Program provisions include a
discussion of the Meaningful Measures
Initiative and propose the removal of
seven measures to further the priorities
of this initiative. In addition, the HH
QRP offers a discussion on social risk
factors and an update on
implementation efforts for certain
provisions of the IMPACT Act. This
proposed rule clarifies the regulatory
text to note that not all OASIS data is
required for the HH QRP. Finally, it
would require that accrediting
organization surveyors take CMSprovided training.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on August 31, 2018.
ADDRESSES: In commenting, please refer
to file code CMS–1689–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1689–P, P.O. Box 8013, Baltimore,
MD 21244–8013. Please allow sufficient
time for mailed comments to be
received before the close of the
comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human

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Services, Attention: CMS–1689–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: For
general information about the Home
Health Prospective Payment System
(HH PPS), send your inquiry via email
to: [email protected].
For general information about home
infusion payment, send your inquiry via
email to: HomeInfusionPolicy@
cms.hhs.gov.
For information about the Home
Health Value-Based Purchasing
(HHVBP) Model, send your inquiry via
email to: HHVBPquestions@
cms.hhs.gov.
For information about the Home
Health Quality Reporting Program (HH
QRP) contact: Joan Proctor, (410) 786–
0949.
For information about home infusion
therapy health and safety standards,
contact: Sonia Swancy, (410) 786–8445
or CAPT Jacqueline Leach, (410) 786–
4282.
For information about health infusion
therapy accreditation and oversight,
contact: Caroline Gallaher (410) 786–
8705.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: http://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs and Benefits
D. Improving Patient Outcomes and
Reducing Burden Through Meaningful
Measures
II. Background
A. Statutory Background
B. Current System for Payment of Home
Health Services
C. Updates to the Home Health Prospective
Payment System
D. Advancing Health Information Exchange
III. Payment Under the Home Health
Prospective Payment System (HH PPS)
A. Monitoring for Potential Impacts—
Affordable Care Act Rebasing
Adjustments
B. Proposed CY 2019 HH PPS Case-Mix
Weights

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C. Proposed CY 2019 Home Health
Payment Rate Update
D. Proposed Rural Add-On Payments for
CYs 2019 Through 2022
E. Proposed Payments for High-Cost
Outliers Under the HH PPS
F. Proposed Implementation of the PatientDriven Groupings Model (PDGM) for CY
2020
G. Proposed Regulations Text Changes
Regarding Certifying and Recertifying
Patient Eligibility for Medicare Home
Health Services
H. The Role of Remote Patient Monitoring
Under the Medicare Home Health
Benefit
IV. Home Health Value-Based Purchasing
(HHVBP) Model
A. Background
B. Quality Measures
C. Performance Scoring Methodology
D. Update on the Public Display of Total
Performance Scores
V. Home Health Quality Reporting Program
(HH QRP)
A. Background and Statutory Authority
B. General Considerations Used for the
Selection of Quality Measures for the HH
QRP
C. Proposed Removal Factors for
Previously Adopted HH QRP Measures
D. Quality Measures Currently Adopted for
the HH QRP
E. Proposed Removal of HH QRP Measures
Beginning With the CY 2021 HH QRP
F. IMPACT Act Implementation Update
G. Form, Manner, and Timing of OASIS
Data Submission
H. Proposed Policies Regarding Public
Display for the HH QRP
I. HHCAHPS
VI. Medicare Coverage of Home Infusion
Therapy Services
A. General Background
B. Proposed Health and Safety Standards
for Home Infusion Therapy
C. Payment for Home Infusion Therapy
Services
D. Approval and Oversight of Accrediting
Organizations for Home Infusion
Therapy (HIT) Suppliers
VII. Changes to the Accreditation
Requirements for Certain Medicare
Certified Providers and Suppliers
A. Background
B. Proposed Changes to Certain
Requirements for Medicare-Certified
Providers and Suppliers at Part 488
VIII. Requests for Information
A. Request for Information on Promoting
Interoperability and Electronic
Healthcare Information Exchange
Through Possible Revisions to the CMS
Patient Health and Safety Requirements
for Hospitals and Other Medicare- and
Medicaid-Participating Providers and
Suppliers
B. Request for Information on Price
Transparency: Improving Beneficiary
Access to Home Health Agency Charge
Information
IX. Collection of Information Requirements
A. Wage Estimates
B. ICRs Regarding the OASIS
C. ICRs Regarding Home Infusion Therapy

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D. ICRs Regarding the Approval and
Oversight of Accrediting Organizations
for Home Infusion Therapy
X. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
D. Detailed Economic Analysis
E. Alternatives Considered
F. Accounting Statement and Tables
G. Regulatory Reform Analysis Under E.O.
13771
H. Conclusion
Regulation Text

I. Executive Summary
A. Purpose
1. Home Health Prospective Payment
System (HH PPS)
This proposed rule would update the
payment rates for home health agencies
(HHAs) for calendar year (CY) 2019, as
required under section 1895(b) of the
Social Security Act (the Act). This
proposed rule would also update the
case-mix weights under section
1895(b)(4)(A)(i) and (b)(4)(B) of the Act
for CY 2019. For home health services
beginning on or after January 1, 2020,
this rule proposes case-mix
methodology refinements, which
eliminate the use of therapy thresholds
for case-mix adjustment purposes; and
proposes to change the unit of payment
from a 60-day episode of care to a 30day period of care, as mandated by
section 51001 of the Bipartisan Budget
Act of 2018 (Pub. L. 115–123)
(hereinafter referred to as the ‘‘BBA of
2018’’). This proposed rule also:
Proposes the methodology used to
determine rural add-on payments for
CYs 2019 through 2022, as required by
section 50208 of the BBA of 2018;
proposes regulations text changes
regarding certifying and recertifying
patient eligibility for Medicare home
health services under sections 1814(a)
and 1835(a) of the Act; and proposes to
define ‘‘remote patient monitoring’’
under the Medicare home health benefit
and to include the costs of such
monitoring as an allowable
administrative cost. Lastly, this rule
proposes changes to the Home Health
Value Based Purchasing (HHVBP)
Model under the authority of section
1115A of the Act, and the Home Health
Quality Reporting Program (HH QRP)
requirements under the authority of
section 1895(b)(3)(B)(v) of the Act.
2. Home Infusion Therapy Services
This proposed rule would establish a
transitional payment for home infusion
therapy services for CYs 2019 and 2020,
as required by section 50401 of the BBA
of 2018. In addition, this rule proposes
health and safety standards for home

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infusion therapy, proposes an
accreditation and oversight process for
qualified home infusion therapy
suppliers, and solicits comments
regarding payment for the home
infusion therapy services benefit for CY
2021 and subsequent years, as required
by section 5012 of the 21st Century
Cures Act (Pub. L. 114–255).
3. Safety Standards for Home Infusion
Therapy Services
This proposed rule would establish
health and safety standards for qualified
home infusion therapy suppliers as
required by Section 5012 of the 21st
Century Cures Act. These proposed
standards would establish a foundation
for ensuring patient safety and quality
care by establishing requirements for the
plan of care to be initiated and updated
by a physician; 7-day-a-week, 24-houra-day access to services and remote
monitoring; and patient education and
training regarding their home infusion
therapy care.
B. Summary of the Major Provisions
1. Home Health Prospective Payment
System (HH PPS)
Section III.A. of this rule discusses
our efforts to monitor for potential
impacts due to the rebasing adjustments
implemented in CY 2014 through CY
2017, as mandated by section 3131(a) of
the Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111–148,
enacted March 23, 2010) as amended by
the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152, enacted March 30, 2010),
collectively referred to as the
‘‘Affordable Care Act’’. In the CY 2015
HH PPS final rule (79 FR 66072), we
finalized our proposal to recalibrate the
case-mix weights every year with the
most current and complete data
available at the time of rulemaking. In
section III.B of this rule, we are
recalibrating the HH PPS case-mix
weights, using the most current cost and
utilization data available, in a budgetneutral manner. In section III.C., we
propose to rebase the home health
market basket and update the payment
rates under the HH PPS by the home
health payment update percentage of 2.1
percent (using the proposed 2016-based
Home Health Agency (HHA) market
basket update of 2.8 percent, minus 0.7
percentage point for multifactor
productivity) as required by section
1895(b)(3)(B)(vi)(I) of the Act. Also in
section III.C. of this proposed rule, we
propose to decrease the labor-related
share from 78.5 to 76.1 percent of total
costs on account of the rebasing of the
home health market basket. Lastly, in

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section III.C. of this rule, we propose to
update the CY 2019 home health wage
index using FY 2015 hospital cost report
data. In section III.D. of this proposed
rule, we are proposing a new
methodology for applying rural add-on
payments for CYs 2019 through 2022, as
required by section 50208 of the BBA of
2018. In section III.E. of this rule, we are
proposing to reduce the fixed-dollar loss
ratio from 0.55 to 0.51 for CY 2019 in
order to increase outlier payments as a
percentage of total payments so that this
percentage is closer to, but no more
than, 2.5 percent.
In the CY 2018 HH PPS proposed
rule, CMS proposed an alternative casemix model, called the Home Health
Groupings Model (HHGM). Ultimately
the HHGM, including a proposed
change in the unit of payment from 60
days to 30 days, was not finalized in the
CY 2018 HH PPS final rule in order to
allow CMS additional time to consider
public comments for potential
refinements to the model and other
alternative case-mix models (82 FR
51676). In section III.F. of this proposed
rule, we are again proposing to
implement case-mix methodology
refinements and a change in the unit of
payment from a 60-day episode of care
to a 30-day period of care; however,
these changes would be effective
January 1, 2020 and would be
implemented in a budget neutral
manner, as required by section 51001 of
the BBA of 2018. Since the proposed
case-mix methodology refinements
represent a more patient-driven
approach to payment we are renaming
the proposed case-mix adjustment
methodology refinements, formerly
known as the Home Health Groupings
Model or ‘‘HHGM’’, as the ‘‘PatientDriven Groupings Model’’ or PDGM.
The proposed PDGM relies more heavily
on clinical characteristics and other
patient information to place patients
into meaningful payment categories and
eliminates the use of therapy service
thresholds, as required by section
51001(a)(3) of the BBA of 2018, that are
currently used to case-mix adjust
payments under the HH PPS. There is
also a proposal regarding how CMS
would determine whether 30-day
periods of care are subject to a LowUtilization Payment Adjustment
(LUPA). The LUPA add-on policy, the
partial episode payment adjustment
policy, and the methodology used to
calculate payments for high-cost outliers
would remain unchanged except for
occurring on a 30-day basis rather than
a 60-day basis.
In section III.G. of this proposed rule,
we are proposing regulation text
changes at 42 CFR 424.22(b)(2) to

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eliminate the requirement that the
certifying physician must estimate how
much longer skilled services will be
needed as part of the recertification
statement. In addition, in section III.G of
this rule, consistent with section 51002
of the BBA of 2018, we are proposing to
align the regulations text at 42 CFR
424.22(c) with current subregulatory
guidance to allow medical record
documentation from the HHA to be used
to support the basis for certification
and/or recertification of home health
eligibility, if certain requirements are
met.
In section III.H. of this proposed rule,
we propose to define ‘‘remote patient
monitoring’’ under the Medicare home
health benefit as the collection of
physiologic data (for example, ECG,
blood pressure, glucose monitoring)
digitally stored and/or transmitted by
the patient and/or caregiver to the HHA.
Additionally in this section of the rule,
we propose changes to the regulations at
42 CFR 409.46 to include costs of
remote patient monitoring as allowable
administrative costs.
2. Home Health Value Based Purchasing
In section IV of this proposed rule, we
are proposing changes to the Home
Health Value Based Purchasing
(HHVBP) Model implemented January
1, 2016. We are proposing, beginning
with performance year (PY) 4, to:
Remove two Outcome and Assessment
Information Set (OASIS) based
measures, Influenza Immunization
Received for Current Flu Season and
Pneumococcal Polysaccharide Vaccine
Ever Received, from the set of
applicable measures; replace three
OASIS-based measures (Improvement in
Ambulation-Locomotion, Improvement
in Bed Transferring, and Improvement
in Bathing) with two proposed
composite measures on total normalized
composite change in self-care and
mobility; change how we calculate the
Total Performance Scores by changing
the weighting methodology for the
OASIS-based, claims-based, and
HHCAHPS measures; and change the
scoring methodology by reducing the
maximum amount of improvement
points an HHA could earn, from 10
points to 9 points. While we are not
making a specific proposal at this time,
we are also providing an update on the
progress towards developing public
reporting of performance under the
HHVBP Model and seeking comment on
what information should be made
publicly available.

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3. Home Health Quality Reporting
Program
In section V. of this proposed rule, we
are proposing to update our policy for
removing previously adopted Home
Health (HH) Quality Reporting Program
(QRP) measures and to adopt eight
measure removal factors to align with
other QRPs, to remove seven measures
beginning with the CY 2021 HH QRP,
and to update our regulations to clarify
that not all OASIS data is required for
the HH QRP. We are also providing an
update on the implementation of certain
provisions of the IMPACT Act, and a
discussion of accounting for social risk
factors in the HH QRP. Finally, we are
proposing to increase the number of
years of data used to calculate the
Medicare Spending per Beneficiary
measure for purposes of display from 1
year to 2 years.
4. Home Infusion Therapy
In section VI.A. of this proposed rule,
we discuss general background of home
infusion therapy services and how that
will relate to the implementation of the
new home infusion benefit. In section
VI.B. of this proposed rule, we are
proposing to add a new subpart I under
the regulations at 42 CFR part 486 to
incorporate health and safety
requirements for home infusion therapy
suppliers. The proposed regulations
would provide a framework for CMS to
approve home infusion therapy
accreditation organizations. Proposed
subpart I would include General
Provisions (Scope and Purpose, and
Definitions) and Standards for Home
Infusion Therapy (Plan of Care and
Required Services). In section VI.C. of
this proposed rule, we include
information on temporary transitional
payments for home infusion therapy
services for CYs 2019 and 2020 as
mandated by section 50401 of the BBA
of 2018, and solicits comments on the
proposed regulatory definition of
‘‘Infusion Drug Administration Calendar
Day’’. Also in section VI.C. of this
proposed rule, we solicit comments
regarding payment for home infusion
therapy services for CY 2021 and
subsequent years as required by section
5012(d) of the 21st Century Cures Act.
In section VI.D. of this proposed rule,
we discuss the requirements set forth in
section 1861(iii)(3)(D)(III) of the Act,
which mandates that suppliers of home
infusion therapy receive accreditation
from a CMS-approved Accrediting
Organization (AO) in order to receive
Medicare payment. The Secretary must
designate AOs to accredit suppliers
furnishing Home Infusion therapy (HIT)
not later than January 1, 2021. Qualified

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HIT suppliers are required to receive
accreditation before receiving Medicare
payment for services provided to
Medicare beneficiaries.
At this time, no regulations exist to
address the following elements of CMS’
approval and oversight of the AOs that
accredit suppliers of Home Infusion
Therapy: (1) The required components
to be included in a Home Infusion
Therapy AO’s initial or renewal
accreditation program application; (2)
regulations related to CMS’ review and
approval of the Home Infusion Therapy
AOs application for approval of its
accreditation program; and (3) the
ongoing monitoring and oversight of
CMS-approved Home Infusion Therapy

AOs. Therefore in this rule, we propose
to establish a set of regulations that will
govern the CMS approval and oversight
process for all HIT AOs.
We also propose to modify the
regulations for oversight for AOs that
accredit any Medicare-certified
providers and suppliers at 42 CFR 488.5
by adding a requirement that the AOs
must include a statement with their
application acknowledging that all AO
surveyors are required to complete the
relevant program specific CMS online
trainings initially, and thereafter,
consistent with requirements
established by CMS for state and federal
surveyors. We would also add another
requirement at § 488.5 that would

require the AOs for Medicare certified
providers and suppliers to provide a
written statement with their application
stating that if a fully accredited and
facility deemed to be in good-standing
provides written notification that they
wish to voluntarily withdraw from the
AO’s CMS-approved accreditation
program, the AO must continue the
facility’s current accreditation until the
effective date of withdrawal identified
by the facility or the expiration date of
the term of accreditation, whichever
comes first.
C. Summary of Costs, Transfers, and
Benefits

TABLE 1—SUMMARY OF COSTS, TRANSFERS, AND BENEFITS
Provision
description

Costs and cost savings

Transfers

Benefits

CY 2019 HH PPS Payment Rate
Update.

.......................................................

To ensure home health payments
are consistent with statutory
payment authority for CY 2019.

CY 2019 Temporary Transitional
Payments for Home Infusion
Therapy Services.

.......................................................

CY 2019 HHVBP Model ................

.......................................................

CY 2020 OASIS Changes .............

The overall economic impact of
the HH QRP and the case-mix
adjustment
methodology
changes is annual savings to
HHAs of an estimated $60 million.
.......................................................

The overall economic impact of
the HH PPS payment rate update is an estimated $400 million (2.1 percent) in increased
payments to HHAs in CY 2019.
The overall economic impact of
the temporary transitional payment for home infusion therapy
services is an estimated $60
million in increased payments
to home infusion therapy suppliers in CY 2019.
The overall economic impact of
the HHVBP Model provision for
CY 2018 through 2022 is an estimated $378 million in total
savings from a reduction in unnecessary hospitalizations and
SNF usage as a result of greater quality improvements in the
HH industry (none of which is
attributable to the changes proposed in this proposed rule). As
for payments to HHAs, there
are no aggregate increases or
decreases expected to be applied to the HHAs competing in
the model.
.......................................................

The overall economic impact of
the proposed case-mix adjustment methodology changes, including a change in the unit of
service from 60 to 30 days, for
CY 2020 results in no estimated dollar impact to HHAs,
as section 51001(a) of the BBA
of 2018 requires such change
to be implemented in a budgetneutral manner.

To ensure home health payments
are consistent with statutory
payment authority for CY 2020.

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CY 2020 Case-Mix Adjustment
Methodology Changes, Including
a Change in the Unit of Service
from 60 to 30 days.

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To ensure temporary transitional
payments for home infusion
therapy are consistent with statutory authority for CY 2019.

A reduction in burden to HHAs of
approximately 73 hours annually for a savings of approximately $5,150 annually per
HHA.

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TABLE 1—SUMMARY OF COSTS, TRANSFERS, AND BENEFITS—Continued
Provision
description

Costs and cost savings

Transfers

Accreditation for Home Infusion
Therapy suppliers.

.......................................................

The cost related to an AO obtaining CMS approval of a home infusion therapy accreditation
program is estimated to be
$8,014.50 per each AO, for
AOs that have previously submitted an accreditation application to CMS. The cost across
the potential 6 home infusion
therapy AOs would be $48,087.
The cost related to each home infusion therapy AO for obtaining
CMS approval of a home infusion therapy accreditation program is estimated to be
$12,453 per each AO, for AOs
that have not previously submitted an accreditation application to CMS. The cost across
the potential 6 home infusion
therapy AOs would be $74,718.
We further estimate that each
home infusion therapy AO
would incur an estimated cost
burden in the amount of
$23,258 for compliance with the
proposed home infusion therapy AO approval and oversight
regulations
at
§§ 488.1010
through 488.1050 (including the
filing of an application). The
cost across the 6 potential
home infusion therapy AOs
would be $139,548.

D. Improving Patient Outcomes and
Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing
regulatory burden are high priorities for
us. To reduce the regulatory burden on
the healthcare industry, lower health
care costs, and enhance patient care, in
October 2017, we launched the
Meaningful Measures Initiative.1 This
initiative is one component of our
agency-wide Patients Over Paperwork
Initiative 2 which is aimed at evaluating
and streamlining regulations with a goal
to reduce unnecessary cost and burden,
increase efficiencies, and improve
beneficiary experience. The Meaningful
Measures Initiative is aimed at
identifying the highest priority areas for

quality measurement and quality
improvement in order to assess the core
quality of care issues that are most vital
to advancing our work to improve
patient outcomes. The Meaningful
Measures Initiative represents a new
approach to quality measures that
fosters operational efficiencies, and will
reduce costs including, the collection
and reporting burden while producing
quality measurement that is more
focused on meaningful outcomes.
The Meaningful Measures Framework
has the following objectives:
• Address high-impact measure areas
that safeguard public health;
• Patient-centered and meaningful to
patients;
• Outcome-based where possible;

Benefits

• Fulfill each program’s statutory
requirements;
• Minimize the level of burden for
health care providers (for example,
through a preference for EHR-based
measures where possible, such as
electronic clinical quality measures);
• Provide significant opportunity for
improvement;
• Address measure needs for
population based payment through
alternative payment models; and
• Align across programs and/or with
other payers.
In order to achieve these objectives,
we have identified 19 Meaningful
Measures areas and mapped them to six
overarching quality priorities as shown
in Table 2:

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TABLE 2—MEANINGFUL MEASURES FRAMEWORK DOMAINS AND MEASURE AREAS
Quality priority

Meaningful measure area

Making Care Safer by Reducing Harm Caused in the Delivery of Care

1 Meaningful Measures web page: https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/QualityInitiativesGenInfo/
MMF/General-info-Sub-Page.html.

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Healthcare-Associated Infections.
Preventable Healthcare Harm.

2 See Remarks by Administrator Seema Verma at
the Health Care Payment Learning and Action
Network (LAN) Fall Summit, as prepared for
delivery on October 30, 2017 https://www.cms.gov/

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TABLE 2—MEANINGFUL MEASURES FRAMEWORK DOMAINS AND MEASURE AREAS—Continued
Quality priority

Meaningful measure area

Strengthen Person and Family Engagement as Partners in Their Care

Promote Effective Communication and Coordination of Care .................
Promote Effective Prevention and Treatment of Chronic Disease ..........

Work with Communities to Promote Best Practices of Healthy Living ....
Make Care Affordable ..............................................................................

By including Meaningful Measures in
our programs, we believe that we can
also address the following cross-cutting
measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and
impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural
communities; and
• Reducing burden.
We believe that the Meaningful
Measures Initiative will improve
outcomes for patients, their families,
and health care providers while
reducing burden and costs for clinicians
and providers and promoting
operational efficiencies.
II. Background
A. Statutory Background
1. Home Health Prospective Payment
System

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a. Background
The Balanced Budget Act of 1997
(BBA) (Pub. L. 105–33, enacted August
5, 1997), significantly changed the way
Medicare pays for Medicare home
health services. Section 4603 of the BBA
mandated the development of the HH
PPS. Until the implementation of the
HH PPS on October 1, 2000, HHAs
received payment under a retrospective
reimbursement system.
Section 4603(a) of the BBA mandated
the development of a HH PPS for all
Medicare-covered home health services
provided under a plan of care (POC) that
were paid on a reasonable cost basis by
adding section 1895 of the Act, entitled
‘‘Prospective Payment For Home Health
Services.’’ Section 1895(b)(1) of the Act
requires the Secretary to establish a HH
PPS for all costs of home health services
paid under Medicare. Section 1895(b)(2)

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Care is Personalized and Aligned with Patient’s Goals.
End of Life Care according to Preferences.
Patient’s Experience of Care.
Patient Reported Functional Outcomes.
Medication Management.
Admissions and Readmissions to Hospitals.
Transfer of Health Information and Interoperability.
Preventive Care.
Management of Chronic Conditions.
Prevention, Treatment, and Management of Mental Health.
Prevention and Treatment of Opioid and Substance Use Disorders.
Risk Adjusted Mortality.
Equity of Care.
Community Engagement.
Appropriate Use of Healthcare.
Patient-focused Episode of Care.
Risk Adjusted Total Cost of Care.

of the Act requires that, in defining a
prospective payment amount, the
Secretary will consider an appropriate
unit of service and the number, type,
and duration of visits provided within
that unit, potential changes in the mix
of services provided within that unit
and their cost, and a general system
design that provides for continued
access to quality services.
Section 1895(b)(3)(A) of the Act
requires the following: (1) The
computation of a standard prospective
payment amount that includes all costs
for HH services covered and paid for on
a reasonable cost basis, and that such
amounts be initially based on the most
recent audited cost report data available
to the Secretary (as of the effective date
of the 2000 final rule), and (2) the
standardized prospective payment
amount be adjusted to account for the
effects of case-mix and wage levels
among HHAs.
Section 1895(b)(3)(B) of the Act
requires the standard prospective
payment amounts be annually updated
by the home health applicable
percentage increase. Section 1895(b)(4)
of the Act governs the payment
computation. Sections 1895(b)(4)(A)(i)
and (b)(4)(A)(ii) of the Act require the
standard prospective payment amount
to be adjusted for case-mix and
geographic differences in wage levels.
Section 1895(b)(4)(B) of the Act requires
the establishment of an appropriate
case-mix change adjustment factor for
significant variation in costs among
different units of services.
Similarly, section 1895(b)(4)(C) of the
Act requires the establishment of wage
adjustment factors that reflect the
relative level of wages, and wage-related
costs applicable to home health services
furnished in a geographic area
compared to the applicable national

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average level. Under section
1895(b)(4)(C) of the Act, the wageadjustment factors used by the Secretary
may be the factors used under section
1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the
Secretary the option to make additions
or adjustments to the payment amount
otherwise paid in the case of outliers
due to unusual variations in the type or
amount of medically necessary care.
Section 3131(b)(2) of the Affordable
Care Act revised section 1895(b)(5) of
the Act so that total outlier payments in
a given year would not exceed 2.5
percent of total payments projected or
estimated. The provision also made
permanent a 10 percent agency-level
outlier payment cap.
In accordance with the statute, as
amended by the BBA, we published a
final rule in the July 3, 2000 Federal
Register (65 FR 41128) to implement the
HH PPS legislation. The July 2000 final
rule established requirements for the
new HH PPS for home health services
as required by section 4603 of the BBA,
as subsequently amended by section
5101 of the Omnibus Consolidated and
Emergency Supplemental
Appropriations Act for Fiscal Year 1999
(OCESAA), (Pub. L. 105–277, enacted
October 21, 1998); and by sections 302,
305, and 306 of the Medicare, Medicaid,
and SCHIP Balanced Budget Refinement
Act of 1999, (BBRA) (Pub. L. 106–113,
enacted November 29, 1999). The
requirements include the
implementation of a HH PPS for home
health services, consolidated billing
requirements, and a number of other
related changes. The HH PPS described
in that rule replaced the retrospective
reasonable cost-based system that was
used by Medicare for the payment of
home health services under Part A and
Part B. For a complete and full

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description of the HH PPS as required
by the BBA, see the July 2000 HH PPS
final rule (65 FR 41128 through 41214).
Section 5201(c) of the Deficit
Reduction Act of 2005 (DRA) (Pub. L.
109–171, enacted February 8, 2006)
added new section 1895(b)(3)(B)(v) to
the Act, requiring HHAs to submit data
for purposes of measuring health care
quality, and linking the quality data
submission to the annual applicable
payment percentage increase. This data
submission requirement is applicable
for CY 2007 and each subsequent year.
If an HHA does not submit quality data,
the home health market basket
percentage increase is reduced by 2
percentage points. In the November 9,
2006 Federal Register (71 FR 65884,
65935), we published a final rule to
implement the pay-for-reporting
requirement of the DRA, which was
codified at § 484.225(h) and (i) in
accordance with the statute. The payfor-reporting requirement was
implemented on January 1, 2007.
The Affordable Care Act made
additional changes to the HH PPS. One
of the changes in section 3131 of the
Affordable Care Act is the amendment
to section 421(a) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173, enacted on December 8,
2003) as amended by section 5201(b) of
the DRA. Section 421(a) of the MMA, as
amended by section 3131 of the
Affordable Care Act, requires that the
Secretary increase, by 3 percent, the
payment amount otherwise made under
section 1895 of the Act, for HH services
furnished in a rural area (as defined in
section 1886(d)(2)(D) of the Act) with
respect to episodes and visits ending on
or after April 1, 2010, and before
January 1, 2016.
Section 210 of the Medicare Access
and CHIP Reauthorization Act of 2015
(Pub. L. 114–10) (MACRA) amended
section 421(a) of the MMA to extend the
3 percent rural add-on payment for
home health services provided in a rural
area (as defined in section 1886(d)(2)(D)
of the Act) through January 1, 2018. In
addition, section 411(d) of MACRA
amended section 1895(b)(3)(B) of the
Act such that CY 2018 home health
payments be updated by a 1 percent
market basket increase. This year,
section 50208(a)(1) of the BBA of 2018
again extended the rural add-on through
the end of 2018. In addition, this section
of the BBA of 2018 made some
important changes to the rural add-on
for CYs 2019 through 2022, to be
discussed below.

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b. Current System for Payment of Home
Health Services
Generally, Medicare currently makes
payment under the HH PPS on the basis
of a national, standardized 60-day
episode payment rate that is adjusted for
the applicable case-mix and wage index.
The national, standardized 60-day
episode rate includes the six home
health disciplines (skilled nursing,
home health aide, physical therapy,
speech-language pathology,
occupational therapy, and medical
social services). Payment for nonroutine supplies (NRS) is not part of the
national, standardized 60-day episode
rate, but is computed by multiplying the
relative weight for a particular NRS
severity level by the NRS conversion
factor. Payment for durable medical
equipment covered under the HH
benefit is made outside the HH PPS
payment system. To adjust for case-mix,
the HH PPS uses a 153-category casemix classification system to assign
patients to a home health resource
group (HHRG). The clinical severity
level, functional severity level, and
service utilization are computed from
responses to selected data elements in
the OASIS assessment instrument and
are used to place the patient in a
particular HHRG. Each HHRG has an
associated case-mix weight which is
used in calculating the payment for an
episode. Therapy service use is
measured by the number of therapy
visits provided during the episode and
can be categorized into nine visit level
categories (or thresholds): 0 to 5; 6; 7 to
9; 10; 11 to 13; 14 to 15; 16 to 17; 18
to 19; and 20 or more visits.
For episodes with four or fewer visits,
Medicare pays national per-visit rates
based on the discipline(s) providing the
services. An episode consisting of four
or fewer visits within a 60-day period
receives what is referred to as a lowutilization payment adjustment (LUPA).
Medicare also adjusts the national
standardized 60-day episode payment
rate for certain intervening events that
are subject to a partial episode payment
adjustment (PEP adjustment). For
certain cases that exceed a specific cost
threshold, an outlier adjustment may
also be available.
c. Updates to the Home Health
Prospective Payment System
As required by section 1895(b)(3)(B)
of the Act, we have historically updated
the HH PPS rates annually in the
Federal Register. The August 29, 2007
final rule with comment period set forth
an update to the 60-day national
episode rates and the national per-visit
rates under the HH PPS for CY 2008.

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The CY 2008 HH PPS final rule
included an analysis performed on CY
2005 home health claims data, which
indicated a 12.78 percent increase in the
observed case-mix since 2000. Case-mix
represents the variations in conditions
of the patient population served by the
HHAs. Subsequently, a more detailed
analysis was performed on the 2005
case-mix data to evaluate if any portion
of the 12.78 percent increase was
associated with a change in the actual
clinical condition of home health
patients. We identified 8.03 percent of
the total case-mix change as real, and
therefore, decreased the 12.78 percent of
total case-mix change by 8.03 percent to
get a final nominal case-mix increase
measure of 11.75 percent (0.1278 *
(1¥0.0803) = 0.1175).
To account for the changes in casemix that were not related to an
underlying change in patient health
status, we implemented a reduction,
over 4 years, to the national,
standardized 60-day episode payment
rates. That reduction was to be 2.75
percent per year for 3 years beginning in
CY 2008 and 2.71 percent for the fourth
year in CY 2011. In the CY 2011 HH PPS
final rule (76 FR 68532), we updated our
analyses of case-mix change and
finalized a reduction of 3.79 percent,
instead of 2.71 percent, for CY 2011 and
deferred finalizing a payment reduction
for CY 2012 until further study of the
case-mix change data and methodology
was completed.
In the CY 2012 HH PPS final rule (76
FR 68526), we updated the 60-day
national episode rates and the national
per-visit rates. In addition, as discussed
in the CY 2012 HH PPS final rule (76
FR 68528), our analysis indicated that
there was a 22.59 percent increase in
overall case-mix from 2000 to 2009 and
that only 15.76 percent of that overall
observed case-mix percentage increase
was due to real case-mix change. As a
result of our analysis, we identified a
19.03 percent nominal increase in casemix. At that time, to fully account for
the 19.03 percent nominal case-mix
growth identified from 2000 to 2009, we
finalized a 3.79 percent payment
reduction in CY 2012 and a 1.32 percent
payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77
FR 67078), we implemented the 1.32
percent reduction to the payment rates
for CY 2013 finalized the previous year,
to account for nominal case-mix growth
from 2000 through 2010. When taking
into account the total measure of casemix change (23.90 percent) and the
15.97 percent of total case-mix change
estimated as real from 2000 to 2010, we
obtained a final nominal case-mix
change measure of 20.08 percent from

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2000 to 2010 (0.2390 * (1 ¥ 0.1597) =
0.2008). To fully account for the
remainder of the 20.08 percent increase
in nominal case-mix beyond that which
was accounted for in previous payment
reductions, we estimated that the
percentage reduction to the national,
standardized 60-day episode rates for
nominal case-mix change would be 2.18
percent. Although we considered
proposing a 2.18 percent reduction to
account for the remaining increase in
measured nominal case-mix, we
finalized the 1.32 percent payment
reduction to the national, standardized
60-day episode rates in the CY 2012 HH
PPS final rule (76 FR 68532). Section
3131(a) of the Affordable Care Act
added new section 1895(b)(3)(A)(iii) to
the Act, which required that, beginning
in CY 2014, we apply an adjustment to
the national, standardized 60-day
episode rate and other amounts that
reflect factors such as changes in the
number of visits in an episode, the mix
of services in an episode, the level of
intensity of services in an episode, the
average cost of providing care per
episode, and other relevant factors.
Additionally, we were required to phase
in any adjustment over a 4-year period
in equal increments, not to exceed 3.5
percent of the payment amount (or
amounts) as of the date of enactment of
the Affordable Care Act in 2010, and
fully implement the rebasing
adjustments by CY 2017. Therefore, in
the CY 2014 HH PPS final rule (78 FR
72256) for each year, CY 2014 through
CY 2017, we finalized a fixed-dollar
reduction to the national, standardized
60-day episode payment rate of $80.95
per year, increases to the national pervisit payment rates per year, and a
decrease to the NRS conversion factor of
2.82 percent per year. We also finalized
three separate LUPA add-on factors for
skilled nursing, physical therapy, and
speech-language pathology and removed
170 diagnosis codes from assignment to
diagnosis groups in the HH PPS
Grouper. In the CY 2015 HH PPS final
rule (79 FR 66032), we implemented the
second year of the 4-year phase-in of the
rebasing adjustments to the HH PPS
payment rates and made changes to the
HH PPS case-mix weights. In addition,
we simplified the face-to-face encounter
regulatory requirements and the therapy
reassessment timeframes.
In the CY 2016 HH PPS final rule (80
FR 68624), we implemented the third
year of the 4-year phase-in of the
rebasing adjustments to the national,
standardized 60-day episode payment
amount, the national per-visit rates and
the NRS conversion factor (as discussed
previously). In the CY 2016 HH PPS

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final rule, we also recalibrated the HH
PPS case-mix weights, using the most
current cost and utilization data
available, in a budget-neutral manner
and finalized reductions to the national,
standardized 60-day episode payment
rate in CY 2016, CY 2017, and CY 2018
of 0.97 percent in each year to account
for estimated case-mix growth unrelated
to increases in patient acuity (that is,
nominal case-mix growth) between CY
2012 and CY 2014. Finally, section
421(a) of the MMA, as amended by
section 210 of the MACRA, extended
the payment increase of 3 percent for
HH services provided in rural areas (as
defined in section 1886(d)(2)(D) of the
Act) to episodes or visits ending before
January 1, 2018.
In the CY 2017 HH PPS final rule (81
FR 76702), we implemented the last
year of the 4-year phase-in of the
rebasing adjustments to the national,
standardized 60-day episode payment
amount, the national per-visit rates and
the NRS conversion factor (as outlined
previously). We also finalized changes
to the methodology used to calculate
outlier payments under the authority of
section 1895(b)(5) of the Act. Lastly, in
accordance with section 1834(s) of the
Act, as added by section 504(a) of the
Consolidated Appropriations Act, 2016
(Pub. L. 114–113, enacted December 18,
2015), we implemented changes in
payment for furnishing Negative
Pressure Wound Therapy (NPWT) using
a disposable device for patients under a
home health plan of care for which
payment would otherwise be made
under section 1895(b) of the Act.
2. Home Infusion Therapy
Section 5012 of the 21st Century
Cures Act (‘‘the Cures Act’’) (Pub. L.
114–255), which amended sections
1861(s)(2) and 1861(iii) of the Act,
established a new Medicare home
infusion therapy benefit. The Medicare
home infusion therapy benefit covers
the professional services including
nursing services furnished in
accordance with the plan of care,
patient training and education (not
otherwise covered under the durable
medical equipment benefit), remote
monitoring, and monitoring services for
the provision of home infusion therapy
and home infusion drugs furnished by
a qualified home infusion therapy
supplier. This benefit will ensure
consistency in coverage for home
infusion benefits for all Medicare
beneficiaries. Section 50401 of the BBA
of 2018 amended section 1834(u) of the
Act by adding a new paragraph (7) that
establishes a home infusion therapy
services temporary transitional payment
for eligible home infusion suppliers for

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certain items and services furnished in
coordination with the furnishing of
transitional home infusion drugs
beginning January 1, 2019. This
temporary payment covers the cost of
the same items and services, as defined
in section 1861(iii)(2)(A) and (B) of the
Act, related to the administration of
home infusion drugs. The temporary
transitional payment would begin on
January 1, 2019 and end the day before
the full implementation of the home
infusion therapy benefit on January 1,
2021, as required by section 5012 of the
21st Century Cures Act.
Home infusion therapy is a treatment
option for patients with a wide range of
acute and chronic conditions, ranging
from bacterial infections to more
complex conditions such as late-stage
heart failure and immune deficiencies.
Home infusion therapy affords a patient
independence and better quality of life,
because it is provided in the comfort of
the patient’s home at a time that best fits
his or her needs. This is significant,
because generally patients can return to
their daily activities after they receive
their infusion treatments and, in many
cases, they can continue their activities
while receiving their treatments. In
addition, home infusion therapy can
provide improved safety and better
outcomes. The home has been shown to
be a safe setting for patients to receive
infusion therapy.3 Additionally,
patients receiving treatment outside of
the hospital setting may be at lower risk
of hospital-acquired infections, which
can be more difficult to treat because of
multi-drug resistance than those that are
community-acquired. This is
particularly important for vulnerable
patients such as those who are
immunocompromised, as hospitalacquired infections are increasingly
caused by antibiotic-resistant pathogens.
Infusion therapy typically means that
a drug is administered intravenously,
but the term may also refer to situations
where drugs are provided through other
non-oral routes, such as intramuscular
injections and epidural routes (into the
membranes surrounding the spinal
cord). Diseases that may require
infusion therapy include infections that
are unresponsive to oral antibiotics,
cancer and cancer-related pain,
3 Bhole, M.V., Burton, J., & Chapel, H.M., (2008).
Self-infusion programs for immunoglobulin
replacement at home: Feasibility, safety and
efficacy. Immunology and Allergy Clinics of North
America, 28(4), 821–832. doi:10.1016/j.iac.2008.06.
005.
Souayah, N., Hasan, A., Khan, H., et al. (2011).
The safety profile of home infusion of intravenous
immunoglobulin in patients with
neuroimmunologic disorders. Journal of Clinical
Neuromuscular Disease, 12(supp 4), S1–10. doi:
10.1097/CND.0b013e3182212589.

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dehydration, and gastrointestinal
diseases or disorders which prevent
normal functioning of the
gastrointestinal system. Other
conditions treated with specialty
infusion therapies may include some
forms of cancers, congestive heart
failure, Crohn’s Disease, hemophilia,
hepatitis, immune deficiencies, multiple
sclerosis and rheumatoid arthritis.
Infusion therapy originates with a
prescription order from a physician or
another qualified prescriber who is
overseeing the care of the patient. The
prescription order is sent to a home
infusion therapy supplier, which is a
state-licensed pharmacy, physician, or
other provider of services or suppliers
licensed by the state.
A 2010 Government Accountability
Office (GAO) report (10–426) found that
most health insurers rely on
credentialing, accreditation, or both to
help ensure that plan members receive
quality home infusion services from
their network suppliers.4 Home infusion
AOs conduct on-site surveys to evaluate
all components of the service, including
medical equipment, nursing, and
pharmacy. Accreditation standards can
include such requirements as the CMS
Conditions of Participation for home
health services, other Federal
government regulations, and industry
best practices. All of the accreditation
standards evaluate a range of provider
competencies, such as having a
complete plan of care, response to
adverse events, and implementation of a
quality improvement plan.
Sections 1861(iii)(3)(D)(III) and
1834(u)(5) of the Act, as amended by
section 5012 of the Cures Act requires
that, in order to participate in Medicare,
home infusion therapy suppliers must
select a CMS-approved AO and undergo
an accreditation review process to
demonstrate that the home infusion
therapy program meets the accreditation
organization’s standards. Section
1861(iii) of the Act, as amended by
section 5012 of the Cures Act, sets forth
standards in three areas: (1) Ensuring
that all patients have a plan of care
established and updated by a physician
that sets out the care and prescribed
infusion therapy necessary to meet the
patient-specific needs, (2) having
procedures to ensure that remote
monitoring services associated with
administering infusion drugs in a
4 https://www.gao.gov/assets/310/305261.pdf.

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patient’s home are provided, and (3)
having procedures to ensure that
patients receive education and training
on the effective use of medications and
equipment in the home.
D. Advancing Health Information
Exchange
The Department of Health and Human
Services (HHS) has a number of
initiatives designed to encourage and
support the adoption of interoperable
health information technology and to
promote nationwide health information
exchange to improve health care. The
Office of the National Coordinator for
Health Information Technology (ONC)
and CMS work collaboratively to
advance interoperability across settings
of care, including post-acute care.
The Improving Medicare Post-Acute
Care Transformation Act of 2014 (Pub.
L. 113–185) (IMPACT Act) requires
assessment data to be standardized and
interoperable to allow for exchange of
the data among post-acute providers and
other providers. To further
interoperability in post-acute care, CMS
is developing a Data Element Library to
serve as a publically available
centralized, authoritative resource for
standardized data elements and their
associated mappings to health IT
standards. These interoperable data
elements can reduce provider burden by
allowing the use and reuse of healthcare
data, support provider exchange of
electronic health information for care
coordination, person-centered care, and
support real-time, data driven, clinical
decision making. Once available,
standards in the Data Element Library
can be referenced on the CMS website
and in the ONC Interoperability
Standards Advisory (ISA).
The 2018 Interoperability Standards
Advisory (ISA) is available at: https://
www.healthit.gov/standards-advisory.
Most recently, the 21st Century Cures
Act (Pub. L. 114–255), enacted in 2016,
requires HHS to take new steps to
enable the electronic sharing of health
information ensuring interoperability
for providers and settings across the
care continuum. Specifically, Congress
directed ONC to ‘‘develop or support a
trusted exchange framework, including
a common agreement among health
information networks nationally.’’ This
framework (https://beta.healthit.gov/
topic/interoperability/trusted-exchangeframework-and-common-agreement)
outlines a common set of principles for

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trusted exchange and minimum terms
and conditions for trusted exchange in
order to enable interoperability across
disparate health information networks.
In another important provision,
Congress defined ‘‘information
blocking’’ as practices likely to interfere
with, prevent, or materially discourage
access, exchange, or use of electronic
health information, and established new
authority for HHS to discourage these
practices. We invite providers to learn
more about these important
developments and how they are likely
to affect HHAs.
III. Proposed Provisions for Payment
Under the Home Health Prospective
Payment System (HH PPS)
A. Monitoring for Potential Impacts—
Affordable Care Act Rebasing
Adjustments
1. Analysis of FY 2016 HHA Cost Report
Data
As part of our efforts in monitoring
the potential impacts of the rebasing
adjustments finalized in the CY 2014
HH PPS final rule (78 FR 72293), we
continue to update our analysis of home
health cost report and claims data.
Previous years’ cost report and claims
data analyses and results can be found
in the CY 2018 HH PPS proposed rule
(82 FR 35277–35278). For this proposed
rule, we analyzed the 2016 HHA cost
report data (the most recent, complete
data available at the time of this
proposed rule) and 2016 HHA claims
data to obtain the average number of
visits per episode that match to the year
of cost report data analyzed. To
determine the 2016 average cost per
visit per discipline, we applied the same
trimming methodology outlined in the
CY 2014 HH PPS proposed rule (78 FR
40284) and weighted the costs per visit
from the 2016 cost reports by size,
facility type, and urban/rural location so
the costs per visit were nationally
representative according to 2016 claims
data. The 2016 average number of visits
was taken from 2016 claims data. We
estimated the cost of a 60-day episode
in CY 2016 to be $2,538.54 using 2016
cost report data (Table 2). However, the
national, standardized 60-day episode
payment amount in CY 2016 was
$2,965.12. The difference between the
60-day episode payment rate and
average cost per episode of care for CY
2016 was 16.8 percent.

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TABLE 2—2016 ESTIMATED COST PER EPISODE
2016 Average
costs per visit

2016 Average
NRS costs per
visit

2016 Average
cost + NRS
per visit

2016 Average
number of
visits

2016 60-Day
episode costs

Skilled Nursing .....................................................................
Physical Therapy .................................................................
Occupational Therapy ..........................................................
Speech Pathology ................................................................
Medical Social Services .......................................................
Home Health Aides ..............................................................

$132.83
156.04
153.53
170.06
219.73
60.50

$3.41
3.41
3.41
3.41
3.41
3.41

$136.24
159.45
156.94
173.47
223.14
63.91

8.81
5.58
1.56
0.32
0.14
1.83

$1,200.27
889.73
244.83
55.51
31.24
116.96

Total ..............................................................................

........................

........................

........................

18.24

2,538.54

Discipline

Source: Medicare cost reports pulled in March 2018 and Medicare claims data from 2015 and 2016 for episodes (excluding low-utilization payment adjusted episodes and partial-episode-payment adjusted episodes), linked to OASIS assessments for episodes ending in CY 2016.

2. Analysis of CY 2017 HHA Claims
Data
In the CY 2014 HH PPS final rule (78
FR 72256), some commenters expressed
concern that the rebasing of the HH PPS
payment rates would result in HHA
closures and would therefore diminish
access to home health services. In
addition to examining more recent cost
report data, for this proposed rule we
examined home health claims data from
all four years during which rebasing
adjustments were made (CY 2014, CY
2015, CY 2016, and CY 2017), the first
calendar year of the HH PPS (CY 2001),

and claims data for the year prior to the
implementation of the rebasing
adjustments (CY 2013). Preliminary
analysis of CY 2017 home health claims
data indicates that the number of
episodes decreased by 5.3 percent and
the number of home health users that
received at least one episode of care
decreased by 3.2 percent from 2016 to
2017, while the number of FFS
beneficiaries decreased 0.1 percent from
2016 to 2017. Between 2013 and 2014
there appears to be a net decrease in the
number of HHAs billing Medicare for
home health services of 1.6 percent, a
continued decrease of 1.7 percent from

2014 to 2015, a decrease of 3.4 percent
from 2015 to 2016, and a decrease of 4.4
percent from 2016 to 2017. We note that
in CY 2016 there were 2.9 HHAs per
10,000 FFS beneficiaries and 2.8 HHAs
per 10,000 FFS beneficiaries in CY
2017, which remains markedly higher
than the 1.9 HHAs per 10,000 FFS
beneficiaries close to the inception of
the HH PPS in 2001 (the HH PPS was
implemented on October 1, 2000). The
number of home health users, as a
percentage of FFS beneficiaries, has
decreased from 9.0 percent in 2013 to
8.4 percent in 2017.

TABLE 3—HOME HEALTH STATISTICS, CY 2001 AND CY 2013 THROUGH CY 2017

Number of episodes .................................
Beneficiaries receiving at least 1 episode
(Home Health Users) ...........................
Part A and/or B FFS beneficiaries ...........
Episodes per Part A and/or B FFS beneficiaries .................................................
Home health users as a percentage of
Part A and/or B FFS beneficiaries .......
HHAs providing at least 1 episode ..........
HHAs per 10,000 Part A and/or B FFS
beneficiaries .........................................

2001

2013

2014

2015

2016

2017

3,896,502

6,708,923

6,451,283

6,340,932

6,294,234

5,963,780

2,412,318
34,899,167

3,484,579
38,505,609

3,381,635
38,506,534

3,365,512
38,506,534

3,350,174
38,555,150

3,242,346
38,509,031

0.11

0.17

0.17

0.17

0.16

0.15

6.9%
6,511

9.0%
11,889

8.8%
11,693

8.8%
11,381

8.7%
11,102

8.4%
10,612

1.9

3.1

3.0

3.0

2.9

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Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)—Accessed on May 14, 2014 and August 19,
2014 for CY 2013 data; accessed on May 7, 2015 for CY 2001 and CY 2014 data; accessed on April 7, 2016 for CY 2015 data; accessed on
March 20, 2017 for CY 2016 data; accessed on March 8, 2018 for CY 2017 data; and Medicare enrollment information obtained from the CCW
Master Beneficiary Summary File. Beneficiaries are the total number of beneficiaries in a given year with at least 1 month of Part A and/or Part B
Fee-for-Service coverage without having any months of Medicare Advantage coverage.
Note(s): These results include all episode types (Normal, PEP, Outlier, LUPA) and also include episodes from outlying areas (outside of 50
States and District of Columbia). Only episodes with a through date in the year specified are included. Episodes with a claim frequency code
equal to ‘‘0’’ (‘‘Non-payment/zero claims’’) and ‘‘2’’ (‘‘Interim—first claim’’) are excluded. If a beneficiary is treated by providers from multiple
states within a year the beneficiary is counted within each state’s unique number of beneficiaries served.

In addition to examining home health
claims data from all four years of the
implementation of rebasing adjustments
required by the Affordable Care Act, we
examined trends in home health
utilization for all years starting in CY
2001 and up through CY 2017. Figure 1,
displays the average number of visits
per 60-day episode of care and the

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average payment per visit. While the
average payment per visit has steadily
increased from approximately $116 in
CY 2001 to $170 for CY 2017, the
average total number of visits per 60-day
episode of care has declined, most
notably between CY 2009 (21.7 visits
per episode) and CY 2010 (19.8 visits
per episode), which was the first year

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that the 10 percent agency-level cap on
HHA outlier payments was
implemented. The average of total visits
per episode has steadily decreased from
21.7 in 2009 to 17.9 in 2017.
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Figure 2 displays the average number
of visits by discipline type for a 60-day
episode of care and shows that while
the number of therapy visits per 60-day
episode of care has increased steadily,
the number of skilled nursing and home
health aide visits have decreased
between CY 2009 and CY 2017. The
results of the Report to Congress,
‘‘Medicare Home Health Study: An
Investigation on Access to Care and

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Payment for Vulnerable Patient
Populations’’, required by section
3131(d) of the Affordable Care Act,
suggests that the current home health
payment system may discourage HHAs
from serving patients with clinically
complex and/or poorly controlled
chronic conditions who do not qualify
for therapy but require a large number
of skilled nursing visits.5 The home
5 Report to Congress Medicare Home Health
Study: An Investigation on Access to Care and

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health study results seem to be
consistent with the recent trend in the
decreased number of visits per episode
of care driven by decreases in skilled
nursing and home health aide services
evident in Figures 1 and 2.

Payment for Vulnerable Patient Populations (2014).
Available at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HomeHealthPPS/Downloads/HH-Report-toCongress.pdf.

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As part of our monitoring efforts, we
also examined the trends in episode
timing and service use over time.
Specifically, we examined the
percentage of early episodes with 0 to
19 therapy visits, late episodes with 0 to
19 therapy visits, and episodes with 20+
therapy visits from CY 2008 to CY 2017.
In CY 2008, we implemented
refinements to the HH PPS case-mix
system. As part of those refinements, we
added additional therapy thresholds
and differentiated between early and
late episodes for those episodes with
less than 20+ therapy visits. Early
episodes are defined as the 1st or 2nd
episode in a sequence of adjacent

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covered episodes. Late episodes are
defined as the 3rd and subsequent
episodes in a sequence of adjacent
covered episodes. Table 4 shows that
the percentage of early and late episodes
from CY 2008 to CY 2017 has remained
relatively stable over time. There has
been a decrease in the percentage of
early episodes with 0 to 19 therapy
visits from 65.9 percent in CY 2008 to
61.3 percent in CY 2017 and a slight
increase in the percentage of late
episodes with 0 to 19 therapy visits
from 29.5 percent in CY 2008 to 31.2
percent in CY 2017. In 2015, the casemix weights for the third and later
episodes of care with 0 to 19 therapy

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32351

visits decreased as a result of the CY
2015 recalibration of the case-mix
weights. Despite the decreases in the
case-mix weights for the later episodes,
the percentage of late episodes with 0 to
19 therapy visits did not change
substantially. However, episode timing
is not a variable in the determination of
the case-mix weights for those episodes
with 20+ therapy visits and the
percentage of episodes with 20+ therapy
visits has increased from 4.6 percent in
CY 2008 to 7.6 percent in CY 2017.

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TABLE 4—HOME HEALTH EPISODES BY EPISODE TIMING, CY 2008 THROUGH CY 2017

Year

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017

All episodes

.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................

Number of
early episodes
(excluding
episodes with
20+ visits)

5,423,037
6,530,200
6,877,598
6,857,885
6,767,576
6,733,146
6,616,875
6,644,922
6,294,232
5,963,778

% of early
episodes
(excluding
episodes with
20+ visits)

3,571,619
3,701,652
3,872,504
3,912,982
3,955,207
4,023,486
3,980,151
4,008,279
3,802,254
3,655,636

Number of
late episodes
(excluding
episodes with
20+ visits)

65.9
56.7
56.3
57.1
58.4
59.8
60.2
60.3
60.4
61.3

% of late
episodes
(excluding
episodes
with
20+ visits)

1,600,587
2,456,308
2,586,493
2,564,859
2,458,734
2,347,420
2,263,638
2,205,052
2,053,972
1,857,840

29.5
37.6
37.6
37.4
36.3
34.9
34.2
33.2
32.6
31.2

Number of
episodes with
20+ visits

250,831
372,240
418,601
380,044
353,635
362,240
373,086
431,591
438,006
450,302

% of episodes
with
20+ visits

4.6
5.7
6.1
5.5
5.2
5.4
5.6
6.5
7.0
7.6

Source: National claims history (NCH) data obtained from Chronic Condition Warehouse (CCW)—Accessed on March 6, 2018.
Note(s): Only episodes with a through date in the year specified are included. Episodes with a claim frequency code equal to ‘‘0’’ (‘‘Non-payment/zero claims’’) and ‘‘2’’ (‘‘Interim—first claim’’) are excluded.

amozie on DSK3GDR082PROD with PROPOSALS2

We also examined trends in
admission source for home health
episodes over time. Specifically, we
examined the admission source for the
‘‘first or only’’ episodes of care (first
episodes in a sequence of adjacent
episodes of care or the only episode of
care) from CY 2008 through CY 2017
(Figure 3). The percentage of first or
only episodes with an acute admission
source, defined as episodes with an
inpatient hospital stay within the 14
days prior to a home health episode, has
decreased from 38.6 percent in CY 2008
to 34.8 percent in CY 2017. The
percentage of first or only episodes with
a post-acute admission source, defined
as episodes which had a stay at a skilled
nursing facility (SNF), inpatient
rehabilitation facility (IRF), or long term
care hospital (LTCH) within 14 days

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prior to the home health episode, has
slightly increased from 16.4 percent in
CY 2008 to 17.6 percent in CY 2017.
The percentage of first or only episodes
with a community admission source,
defined as episodes which did not have
an acute or post-acute stay in the 14
days prior to the home health episode,
increased from 37.4 percent in CY 2008
to 41.5 percent in CY 2017. Our findings
on the trends in admission source show
a similar pattern with MedPAC’s as
outlined in their 2015 Report to the
Congress.6 MedPAC concluded that
6 Medicare Payment Advisory Commission
(MedPAC). ‘‘Home Health Care Services.’’ Report to
the Congress: Medicare Payment Policy.
Washington, DC, March 2015. P. 214. Accessed on
3/28/2017 at: http://www.medpac.gov/docs/defaultsource/reports/chapter-9-home-health-careservices-march-2015-report-.pdf?sfvrsn=0.

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there has been tremendous growth in
the use of home health for patients
residing in the community (that is,
episodes not preceded by a prior
hospitalization) and that these episodes
have more than doubled since 2001.
However, MedPAC examined admission
source trends from 2002 up through
2013 and included first and subsequent
episodes of care, whereas CMS analysis,
as described above, included ‘‘first or
only’’ episodes of care. Nonetheless,
both analyses show a trend of increasing
episodes of care without a preceding
inpatient stay. MedPAC suggests there is
significant potential for overuse,
particularly since Medicare does not
currently require any cost sharing for
home health care.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

amozie on DSK3GDR082PROD with PROPOSALS2

B. Proposed CY 2019 HH PPS Case-Mix
Weights
In the CY 2015 HH PPS final rule (79
FR 66072), we finalized a policy to
annually recalibrate the HH PPS casemix weights—adjusting the weights
relative to one another—using the most
current, complete data available. To
recalibrate the HH PPS case-mix weights
for CY 2018, we will use the same
methodology finalized in the CY 2008
HH PPS final rule (72 FR 49762), the CY

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2012 HH PPS final rule (76 FR 68526),
and the CY 2015 HH PPS final rule (79
FR 66032). Annual recalibration of the
HH PPS case-mix weights ensures that
the case-mix weights reflect, as
accurately as possible, current home
health resource use and changes in
utilization patterns.
To generate the proposed CY 2019 HH
PPS case-mix weights, we used CY 2017
home health claims data (as of March 2,
2018) with linked OASIS data. These
data are the most current and complete
data available at this time. We will use
CY 2017 home health claims data (as of
June 30, 2018 or later) with linked
OASIS data to generate the CY 2019 HH
PPS case-mix weights in the CY 2019
HH PPS final rule. The process we used
to calculate the HH PPS case-mix
weights are outlined below.

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Step 1: Re-estimate the four-equation
model to determine the clinical and
functional points for an episode using
wage-weighted minutes of care as our
dependent variable for resource use.
The wage-weighted minutes of care are
determined using the CY 2016 Bureau of
Labor Statistics national hourly wage
plus fringe rates for the six home health
disciplines and the minutes per visit
from the claim. The points for each of
the variables for each leg of the model,
updated with CY 2017 home health
claims data, are shown in Table 5. The
points for the clinical variables are
added together to determine an
episode’s clinical score. The points for
the functional variables are added
together to determine an episode’s
functional score.
BILLING CODE 4120–01–P

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EP12JY18.002

We will continue to monitor for
potential impacts due to the rebasing
adjustments required by section 3131(a)
of the Affordable Care Act and other
policy changes in the future.
Independent effects of any one policy
may be difficult to discern in years
where multiple policy changes occur in
any given year.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

TABLE 5: CASE-MIX ADJUSTMENT VARIABLES AND SCORES

EQUATION:

1
2
3
4
5
6

7
8
9

10

11
12
13

14
15
16

amozie on DSK3GDR082PROD with PROPOSALS2

17

18

CLINICAL DIMENSION
Primary or Other Diagnosis = Blindness/Low Vision
Primary or Other Diagnosis = Blood disorders
Primary or Other Diagnosis = Cancer, selected benign neoplasms
Primary Diagnosis = Diabetes
Other Diagnosis = Diabetes
Primary or Other Diagnosis = Dysphagia
AND
Primary or Other Diagnosis= Neuro 3- Stroke
Primary or Other Diagnosis = Dysphagia
AND
M1030 (Therapy at home)= 3 (Enteral)
Primary or Other Diagnosis = Gastrointestinal disorders
Primary or Other Diagnosis = Gastrointestinal disorders
AND
M1630 (ostomy)= 1 or 2
Primary or Other Diagnosis = Gastrointestinal disorders
AND
Primary or Other Diagnosis = Neuro 1 -Brain disorders and paralysis,
OR Neuro 2 - Peripheral neurological disorders, OR Neuro 3 - Stroke,
OR Neuro 4- Multiple Sclerosis
Primary or Other Diagnosis= Heart Disease OR Hypertension
Primary Diagnosis = Neuro 1 -Brain disorders and paralysis
Primary or Other Diagnosis = Neuro 1 -Brain disorders and paralysis
AND
M1840 (Toilet transfer)= 2 or more
Primary or Other Diagnosis = Neuro 1 -Brain disorders and paralysis
OR Neuro 2 - Peripheral neurological disorders
AND
M1810 or M1820 (Dressing upper or lower body)= 1, 2, or 3
Primary or Other Diagnosis= Neuro 3- Stroke
Primary or Other Diagnosis= Neuro 3- Stroke
AND
Ml810 or Ml820 (Dressing upper or lower body)= 1, 2, or 3
Primary or Other Diagnosis= Neuro 3- Stroke
AND
M1860 (Ambulation) = 4 or more
Primary or Other Diagnosis= Neuro 4 -Multiple Sclerosis AND AT
LEAST ONE OF THE FOLLOWING:
M1830 (Bathing)= 2 or more
OR
M1840 (Toilet transfer)= 2 or more
OR
M1850 (Transferring) = 2 or more

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1 or 2
0-13

1 or 2
14+

3+
0-13

3+
14+

1

2

3

4

2

2
4
2

4
2

15

15

5

5

1

2

5

2
2

3
7

4

2
7

3

2

3

5

2

3

6

2

3

2

12JYP2

7

3

7

EP12JY18.014

Episode number within sequence of adjacent episodes
Therapy visits

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20

21
22
23
24
25
26

27

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28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49

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7

2

7

2

3

1
2

14

6

14

5

11

7

11

1
1

14
10
17
10
13

7

14
10
10
10
7

1
3
2
3
5
3
5
2
1
2

1
6
1
2

12JYP2

4
16
27
12
15
6
5
1
4
9

1

2
2
6
8
5
7
4
4

15
22
12
15
11
8

2

3
7

2
4

5

1

2

EP12JY18.015

19

OR
Ml860 (Ambulation) = 4 or more
Primary or Other Diagnosis = Ortho 1 - Leg Disorders or Gait Disorders
AND
Ml324 (most problematic pressure ulcer stage)= 1, 2, 3 or 4
Primary or Other Diagnosis= Ortho 1 -Leg OR Ortho 2- Other
orthopedic disorders
AND
Ml 030 (Therapy at home) = 1 (IV/Infusion) or 2 (Parenteral)
Primary or Other Diagnosis = Psych 1 - Affective and other psychoses,
depression
Primary or Other Diagnosis = Psych 2 - Degenerative and other organic
psychiatric disorders
Primary or Other Diagnosis = Pulmonary disorders
Primary or Other Diagnosis = Pulmonary disorders AND
Ml860 (Ambulation) = 1 or more
Primary Diagnosis= Skin 1 -Traumatic wounds, bums, and postoperative complications
Other Diagnosis= Skin 1 -Traumatic wounds, bums, post-operative
complications
Primary or Other Diagnosis = Skin 1 -Traumatic wounds, bums, and
post-operative complications OR Skin 2 - Ulcers and other skin
conditions
AND
Ml 030 (Therapy at home) = 1 (IV/Infusion) or 2 (Parenteral)
Primary or Other Diagnosis = Skin 2 - Ulcers and other skin conditions
Primary or Other Diagnosis = Tracheostomy
Primary or Other Diagnosis= Urostomy/Cystostomy
Ml 030 (Therapy at home) = 1 (IV/Infusion) or 2 (Parenteral)
Ml030 (Therapy at home)= 3 (Enteral)
Ml200 (Vision)= 1 or more
Ml242 (Pain)= 3 or 4
Ml308 = Two or more pressure ulcers at stage 3 or 4
Ml324 (Most problematic pressure ulcer stage)= 1 or 2
Ml324 (Most problematic pressure ulcer stage)= 3 or 4
Ml334 (Stasis ulcer status)= 2
Ml334 (Stasis ulcer status)= 3
Ml342 (Surgical wound status)= 2
Ml342 (Surgical wound status)= 3
Ml400 (Dyspnea)= 2, 3, or 4
Ml620 (Bowel Incontinence)= 2 to 5
Ml630 (Ostomy)= 1 or 2
M2030 (Injectable Drug Use)= 0, 1, 2, or 3
FUNCTIONAL DIMENSION
Ml810 or Ml820 (Dressing upper orlower body)= 1, 2, or 3
Ml830 (Bathing)= 2 or more
Ml840 (Toilet transferring)= 2 or more
Ml850 (Transferring)= 2 or more

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BILLING CODE 4120–01–C

In updating the four-equation model
for CY 2019, using 2017 home health
claims data (the last update to the fourequation model for CY 2018 used CY
2016 home health claims data), there
were few changes to the point values for
the variables in the four-equation
model. These relatively minor changes
reflect the change in the relationship
between the grouper variables and
resource use between CY 2016 and CY
2017. The CY 2019 four-equation model
resulted in 113 point-giving variables
being used in the model (as compared
to the 119 variables for the CY 2018
recalibration, which can be found in
Table 2 of the CY 2018 HH PPS final
rule (82 FR 51684)). There were 7
variables that were added to the model
and 13 variables that were dropped from
the model due to the absence of
additional resources associated with the
variable. Of the variables that were in
both the four-equation model for CY
2019 and the four-equation model for

CY 2018, the points for 10 variables
increased in the CY 2019 four-equation
model and the points for 67 variables
decreased in the CY 2019 4-equation
model. There were 29 variables with the
same point values.
Step 2: Re-defining the clinical and
functional thresholds so they are
reflective of the new points associated
with the CY 2019 four-equation model.
After estimating the points for each of
the variables and summing the clinical
and functional points for each episode,
we look at the distribution of the
clinical score and functional score,
breaking the episodes into different
steps. The categorizations for the steps
are as follows:
• Step 1: First and second episodes,
0–13 therapy visits.
• Step 2.1: First and second episodes,
14–19 therapy visits.
• Step 2.2: Third episodes and
beyond, 14–19 therapy visits.
• Step 3: Third episodes and beyond,
0–13 therapy visits.

• Step 4: Episodes with 20+ therapy
visits.
We then divide the distribution of the
clinical score for episodes within a step
such that a third of episodes are
classified as low clinical score, a third
of episodes are classified as medium
clinical score, and a third of episodes
are classified as high clinical score. The
same approach is then done looking at
the functional score. It was not always
possible to evenly divide the episodes
within each step into thirds due to
many episodes being clustered around
one particular score.7 Also, we looked at
the average resource use associated with
each clinical and functional score and
used that as a guide for setting our
thresholds. We grouped scores with
similar average resource use within the
same level (even if it meant that more
or less than a third of episodes were
placed within a level). The new
thresholds, based off the CY 2019 fourequation model points are shown in
Table 6.

TABLE 6—PROPOSED CY 2019 CLINICAL AND FUNCTIONAL THRESHOLDS
All Episodes

0 to 13
therapy visits

14 to 19
therapy visits

0 to 13
therapy visits

14 to 19
therapy visits

20+ therapy
visits

Grouping Step

1

2

3

4

5

Equations used to calculate points
(see Table 2)

1

2

3

4

(2&4)

...........................

...........................

...........................

...........................

...........................

0 to 1 ................
2 to 3 ................
4+ .....................
0 to 12 ..............
13 .....................
14+ ...................

0 to 1 ................
2 to 7 ................
8+ .....................
0 to 7 ................
8 to 12 ..............
13+ ...................

0 to 1 ................
2 .......................
3+ .....................
0 to 6 ................
7 to 10 ..............
11+ ...................

0 to 1 ................
2 to 9 ................
10+ ...................
0 to 2 ................
3 to 7 ................
8+ .....................

0 to 3.
4 to 16.
17+.
0 to 2.
3 to 6.
7+.

Dimension

Severity
Level

Clinical .............................................
Functional ........................................

amozie on DSK3GDR082PROD with PROPOSALS2

3rd+ Episodes

C1
C2
C3
F1
F2
F3

............
............
............
............
............
............

Step 3: Once the clinical and
functional thresholds are determined
and each episode is assigned a clinical
and functional level, the payment
regression is estimated with an
episode’s wage-weighted minutes of

care as the dependent variable.
Independent variables in the model are
indicators for the step of the episode as
well as the clinical and functional levels
within each step of the episode. Like the
four-equation model, the payment

regression model is also estimated with
robust standard errors that are clustered
at the beneficiary level. Table 7 shows
the regression coefficients for the
variables in the payment regression
model updated with CY 2017 home

7 For Step 1, 41% of episodes were in the medium
functional level (All with score 13).
For Step 2.1, 86.7% of episodes were in the low
functional level (Most with scores 6 to 7).

For Step 2.2, 81.5% of episodes were in the low
functional level (Most with score 0).
For Step 3, 46.7% of episodes were in the
medium functional level (Most with score 9).

For Step 4, 29.9% of episodes were in the
medium functional level (Most with score 6).

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1st and 2nd Episodes

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
health claims data. The R-squared value
for the payment regression model is

32357

0.5508 (an increase from 0.5095 for the
CY 2018 recalibration).

TABLE 7—PAYMENT REGRESSION MODEL
Payment
regression
from
4-equation
model for
CY 2019
Step 1, Clinical Score Medium ............................................................................................................................................................
Step 1, Clinical Score High .................................................................................................................................................................
Step 1, Functional Score Medium .......................................................................................................................................................
Step 1, Functional Score High ............................................................................................................................................................
Step 2.1, Clinical Score Medium .........................................................................................................................................................
Step 2.1, Clinical Score High ..............................................................................................................................................................
Step 2.1, Functional Score Medium ....................................................................................................................................................
Step 2.1, Functional Score High .........................................................................................................................................................
Step 2.2, Clinical Score Medium .........................................................................................................................................................
Step 2.2, Clinical Score High ..............................................................................................................................................................
Step 2.2, Functional Score Medium ....................................................................................................................................................
Step 2.2, Functional Score High .........................................................................................................................................................
Step 3, Clinical Score Medium ............................................................................................................................................................
Step 3, Clinical Score High .................................................................................................................................................................
Step 3, Functional Score Medium .......................................................................................................................................................
Step 3, Functional Score High ............................................................................................................................................................
Step 4, Clinical Score Medium ............................................................................................................................................................
Step 4, Clinical Score High .................................................................................................................................................................
Step 4, Functional Score Medium .......................................................................................................................................................
Step 4, Functional Score High ............................................................................................................................................................
Step 2.1, 1st and 2nd Episodes, 14 to 19 Therapy Visits ..................................................................................................................
Step 2.2, 3rd+ Episodes, 14 to 19 Therapy Visits ..............................................................................................................................
Step 3, 3rd+ Episodes, 0–13 Therapy Visits ......................................................................................................................................
Step 4, All Episodes, 20+ Therapy Visits ............................................................................................................................................
Intercept ...............................................................................................................................................................................................

$21.81
54.06
70.54
99.78
50.90
118.77
25.36
31.96
48.03
187.73
50.06
0.00
18.05
83.67
56.10
81.90
70.97
245.97
4.60
17.77
515.04
510.26
¥60.34
895.79
375.32

amozie on DSK3GDR082PROD with PROPOSALS2

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018) for which we had a linked
OASIS assessment.

Step 4: We use the coefficients from
the payment regression model to predict
each episode’s wage-weighted minutes
of care (resource use). We then divide
these predicted values by the mean of
the dependent variable (that is, the
average wage-weighted minutes of care
across all episodes used in the payment
regression). This division constructs the
weight for each episode, which is
simply the ratio of the episode’s
predicted wage-weighted minutes of
care divided by the average wageweighted minutes of care in the sample.
Each episode is then aggregated into one
of the 153 home health resource groups
(HHRGs) and the ‘‘raw’’ weight for each
HHRG was calculated as the average of
the episode weights within the HHRG.
Step 5: The raw weights associated
with 0 to 5 therapy visits are then
increased by 3.75 percent, the weights
associated with 14–15 therapy visits are
decreased by 2.5 percent, and the
weights associated with 20+ therapy

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visits are decreased by 5 percent. These
adjustments to the case-mix weights
were finalized in the CY 2012 HH PPS
final rule (76 FR 68557) and were done
to address MedPAC’s concerns that the
HH PPS overvalues therapy episodes
and undervalues non-therapy episodes
and to better align the case-mix weights
with episode costs estimated from cost
report data.8
Step 6: After the adjustments in step
5 are applied to the raw weights, the
weights are further adjusted to create an
increase in the payment weights for the
therapy visit steps between the therapy
thresholds. Weights with the same
clinical severity level, functional
severity level, and early/later episode
status were grouped together. Then
within those groups, the weights for
each therapy step between thresholds
are gradually increased. We do this by
Payment Advisory Commission
(MedPAC), Report to the Congress: Medicare
Payment Policy. March 2011, P. 176.

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interpolating between the main
thresholds on the model (from 0–5 to
14–15 therapy visits, and from 14–15 to
20+ therapy visits). We use a linear
model to implement the interpolation so
the payment weight increase for each
step between the thresholds (such as the
increase between 0–5 therapy visits and
6 therapy visits and the increase
between 6 therapy visits and 7–9
therapy visits) are constant. This
interpolation is identical to the process
finalized in the CY 2012 HH PPS final
rule (76 FR 68555).
Step 7: The interpolated weights are
then adjusted so that the average casemix for the weights is equal to 1.0000.9
This last step creates the proposed CY
2019 case-mix weights shown in Table
8.
9 When computing the average, we compute a
weighted average, assigning a value of one to each
normal episode and a value equal to the episode
length divided by 60 for PEPs.

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TABLE 8—PROPOSED CY 2019 CASE-MIX PAYMENT WEIGHTS

amozie on DSK3GDR082PROD with PROPOSALS2

Pay group

10111
10112
10113
10114
10115
10121
10122
10123
10124
10125
10131
10132
10133
10134
10135
10211
10212
10213
10214
10215
10221
10222
10223
10224
10225
10231
10232
10233
10234
10235
10311
10312
10313
10314
10315
10321
10322
10323
10324
10325
10331
10332
10333
10334
10335
21111
21112
21113
21121
21122
21123
21131
21132
21133
21211
21212
21213
21221
21222
21223
21231
21232
21233
21311
21312
21313
21321
21322

............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............

VerDate Sep<11>2014

Clinical and
functional
levels
(1 = low;
2 = medium;
3 = high)

Description

1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st
1st

and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and
and

2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd
2nd

Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,
Episodes,

17:39 Jul 11, 2018

0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
0 to 5 Therapy Visits ...............................................................................
6 Therapy Visits ......................................................................................
7 to 9 Therapy Visits ...............................................................................
10 Therapy Visits ....................................................................................
11 to 13 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................
18 to 19 Therapy Visits ...........................................................................
14 to 15 Therapy Visits ...........................................................................
16 to 17 Therapy Visits ...........................................................................

Jkt 244001

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E:\FR\FM\12JYP2.SGM

12JYP2

C1F1S1
C1F1S2
C1F1S3
C1F1S4
C1F1S5
C1F2S1
C1F2S2
C1F2S3
C1F2S4
C1F2S5
C1F3S1
C1F3S2
C1F3S3
C1F3S4
C1F3S5
C2F1S1
C2F1S2
C2F1S3
C2F1S4
C2F1S5
C2F2S1
C2F2S2
C2F2S3
C2F2S4
C2F2S5
C2F3S1
C2F3S2
C2F3S3
C2F3S4
C2F3S5
C3F1S1
C3F1S2
C3F1S3
C3F1S4
C3F1S5
C3F2S1
C3F2S2
C3F2S3
C3F2S4
C3F2S5
C3F3S1
C3F3S2
C3F3S3
C3F3S4
C3F3S5
C1F1S1
C1F1S2
C1F1S3
C1F2S1
C1F2S2
C1F2S3
C1F3S1
C1F3S2
C1F3S3
C2F1S1
C2F1S2
C2F1S3
C2F2S1
C2F2S2
C2F2S3
C2F3S1
C2F3S2
C2F3S3
C3F1S1
C3F1S2
C3F1S3
C3F2S1
C3F2S2

Proposed
weights for
CY 2019

0.5459
0.6801
0.8143
0.9485
1.0828
0.6485
0.7691
0.8897
1.0104
1.1310
0.6910
0.8049
0.9189
1.0328
1.1467
0.5776
0.7194
0.8612
1.0030
1.1448
0.6802
0.8084
0.9366
1.0648
1.1930
0.7227
0.8442
0.9657
1.0872
1.2087
0.6245
0.7755
0.9264
1.0774
1.2284
0.7271
0.8645
1.0019
1.1392
1.2766
0.7696
0.9003
1.0310
1.1617
1.2923
1.2170
1.3756
1.5342
1.2516
1.4008
1.5499
1.2607
1.4126
1.5646
1.2866
1.4535
1.6204
1.3212
1.4786
1.6361
1.3302
1.4905
1.6508
1.3793
1.5930
1.8067
1.4140
1.6182

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

32359

TABLE 8—PROPOSED CY 2019 CASE-MIX PAYMENT WEIGHTS—Continued

amozie on DSK3GDR082PROD with PROPOSALS2

Pay group

21323
21331
21332
21333
22111
22112
22113
22121
22122
22123
22131
22132
22133
22211
22212
22213
22221
22222
22223
22231
22232
22233
22311
22312
22313
22321
22322
22323
22331
22332
22333
30111
30112
30113
30114
30115
30121
30122
30123
30124
30125
30131
30132
30133
30134
30135
30211
30212
30213
30214
30215
30221
30222
30223
30224
30225
30231
30232
30233
30234
30235
30311
30312
30313
30314
30315
30321
30322

............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............

VerDate Sep<11>2014

Clinical and
functional
levels
(1 = low;
2 = medium;
3 = high)

Description

1st and 2nd Episodes, 18 to 19 Therapy Visits ...........................................................................
1st and 2nd Episodes, 14 to 15 Therapy Visits ...........................................................................
1st and 2nd Episodes, 16 to 17 Therapy Visits ...........................................................................
1st and 2nd Episodes, 18 to 19 Therapy Visits ...........................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 14 to 15 Therapy Visits .......................................................................................
3rd+ Episodes, 16 to 17 Therapy Visits .......................................................................................
3rd+ Episodes, 18 to 19 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................

17:39 Jul 11, 2018

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12JYP2

C3F2S3
C3F3S1
C3F3S2
C3F3S3
C1F1S1
C1F1S2
C1F1S3
C1F2S1
C1F2S2
C1F2S3
C1F3S1
C1F3S2
C1F3S3
C2F1S1
C2F1S2
C2F1S3
C2F2S1
C2F2S2
C2F2S3
C2F3S1
C2F3S2
C2F3S3
C3F1S1
C3F1S2
C3F1S3
C3F2S1
C3F2S2
C3F2S3
C3F3S1
C3F3S2
C3F3S3
C1F1S1
C1F1S2
C1F1S3
C1F1S4
C1F1S5
C1F2S1
C1F2S2
C1F2S3
C1F2S4
C1F2S5
C1F3S1
C1F3S2
C1F3S3
C1F3S4
C1F3S5
C2F1S1
C2F1S2
C2F1S3
C2F1S4
C2F1S5
C2F2S1
C2F2S2
C2F2S3
C2F2S4
C2F2S5
C2F3S1
C2F3S2
C2F3S3
C2F3S4
C2F3S5
C3F1S1
C3F1S2
C3F1S3
C3F1S4
C3F1S5
C3F2S1
C3F2S2

Proposed
weights for
CY 2019

1.8224
1.4230
1.6300
1.8371
1.2104
1.3713
1.5321
1.2789
1.4189
1.5589
1.2789
1.4248
1.5706
1.2761
1.4465
1.6169
1.3445
1.4942
1.6438
1.3445
1.5000
1.6555
1.4670
1.6515
1.8360
1.5355
1.6992
1.8629
1.5355
1.7050
1.8746
0.4581
0.6086
0.7591
0.9095
1.0600
0.5397
0.6876
0.8354
0.9832
1.1310
0.5772
0.7176
0.8579
0.9982
1.1385
0.4844
0.6427
0.8011
0.9594
1.1178
0.5660
0.7217
0.8774
1.0331
1.1888
0.6035
0.7517
0.8999
1.0481
1.1963
0.5798
0.7573
0.9347
1.1122
1.2896
0.6614
0.8362

32360

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 8—PROPOSED CY 2019 CASE-MIX PAYMENT WEIGHTS—Continued

Pay group

30323
30324
30325
30331
30332
30333
30334
30335
40111
40121
40131
40211
40221
40231
40311
40321
40331

Description

............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............
............

3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
3rd+ Episodes, 0 to 5 Therapy Visits ...........................................................................................
3rd+ Episodes, 6 Therapy Visits ..................................................................................................
3rd+ Episodes, 7 to 9 Therapy Visits ...........................................................................................
3rd+ Episodes, 10 Therapy Visits ................................................................................................
3rd+ Episodes, 11 to 13 Therapy Visits .......................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................
All Episodes, 20+ Therapy Visits .................................................................................................

To ensure the changes to the HH PPS
case-mix weights are implemented in a
budget neutral manner, we then apply a
case-mix budget neutrality factor to the
proposed CY 2019 national,
standardized 60-day episode payment
rate (see section III.C.3. of this proposed
rule). The case-mix budget neutrality
factor is calculated as the ratio of total
payments when the CY 2019 HH PPS
case-mix weights (developed using CY
2017 home health claims data) are
applied to CY 2017 utilization (claims)
data to total payments when CY 2018
HH PPS case-mix weights (developed
using CY 2016 home health claims data)
are applied to CY 2017 utilization data.
This produces a case-mix budget
neutrality factor for CY 2019 of 1.0163.
C. CY 2019 Home Health Payment Rate
Update
1. Rebasing and Revising of the Home
Health Market Basket

amozie on DSK3GDR082PROD with PROPOSALS2

a. Background
Section 1895(b)(3)(B) of the Act
requires that the standard prospective
payment amounts for CY 2019 be
increased by a factor equal to the
applicable home health market basket
update for those HHAs that submit
quality data as required by the
Secretary. Effective for cost reporting
periods beginning on or after July 1,
1980, we developed and adopted an
HHA input price index (that is, the
home health ‘‘market basket’’). Although
‘‘market basket’’ technically describes
the mix of goods and services used to
produce home health care, this term is
also commonly used to denote the input
price index derived from that market

VerDate Sep<11>2014

Clinical and
functional
levels
(1 = low;
2 = medium;
3 = high)

17:39 Jul 11, 2018

Jkt 244001

basket. Accordingly, the term ‘‘home
health market basket’’ used in this
document refers to the HHA input price
index.
The percentage change in the home
health market basket reflects the average
change in the price of goods and
services purchased by HHAs in
providing an efficient level of home
health care services. We first used the
home health market basket to adjust
HHA cost limits by an amount that
reflected the average increase in the
prices of the goods and services used to
furnish reasonable cost home health
care. This approach linked the increase
in the cost limits to the efficient
utilization of resources. For a greater
discussion on the home health market
basket, see the notice with comment
period published in the February 15,
1980 Federal Register (45 FR 10450,
10451), the notice with comment period
published in the February 14, 1995
Federal Register (60 FR 8389, 8392),
and the notice with comment period
published in the July 1, 1996 Federal
Register (61 FR 34344, 34347).
Beginning with the FY 2002 HHA PPS
payments, we used the home health
market basket to update payments under
the HHA PPS. We last rebased the home
health market basket effective with the
CY 2013 update (77 FR 67081).
The home health market basket is a
fixed-weight, Laspeyres-type price
index. A Laspeyres-type price index
measures the change in price, over time,
of the same mix of goods and services
purchased in the base period. Any
changes in the quantity or mix of goods
and services (that is, intensity)
purchased over time are not measured.

PO 00000

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C3F2S3
C3F2S4
C3F2S5
C3F3S1
C3F3S2
C3F3S3
C3F3S4
C3F3S5
C1F1S1
C1F2S1
C1F3S1
C2F1S1
C2F2S1
C2F3S1
C3F1S1
C3F2S1
C3F3S1

Proposed
weights for
CY 2019

1.0110
1.1858
1.3607
0.6989
0.8662
1.0336
1.2009
1.3682
1.6929
1.6990
1.7165
1.7874
1.7935
1.8110
2.0204
2.0266
2.0441

The index itself is constructed in
three steps. First, a base period is
selected (in this proposed rule, we are
proposing to use 2016 as the base
period) and total base period
expenditures are estimated for a set of
mutually exclusive and exhaustive
spending categories, with the proportion
of total costs that each category
represents being calculated. These
proportions are called ‘‘cost weights’’ or
‘‘expenditure weights.’’ Second, each
expenditure category is matched to an
appropriate price or wage variable,
referred to as a ‘‘price proxy.’’ In almost
every instance, these price proxies are
derived from publicly available
statistical series that are published on a
consistent schedule (preferably at least
on a quarterly basis). Finally, the
expenditure weight for each cost
category is multiplied by the level of its
respective price proxy. The sum of these
products (that is, the expenditure
weights multiplied by their price index
levels) for all cost categories yields the
composite index level of the market
basket in a given period. Repeating this
step for other periods produces a series
of market basket levels over time.
Dividing an index level for a given
period by an index level for an earlier
period produces a rate of growth in the
input price index over that timeframe.
As noted previously, the market
basket is described as a fixed-weight
index because it represents the change
in price over time of a constant mix
(quantity and intensity) of goods and
services needed to provide HHA
services. The effects on total
expenditures resulting from changes in
the mix of goods and services purchased

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subsequent to the base period are not
measured. For example, a HHA hiring
more nurses to accommodate the needs
of patients would increase the volume
of goods and services purchased by the
HHA, but would not be factored into the
price change measured by a fixedweight home health market basket. Only
when the index is rebased would
changes in the quantity and intensity be
captured, with those changes being
reflected in the cost weights. Therefore,
we rebase the market basket periodically
so that the cost weights reflect recent
changes in the mix of goods and
services that HHAs purchase (HHA
inputs) to furnish inpatient care
between base periods.
b. Rebasing and Revising the Home
Health Market Basket
We believe that it is desirable to
rebase the home health market basket
periodically so that the cost category
weights reflect changes in the mix of
goods and services that HHAs purchase
in furnishing home health care. We
based the cost category weights in the
current home health market basket on
CY 2010 data. We are proposing to
rebase and revise the home health
market basket to reflect 2016 Medicare
cost report (MCR) data, the latest
available and most complete data on the
actual structure of HHA costs.
The terms ‘‘rebasing’’ and ‘‘revising,’’
while often used interchangeably,
denote different activities. The term
‘‘rebasing’’ means moving the base year
for the structure of costs of an input
price index (that is, in this exercise, we
are proposing to move the base year cost
structure from CY 2010 to CY 2016)
without making any other major
changes to the methodology. The term
‘‘revising’’ means changing data sources,
cost categories, and/or price proxies
used in the input price index.
For this proposed rebasing and
revising, we are rebasing the detailed
wages and salaries and benefits cost
weights to reflect 2016 BLS
Occupational Employment Statistics
(OES) data on HHAs. The 2010-based
home health market basket used 2010
BLS OES data on HHAs. We are also
proposing to break out the All Other
(residual) cost category weight into
more detailed cost categories, based on
the 2007 Benchmark U.S. Department of
Commerce, Bureau of Economic
Analysis (BEA) Input-Output (I–O)
Table for HHAs. The 2010-based home
health market basket used the 2002 I–O
data. Finally, due to its small weight, we
are proposing to eliminate the cost
category ‘Postage’ and include these
expenses in the ‘All Other Services’ cost
weight.

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c. Derivation of the Proposed 2016Based Home Health Market Basket Cost
Weights
The major cost weights for this
proposed revised and rebased home
health market basket are derived from
the Medicare Cost Reports (MCR; CMS
Form 1728–94) data for freestanding
HHAs whose cost reporting period
began on or after October 1, 2015 and
before October 1, 2016. Of the 2016
Medicare cost reports for freestanding
HHAs, approximately 84 percent of the
reports had a begin date on January 1,
2016, approximately 6 percent had a
begin date on July 1, 2016, and
approximately 4 percent had a begin
date on October 1, 2015. Using this
methodology allowed our sample to
include HHAs with varying cost report
years including, but not limited to, the
Federal fiscal or calendar year. We refer
to the market basket as a calendar year
market basket because the base period
for all price proxies and weights are set
to CY 2016.
We propose to maintain our policy of
using data from freestanding HHAs,
which account for over 90 percent of
HHAs (82 FR 35383), because we have
determined that they better reflect
HHAs’ actual cost structure. Expense
data for hospital-based HHAs can be
affected by the allocation of overhead
costs over the entire institution.
We are proposing to derive eight
major expense categories (Wages and
Salaries, Benefits, Contract Labor,
Transportation, Professional Liability
Insurance (PLI), Fixed Capital, Movable
Capital, and a residual ‘‘All Other’’)
from the 2016 Medicare HHA cost
reports. Due to its small weight, we are
proposing to eliminate the cost category
‘Postage’ and include these expenses in
the ‘‘All Other (residual)’’ cost weight.
These major expense categories are
based on those cost centers that are
reimbursable under the HHA PPS,
specifically Skilled Nursing Care,
Physical Therapy, Occupational
Therapy, Speech Pathology, Medical
Social Services, Home Health Aide, and
Supplies. These are the same cost
centers that were used in the 2014 base
payment rebasing (78 FR 72276), which
are described in the Abt Associates Inc.
June 2013, Technical Paper, ‘‘Analyses
In Support of Rebasing and Updating
Medicare Home Health Payment Rates’’
(https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HomeHealthPPS/Downloads/Analysesin-Support-of-Rebasing-and-Updatingthe-Medicare-Home-Health-PaymentRates-Technical-Report.pdf). Total costs
for the HHA PPS reimbursable services
reflect overhead allocation. We provide

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detail on the calculations for each major
expense category.
(1) Wages and Salaries: Wages and
Salaries costs reflect direct patient care
wages and salaries costs as well as
wages and salaries costs associated with
Plant Operations and Maintenance,
Transportation, and Administrative and
General. Specifically, we are proposing
to calculate Wages and Salaries by
summing costs from Worksheet A,
column 1, lines 3 through 12 and
subtracting line 5.03 (A&G
Nonreimbursable costs).
(2) Benefits: Benefits costs reflect
direct patient care benefit costs as well
as benefit costs associated with Plant
Operations and Maintenance,
Transportation, and Administrative and
General. Specifically, we are proposing
to calculate Benefits by summing costs
from Worksheet A, column 2, lines 3
through 12 and subtracting line 5.03
(A&G Nonreimbursable costs).
(3) Direct Patient Care Contract Labor:
Contract Labor costs reflect direct
patient care contract labor. Specifically,
we are proposing to calculate Contract
Labor by summing costs from
Worksheet A, column 4, lines 6 through
11.
(4) Transportation: Transportation
costs reflect direct patient care costs as
well as transportation costs associated
with Capital Expenses, Plant Operations
and Maintenance, and Administrative
and General. Specifically, we are
proposing to calculate Transportation by
summing costs from Worksheet A,
column 3, lines 1 through 12 and
subtracting line 5.03 (A&G
Nonreimbursable costs).
(5) Professional Liability Insurance:
Professional Liability Insurance reflects
premiums, paid losses, and selfinsurance costs. Specifically we are
proposing to calculate Professional
Liability Insurance by summing costs
from Worksheet S2, lines 27.01, 27.02
and 27.03.
(6) Fixed Capital: Fixed Capitalrelated costs reflect the portion of
Medicare-allowable costs reported in
‘‘Capital Related Buildings and
Fixtures’’ (Worksheet A, column 5, line
1). We calculate this Medicare allowable
portion by first calculating a ratio for
each provider that reflects fixed capital
costs as a percentage of HHA
reimbursable services. Specifically this
ratio is calculated as the sum of costs
from Worksheet B, column 1, lines 6
through 12 divided by the sum of costs
from Worksheet B, column 1, line 1
minus lines 3 through 5. This
percentage is then applied to the sum of
the costs from Worksheet A, column 5,
line 1.

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(7) Movable Capital: Movable Capitalrelated costs reflect the portion of
Medicare-allowable costs reported in
‘‘Capital Related Moveable Equipment’’
(Worksheet A, column 5, line 2). We
calculate this Medicare allowable
portion by first calculating a ratio for
each provider that reflects movable
capital costs as a percentage of HHA
reimbursable services. Specifically this
ratio is calculated as the sum of costs
from Worksheet B, column 2, lines 6
through 12 divided by the sum of costs
from Worksheet B, column 2, line 2
minus lines 3 through 5. This
percentage is then applied to the sum of
the costs from Worksheet A, column 5,
line 2.

(8) All Other (residual): The ‘‘All
Other’’ cost weight is a residual,
calculated by subtracting the major cost
weight percentages (Wages and Salaries,
Benefits, Direct Patient Care Contract
Labor, Transportation, Professional
Liability Insurance, Fixed Capital, and
Movable Capital) from 1.
As prescription drugs and DME are
not payable under the HH PPS, we
continue to exclude those items from
the home health market basket. Totals
within each of the major cost categories
were edited to remove reports where the
data were deemed unreasonable (for
example, when total costs were not
greater than zero). We then determined
the proportion of total Medicare
allowable costs that each category

represents. For all of the major cost
categories except the ‘‘residual’’ All
Other cost weight, we then removed
those providers whose derived cost
weights fall in the top and bottom five
percent of provider-specific cost weights
to ensure the removal of outliers. After
the outliers were removed, we summed
the costs for each category across all
remaining providers. We then divided
this by the sum of total Medicare
allowable costs across all remaining
providers to obtain a cost weight for the
proposed 2016-based home health
market basket for the given category.
Table 9 shows the major cost
categories and their respective cost
weights as derived from the Medicare
cost reports for this proposed rule.

TABLE 9—MAJOR COST CATEGORIES AS DERIVED FROM THE MEDICARE COST REPORTS
Major cost categories

2010 based

Wages and Salaries (including allocated direct patient care contract labor) ..........................................................
Benefits (including allocated direct patient care contract labor) .............................................................................
Transportation ..........................................................................................................................................................
Professional Liability Insurance (Malpractice) .........................................................................................................
Fixed Capital ............................................................................................................................................................
Moveable Capital .....................................................................................................................................................
‘‘All Other’’ residual ..................................................................................................................................................

66.3
12.2
2.5
0.4
1.5
0.6
16.5

Proposed
2016 based
65.1
10.9
2.6
0.3
1.4
0.6
19.0

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* Figures may not sum to 100.0 due to rounding.

The decrease in the wages and
salaries cost weight of 1.2 percentage
points and the decrease in the benefits
cost weight of 1.3 percentage points is
attributable to both employed
compensation and direct patient care
contract labor costs as reported on the
MCR data. Our analysis of the MCR data
shows that the decrease in the
compensation cost weight of 2.4
percentage points (calculated by
combining wages and salaries and
benefits) from 2010 to 2016 occurred
among for-profit, nonprofit, and
government providers and among
providers serving only rural
beneficiaries, only urban beneficiaries,
or both rural and urban beneficiaries.
Over the 2010 to 2016 time period,
the average number of FTEs per
provider decreased considerably. This
corresponds with the HHA claims
analysis published on page 35279 of the
CY 2018 proposed rule (https://
www.gpo.gov/fdsys/pkg/FR-2017-07-28/
pdf/2017-15825.pdf), which shows that
the number of visits per 60-day episode
has decreased from 19.8 visits in 2010
to 17.9 visits in 2016 for Medicare PPS.
Medicare visits account for
approximately 60 percent of total visits.
The direct patient care contract labor
costs are contract labor costs for skilled
nursing, physical therapy, occupational

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therapy, speech therapy, and home
health aide cost centers. We allocated
these direct patient care contract labor
costs to the Wages and Salaries and
Benefits cost categories based on each
provider’s relative proportions of both
employee wages and salaries and
employee benefits costs. For example,
the direct patient care contract labor
costs that are allocated to wages and
salaries is equal to: (A) The employee
wages and salaries costs as a percent of
the sum of employee wages and salaries
costs and employee benefits costs times;
and (B) direct patient care contract labor
costs. Nondirect patient care contract
labor costs (such as contract labor costs
reported in the Administrative and
General cost center of the MCR) are
captured in the ‘‘All Other’’ residual
cost weight and later disaggregated into
more detail as described below. This is
a similar methodology that was
implemented for the 2010-based home
health market basket.
We further divide the ‘‘All Other’’
residual cost weight estimated from the
2016 Medicare cost report data into
more detailed cost categories. To divide
this cost weight we are proposing to use
the 2007 Benchmark I–O ‘‘Use Tables/
Before Redefinitions/Purchaser Value’’
for NAICS 621600, Home Health
Agencies, published by the BEA. These

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data are publicly available at http://
www.bea.gov/industry/io_annual.htm.
The BEA Benchmark I–O data are
generally scheduled for publication
every five years. The most recent data
available at the time of rebasing was for
2007. The 2007 Benchmark I–O data are
derived from the 2007 Economic Census
and are the building blocks for BEA’s
economic accounts. Therefore, they
represent the most comprehensive and
complete set of data on the economic
processes or mechanisms by which
output is produced and distributed.10
Besides Benchmark I–O estimates, BEA
also produces Annual I–O estimates.
While based on a similar methodology,
the Annual I–O estimates reflect less
comprehensive and less detailed data
sources and are subject to revision when
benchmark data become available.
Instead of using the less detailed
Annual I–O data, we are proposing to
inflate the detailed 2007 Benchmark I–
O data forward to 2016 by applying the
annual price changes from the
respective price proxies to the
appropriate market basket cost
categories that are obtained from the
2007 Benchmark I–O data. We repeated
this practice for each year. We then
calculated the cost shares that each cost
10 http://www.bea.gov/papers/pdf/IOmanual_
092906.pdf.

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category represents of the 2007 data
inflated to 2016. These resulting 2016
cost shares were applied to the ‘‘All
Other’’ residual cost weight to obtain
the detailed cost weights for the
proposed 2016-based home health
market basket. For example, the cost for
Operations and Maintenance represents
8.0 percent of the sum of the ‘‘All
Other’’ 2007 Benchmark I–O HHA
Expenditures inflated to 2016.
Therefore, the Operations and
Maintenance cost weight represents 8.0
percent of the proposed 2016-based
home health market basket’s ‘‘All
Other’’ cost category (19.0 percent),

yielding an Operations and
Maintenance proposed cost weight of
1.5 percent in the proposed 2016-based
home health market basket (0.080 × 19.0
percent = 1.5 percent). For the 2010based home health market basket, we
used the same methodology utilizing the
2002 Benchmark I–O data (aged to
2010).
Using this methodology, we are
proposing to derive nine detailed cost
categories from the proposed 2016based home health market basket ‘‘All
Other’’ residual cost weight (19.0
percent). These categories are: (1)
Operations and Maintenance; (2)
Administrative Support; (3) Financial

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Services; (4) Medical Supplies; (5)
Rubber and Plastics; (6) Telephone; (7)
Professional Fees; (8) Other Products;
and (9) Other Services. The 2010-based
home health market basket included a
separate cost category for Postage;
however, due to its small weight for the
2016-based home health market basket,
we propose to eliminate the stand-alone
cost category for Postage and include
these expenses in the Other Services
cost category.
Table 10 lists the proposed 2016based home health market basket cost
categories, cost weights, and price
proxies.

TABLE 10—COST CATEGORIES, WEIGHTS, AND PRICE PROXIES
IN PROPOSED 2016-BASED HOME HEALTH MARKET BASKET
Cost categories

Weight

Price proxy

Compensation, including allocated contract services’
labor.
Wages and Salaries, including allocated contract
services’ labor.
Benefits, including allocated contract services’
labor.
Operations & Maintenance ..............................................
Professional Liability Insurance .......................................
Administrative & General & Other Expenses including
allocated contract services’ labor.
Administrative Support .............................................

76.1

Financial Services ....................................................

1.9

Medical Supplies ......................................................
Rubber & Plastics ....................................................
Telephone ................................................................
Professional Fees ....................................................

0.9
1.6
0.7
5.3

Other Products .........................................................
Other Services .........................................................

2.8
3.2

Transportation .................................................................
Capital-Related ................................................................
Fixed Capital ............................................................
Movable Capital .......................................................

2.6
2.1
1.4
0.6

Total .........................................................................

* 100.0

65.1

Proposed Home Health Blended Wages and Salaries Index (2016).

10.9

Proposed Home Health Blended Benefits Index (2016).

1.5
0.3
17.4

CPI–U for Fuel and utilities.
CMS Physician Professional Liability Insurance Index.

1.0

ECI for Total compensation for Private industry workers in Office and
administrative support.
ECI for Total compensation for Private industry workers in Financial
activities.
PPI Commodity data for Medical, surgical & personal aid devices.
PPI Commodity data for Rubber and plastic products.
CPI–U for Telephone services.
ECI for Total compensation for Private industry workers in Professional and related.
PPI Commodity data for Finished goods less foods and energy.
ECI for Total compensation for Private industry workers in Service
occupations.
CPI–U for Transportation.
CPI–U for Owners’ equivalent rent of residences.
PPI Commodity data for Machinery and equipment.

* Figures may not sum due to rounding.

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d. Proposed 2016-Based Home Health
Market Basket Price Proxies
After we computed the CY 2016 cost
category weights for the proposed
rebased home health market basket, we
selected the most appropriate wage and
price indexes to proxy the rate of change
for each expenditure category. With the
exception of the price index for
Professional Liability Insurance costs,
the proposed price proxies are based on
Bureau of Labor Statistics (BLS) data
and are grouped into one of the
following BLS categories:
• Employment Cost Indexes—
Employment Cost Indexes (ECIs)
measure the rate of change in employee

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wage rates and employer costs for
employee benefits per hour worked.
These indexes are fixed-weight indexes
and strictly measure the change in wage
rates and employee benefits per hour.
They are not affected by shifts in skill
mix. ECIs are superior to average hourly
earnings as price proxies for input price
indexes for two reasons: (a) They
measure pure price change; and (b) they
are available by occupational groups,
not just by industry.
• Consumer Price Indexes—
Consumer Price Indexes (CPIs) measure
change in the prices of final goods and
services bought by the typical
consumer. Consumer price indexes are

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used when the expenditure is more
similar to that of a purchase at the retail
level rather than at the wholesale level,
or if no appropriate Producer Price
Indexes (PPIs) were available.
• Producer Price Indexes—PPIs
measures average changes in prices
received by domestic producers for their
goods and services. PPIs are used to
measure price changes for goods sold in
other than retail markets. For example,
a PPI for movable equipment is used
rather than a CPI for equipment. PPIs in
some cases are preferable price proxies
for goods that HHAs purchase at
wholesale levels. These fixed-weight
indexes are a measure of price change

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at the producer or at the intermediate
stage of production.
We evaluated the price proxies using
the criteria of reliability, timeliness,
availability, and relevance. Reliability
indicates that the index is based on
valid statistical methods and has low
sampling variability. Widely accepted
statistical methods ensure that the data
were collected and aggregated in way
that can be replicated. Low sampling
variability is desirable because it
indicates that sample reflects the typical
members of the population. (Sampling
variability is variation that occurs by
chance because a sample was surveyed
rather than the entire population.)
Timeliness implies that the proxy is
published regularly, preferably at least
once a quarter. The market baskets are
updated quarterly and therefore it is
important the underlying price proxies
be up-to-date, reflecting the most recent
data available. We believe that using
proxies that are published regularly
helps ensure that we are using the most
recent data available to update the
market basket. We strive to use
publications that are disseminated
frequently because we believe that this
is an optimal way to stay abreast of the
most current data available. Availability
means that the proxy is publicly
available. We prefer that our proxies are
publicly available because this will help
ensure that our market basket updates
are as transparent to the public as
possible. In addition, this enables the

public to be able to obtain the price
proxy data on a regular basis. Finally,
relevance means that the proxy is
applicable and representative of the cost
category weight to which it is applied.
The CPIs, PPIs, and ECIs selected by us
to be proposed in this regulation meet
these criteria. Therefore, we believe that
they continue to be the best measure of
price changes for the cost categories to
which they would be applied.
As part of the revising and rebasing of
the home health market basket, we are
proposing to rebase the home health
blended Wages and Salaries index and
the home health blended Benefits index.
We propose to use these blended
indexes as price proxies for the Wages
and Salaries and the Benefits portions of
the proposed 2016-based home health
market basket, as we did in the 2010based home health market basket. A
more detailed discussion is provided
below.
• Wages and Salaries: For measuring
price growth in the 2016-based home
health market basket, we are proposing
to apply six price proxies to six
occupational subcategories within the
Wages and Salaries component, which
would reflect the HHA occupational
mix. This is the same approach used for
the 2010-based index. We use a blended
wage proxy because there is not a
published wage proxy specific to the
home health industry.
We are proposing to continue to use
the National Industry-Specific

Occupational Employment and Wage
estimates for North American Industrial
Classification System (NAICS) 621600,
Home Health Care Services, published
by the BLS Office of Occupational
Employment Statistics (OES) as the data
source for the cost shares of the home
health blended wage and benefits proxy.
This is the same data source that was
used for the 2010-based HHA blended
wage and benefit proxies; however, we
are proposing to use the May 2016
estimates in place of the May 2010
estimates. Detailed information on the
methodology for the national industryspecific occupational employment and
wage estimates survey can be found at
http://www.bls.gov/oes/current/oes_
tec.htm.
The needed data on HHA
expenditures for the six occupational
subcategories (Health-Related
Professional and Technical, Non HealthRelated Professional and Technical,
Management, Administrative, Health
and Social Assistance Service, and
Other Service Workers) for the wages
and salaries component were tabulated
from the May 2016 OES data for NAICS
621600, Home Health Care Services.
Table 11 compares the proposed 2016
occupational assignments to the 2010
occupational assignments of the six
CMS designated subcategories. If an
OES occupational classification does
not exist in the 2010 or 2016 data we
use ‘‘n/a.’’

TABLE 11—PROPOSED 2016 OCCUPATIONAL ASSIGNMENTS COMPARED TO 2010 OCCUPATIONAL ASSIGNMENTS FOR CMS
HOME HEALTH WAGES AND SALARIES BLEND

amozie on DSK3GDR082PROD with PROPOSALS2

2016 proposed occupational groupings

2010 occupational groupings

Group 1

Health-related professional and technical

Group 1

Health-related professional and technical

n/a ..................
29–1031 .........
29–1051 .........
29–1062 .........
29–1063 .........
29–1065 .........
29–1066 .........
29–1069 .........
29–1071 .........
n/a ..................
29–1122 .........
29–1123 .........
29–1125 .........
29–1126 .........
29–1127 .........
29–1129 .........
29–1141 .........
29–1171 .........
29–1199 .........

n/a ................................................................................
Dietitians and Nutritionists ...........................................
Pharmacists ..................................................................
Family and General Practitioners ................................
Internists, General ........................................................
Pediatricians, General ..................................................
Psychiatrists .................................................................
Physicians and Surgeons, All Other ............................
Physician Assistants ....................................................
n/a ................................................................................
Occupational Therapists ..............................................
Physical Therapists ......................................................
Recreational Therapists ...............................................
Respiratory Therapists .................................................
Speech-Language Pathologists ...................................
Therapists, All Other ....................................................
Registered Nurses .......................................................
Nurse Practitioners .......................................................
Health Diagnosing and Treating Practitioners, All
Other.

29–1021 .........
29–1031 .........
29–1051 .........
29–1062 .........
29–1063 .........
n/a ..................
n/a ..................
29–1069 .........
29–1071 .........
29–1111 .........
29–1122 .........
29–1123 .........
29–1125 .........
29–1126 .........
29–1127 .........
29–1129 .........
n/a ..................
n/a ..................
29–1199 .........

Dentists, General.
Dietitians and Nutritionists.
Pharmacists.
Family and General Practitioners.
Internists, General.
n/a.
n/a.
Physicians and Surgeons, All Other.
Physician Assistants.
Registered Nurses.
Occupational Therapists.
Physical Therapists.
Recreational Therapists.
Respiratory Therapists.
Speech-Language Pathologists.
Therapists, All Other.
n/a.
n/a.
Health Diagnosing and Treating Practitioners, All
Other.

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2016 proposed occupational groups

2010 occupational groupings

Group 2

Non health related professional & technical

13–0000 .........
15–0000 .........
n/a ..................
19–0000 .........
n/a ..................
25–0000 .........
27–0000 .........

Business and Financial Operations Occupations ........
Computer and Mathematical Occupations ...................
n/a ................................................................................
Life, Physical, and Social Science Occupations ..........
n/a ................................................................................
Education, Training, and Library Occupations .............
Arts, Design, Entertainment, Sports, and Media Occupations.

Group 3

Management

Group 3

11–0000 .........

Management Occupations ...........................................

11–0000 .........

Group 4

Administrative

Group 4

43–0000 .........

Office and Administrative Support Occupations ..........

43–0000 .........

Group 5

Health and social assistance services

Group 5

Health and social assistance services

21–0000 .........
29–2011 .........
29–2012 .........
29–2021 .........
29–2032 .........
29–2034 .........
29–2041 .........
29–2051 .........
29–2052 .........
29–2053 .........
29–2054 .........
29–2055 .........
29–2061 .........
29–2071 .........
29–2099 .........
n/a ..................
29–9099 .........

21–0000 .........
29–2011 .........
29–2012 .........
29–2021 .........
29–2032 .........
29–2034 .........
29–2041 .........
29–2051 .........
29–2052 .........
n/a ..................
29–2054 .........
n/a ..................
29–2061 .........
29–2071 .........
29–2099 .........
29–9012 .........
29–9099 .........

31–0000 .........

Community and Social Service Occupations ...............
Medical and Clinical Laboratory Technologists ...........
Medical and Clinical Laboratory Technicians ..............
Dental Hygienists .........................................................
Diagnostic Medical Sonographers ...............................
Radiologic Technologists .............................................
Emergency Medical Technicians and Paramedics ......
Dietetic Technicians .....................................................
Pharmacy Technicians .................................................
Psychiatric Technicians ................................................
Respiratory Therapy Technicians ................................
Surgical Technologists .................................................
Licensed Practical and Licensed Vocational Nurses ...
Medical Records and Health Information Technicians
Health Technologists and Technicians, All Other ........
n/a ................................................................................
Healthcare Practitioners and Technical Workers, All
Other.
Healthcare Support Occupations .................................

31–0000 .........

Community and Social Services Occupations.
Medical and Clinical Laboratory Technologists.
Medical and Clinical Laboratory Technicians.
Dental Hygienists.
Diagnostic Medical Sonographers.
Radiologic Technologists and Technicians.
Emergency Medical Technicians and Paramedics.
Dietetic Technicians.
Pharmacy Technicians.
n/a.
Respiratory Therapy Technicians.
n/a.
Licensed Practical and Licensed Vocational Nurses.
Medical Records and Health Information Technicians.
Health Technologists and Technicians, All Other.
Occupational Health and Safety Technicians.
Healthcare Practitioner and Technical Workers, All
Other.
Healthcare Support Occupations.

Group 6

Other service workers

Group 6

Other service workers

33–0000 .........
35–0000 .........
37–0000 .........

Protective Service Occupations ...................................
Food Preparation and Serving Related Occupations ..
Building and Grounds Cleaning and Maintenance Occupations.
Personal Care and Service Occupations .....................
Sales and Related Occupations ..................................
Construction and Extraction Occupations ....................
Installation, Maintenance, and Repair Occupations ....
Production Occupations ...............................................
Transportation and Material Moving Occupations .......

33–0000 .........
35–0000 .........
37–0000 .........

Protective Service Occupations.
Food Preparation and Serving Related Occupations.
Building and Grounds Cleaning and Maintenance Occupations.
Personal Care and Service Occupations.
Sales and Related Occupations.
n/a.
Installation, Maintenance, and Repair Occupations.
Production Occupations.
Transportation and Material Moving Occupations.

39–0000
41–0000
47–0000
49–0000
51–0000
53–0000

.........
.........
.........
.........
.........
.........

Total expenditures by occupation
were calculated by taking the OES
number of employees multiplied by the

Group 2
13–0000
15–0000
17–0000
19–0000
23–0000
25–0000
27–0000

.........
.........
.........
.........
.........
.........
.........

39–0000 .........
41–0000 .........
n/a ..................
49–0000 .........
51–0000 .........
53–0000 .........

Non health related professional & technical
Business and Financial Operations Occupations.
Computer and Mathematical Science Occupations.
Architecture and Engineering Occupations.
Life, Physical, and Social Science Occupations.
Legal Occupations.
Education, Training, and Library Occupations.
Arts, Design, Entertainment, Sports, and Media Occupations.
Management
Management Occupations.
Administrative
Office and Administrative Support Occupations.

OES annual average salary for each
subcategory, and then calculating the
proportion of total wage costs that each

subcategory represents. The proportions
listed in Table 12 represent the Wages
and Salaries blend weights.

TABLE 12—COMPARISON OF THE PROPOSED 2016-BASED HOME HEALTH WAGES AND SALARIES BLEND AND THE 2010BASED HOME HEALTH WAGES AND SALARIES BLEND
Proposed
2016 weight

amozie on DSK3GDR082PROD with PROPOSALS2

Cost subcategory

2010 weight

Health-Related Professional and
Technical.
Non Health-Related Professional
and Technical.

33.7

33.4

2.3

2.3

Management ................................

7.6

8.3

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Price proxy

BLS series ID

ECI for Wages and salaries for All Civilian workers in Hospitals.
ECI for Wages and salaries for Private industry
workers in Professional, scientific, and technical services.
ECI for Wages and salaries for Private industry
workers in Management, business, and financial.

CIU1026220000000I.

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CIU2025400000000I.

CIU2020000110000I.

32366

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

TABLE 12—COMPARISON OF THE PROPOSED 2016-BASED HOME HEALTH WAGES AND SALARIES BLEND AND THE 2010BASED HOME HEALTH WAGES AND SALARIES BLEND—Continued
Proposed
2016 weight

Cost subcategory

2010 weight

Administrative ..............................

6.7

7.7

Health and Social Assistance
Services.
Other Service Occupations .........

35.3

35.8

14.4

12.6

Total * ....................................

100.0

100.0

Price proxy

BLS series ID

ECI for Wages and salaries for Private industry
workers in Office and administrative support.
ECI for Wages and salaries for All Civilian workers in Health care and social assistance.
ECI for Wages and salaries for Private industry
workers in Service occupations.

CIU2020000220000I.
CIU1026200000000I.
CIU2020000300000I.

* Totals may not sum due to rounding.

A comparison of the yearly changes
from CY 2016 to CY 2019 for the 2010based home health Wages and Salaries

blend and the proposed 2016-based
home health Wages and Salaries blend
is shown in Table 13. The annual

increases in the two price proxies are
the same when rounded to one decimal
place.

TABLE 13—ANNUAL GROWTH IN PROPOSED 2016 AND 2010 HOME HEALTH WAGES AND SALARIES BLEND
2016
Wage Blend 2016 ............................................................................................
Wage Blend 2010 ............................................................................................

2017
2.3
2.3

2018
2.5
2.5

2019
2.6
2.6

3.0
3.0

Source: IHS Global Insight Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.

• Benefits: For measuring Benefits
price growth in the proposed 2016based home health market basket, we
are proposing to apply applicable price

proxies to the six occupational
subcategories that are used for the
Wages and Salaries blend. The proposed
six categories in Table 14 are the same

as those in the 2010-based home health
market basket and include the same
occupational mix as listed in Table 14.

TABLE 14—COMPARISON OF THE PROPOSED 2016-BASED HOME HEALTH BENEFITS BLEND AND 2010-BASED HOME
HEALTH BENEFITS BLEND
Proposed
2016 weight

Cost category

2010 weight

Health-Related Professional and Technical
Non Health-Related Professional and
Technical.
Management ...............................................

33.9
2.3

33.5
2.2

7.3

8.0

Administrative ..............................................

6.7

7.8

Health and Social Assistance Services ......

35.5

35.9

Other Service Workers ................................

14.2

12.5

Total * ...................................................

100.0

100.0

Price proxy
ECI for Benefits for All Civilian workers in Hospitals.
ECI for Benefits for Private industry workers in Professional, scientific, and technical services.
ECI for Benefits for Private industry workers in Management,
business, and financial.
ECI for Benefits for Private industry workers in Office and administrative support.
ECI for Benefits for All Civilian workers in Health care and social
assistance.
ECI for Benefits for Private industry workers in Service occupations.

amozie on DSK3GDR082PROD with PROPOSALS2

* Totals may not sum due to rounding.

There is no available data source that
exists for benefit expenditures by
occupation for the home health
industry. Thus, to construct weights for
the home health benefits blend we
calculated the ratio of benefits to wages
and salaries for CY 2016 for the six ECI
series we are proposing to use in the
blended ‘wages and salaries’ and
‘benefits’ indexes. To derive the relevant
benefits weight, we applied the benefitto-wage ratios to each of the six
occupational subcategories from the

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2016 OES wage and salary weights, and
normalized. For example, the ratio of
benefits to wages from the 2016 home
health wages and salaries blend and the
benefits blend for the management
category is 0.984. We apply this ratio to
the 2016 OES weight for wages and
salaries for management, 7.6 percent,
and then normalize those weights
relative to the other five benefit
occupational categories to obtain a
benefit weight for management of 7.3
percent.

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A comparison of the yearly changes
from CY 2016 to CY 2019 for the 2010based home health Benefits blend and
the proposed 2016-based home health
Benefits blend is shown in Table 15.
With the exception of a 0.1 percentage
point difference in 2019, the annual
increases in the two price proxies are
the same when rounded to one decimal
place.

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32367

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

TABLE 15—ANNUAL GROWTH IN THE PROPOSED 2016 HOME HEALTH BENEFITS BLEND AND THE 2010 HOME HEALTH
BENEFITS BLEND
2016
Benefits Blend 2016 ........................................................................................
Benefits Blend 2010 ........................................................................................

2017
1.7
1.7

2018
1.9
1.9

2019
2.4
2.4

3.0
2.9

Source: IHS Global Insight Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.

• Operations and Maintenance: We
are proposing to use CPI U.S. city
average for Fuel and utilities (BLS series
code #CUUR0000SAH2) to measure
price growth of this cost category. The
same proxy was used for the 2010-based
home health market basket.
• Professional Liability Insurance: We
are proposing to use the CMS Physician
Professional Liability Insurance price
index to measure price growth of this
cost category. The same proxy was used
for the 2010-based home health market
basket.
To accurately reflect the price changes
associated with physician PLI, each year
we collect PLI premium data for
physicians from a representative sample
of commercial carriers and publically
available rate filings as maintained by
each State’s Association of Insurance
Commissioners. As we require for our
other price proxies, the PLI price proxy
is intended to reflect the pure price
change associated with this particular
cost category. Thus, the level of liability
coverage is held constant from year to
year. To accomplish this, we obtain
premium information from a sample of
commercial carriers for a fixed level of
coverage, currently $1 million per
occurrence and a $3 million annual
limit. This information is collected for
every State by physician specialty and
risk class. Finally, the State-level,
physician-specialty data are aggregated
to compute a national total, using
counts of physicians by State and
specialty as provided in the AMA
publication, Physician Characteristics
and Distribution in the U.S.
• Administrative and Support: We are
proposing to use the ECI for Total
compensation for Private industry

workers in Office and administrative
support (BLS series code
#CIU2010000220000I) to measure price
growth of this cost category. The same
proxy was used for the 2010-based
home health market basket.
• Financial Services: We are
proposing to use the ECI for Total
compensation for Private industry
workers in Financial activities (BLS
series code #CIU201520A000000I) to
measure price growth of this cost
category. The same proxy was used for
the 2010-based home health market
basket.
• Medical Supplies: We are proposing
to use the PPI Commodity data for
Miscellaneous products-Medical,
surgical & personal aid devices (BLS
series code #WPU156) to measure price
growth of this cost category. The same
proxy was used for the 2010-based
home health market basket.
• Rubber and Plastics: We are
proposing to use the PPI Commodity
data for Rubber and plastic products
(BLS series code #WPU07) to measure
price growth of this cost category. The
same proxy was used for the 2010-based
home health market basket.
• Telephone: We are proposing to use
CPI U.S. city average for Telephone
services (BLS series code
#CUUR0000SEED) to measure price
growth of this cost category. The same
proxy was used for the 2010-based
home health market basket.
• Professional Fees: We are proposing
to use the ECI for Total compensation
for Private industry workers in
Professional and related (BLS series
code #CIS2010000120000I) to measure
price growth of this category. The same
proxy was used for the 2010-based
home health market basket.

• Other Products: We are proposing
to use the PPI Commodity data for Final
demand-Finished goods less foods and
energy (BLS series code #WPUFD4131)
to measure price growth of this category.
The same proxy was used for the 2010based home health market basket.
• Other Services: We are proposing to
use the ECI for Total compensation for
Private industry workers in Service
occupations (BLS series code
#CIU2010000300000I) to measure price
growth of this category. The same proxy
was used for the 2010-based home
health market basket.
• Transportation: We are proposing
to use the CPI U.S. city average for
Transportation (BLS series code
#CUUR0000SAT) to measure price
growth of this category. The same proxy
was used for the 2010-based home
health market basket.
• Fixed capital: We are proposing to
use the CPI U.S. city average for
Owners’ equivalent rent of residences
(BLS series code #CUUS0000SEHC) to
measure price growth of this cost
category. The same proxy was used for
the 2010-based home health market
basket.
• Movable Capital: We are proposing
to use the PPI Commodity data for
Machinery and equipment (BLS series
code #WPU11) to measure price growth
of this cost category. The same proxy
was used for the 2010-based home
health market basket.
e. Rebasing Results
A comparison of the yearly changes
from CY 2014 to CY 2021 for the 2010based home health market basket and
the proposed 2016-based home health
market basket is shown in Table 16.

amozie on DSK3GDR082PROD with PROPOSALS2

TABLE 16—COMPARISON OF THE 2010-BASED HOME HEALTH MARKET BASKET AND THE PROPOSED 2016-BASED HOME
HEALTH MARKET BASKET, PERCENT CHANGE, 2014–2021
Home health
market
basket,
2010-based
Historical data:
CY 2014 ................................................................................................................................
CY 2015 ................................................................................................................................
CY 2016 ................................................................................................................................
CY 2017 ................................................................................................................................

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1.6
1.6
2.0
2.3

12JYP2

Proposed
home health
market
basket,
2016-based

1.6
1.5
2.0
2.3

Difference
(proposed
2016-based
less
2010-based)

0.0
¥0.1
0.0
0.0

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

TABLE 16—COMPARISON OF THE 2010-BASED HOME HEALTH MARKET BASKET AND THE PROPOSED 2016-BASED HOME
HEALTH MARKET BASKET, PERCENT CHANGE, 2014–2021—Continued
Home health
market
basket,
2010-based
Average CYs 2014–2017 ..............................................................................................
Forecast:
CY 2018 ................................................................................................................................
CY 2019 ................................................................................................................................
CY 2020 ................................................................................................................................
CY 2021 ................................................................................................................................
Average CYs 2018–2021 ..............................................................................................

Proposed
home health
market
basket,
2016-based

Difference
(proposed
2016-based
less
2010-based)

1.9

1.9

0.0

2.5
2.8
3.0
3.0
2.8

2.5
2.8
3.0
3.0
2.8

0.0
0.0
0.0
0.0
0.0

Source: IHS Global Inc. 1st Quarter 2018 forecast with historical data through 4th Quarter 2017.

Table 16 shows that the forecasted
rate of growth for CY 2019 for the
proposed 2016-based home health
market basket is 2.8 percent, the same
rate of growth as estimated using the
2010-based home health market basket;
other forecasted years also show a
similar increase. Similarly, the
historical estimates of the growth in the
2016-based and 2010-based home health
market basket are the same except for
CY 2015 where the 2010-based home
health market basket is 0.1 percentage
point higher. We note that if more
recent data are subsequently available
(for example, a more recent estimate of

the market basket), we would use such
data to determine the market basket
increases in the final rule.
f. Labor-Related Share
Effective for CY 2019, we are
proposing to revise the labor-related
share to reflect the proposed 2016-based
home health market basket
Compensation (Wages and Salaries plus
Benefits) cost weight. The current laborrelated share is based on the
Compensation cost weight of the 2010based home health market basket. Based
on the proposed 2016-based home
health market basket, the labor-related
share would be 76.1 percent and the

proposed non-labor-related share would
be 23.9 percent. The labor-related share
for the 2010-based home health market
basket was 78.5 percent and the nonlabor-related share was 21.5 percent. As
explained earlier, the decrease in the
compensation cost weight of 2.4
percentage points is attributable to both
employed compensation (wages and
salaries and benefits for employees) and
direct patient care contract labor costs
as reported in the MCR data. Table 17
details the components of the laborrelated share for the 2010-based and
proposed 2016-based home health
market baskets.

TABLE 17—LABOR–RELATED SHARE OF CURRENT AND PROPOSED HOME HEALTH MARKET BASKETS
Cost category

Wages and Salaries ................................................................................................................................................
Employee Benefits ...................................................................................................................................................
Total Labor-Related .................................................................................................................................................
Total Non Labor-Related .........................................................................................................................................

We propose to implement the
proposed revision to the labor-related
share of 76.1 percent in a budget neutral
manner. This proposal would be
consistent with our policy of
implementing the annual recalibration
of the case-mix weights and update of
the home health wage index in a budget
neutral manner.

amozie on DSK3GDR082PROD with PROPOSALS2

g. Multifactor Productivity
In the CY 2015 HHA PPS final rule
(79 FR 38384 through 38384), we
finalized our methodology for
calculating and applying the MFP
adjustment. As we explained in that
rule, section 1895(b)(3)(B)(vi) of the Act,
requires that, in CY 2015 (and in
subsequent calendar years, except CY
2018 (under section 411(c) of the
Medicare Access and CHIP

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Reauthorization Act of 2015 (MACRA)
(Pub. L. 114–10, enacted April 16,
2015)), the market basket percentage
under the HHA prospective payment
system as described in section
1895(b)(3)(B) of the Act be annually
adjusted by changes in economy-wide
productivity. Section
1886(b)(3)(B)(xi)(II) of the Act defines
the productivity adjustment to be equal
to the 10-year moving average of change
in annual economy-wide private
nonfarm business multifactor
productivity (MFP) (as projected by the
Secretary for the 10-year period ending
with the applicable fiscal year, calendar
year, cost reporting period, or other
annual period) (the ‘‘MFP adjustment’’).
The Bureau of Labor Statistics (BLS) is
the agency that publishes the official
measure of private nonfarm business

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2010-based
market basket
weight

Proposed
2016-based
market basket
weight

66.3
12.2
78.5
21.5

65.1
11.0
76.1
23.9

MFP. Please see http://www.bls.gov/
mfp, to obtain the BLS historical
published MFP data.
Based on IHS Global Inc.’s (IGI’s) first
quarter 2018 forecast with history
through the fourth quarter of 2017, the
projected MFP adjustment (the 10-year
moving average of MFP for the period
ending December 31, 2019) for CY 2019
is 0.7 percent. IGI is a nationally
recognized economic and financial
forecasting firm that contracts with CMS
to forecast the components of the market
baskets. We note that if more recent data
are subsequently available (for example,
a more recent estimate of the MFP
adjustment), we would use such data to
determine the MFP adjustment in the
final rule.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
2. Proposed CY 2019 Market Basket
Update for HHAs
Using IGI’s first quarter 2018 forecast,
the MFP adjustment for CY 2019 is
projected to be 0.7 percent. In
accordance with section
1895(b)(3)(B)(iii) of the Act, we propose
to base the CY 2019 market basket
update, which is used to determine the
applicable percentage increase for HHA
payments, on the most recent estimate
of the proposed 2016-based home health
market basket. Based on IGI’s first
quarter 2018 forecast with history
through the fourth quarter of 2017, the
projected increase of the proposed 2016based home health market basket for CY
2019 is 2.8 percent. We propose to then
reduce this percentage increase by the
current estimate of the MFP adjustment
for CY 2019 of 0.7 percentage point in
accordance with 1895(b)(3)(B)(vi) of the
Act. Therefore, the current estimate of
the CY 2019 HHA payment update is 2.1
percent (2.8 percent market basket
update, less 0.7 percentage point MFP
adjustment). Furthermore, we note that
if more recent data are subsequently
available (for example, a more recent
estimate of the market basket and MFP
adjustment), we would use such data to
determine the CY 2019 market basket
update and MFP adjustment in the final
rule.
Section 1895(b)(3)(B)(v) of the Act
requires that the home health update be
decreased by 2 percentage points for
those HHAs that do not submit quality
data as required by the Secretary. For
HHAs that do not submit the required
quality data for CY 2019, the home
health payment update will be 0.1
percent (2.1 percent minus 2 percentage
points).

amozie on DSK3GDR082PROD with PROPOSALS2

3. CY 2019 Home Health Wage Index
Sections 1895(b)(4)(A)(ii) and (b)(4)(C)
of the Act require the Secretary to
provide appropriate adjustments to the
proportion of the payment amount
under the HH PPS that account for area
wage differences, using adjustment
factors that reflect the relative level of
wages and wage-related costs applicable
to the furnishing of HH services. Since
the inception of the HH PPS, we have
used inpatient hospital wage data in
developing a wage index to be applied
to HH payments. We propose to
continue this practice for CY 2019, as
we continue to believe that, in the
absence of HH-specific wage data that
accounts for area differences, using
inpatient hospital wage data is
appropriate and reasonable for the HH
PPS. Specifically, we propose to
continue to use the pre-floor, prereclassified hospital wage index as the

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wage adjustment to the labor portion of
the HH PPS rates. For CY 2019, the
updated wage data are for hospital cost
reporting periods beginning on or after
October 1, 2014, and before October 1,
2015 (FY 2015 cost report data). We
apply the appropriate wage index value
to the labor portion of the HH PPS rates
based on the site of service for the
beneficiary (defined by section 1861(m)
of the Act as the beneficiary’s place of
residence).
To address those geographic areas in
which there are no inpatient hospitals,
and thus, no hospital wage data on
which to base the calculation of the CY
2019 HH PPS wage index, we propose
to continue to use the same
methodology discussed in the CY 2007
HH PPS final rule (71 FR 65884) to
address those geographic areas in which
there are no inpatient hospitals. For
rural areas that do not have inpatient
hospitals, we propose to use the average
wage index from all contiguous Core
Based Statistical Areas (CBSAs) as a
reasonable proxy. Currently, the only
rural area without a hospital from which
hospital wage data could be derived is
Puerto Rico. However, for rural Puerto
Rico, we do not apply this methodology
due to the distinct economic
circumstances that exist there (for
example, due to the close proximity to
one another of almost all of Puerto
Rico’s various urban and non-urban
areas, this methodology would produce
a wage index for rural Puerto Rico that
is higher than that in half of its urban
areas). Instead, we propose to continue
to use the most recent wage index
previously available for that area. For
urban areas without inpatient hospitals,
we use the average wage index of all
urban areas within the state as a
reasonable proxy for the wage index for
that CBSA. For CY 2019, the only urban
area without inpatient hospital wage
data is Hinesville, GA (CBSA 25980).
On February 28, 2013, OMB issued
Bulletin No. 13–01, announcing
revisions to the delineations of MSAs,
Micropolitan Statistical Areas, and
CBSAs, and guidance on uses of the
delineation of these areas. In the CY
2015 HH PPS final rule (79 FR 66085
through 66087), we adopted the OMB’s
new area delineations using a 1-year
transition.
On August 15, 2017, OMB issued
Bulletin No. 17–01 in which it
announced that one Micropolitan
Statistical Area, Twin Falls, Idaho, now
qualifies as a Metropolitan Statistical
Area. The new CBSA (46300) comprises
the principal city of Twin Falls, Idaho
in Jerome County, Idaho and Twin Falls
County, Idaho. The CY 2019 HH PPS
wage index value for CBSA 46300, Twin

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32369

Falls, Idaho, will be 0.8335. Bulletin No.
17–01 is available at https://
www.whitehouse.gov/sites/
whitehouse.gov/files/omb/bulletins/
2017/b-17-01.pdf.11
The most recent OMB Bulletin (No.
18–03) was published on April 10, 2018
and is available at https://
www.whitehouse.gov/wp-content/
uploads/2018/04/OMB-BULLETIN-NO.18-03-Final.pdf.12 The revisions
contained in OMB Bulletin No. 18–03
have no impact on the geographic area
delineations that are used to wage adjust
HH PPS payments.
The CY 2019 wage index is available
on the CMS website at http://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HomeHealthPPS/
Home-Health-Prospective-PaymentSystem-Regulations-and-Notices.html.
4. CY 2019 Annual Payment Update
a. Background
The Medicare HH PPS has been in
effect since October 1, 2000. As set forth
in the July 3, 2000 final rule (65 FR
41128), the base unit of payment under
the Medicare HH PPS is a national,
standardized 60-day episode payment
rate. As set forth in § 484.220, we adjust
the national, standardized 60-day
episode payment rate by a case-mix
relative weight and a wage index value
based on the site of service for the
beneficiary.
To provide appropriate adjustments to
the proportion of the payment amount
under the HH PPS to account for area
wage differences, we apply the
appropriate wage index value to the
labor portion of the HH PPS rates. As
discussed in section III.C.1 of this
proposed rule, based on the proposed
2016-based home health market basket,
the proposed labor-related share would
be 76.1 percent and the proposed nonlabor-related share would be 23.9
percent for CY 2019. The CY 2019 HH
PPS rates use the same case-mix
methodology as set forth in the CY 2008
HH PPS final rule with comment period
(72 FR 49762) and will be adjusted as
described in section III.B of this
proposed rule. The following are the
steps we take to compute the case-mix
11 ‘‘Revised Delineations of Metropolitan
Statistical Areas, Micropolitan Statistical Areas, and
Combined Statistical Areas, and Guidance on Uses
of the Delineations of These Areas’’. OMB
BULLETIN NO. 17–01. August 15, 2017. https://
www.whitehouse.gov/sites/whitehouse.gov/files/
omb/bulletins/2017/b-17-01.pdf.
12 ‘‘Revised Delineations of Metropolitan
Statistical Areas, Micropolitan Statistical Areas, and
Combined Statistical Areas, and Guidance on Uses
of the Delineations of These Areas’’. OMB
BULLETIN NO. 18–03. April 10, 2018. https://
www.whitehouse.gov/wp-content/uploads/2018/04/
OMB-BULLETIN-NO.-18-03-Final.pdf.

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and wage-adjusted 60-day episode rate
for CY 2019:
• Multiply the national 60-day
episode rate by the patient’s applicable
case-mix weight.
• Divide the case-mix adjusted
amount into a labor (76.1 percent) and
a non-labor portion (23.9 percent).
• Multiply the labor portion by the
applicable wage index based on the site
of service of the beneficiary.
• Add the wage-adjusted portion to
the non-labor portion, yielding the casemix and wage adjusted 60-day episode
rate, subject to any additional applicable
adjustments.
In accordance with section
1895(b)(3)(B) of the Act, we propose the
annual update of the HH PPS rates.
Section 484.225 sets forth the specific
annual percentage update methodology.
In accordance with § 484.225(i), for a
HHA that does not submit HH quality
data, as specified by the Secretary, the
unadjusted national prospective 60-day
episode rate is equal to the rate for the
previous calendar year increased by the
applicable HH market basket index
amount minus 2 percentage points. Any
reduction of the percentage change
would apply only to the calendar year
involved and would not be considered
in computing the prospective payment
amount for a subsequent calendar year.
Medicare pays the national,
standardized 60-day case-mix and wageadjusted episode payment on a split
percentage payment approach. The split
percentage payment approach includes
an initial percentage payment and a
final percentage payment as set forth in
§ 484.205(b)(1) and (b)(2). We may base
the initial percentage payment on the
submission of a request for anticipated
payment (RAP) and the final percentage
payment on the submission of the claim
for the episode, as discussed in § 409.43.

The claim for the episode that the HHA
submits for the final percentage
payment determines the total payment
amount for the episode and whether we
make an applicable adjustment to the
60-day case-mix and wage-adjusted
episode payment. The end date of the
60-day episode as reported on the claim
determines which calendar year rates
Medicare will use to pay the claim.
We may also adjust the 60-day casemix and wage-adjusted episode
payment based on the information
submitted on the claim to reflect the
following:
• A low-utilization payment
adjustment (LUPA) is provided on a pervisit basis as set forth in §§ 484.205(c)
and 484.230.
• A partial episode payment (PEP)
adjustment as set forth in §§ 484.205(d)
and 484.235.
• An outlier payment as set forth in
§§ 484.205(e) and 484.240.
b. CY 2019 National, Standardized 60Day Episode Payment Rate
Section 1895(b)(3)(A)(i) of the Act
requires that the 60-day episode base
rate and other applicable amounts be
standardized in a manner that
eliminates the effects of variations in
relative case-mix and area wage
adjustments among different home
health agencies in a budget neutral
manner. To determine the CY 2019
national, standardized 60-day episode
payment rate, we apply a wage index
budget neutrality factor and a case-mix
budget neutrality factor described in
section III.B of this proposed rule; and
the home health payment update
percentage discussed in section III.C.2
of this proposed rule.
To calculate the wage index budget
neutrality factor, we simulated total
payments for non-LUPA episodes using

the CY 2019 wage index (including the
application of the proposed laborrelated share of 76.1 percent and the
proposed non-labor-related share of 23.9
percent) and compared it to our
simulation of total payments for nonLUPA episodes using the CY 2018 wage
index and CY 2018 (including the
application of the current labor-related
share of 78.535 percent and the nonlabor-related of 21.465). By dividing the
total payments for non-LUPA episodes
using the CY 2019 wage index by the
total payments for non-LUPA episodes
using the CY 2018 wage index, we
obtain a wage index budget neutrality
factor of 0.9991. We would apply the
wage index budget neutrality factor of
0.9991 to the calculation of the CY 2019
national, standardized 60-day episode
payment rate.
As discussed in section III.B of this
proposed rule, to ensure the changes to
the case-mix weights are implemented
in a budget neutral manner, we propose
to apply a case-mix weight budget
neutrality factor to the CY 2019
national, standardized 60-day episode
payment rate. The case-mix weight
budget neutrality factor is calculated as
the ratio of total payments when CY
2019 case-mix weights are applied to CY
2017 utilization (claims) data to total
payments when CY 2018 case-mix
weights are applied to CY 2017
utilization data. The case-mix budget
neutrality factor for CY 2019 is 1.0163
as described in section III.B of this
proposed rule.
Next, we would update the payment
rates by the CY 2019 home health
payment update percentage of 2.1
percent as described in section III.C.2 of
this proposed rule. The CY 2019
national, standardized 60-day episode
payment rate is calculated in Table 18.

amozie on DSK3GDR082PROD with PROPOSALS2

TABLE 18—CY 2019 60-DAY NATIONAL, STANDARDIZED 60-DAY EPISODE PAYMENT AMOUNT

CY 2018 national, standardized 60-day episode payment

Wage index
budget
neutrality
factor

Case-mix
weights
budget
neutrality
factor

CY 2019 HH
payment
update

CY 2019
National,
standardized
60-day
episode
payment

$3,039.64 ..........................................................................................................

× 0.9991

× 1.0163

× 1.021

$3,151.22

The CY 2019 national, standardized
60-day episode payment rate for an
HHA that does not submit the required

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percent minus 2 percentage points and
is shown in Table 19.

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32371

TABLE 19—CY 2019 NATIONAL, STANDARDIZED 60-DAY EPISODE PAYMENT AMOUNT FOR HHAS THAT DO NOT SUBMIT
THE QUALITY DATA

CY 2018 national, standardized 60-day episode payment

Wage index
budget
neutrality
factor

Case-mix
weights
budget
neutrality
factor

CY 2019
HH payment
update minus
2 percentage
points

CY 2019
National,
standardized
60-day
episode
payment

$3,039.64 ..........................................................................................................

× 0.9991

× 1.0163

× 1.001

$3,089.49

c. CY 2019 National Per-Visit Rates
The national per-visit rates are used to
pay LUPAs (episodes with four or fewer
visits) and are also used to compute
imputed costs in outlier calculations.
The per-visit rates are paid by type of
visit or HH discipline. The six HH
disciplines are as follows:
• Home health aide (HH aide).
• Medical Social Services (MSS).
• Occupational therapy (OT).
• Physical therapy (PT).
• Skilled nursing (SN).
• Speech-language pathology (SLP).
To calculate the CY 2019 national pervisit rates, we started with the CY 2018
national per-visit rates. Then we applied
a wage index budget neutrality factor to
ensure budget neutrality for LUPA per-

visit payments. We calculated the wage
index budget neutrality factor by
simulating total payments for LUPA
episodes using the CY 2019 wage index
and comparing it to simulated total
payments for LUPA episodes using the
CY 2018 wage index. By dividing the
total payments for LUPA episodes using
the CY 2019 wage index by the total
payments for LUPA episodes using the
CY 2018 wage index, we obtained a
wage index budget neutrality factor of
1.0000. We apply the wage index budget
neutrality factor of 1.0000 in order to
calculate the CY 2019 national per-visit
rates.
The LUPA per-visit rates are not
calculated using case-mix weights.
Therefore, no case-mix weights budget

neutrality factor is needed to ensure
budget neutrality for LUPA payments.
Lastly, the per-visit rates for each
discipline are updated by the CY 2019
home health payment update percentage
of 2.1 percent. The national per-visit
rates are adjusted by the wage index
based on the site of service of the
beneficiary. The per-visit payments for
LUPAs are separate from the LUPA addon payment amount, which is paid for
episodes that occur as the only episode
or initial episode in a sequence of
adjacent episodes. The CY 2019 national
per-visit rates for HHAs that submit the
required quality data are updated by the
CY 2019 HH payment update percentage
of 2.1 percent and are shown in Table
20.

TABLE 20—CY 2019 NATIONAL PER-VISIT PAYMENT AMOUNTS FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY
DATA
HH Discipline

CY 2018
per-visit
payment

Home Health Aide ............................................................................................
Medical Social Services ...................................................................................
Occupational Therapy ......................................................................................
Physical Therapy ..............................................................................................
Skilled Nursing .................................................................................................
Speech-Language Pathology ...........................................................................

$64.94
229.86
157.83
156.76
143.40
170.38

The CY 2019 per-visit payment rates
for HHAs that do not submit the

required quality data are updated by the
CY 2019 HH payment update percentage

Wage index
budget
neutrality
factor
×
×
×
×
×
×

1.0000
1.0000
1.0000
1.0000
1.0000
1.0000

CY 2019
HH payment
update
×
×
×
×
×
×

1.021
1.021
1.021
1.021
1.021
1.021

CY 2019
per-visit
payment
$66.30
234.69
161.14
160.05
146.41
173.96

of 2.1 percent minus 2 percentage points
and are shown in Table 21.

amozie on DSK3GDR082PROD with PROPOSALS2

TABLE 21—CY 2019 NATIONAL PER-VISIT PAYMENT AMOUNTS FOR HHAS THAT DO NOT SUBMIT THE REQUIRED
QUALITY DATA

HH Discipline

CY 2018
per-visit rates

Home Health Aide ............................................................................................
Medical Social Services ...................................................................................
Occupational Therapy ......................................................................................
Physical Therapy ..............................................................................................
Skilled Nursing .................................................................................................
Speech-Language Pathology ...........................................................................

$64.94
229.86
157.83
156.76
143.40
170.38

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Wage index
budget
neutrality
factor
×
×
×
×
×
×

1.0000
1.0000
1.0000
1.0000
1.0000
1.0000

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12JYP2

CY 2019
HH payment
update minus
2 percentage
points
×
×
×
×
×
×

1.001
1.001
1.001
1.001
1.001
1.001

CY 2019
per-visit rates

$65.00
230.09
157.99
156.92
143.54
170.55

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d. Low-Utilization Payment Adjustment
(LUPA) Add-On Factors
LUPA episodes that occur as the only
episode or as an initial episode in a
sequence of adjacent episodes are
adjusted by applying an additional
amount to the LUPA payment before
adjusting for area wage differences. In
the CY 2014 HH PPS final rule (78 FR
72305), we changed the methodology for
calculating the LUPA add-on amount by
finalizing the use of three LUPA add-on
factors: 1.8451 for SN; 1.6700 for PT;
and 1.6266 for SLP. We multiply the
per-visit payment amount for the first
SN, PT, or SLP visit in LUPA episodes
that occur as the only episode or an
initial episode in a sequence of adjacent

episodes by the appropriate factor to
determine the LUPA add-on payment
amount. For example, in the case of
HHAs that do submit the required
quality data, for LUPA episodes that
occur as the only episode or an initial
episode in a sequence of adjacent
episodes, if the first skilled visit is SN,
the payment for that visit will be
$270.14 (1.8451 multiplied by $146.41),
subject to area wage adjustment.
e. CY 2019 Non-Routine Medical
Supply (NRS) Payment Rates
All medical supplies (routine and
nonroutine) must be provided by the
HHA while the patient is under a home
health plan of care. Examples of
supplies that can be considered non-

routine include dressings for wound
care, I.V. supplies, ostomy supplies,
catheters, and catheter supplies.
Payments for NRS are computed by
multiplying the relative weight for a
particular severity level by the NRS
conversion factor. To determine the CY
2019 NRS conversion factor, we
updated the CY 2018 NRS conversion
factor ($53.03) by the CY 2019 home
health payment update percentage of 2.1
percent. We did not apply a
standardization factor as the NRS
payment amount calculated from the
conversion factor is not wage or casemix adjusted when the final claim
payment amount is computed. The
proposed NRS conversion factor for CY
2019 is shown in Table 22.

TABLE 22—CY 2019 NRS CONVERSION FACTOR FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY DATA
CY 2018 NRS conversion factor

CY 2019
HH payment
update

CY 2019
NRS
conversion
factor

$53.03 ......................................................................................................................................................................

× 1.021

$54.14

Using the CY 2019 NRS conversion
factor, the payment amounts for the six
severity levels are shown in Table 23.

TABLE 23—CY 2019 NRS PAYMENT AMOUNTS FOR HHAS THAT DO SUBMIT THE REQUIRED QUALITY DATA
Severity level
1
2
3
4
5
6

...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................

For HHAs that do not submit the
required quality data, we updated the
CY 2018 NRS conversion factor ($53.03)

by the CY 2019 home health payment
update percentage of 2.1 percent minus
2 percentage points. The proposed CY

Points
(scoring)

Relative
weight

CY 2019
NRS payment
amounts

0
1 to 14
15 to 27
28 to 48
49 to 98
99+

0.2698
0.9742
2.6712
3.9686
6.1198
10.5254

$ 14.61
52.74
144.62
214.86
331.33
569.85

2019 NRS conversion factor for HHAs
that do not submit quality data is shown
in Table 24.

amozie on DSK3GDR082PROD with PROPOSALS2

TABLE 24—CY 2019 NRS CONVERSION FACTOR FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA

CY 2018 NRS conversion factor

CY 2019
HH payment
update
percentage
minus
2 percentage
points

CY 2019
NRS
conversion
factor

$53.03 ......................................................................................................................................................................

× 1.001

$53.08

The payment amounts for the various
severity levels based on the updated

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Table 25.

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32373

TABLE 25—CY 2019 NRS PAYMENT AMOUNTS FOR HHAS THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA
Severity level

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1
2
3
4
5
6

...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................

D. Proposed Rural Add-On Payments for
CYs 2019 Through 2022

described in CMS Transmittal 2047
published on March 20, 2018.

1. Background
Section 421(a) of the MMA required,
for HH services furnished in a rural
areas (as defined in section
1886(d)(2)(D) of the Act), for episodes or
visits ending on or after April 1, 2004,
and before April 1, 2005, that the
Secretary increase the payment amount
that otherwise would have been made
under section 1895 of the Act for the
services by 5 percent.
Section 5201 of the DRA amended
section 421(a) of the MMA. The
amended section 421(a) of the MMA
required, for HH services furnished in a
rural area (as defined in section
1886(d)(2)(D) of the Act), on or after
January 1, 2006, and before January 1,
2007, that the Secretary increase the
payment amount otherwise made under
section 1895 of the Act for those
services by 5 percent.
Section 3131(c) of the Affordable Care
Act amended section 421(a) of the MMA
to provide an increase of 3 percent of
the payment amount otherwise made
under section 1895 of the Act for HH
services furnished in a rural area (as
defined in section 1886(d)(2)(D) of the
Act), for episodes and visits ending on
or after April 1, 2010, and before
January 1, 2016.
Section 210 of the MACRA amended
section 421(a) of the MMA to extend the
rural add-on by providing an increase of
3 percent of the payment amount
otherwise made under section 1895 of
the Act for HH services provided in a
rural area (as defined in section
1886(d)(2)(D) of the Act), for episodes
and visits ending before January 1, 2018.
Section 50208(a) of the Bipartisan
Budget Act of 2018 amended section
421(a) of the MMA to extend the rural
add-on by providing an increase of 3
percent of the payment amount
otherwise made under section 1895 of
the Act for HH services provided in a
rural area (as defined in section
1886(d)(2)(D) of the Act), for episodes
and visits ending before January 1, 2019.
This extension of the rural add-on
payments was implemented as

2. Proposed Rural Add-On Payments for
CYs 2019 Through 2022

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Section 50208(a)(1)(D) of the BBA of
2018 adds a new subsection (b) to
section 421 of the MMA to provide rural
add-on payments for episodes and visits
ending during CYs 2019 through 2022 .
It also mandates implementation of a
new methodology for applying those
payments. Unlike previous rural addons, which were applied to all rural
areas uniformly, the extension provides
varying add-on amounts depending on
the rural county (or equivalent area)
classification by classifying each rural
county (or equivalent area) into one of
three distinct categories.
Specifically, section 421(b)(1) of the
MMA, as amended by section 50208 of
the BBA of 2018, provides that rural
counties (or equivalent areas) would be
placed into one of three categories for
purposes of HH rural add-on payments:
(1) Rural counties and equivalent areas
in the highest quartile of all counties
and equivalent areas based on the
number of Medicare home health
episodes furnished per 100 individuals
who are entitled to, or enrolled for,
benefits under part A of Medicare or
enrolled for benefits under part B of
Medicare only, but not enrolled in a
Medicare Advantage plan under part C
of Medicare, as provided in section
421(b)(1)(A) of the MMA (the ‘‘High
utilization’’ category); (2) rural counties
and equivalent areas with a population
density of 6 individuals or fewer per
square mile of land area and are not
included in the category provided in
section 421(b)(1)(A) of the MMA, as
provided in section 421(b)(1)(B) of the
MMA (the Low population density’’
category); and (3) rural counties and
equivalent areas not in the categories
provided in either sections 421(b)(1)(A)
or 421(b)(1)(B) of the MMA, as provided
in section 421(b)(1)(C) of the MMA (the
‘‘All other’’ category). The list of
counties and equivalent areas used in
our analysis is based on the CY 2015 HH
PPS wage index file, which includes the

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Points
(scoring)

Relative
weight

CY 2019
NRS payment
amounts

0
1 to 14
15 to 27
28 to 48
49 to 98
99+

0.2698
0.9742
2.6712
3.9686
6.1198
10.5254

$ 14.32
51.71
141.79
210.65
324.84
558.69

names of the constituent counties for
each rural and urban area designation.
We used the 2015 HH PPS wage index
file as the basis for our analysis because
the 2015 HH PPS wage index file
already included SSA state and county
codes not normally included on the HH
PPS wage index files, but were included
in the 2015 HH PPS wage index file due
to the transition to new OMB geographic
area delineations that year. The CY 2015
HH PPS wage index file is available for
download at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/HomeHealthPPS/HomeHealth-Prospective-Payment-SystemRegulations-and-Notices-Items/CMS1611-F.html. This file includes 3,246
counties and equivalent areas and their
urban and rural status and uses the
OMB’s geographic area delineations, as
described in section III.C.3 of this
proposed rule. We updated the
information contained in this file to
include any revisions to the geographic
area delineations as published by the
OMB in their publicly available
bulletins that would reflect a change in
urban and rural status. The states, the
District of Columbia, and the U.S.
territories of Guam, Puerto Rico, and the
U.S. Virgin Islands are included in the
analysis file containing 3,246 counties
and equivalent areas. Of the 3,246 total
counties and equivalent areas that were
used in our analysis, 2,006 of these are
considered rural for purposes of
determining HH rural add-on payments.
We identify equivalent areas based on
the definition of equivalent entities as
defined by the OMB in their most recent
bulletin (No. 18–03) available at https://
www.whitehouse.gov/wp-content/
uploads/2018/04/OMB-BULLETIN-NO.18-03-Final.pdf.13 We consider
boroughs and a municipality in Alaska,
parishes in Louisiana, municipios in
Puerto Rico, and independent cities in
13 ‘‘Revised Delineations of Metropolitan
Statistical Areas, Micropolitan Statistical Areas, and
Combined Statistical Areas, and Guidance on Uses
of the Delineations of These Areas’’. OMB
BULLETIN NO. 18–03. April 10, 2018. https://
www.whitehouse.gov/wp-content/uploads/2018/04/
OMB-BULLETIN-NO.-18-03-Final.pdf.

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Maryland, Missouri, Nevada, and
Virginia as equivalent areas.
Under section 421(b)(1)(A) of the
MMA, one category of rural counties
and equivalent areas for purposes of the
HH rural add-on payment is a category
comprised of rural counties or
equivalent areas that are in the highest
quartile of all counties or equivalent
areas based on the number of Medicare
home health episodes furnished per 100
Medicare beneficiaries. Section
421(b)(2)(B)(i) of the MMA requires the
use of data from 2015 to determine
which counties or equivalent areas are
in the highest quartile of home health
utilization for the category described
under section 421(b)(1)(A) of the MMA,
that is, the ‘‘High utilization’’ category.
Section 421(b)(2)(B)(ii) of the MMA
requires that data from the territories are
to be excluded in determining which
counties or equivalent areas are in the
highest quartile of home health
utilization and requires that the
territories be excluded from the category
described by section 421(b)(1)(A) of the
MMA. Under section 421(b)(2)(B)(iii) of
the MMA, the Secretary may exclude
data from counties or equivalent areas
in rural areas with a low volume of
home health episodes in determining
which counties or equivalent areas are
in the highest quartile of home health
utilization. If data is excluded for a
county or equivalent area, section
421(b)(2)(B)(iii) of the MMA requires
that the county or equivalent area be
excluded from the category described by
section 421(b)(1)(A) of the MMA (the
‘‘High utilization’’ category).
We used CY 2015 claims data and
2015 data from the Medicare Beneficiary
Summary File to classify rural counties
and equivalent areas into the ‘‘High
utilization’’ category. We propose to
classify a rural county or equivalent area
into this category if the county or
equivalent area is in the highest quartile
(top 25th percentile) of all (urban and
rural) counties and equivalent areas
based on the ratio of Medicare home
health episodes furnished per 100
Medicare enrollees. The Medicare
Beneficiary Summary File contained
information on the Social Security
Administration (SSA) state and county
code of the beneficiary’s mailing
address and information on enrollment
in Medicare Part A, B, and C during
2015. The claims data and information
from the Medicare Beneficiary Summary
File were pulled from the Chronic
Condition Warehouse Virtual Research
Data Center during December 2017. We
used the claims data to determine how
many home health episodes (excluding
Requests for Anticipated Payments
(RAPs) and zero payment episodes)

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occurred in each state and county or
equivalent area. We assigned each home
health episode to the state and county
code of the beneficiary’s mailing
address. As stipulated by section
421(b)(2)(B)(ii) of the MMA, we
excluded any data from the territories of
Guam, Puerto Rico, and the U.S. Virgin
Islands for determining which rural
counties and equivalent areas belong in
the ‘‘High utilization’’ category. We note
that the territories of American Samoa
and the Northern Mariana Islands were
not included in the CY 2015 HH PPS
wage index file to identify counties or
equivalent areas for these territories so
no data from these territories were
included in determining the ‘‘High
utilization’’ category. As we are not
aware of any Medicare home health
services being furnished in these two
territories in recent years, we will
address any application of home health
rural add-on payments for these
territories in the future should Medicare
home health services be furnished in
them. Therefore, counties and
equivalent areas in the territories of
American Samoa, Guam, the Northern
Mariana Islands, Puerto Rico, and the
U.S. Virgin Islands are not included in
the ‘‘High utilization’’ category, as
required by section 421(b)(2)(B)(ii) of
the MMA. In addition, under the
authority granted to the Secretary (by
section 421(b)(2)(B)(iii) of the MMA) to
exclude data from counties or
equivalent areas in rural areas with a
low volume of home health episodes,
we excluded data from rural counties
and equivalent areas that had 10 or
fewer episodes during 2015 for
determining which counties and
equivalent areas belong in the ‘‘High
utilization’’ category. We believe that
using a threshold of 10 or fewer
episodes is a reasonable threshold for
defining low volume, in accordance
with section 421(b)(2)(B)(iii) of the
MMA. After excluding data from (1) the
territories of Guam, Puerto Rico, and the
U.S. Virgin Islands and (2) counties and
equivalent areas that had 10 or fewer
episodes during 2015, we determined
the number of home health episodes
furnished per 100 enrollees for the
remaining counties and equivalent
areas. We determined that the counties
or equivalent areas in the highest
quartile have a ratio of episodes to
beneficiaries that is at or above
17.72487. The highest quartile consisted
of 778 counties or equivalent areas. Of
those 778 counties or equivalent areas,
510 are rural and, therefore, we propose
to classify these 510 rural counties or
equivalent areas into the ‘‘High
utilization’’ category.

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Under section 421(b)(1)(B) of the
MMA, another category of rural counties
and equivalent areas for purposes of the
HH rural add-on payment is a category
comprised of rural counties or
equivalent areas with a population
density of 6 individuals or fewer per
square mile of land area and that are not
included in the ‘‘High utilization’’
category. Section 421(b)(2)(C) of the
MMA requires that data from the 2010
decennial Census be used for purposes
of determining population density with
respect to the category provided under
section 421(b)(1)(B) of the MMA, that is,
the ‘‘Low population density’’ category.
We used 2010 Census data gathered
from the tables provided at: https://
factfinder.census.gov/bkmk/table/1.0/
en/DEC/10_SF1/GCTPH1.US05PR and
https://www.census.gov/data/tables/
time-series/dec/cph-series/cph-t/cph-t8.html to determine which counties and
equivalent areas have a population
density of six individuals or fewer per
square mile of land area.14 15 In
examining the rural counties and
equivalent areas that were not already
classified into the ‘‘High utilization’’
category, we identified each rural
county or equivalent area that had a
population density of six individuals or
fewer per square mile of land area. As
a result of that analysis, we determined
there are 334 rural counties or
equivalent areas that have a population
density of six individuals or fewer per
square mile of land area and that are not
already classified into the ‘‘High
utilization’’ category. We propose to
classify 334 rural counties or equivalent
areas into the ‘‘Low population density’’
category.
Lastly, section 421(b)(1)(C) of the
MMA provides for a category comprised
of rural counties or equivalent areas that
are not included in either the ‘‘High
utilization’’ or the ‘‘Low population
density’’ category. After determining
which rural counties and equivalent
areas should be classified into the ‘‘High
utilization’’ and ‘‘Low population
density’’ categories, we have determined
that there are 1,162 remaining rural
counties and equivalent areas that do
not meet the criteria for inclusion in the
‘‘High utilization’’ or ‘‘Low population
density’’ categories. We propose to
classify these 1,162 rural counties and
14 ‘‘Population, Housing Units, Area, and Density:
2010—United States—County by State; and for
Puerto Rico 2010 Census Summary File 1’’. https://
factfinder.census.gov/bkmk/table/1.0/en/DEC/10_
SF1/GCTPH1.US05PR.
15 ‘‘Population, Housing Units, Land Area, and
Density for U.S. Island Areas: 2010 (CPH–T–8)’’. 10/
28/2013. https://www.census.gov/data/tables/timeseries/dec/cph-series/cph-t/cph-t-8.html.

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equivalent areas into the ‘‘All other’’
category.
Section 421(b)(1) of the MMA
specifies varying rural add-on payment
percentages and varying durations of
rural add-on payments for home health
services furnished in a rural county or
equivalent area according to which
category described in section
421(b)(1)(A), 421(b)(1)(B), or

421(b)(1)(C) of the MMA that the rural
county or equivalent area is classified
into. The rural add-on payment
percentages and duration of rural addon payments are shown in Table 26. The
national standardized 60-day episode
payment rate, the national per-visit
rates, and the NRS conversion factor
will be increased by the rural add-on

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payment percentages as noted in Table
26 when services are provided in rural
areas. The HH Pricer module, located
within CMS’ claims processing system,
will increase the base payment rates
provided in Tables 18 through 25 by the
appropriate rural add-on percentage
prior to applying any case-mix and wage
index adjustments.

TABLE 26—HH PPS RURAL ADD-ON PERCENTAGES, CYS 2019–2022
CY 2019
(%)

Category

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High utilization .................................................................................................
Low population density ....................................................................................
All other ............................................................................................................

Section 421(b)(2)(A) of the MMA
provides that the Secretary shall make a
determination only for a single time as
to which category under sections
421(b)(1)(A), 421(b)(1)(B), or
421(b)(1)(C) of the MMA that a rural
county or equivalent area is classified
into, and that the determination applies
for the entire duration of the period for
which rural add-on payments are in
place under section 421(b) of the MMA.
We propose that our proposed
classifications of rural counties and
equivalent areas in the ‘‘High
utilization’’, ‘‘Low population density’’,
and ‘‘All other’’ categories would be
applicable throughout the period of
rural add-on payments established
under section 421(b) of the MMA and
there would be no changes in
classifications. This would mean that a
rural county or equivalent area
classified into the ‘‘High utilization’’
category would remain in that category
through CY 2022 even after rural addon payments for that category ends after
CY 2020. Similarly, a rural county or
equivalent area classified into the ‘‘All
other’’ category would remain in that
category through CY 2022 even after
rural add-on payments for that category
ends after CY 2021. A rural county or
equivalent area classified into the ‘‘Low
population density’’ category would
remain in that category through CY
2022.
Section 421(b)(3) of the MMA
provides that there shall be no
administrative or judicial review of the
classification determinations made for
the rural add-on payments under
section 421(b)(1) of the MMA.
Section 50208(a)(2) of the Bipartisan
Budget Act of 2018 amended section
1895(c) of the Act by adding a new
requirement set out at section 1895(c)(3)
of the Act. This requirement states that
no claim for home health services may

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CY 2020
(%)
1.5
4.0
3.0

be paid unless ‘‘in the case of home
health services furnished on or after
January 1, 2019, the claim contains the
code for the county (or equivalent area)
in which the home health service was
furnished.’’ This information will be
necessary in order to calculate the rural
add-on payments. We are proposing that
HHAs enter the FIPS state and county
code, rather than the SSA state and
county code, on the claim. Many HHAs
are more familiar with using FIPS state
and county codes since HHAs in a
number of States are already using FIPS
state and county codes for Statemandated reporting programs. Our
analysis is based entirely on the SSA
state and county codes as these are the
codes that are included in the Medicare
Beneficiary Summary File. We crosswalked the SSA state and county codes
used in our analysis to the FIPS state
and county codes in order to provide
HHAs with the corresponding FIPS state
and county codes that should be
reported on their claims.
The data used to categorize each
county or equivalent area is available in
the Downloads section associated with
the publication of this proposed rule at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HomeHealthPPS/Home-HealthProspective-Payment-SystemRegulations-and-Notices-Items/CMS1689-P.html. In addition, an Excel file
containing the rural county or
equivalent area names, their FIPS state
and county codes, and their designation
into one of the three rural add-on
categories is available for download.
We are soliciting comments regarding
our application of the methodology
specified by section 50208 of the
Bipartisan Budget Act of 2018.

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0.5
3.0
2.0

CY 2021
(%)

CY 2022
(%)

........................
2.0
1.0

........................
1.0
........................

E. Proposed Payments for High-Cost
Outliers Under the HH PPS
1. Background
Section 1895(b)(5) of the Act allows
for the provision of an addition or
adjustment to the home health payment
amount otherwise made in the case of
outliers because of unusual variations in
the type or amount of medically
necessary care. Under the HH PPS,
outlier payments are made for episodes
whose estimated costs exceed a
threshold amount for each Home Health
Resource Group (HHRG). The episode’s
estimated cost was established as the
sum of the national wage-adjusted pervisit payment amounts delivered during
the episode. The outlier threshold for
each case-mix group or Partial Episode
Payment (PEP) adjustment is defined as
the 60-day episode payment or PEP
adjustment for that group plus a fixeddollar loss (FDL) amount. For the
purposes of the HH PPS, the FDL
amount is calculated by multiplying the
HH FDL ratio by a case’s wage-adjusted
national, standardized 60-day episode
payment rate, which yields an FDL
dollar amount for the case. The outlier
threshold amount is the sum of the wage
and case-mix adjusted PPS episode
amount and wage-adjusted FDL amount.
The outlier payment is defined to be a
proportion of the wage-adjusted
estimated cost beyond the wageadjusted threshold. The proportion of
additional costs over the outlier
threshold amount paid as outlier
payments is referred to as the losssharing ratio.
As we noted in the CY 2011 HH PPS
final rule (75 FR 70397 through 70399),
section 3131(b)(1) of the Affordable Care
Act amended section 1895(b)(3)(C) of
the Act, and required the Secretary to
reduce the HH PPS payment rates such
that aggregate HH PPS payments were

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reduced by 5 percent. In addition,
section 3131(b)(2) of the Affordable Care
Act amended section 1895(b)(5) of the
Act by redesignating the existing
language as section 1895(b)(5)(A) of the
Act, and revising the language to state
that the total amount of the additional
payments or payment adjustments for
outlier episodes could not exceed 2.5
percent of the estimated total HH PPS
payments for that year. Section
3131(b)(2)(C) of the Affordable Care Act
also added section 1895(b)(5)(B) of the
Act which capped outlier payments as
a percent of total payments for each
HHA at 10 percent.
As such, beginning in CY 2011, we
reduce payment rates by 5 percent and
target up to 2.5 percent of total
estimated HH PPS payments to be paid
as outliers. To do so, we first returned
the 2.5 percent held for the target CY
2010 outlier pool to the national,
standardized 60-day episode rates, the
national per visit rates, the LUPA addon payment amount, and the NRS
conversion factor for CY 2010. We then
reduced the rates by 5 percent as
required by section 1895(b)(3)(C) of the
Act, as amended by section 3131(b)(1) of
the Affordable Care Act. For CY 2011
and subsequent calendar years we target
up to 2.5 percent of estimated total
payments to be paid as outlier
payments, and apply a 10 percent
agency-level outlier cap.
In the CY 2017 HH PPS proposed and
final rules (81 FR 43737 through 43742
and 81 FR 76702), we described our
concerns regarding patterns observed in
home health outlier episodes.
Specifically, we noted that the
methodology for calculating home
health outlier payments may have
created a financial incentive for
providers to increase the number of
visits during an episode of care in order
to surpass the outlier threshold; and
simultaneously created a disincentive
for providers to treat medically complex
beneficiaries who require fewer but
longer visits. Given these concerns, in
the CY 2017 HH PPS final rule (81 FR
76702), we finalized changes to the
methodology used to calculate outlier
payments, using a cost-per-unit
approach rather than a cost-per-visit
approach. This change in methodology
allows for more accurate payment for
outlier episodes, accounting for both the
number of visits during an episode of
care and also the length of the visits
provided. Using this approach, we now
convert the national per-visit rates into
per 15-minute unit rates. These per 15minute unit rates are used to calculate
the estimated cost of an episode to
determine whether the claim will
receive an outlier payment and the

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amount of payment for an episode of
care. In conjunction with our finalized
policy to change to a cost-per-unit
approach to estimate episode costs and
determine whether an outlier episode
should receive outlier payments, in the
CY 2017 HH PPS final rule we also
finalized the implementation of a cap on
the amount of time per day that would
be counted toward the estimation of an
episode’s costs for outlier calculation
purposes (81 FR 76725). Specifically,
we limit the amount of time per day
(summed across the six disciplines of
care) to 8 hours (32 units) per day when
estimating the cost of an episode for
outlier calculation purposes.
We plan to publish the cost-per-unit
amounts for CY 2019 in the rate update
change request, which is issued after the
publication of the CY 2019 HH PPS final
rule. We note that in the CY 2017 HH
PPS final rule (81 FR 76724), we stated
that we did not plan to re-estimate the
average minutes per visit by discipline
every year. Additionally, we noted that
the per-unit rates used to estimate an
episode’s cost will be updated by the
home health update percentage each
year, meaning we would start with the
national per-visit amounts for the same
calendar year when calculating the costper-unit used to determine the cost of an
episode of care (81 FR 76727). We note
that we will continue to monitor the
visit length by discipline as more recent
data become available, and we may
propose to update the rates as needed in
the future.
2. Proposed Fixed Dollar Loss (FDL)
Ratio
For a given level of outlier payments,
there is a trade-off between the values
selected for the FDL ratio and the losssharing ratio. A high FDL ratio reduces
the number of episodes that can receive
outlier payments, but makes it possible
to select a higher loss-sharing ratio, and
therefore, increase outlier payments for
qualifying outlier episodes.
Alternatively, a lower FDL ratio means
that more episodes can qualify for
outlier payments, but outlier payments
per episode must then be lower.
The FDL ratio and the loss-sharing
ratio must be selected so that the
estimated total outlier payments do not
exceed the 2.5 percent aggregate level
(as required by section 1895(b)(5)(A) of
the Act). Historically, we have used a
value of 0.80 for the loss-sharing ratio
which, we believe, preserves incentives
for agencies to attempt to provide care
efficiently for outlier cases. With a losssharing ratio of 0.80, Medicare pays 80
percent of the additional estimated costs
above the outlier threshold amount.

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Simulations based on CY 2015 claims
data (as of June 30, 2016) completed for
the CY 2017 HH PPS final rule showed
that outlier payments were estimated to
represent approximately 2.84 percent of
total HH PPS payments in CY 2017, and
as such, we raised the FDL ratio from
0.45 to 0.55. We stated that raising the
FDL ratio to 0.55, while maintaining a
loss-sharing ratio of 0.80, struck an
effective balance of compensating for
high-cost episodes while still meeting
the statutory requirement to target up to,
but no more than, 2.5 percent of total
payments as outlier payments (81 FR
76726). The national, standardized 60day episode payment amount is
multiplied by the FDL ratio. That
amount is wage-adjusted to derive the
wage-adjusted FDL amount, which is
added to the case-mix and wageadjusted 60-day episode payment
amount to determine the outlier
threshold amount that costs have to
exceed before Medicare would pay 80
percent of the additional estimated
costs.
For this proposed rule, simulating
payments using preliminary CY 2017
claims data (as of March 2, 2018) and
the CY 2018 HH PPS payment rates (82
FR 51676), we estimate that outlier
payments in CY 2018 would comprise
2.30 percent of total payments. Based on
simulations using CY 2017 claims data
(as of March 2, 2018) and the proposed
CY 2019 payment rates presented in
section III.C.4 of this proposed rule, we
estimate that outlier payments would
constitute approximately 2.32 percent of
total HH PPS payments in CY 2019. Our
simulations show that the FDL ratio
would need to be changed from 0.55 to
0.51 to pay up to, but no more than, 2.5
percent of total payments as outlier
payments in CY 2019.
Given the statutory requirement that
total outlier payments not exceed 2.5
percent of the total payments estimated
to be made based under the HH PPS, we
are proposing to lower the FDL ratio for
CY 2019 from 0.55 to 0.51 to better
approximate the 2.5 percent statutory
maximum. However, we note that we
are not proposing a change to the losssharing ratio (0.80) for the HH PPS to
remain consistent with payment for
high-cost outliers in other Medicare
payment systems (for example, IRF PPS,
IPPS, etc.). We note that in the final
rule, we will update our estimate of
outlier payments as a percent of total
HH PPS payments using the most
current and complete year of HH PPS
data (CY 2017 claims data as of June 30,
2018 or later) and therefore, we may
adjust the final FDL ratio accordingly.
We invite public comments on the

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proposed change to the FDL ratio for CY
2019.
3. Home Health Outlier Payments:
Clinical Example
In recent months, concerns regarding
the provision of home health care for
Medicare patients with chronic,
complex conditions have been raised by
stakeholders as well as the
press.16 17 18 19 News stories and
anecdotal reports indicate that Medicare
patients with chronic conditions may be
encountering difficulty in accessing
home health care if the goal of home
health care is to maintain or prevent
further decline of the patient’s condition
rather than improvement of the patient’s
condition. While patients must require
skilled care to be eligible to receive
services under the Medicare home
health benefit, as outlined in regulation
at 42 CFR 409.42(c), we note that
coverage does not turn on the presence
or absence of an individual’s potential
for improvement, but rather on the
beneficiary’s need for skilled care.
Skilled care is covered where such
services are necessary to maintain the
patient’s current condition or prevent or
slow further deterioration so long as the
beneficiary requires skilled care for the
services to be safely and effectively
provided. Additionally, there appears to
be confusion among the HHA provider
community regarding possible Medicare
payment through the HH PPS, as it
appears that some perceive that
payment is somewhat fixed and not able
to account for home health stays with
higher costs.
The news stories referenced an
individual with amyotrophic lateral
sclerosis (ALS), also known as Lou
Gehrig’s disease, and the difficulties
encountered in finding Medicare home
health care. Below we describe a
clinical example of how care for a
patient with ALS could qualify for an
additional outlier payment, which
would serve to offset unusually high
costs associated with providing home
health to a patient with unusual
variations in the amount of medically
necessary care. This example, using

payment policies in place for CY 2018,
is provided for illustrative purposes
only. We hope that in providing the
example below, which illustrates how
HHAs could be paid by Medicare for
providing care to patients with higher
resource use in their homes, and by
reiterating that the patient’s condition
does not need to improve for home
health services to be covered by
Medicare, that there will be a better
understanding of Medicare coverage
policies and how outlier payments
promote access to home health services
for such patients under the HH PPS.
a. Clinical Scenario
Amyotrophic Lateral Sclerosis (ALS)
is a progressive neuromuscular
degenerative disease. The incidence
rates of ALS have been increasing over
the last few decades, and the peak
incidence rate occurs at age 75.20 The
prevalence rate of ALS in the United
States is 4.3 per 100,000 population.21
Half of all people affected with ALS live
at least 3 or more years after diagnosis.
Twenty percent live 5 years or more; up
to 10 percent will live more than 10
years.22 Because of the progressive
nature of this disease, care needs change
and generally intensify as different body
systems are affected. As such, patients
with ALS often require a
multidisciplinary approach to meet
their care needs.
The clinical care of a beneficiary with
ALS typically includes the ongoing
assessment of and treatment for many
impacts to the body systems. As a part
of a home health episode, a skilled
nurse could assess the patient for
shortness of breath, mucus secretions,
sialorrhea, pressure sores, and pain.
From these assessments, the nurse could
speak with the doctor about changes to
the care plan. A nurse’s aide could
provide assistance with bathing,
dressing, toileting, and transferring.
Physical therapy services could also
help the patient with range of motion
exercises, adaptive transfer techniques,
and assistive devices in order to
maintain a level of function.
The following is a description of how
the provision of services per the home

32377

health plan of care could emerge for a
beneficiary with ALS who qualifies for
the Medicare home health benefit. We
note that this example is provided for
illustrative purposes only and does not
constitute a specific Medicare payment
scenario.
b. Example One: Home Health Episodes
1 and 2
A beneficiary with ALS may be
assessed by a physician in the
community and subsequently be
deemed to require home health services
for skilled nursing, physical therapy,
occupational therapy, and a home
health aide. The beneficiary could
receive skilled nursing twice a week for
45 minutes to assess dyspnea when
transferring to a bedside commode,
stage two pressure ulcer at the sacrum,
and pain status. In addition, a home
health aide could provide services for
three hours in the morning and three
hours in the afternoon on Monday,
Wednesday, and Friday and two and a
half hours in the morning and 2.5 hours
in the afternoon on Tuesday and
Thursdays to assist with bathing,
dressing, and transferring. Physical
therapy services twice a week for 45
minutes could be provided for adaptive
transfer techniques, and occupational
therapy services could be supplied
twice a week for 45 minutes for
assessment and teaching of assistive
devices for activities of daily living to
prevent or slow deterioration of the
patient’s condition. Given the patient’s
clinical presentation, for the purpose of
this specific example, we will assign the
patient payment group 40331 (C3F3S1
with 20+ therapy visits).
For the purposes of this example, we
assume that services are rendered per
week for a total of 8 weeks per home
health episode. For both the first and
second home health episodes of care,
the calculation to determine outlier
payment utilizing payment amounts and
case mix weights for CY 2018, as
described in the CY 2018 HH PPS final
rule (82 FR 51676), would be as follows,
per 60-day episode:

TABLE 27—CLINICAL SCENARIO CALCULATION TABLE: EPISODES 1 AND 2

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HH outlier—CY 2018 illustrative values

Value

National, Standardized 60-day Episode Payment Rate ....................................
16 https://www.npr.org/sections/health-shots/
2018/01/17/578423012/home-care-agencies-oftenwrongly-deny-medicare-help-to-the-chronically-ill.
17 http://www.alsa.org/als-care/resources/fyi/
medicare-and-home-health-care.html.

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$3,039.64

Operation

Adjuster

Equals

Output

..................

..................

..................

..................

18 https://patientworthy.com/2018/01/31/
chronically-ill-are-being-denied-medicare-coverageby-home-care-agencies/.
19 https://alsnewstoday.com/2018/05/09/alsmedicare-cover-home-healthcare/.

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20 Worms PM, The epidemiology of motor neuron
diseases: A review of recent studies. J Neurol Sci.
2001;191(1–2):3.
21 Mehta P, Prevalence of Amyotrophic Lateral
Sclerosis—United States, 2012–2013. MMWR
Surveill Summ. 2016;65(8):1. Epub 2016 Aug 5.
22 http://www.alsa.org.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 27—CLINICAL SCENARIO CALCULATION TABLE: EPISODES 1 AND 2—Continued
HH outlier—CY 2018 illustrative values

Value

Operation

Adjuster

Equals

Output

2.1359
3,039.64
6,492.37
6,492.37

..................
*
*
*

..................
2.1359
0.78535
0.21465

..................
=
¥
=

..................
6,492.37
5,098.78
1,393.59

1.2781

..................

..................

..................

..................

5,098.78
51.66

*
..................

1.2781
..................

=
=

6,516.75
51.66

..................

..................

..................

=

7,962.00

Case-Mix Weight for Payment Group 4.0331 (for C3F3S1 for 20+ therapy ) ..
Case-Mix Adjusted Episode Payment Amount ..................................................
Labor Portion of the Case-Mix Adjusted Episode Payment Amount ................
Non-Labor Portion of the Case-Mix Adjusted Episode Payment Amount ........
Wage Index Value (Beneficiary resides in 31084, Los Angeles-Long BeachGlendale, CA) .................................................................................................
Wage-Adjusted Labor Portion of the Case-Mix Adjusted Episode Payment
Amount ...........................................................................................................
NRS Payment Amount (Severity Level 2) .........................................................
Total Case-Mix and Wage-Adjusted Episode Payment Amount (WageAdjusted Labor Portion plus Non-Labor Portion of the Case-Mix Adjusted Episode Payment Amount plus the NRS Amount) ......................
Total Wage-Adjusted Fixed Dollar Loss Amount:
Fixed Dollar Loss Amount (National, Standardized 60-day Episode Payment Rate * FDL Ratio) ..........................................................................
Labor Portion of the Fixed Dollar Loss Amount .........................................
Non-Labor Amount of the Fixed Dollar Loss Amount ................................
Wage-Adjusted Fixed Dollar Loss Amount ................................................
Total Wage-Adjusted Fixed Dollar Loss Amount (Wage-Adjusted
Labor Portion plus Non-Labor Portion of the Case-Mix Adjusted
Fixed Dollar Loss Amount) ..............................................................
Total Wage-Adjusted Imputed Cost Amount:
National Per-Unit Payment Amount—Skilled Nursing ................................
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed Skilled Nursing Visit Costs (National Per-Unit Payment Amount
* Number of Units) ..................................................................................
National Per-Unit Payment Amount—Home Health Aide ..........................
Number of 15-minute units (28 hours per week = 112 units per week for
8 weeks) ..................................................................................................
Imputed Home Health Aide Costs (National Per-Unit Payment Amount *
Number of Units) .....................................................................................
National Per-Unit Payment Amount—Occupational Therapy (OT) ............
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed OT Visit Costs (National Per-Unit Payment Amount * Number of
Units) .......................................................................................................
National Per-Unit Payment Amount—Physical Therapy (PT) ....................
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed PT Visit Costs (National Per-Unit Payment Amount * Number of
Units) .......................................................................................................

amozie on DSK3GDR082PROD with PROPOSALS2

Total Imputed Cost Amount for all Disciplines ....................................
Labor Portion of the Imputed Costs for All Disciplines ..............................
Non-Labor Portion of Imputed Cost Amount for All Disciplines .................
CBSA Wage Index (Beneficiary resides in 31084, Los Angeles-Long
Beach-Glendale, CA) ..............................................................................
Wage-Adjusted Labor Portion of the Imputed Cost Amount for All Disciplines ....................................................................................................
Total Wage-Adjusted Imputed Cost Amount (Wage-Adjusted Labor
Portion of the Imputed Cost Amount plus Non-Labor Portion of
the Imputed Cost Amount) ...............................................................
Total Payment Per 60-Day Episode:
Outlier Threshold Amount (Total Wage-Adjusted Fixed Dollar Loss
Amount + Total Case-Mix and Wage-Adjusted Episode Payment
Amount) ...................................................................................................
Total Wage-Adjusted Imputed Cost Amount—Outlier Threshold Amount
(Total Wage-Adjusted Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount) ...........................................
Outlier Payment = Imputed Costs Greater Than the Outlier Threshold *
Loss-Sharing Ratio (0.80) .......................................................................

17:39 Jul 11, 2018

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Frm 00040

Fmt 4701

*
*
*
*

0.55
0.78535
0.21465
1.2781

=
=
=
=

1,671.80
1,312.95
358.85
1,678.08

1,678.08

+

358.85

=

2,036.93

48.01

..................

..................

..................

..................

48

..................

..................

..................

..................

48.01
15.46

*
..................

48
..................

=
..................

2,304.48
..................

896

..................

..................

..................

..................

15.46
50.26

*
..................

896
..................

=
..................

13,852.16
..................

48

..................

..................

..................

..................

50.26
50.46

*
..................

48
..................

=
..................

2,412.48
..................

48

..................

..................

..................

..................

50.46

*

48

=

2,422.08

..................
20,991.20
20,991.20

..................
*
*

..................
0.78535
0.21465

=
=
=

20,991.20
16,485.44
4,505.76

1.2781

..................

..................

..................

..................

16,485.44

*

1.2781

=

21,070.04

21,070.04

+

4,505.76

=

25,575.80

2,036.93

+

7,962.00

=

9,998.93

25,575.80

¥

9,998.93

=

15,576.87

15,576.87

*

0.80

=

12,461.50

7,962.00

+

12,461.50

=

20,423.49

Total Payment Per 60-Day Episode = Total Case-Mix and WageAdjusted Episode Payment Amount + Outlier Payment .................

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1,671.80
1,671.80
1,312.95

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32379

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
For Episodes 1 and 2 of this clinical
scenario, the preceding calculation
illustrates how HHAs are paid by
Medicare for providing care to patients
with higher resource use in their homes.
c. Example Two: Home Health Episodes
3 and 4
ALS is a progressive disease such that
the patient would most likely need care
beyond a second 60-day HH episode. A
beneficiary’s condition could become

more complex, such that the patient
could require a gastrostomy tube, which
could be placed during a hospital stay.
The patient could be discharged to
home for enteral nutrition to maintain
weight and continuing care for his/her
stage two pressure ulcer. Given the
complexity of the beneficiary’s
condition in this example, the episode
could remain at the highest level of care
C3F3S1 and would now fit into
equation 4.

For the purposes of this example, we
assume that services are rendered per
week for a total of 8 weeks per home
health episode. For both the third and
fourth home health episodes of care, the
calculation to determine outlier
payment utilizing payment amounts and
case mix weights for CY 2018 as
described in as described in the CY
2018 HH PPS final rule (82 FR 51676)
would be as follows, per 60-day
episode:

TABLE 28—CLINICAL SCENARIO CALCULATION: EPISODES 3 AND 4
HH outlier—CY 2018 illustrative values

Value

National, Standardized 60-day Episode Payment Rate ....................................
Case-Mix Weight for Payment Group 4.0331 (for C3F3S1 for 20+ therapy) ...
Case-Mix Adjusted Episode Payment Amount ..................................................
Labor Portion of the Case-Mix Adjusted Episode Payment Amount ................
Non-Labor Portion of the Case-Mix Adjusted Episode Payment Amount ........
Wage Index Value (Beneficiary resides in 31084, Los Angeles-Long BeachGlendale, CA) .................................................................................................
Wage-Adjusted Labor Portion of the Case-Mix Adjusted Episode Payment
Amount ...........................................................................................................
NRS Payment Amount (Severity Level 2) .........................................................
Total Case-Mix and Wage-Adjusted Episode Payment Amount (WageAdjusted Labor Portion plus Non-Labor Portion of the Case-Mix Adjusted Episode Payment Amount plus the NRS Amount) ......................
Total Wage-Adjusted Fixed Dollar Loss Amount:
Fixed Dollar Loss Amount (National, Standardized 60-day Episode Payment Rate * FDL Ratio) ..........................................................................
Labor Portion of the Fixed Dollar Loss Amount .........................................
Non-Labor Amount of the Fixed Dollar Loss Amount ................................
Wage-Adjusted Fixed Dollar Loss Amount ................................................

Operation

Adjuster

Equals

Output

$3,039.64
2.1359
3,039.64
6,492.37
6,492.37

..................
..................
*
*
*

..................
..................
2.1359
0.78535
0.21465

..................
..................
=
=
=

..................
..................
$6,492.37
5,098.78
1,393.59

1.2781

..................

..................

..................

..................

5,098.78
324.53

*
..................

1.2781
..................

=
=

6,516.75
324.53

..................

..................

..................

=

8,234.87

amozie on DSK3GDR082PROD with PROPOSALS2

Total Wage-Adjusted Fixed Dollar Loss Amount (Wage-Adjusted
Labor Portion plus Non-Labor Portion of the Case-Mix Adjusted
Fixed Dollar Loss Amount) ..............................................................
Total Wage-Adjusted Imputed Cost Amount:
National Per-Unit Payment Amount—Skilled Nursing ................................
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed Skilled Nursing Visit Costs (National Per-Unit Payment Amount
* Number of Units) ..................................................................................
National Per-Unit Payment Amount—Home Health Aide ..........................
Number of 15-minute units (28 hours per week = 112 units per week for
8 weeks) ..................................................................................................
Imputed Home Health Aide Costs (National Per-Unit Payment Amount *
Number of Units) .....................................................................................
National Per-Unit Payment Amount—Occupational Therapy (OT) ............
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed OT Visit Costs (National Per-Unit Payment Amount * Number of
Units) .......................................................................................................
National Per-Unit Payment Amount—Physical Therapy (PT) ....................
Number of 15-minute units (45 minutes = 3 units twice per week for 8
weeks) .....................................................................................................
Imputed PT Visit Costs (National Per-Unit Payment Amount * Number of
Units) .......................................................................................................
Total Imputed Cost Amount for all Disciplines ....................................
Labor Portion of the Imputed Costs for All Disciplines ..............................
Non-Labor Portion of Imputed Cost Amount for All Disciplines .................
CBSA Wage Index (Beneficiary resides in 31084, Los Angeles-Long
Beach-Glendale, CA) ..............................................................................
Wage-Adjusted Labor Portion of the Imputed Cost Amount for All Disciplines ....................................................................................................
Total Wage-Adjusted Imputed Cost Amount (Wage-Adjusted Labor
Portion of the Imputed Cost Amount plus Non-Labor Portion of
the Imputed Cost Amount) ...............................................................
Total Payment Per 60-Day Episode:

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3,039.64
1,671.80
1,671.80
1,312.95

*
*
*
*

0.55
0.78535
0.21465
1.2781

=
=
=
=

1,671.80
1,312.95
358.85
1,678.08

1,678.08

+

358.85

=

2,036.93

48.01

..................

..................

..................

..................

48

..................

..................

..................

..................

48.01
15.46

*
..................

48
..................

=
..................

2,304.48
..................

896

..................

..................

..................

..................

15.46
50.26

*
..................

896
..................

=
..................

13,852.16
..................

48

..................

..................

..................

..................

50.26
50.46

*
..................

48
..................

=
..................

2,412.48
..................

48

..................

..................

..................

..................

50.46

*

48

=

2,422.08

..................
20,991.20
20,991.20

..................
*
*

..................
0.78535
0.21465

=
=
=

20,991.20
16,485.44
4,505.76

1.2781

..................

..................

..................

..................

16,485.44

*

1.2781

=

21,070.04

21,070.04

+

4,505.76

=

25,575.80

Sfmt 4702

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32380

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 28—CLINICAL SCENARIO CALCULATION: EPISODES 3 AND 4—Continued
HH outlier—CY 2018 illustrative values

Value

Outlier Threshold Amount (Total Wage-Adjusted Fixed Dollar Loss
Amount + Total Case-Mix and Wage-Adjusted Episode Payment
Amount) ...................................................................................................
Total Wage-Adjusted Imputed Cost Amount¥Outlier Threshold Amount
(Total Wage-Adjusted Fixed Dollar Loss Amount + Total Case-Mix and
Wage-Adjusted Episode Payment Amount) ...........................................
Outlier Payment = Imputed Costs Greater Than the Outlier Threshold *
Loss-Sharing Ratio (0.80) .......................................................................
Total Payment Per 60-Day Episode = Total Case-Mix and WageAdjusted Episode Payment Amount + Outlier Payment .................

For Episodes 3 and 4 of this clinical
scenario, the above calculation
demonstrates how outlier payments
could be made for patients with chronic,
complex conditions under the HH PPS.
We reiterate that outlier payments could
provide payment to HHAs for those
patients with higher resource use and
that the patient’s condition does not
need to improve for home health
services to be covered by Medicare. We
appreciate the feedback we have
received from the public on the outlier
policy under the HH PPS and look
forward to ongoing collaboration with
stakeholders on any further refinements
that may be warranted. We note that this
example is presented for illustrative
purposes only, and is not intended to
suggest that all diagnoses of ALS should
receive the grouping assignment or
number of episodes described here. The
CMS Grouper assigns these groups
based on information in the OASIS.
F. Implementation of the Patient-Driven
Groupings Model (PDGM) for CY 2020

amozie on DSK3GDR082PROD with PROPOSALS2

1. Background and Legislation,
Overview, Data, and File Construction
a. Background and Legislation
In the CY 2018 HH PPS proposed
rule, we proposed an alternative case
mix-adjustment methodology (known as
the Home Health Groupings Model or
HHGM), to be implemented for home
health periods of care beginning on or
after January 1, 2019. Ultimately this
proposed alternative case-mix
adjustment methodology, including a
proposed change in the unit of payment
from 60 days to 30 days, was not
finalized in the CY 2018 HH PPS final
rule in order to allow us additional time
to consider public comments for
potential refinements to the
methodology (82 FR 51676).
On February 9, 2018, the Bipartisan
Budget Act of 2018 (BBA of 2018) (Pub.
L. 115–123) was signed into law.
Section 51001(a)(1) of the BBA of 2018
amended section 1895(b)(2) of the Act
by adding a new subparagraph (B) to

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Operation

Frm 00042

Fmt 4701

Equals

Output

2,036.93

+

8,234.87

=

10,271.80

25,575.80

¥

10,271.80

=

15,304.00

15,304.00

*

0.80

=

12,243.20

12,243.20

+

8,234.87

=

20,478.07

require the Secretary to apply a 30-day
unit of service for purposes of
implementing the HH PPS, effective
January 1, 2020. Section 51001(a)(2)(A)
of the BBA of 2018 added a new
subclause (iv) under section
1895(b)(3)(A) of the Act, requiring the
Secretary to calculate a standard
prospective payment amount (or
amounts) for 30-day units of service that
end during the 12-month period
beginning January 1, 2020 in a budget
neutral manner such that estimated
aggregate expenditures under the HH
PPS during CY 2020 are equal to the
estimated aggregate expenditures that
otherwise would have been made under
the HH PPS during CY 2020 in the
absence of the change to a 30-day unit
of service. Section 1895(b)(3)(A)(iv) of
the Act requires that the calculation of
the standard prospective payment
amount (or amounts) for CY 2020 be
made before, and not affect the
application of, the provisions of section
1895(b)(3)(B) of the Act. Section
1895(b)(3)(A)(iv) of the Act additionally
requires that in calculating the standard
prospective payment amount (or
amounts), the Secretary must make
assumptions about behavioral changes
that could occur as a result of the
implementation of the 30-day unit of
service under section 1895(b)(2)(B) of
the Act and case-mix adjustment factors
established under section 1895(b)(4)(B)
of the Act. Section 1895(b)(3)(A)(iv) of
the Act further requires the Secretary to
provide a description of the behavioral
assumptions made in notice and
comment rulemaking.
Section 51001(a)(2)(B) of the BBA of
2018 also added a new subparagraph (D)
to section 1895(b)(3) of the Act. Section
1895(b)(3)(D)(i) of the Act requires the
Secretary to annually determine the
impact of differences between assumed
behavior changes as described in section
1895(b)(3)(A)(iv) of the Act, and actual
behavior changes on estimated aggregate
expenditures under the HH PPS with
respect to years beginning with 2020

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Sfmt 4702

and ending with 2026. Section
1895(b)(3)(D)(ii) of the Act requires the
Secretary, at a time and in a manner
determined appropriate, through notice
and comment rulemaking, provide for
one or more permanent increases or
decreases to the standard prospective
payment amount (or amounts) for
applicable years, on a prospective basis,
to offset for such increases or decreases
in estimated aggregate expenditures, as
determined under section
1895(b)(3)(D)(i) of the Act. Additionally,
1895(b)(3)(D)(iii) of the Act requires the
Secretary, at a time and in a manner
determined appropriate, through notice
and comment rulemaking, to provide for
one or more temporary increases or
decreases to the payment amount for a
unit of home health services for
applicable years, on a prospective basis,
to offset for such increases or decreases
in estimated aggregate expenditures, as
determined under section
1895(b)(3)(D)(i) of the Act. Such a
temporary increase or decrease shall
apply only with respect to the year for
which such temporary increase or
decrease is made, and the Secretary
shall not take into account such a
temporary increase or decrease in
computing the payment amount for a
unit of home health services for a
subsequent year.
Section 51001(a)(3) of the BBA of
2018 amends section 1895(b)(4)(B) of
the Act by adding a new clause (ii) to
require the Secretary to eliminate the
use of therapy thresholds in the casemix system for 2020 and subsequent
years. Lastly, section 51001(b)(4) of the
BBA of 2018 requires the Secretary to
pursue notice and comment rulemaking
no later than December 31, 2019 on a
revised case-mix system for payment of
home health services under the HH PPS
b. Overview
To meet the requirement under
section 51001(b)(4) of the BBA of 2018
to engage in notice and comment
rulemaking on a HH PPS case-mix
system and to better align payment with

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amozie on DSK3GDR082PROD with PROPOSALS2

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
patient care needs and better ensure that
clinically complex and ill beneficiaries
have adequate access to home health
care, we are proposing case-mix
methodology refinements through the
implementation of the Patient-Driven
Groupings Model (PDGM). The
proposed PDGM shares many of the
features included in the alternative case
mix-adjustment methodology proposed
in the CY 2018 HH PPS proposed rule.
We propose to implement the PDGM for
home health periods of care beginning
on or after January 1, 2020. The
implementation of the PDGM will
require provider education and training,
updating and revising relevant manuals,
and changing claims processing
systems. Implementation starting in CY
2020 would provide opportunity for
CMS, its contractors, and the agencies
themselves to prepare. This patientcentered model groups periods of care
in a manner consistent with how
clinicians differentiate between patients
and the primary reason for needing
home health care. As required by
section 1895(b)(2)(B) of the Act, we
propose to use 30-day periods rather
than the 60-day episode used in the
current payment system. In addition,
section 1895(b)(4)(B)(ii) of the Act
eliminates the use of therapy thresholds
in the case-mix adjustment for
determining payment. The proposed
PDGM does not use the number of
therapy visits in determining payment.
The change from the current case-mix
adjustment methodology for the HH
PPS, which relies heavily on therapy
thresholds as a major determinant for
payment and thus provides a higher
payment for a higher volume of therapy
provided, to the PDGM would remove
the financial incentive to overprovide
therapy in order to receive a higher
payment. The PDGM would base casemix adjustment for home health
payment solely on patient
characteristics, a more patient-focused
approach to payment. Finally, the
PDGM relies more heavily on clinical
characteristics and other patient
information (for example, diagnosis,
functional level, comorbid conditions,
admission source) to place patients into
clinically meaningful payment
categories. In total, there are 216
different payment groups in the PDGM.
Costs during an episode/period of
care are estimated based on the concept
of resource use, which measures the
costs associated with visits performed
during a home health episode/period.
For the current HH PPS case-mix
weights, we use Wage Weighted
Minutes of Care (WWMC), which uses
data from the Bureau of Labor Statistics

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(BLS) reflecting the Home Health Care
Service Industry. For the PDGM, we
propose shifting to a Cost-Per-Minute
plus Non-Routine Supplies (CPM +
NRS) approach, which uses information
from the Medicare Cost Report. The
CPM + NRS approach incorporates a
wider variety of costs (such as
transportation) compared to the BLS
estimates and the costs are available for
individual HHA providers while the
BLS costs are aggregated for the Home
Health Care Service industry.
Similar to the current payment
system, 30-day periods under the PDGM
would be classified as ‘‘early’’ or ‘‘late’’
depending on when they occur within
a sequence of 30-day periods. Under the
current HH PPS, the first two 60-day
episodes of a sequence of adjacent 60day episodes are considered early, while
the third 60-day episode of that
sequence and any subsequent episodes
are considered late. Under the PDGM,
the first 30-day period is classified as
early. All subsequent 30-day periods in
the sequence (second or later) are
classified as late. We propose to adopt
this timing classification for 30-day
periods with the implementation of the
PDGM for CY 2020. Similar to the
current payment system, we propose
that a 30-day period could not be
considered early unless there was a gap
of more than 60 days between the end
of one period and the start of another.
The comprehensive assessment would
still be completed within 5 days of the
start of care date and completed no less
frequently than during the last 5 days of
every 60 days beginning with the start
of care date, as currently required by
§ 484.55, Condition of participation:
Comprehensive assessment of patients.
In addition, the plan of care would still
be reviewed and revised by the HHA
and the physician responsible for the
home health plan of care no less
frequently than once every 60 days,
beginning with the start of care date, as
currently required by § 484.60(c),
Condition of participation: Care
planning, coordination of services, and
quality of care.
Under the PDGM, we propose that
each period would be classified into one
of two admission source categories
—community or institutional—
depending on what healthcare setting
was utilized in the 14 days prior to
home health. The 30-day period would
be categorized as institutional if an
acute or post-acute care stay occurred in
the 14 days prior to the start of the 30day period of care. The 30-day period
would be categorized as community if
there was no acute or post-acute care
stay in the 14 days prior to the start of
the 30-day period of care.

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32381

The PDGM would group 30-day
periods into categories based on a
variety of patient characteristics. We
propose grouping periods into one of six
clinical groups based on the principal
diagnosis. The principal diagnosis
reported would provide information to
describe the primary reason for which
patients are receiving home health
services under the Medicare home
health benefit. The proposed six clinical
groups, are as follows:
• Musculoskeletal Rehabilitation.
• Neuro/Stroke Rehabilitation.
• Wounds—Post-Op Wound
Aftercare and Skin/Non-Surgical
Wound Care.
• Complex Nursing Interventions.
• Behavioral Health Care (including
Substance Use Disorders).
• Medication Management, Teaching
and Assessment (MMTA).
Under the PDGM, we propose that
each 30-day period would be placed
into one of three functional levels. The
level would indicate if, on average,
given its responses on certain functional
OASIS items, a 30-day period is
predicted to have higher costs or lower
costs. We are proposing to assign
roughly 33 percent of periods within
each clinical group to each functional
level. The criteria for assignment to each
of the three functional levels may differ
across each clinical group. The
proposed functional level assignment
under the PDGM is very similar to the
functional level assignment in the
current payment system. Finally, the
PDGM includes a comorbidity
adjustment category based on the
presence of secondary diagnoses. We
propose that, depending on a patient’s
secondary diagnoses, a 30-day period
may receive ‘‘no’’ comorbidity
adjustment, a ‘‘low’’ comorbidity
adjustment, or a ‘‘high’’ comorbidity
adjustment. For low-utilization payment
adjustments (LUPAs) under the PDGM,
we propose that the LUPA threshold
would vary for a 30-day period under
the PDGM depending on the PDGM
payment group to which it is assigned.
For each payment group, we propose to
use the 10th percentile value of visits to
create a payment group specific LUPA
threshold with a minimum threshold of
at least 2 for each group.
Figure BBB1 represents how each 30day period of care would be placed into
one of the 216 home health resource
groups (HHRGs) under the proposed
PDGM for CY 2020.
BILLING CODE 4210–01–P

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32382

BILLING CODE 4210–01–C

amozie on DSK3GDR082PROD with PROPOSALS2

c. Data and File Construction
To create the PDGM proposed model
and related analyses, a data file based
on home health episodes of care as
reported in Medicare home health
claims was utilized. The claims data
provide episode-level data (for example,
episode From and Through Dates, total
number of visits, HHRG, diagnoses), as

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well as visit-level data (visit date, visit
length in 15-minute units, discipline of
the staff, etc.). The claims also provide
data on whether NRS was provided
during the episode and total charges for
NRS.
The core file for most of the analyses
for this proposed rule includes 100
percent of home health episode claims
with Through Dates in Calendar Year
(CY) 2017, processed by March 2, 2018,

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accessed via the Chronic Conditions
Data Warehouse (CCW). Original or
adjustment claims processed after
March 2, 2018, would not be reflected
in the core file. The claims-based file
was supplemented with additional
variables that were obtained from the
CCW, such as information regarding
other Part A and Part B utilization.
The data were cleaned by processing
any remaining adjustments and by

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EP12JY18.003

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
excluding duplicates and claims that
were Requests for Anticipated Payment
(RAP). In addition, visit-level variables
needed for the analysis were extracted
from the revenue center trailers (that is,
the line items that describe the visits)
and downloaded as a separate visit-level
file, with selected episode-level
variables merged onto the records for
visits during those episodes. To account
for potential data entry errors, the visitlevel variables for visit length were topcensored at 8 hours.23
A set of data cleaning exclusions were
applied to the episode-level file, which
resulted in the exclusion of the
following:
• Episodes that were RAPs.
• Episodes with no covered visits.
• Episodes with any missing units or
visit data.
• Episodes with zero payments.
• Episodes with no charges.
• Non-LUPA episodes missing an
HHRG.
The analysis file also includes data on
patient characteristics obtained from the
OASIS assessments conducted by home
health agency (HHA) staff at the start of
each episode. The assessment data are
electronically submitted by HHAs to a
central CMS repository. In constructing
the core data file, 100 percent of the
OASIS assessments submitted October
2016 through December 2017 from the
CMS repository were uploaded by CMS
to the CCW. A CCW-derived linking key

(Bene ID) was used to match the OASIS
data with CY 2017 episodes of care.
Episodes that could not be linked with
an OASIS assessment were excluded
from the analysis file, as they included
insufficient patient-level data to create
the PDGM.
To construct measures of resource
use, a variety of data sources were used
(see section III.F.2 of this proposed rule
for the proposed methodology used to
calculate the cost of care under the
PDGM). First, BLS data on average
wages and fringe benefits were used to
produce wage-weighted minutes of care
(WWMC), the approach used in the
current system to calculate the cost of
care. The wage data are for North
American Industry Classification
System (NAICS) 621600—Home Health
Care Services (see Table 29).

TABLE 29—BLS STANDARD OCCUPATION CLASSIFICATION (SOC) CODES
FOR HOME HEALTH PROVIDERS—
Continued
Standard
Occupation
Code (SOC) No.
29–1127 ................
21–1022 ................
21–1023 ................
31–1011 ................

Occupation
title
Speech-Language Pathologists.
Medical and Public Health Social Workers.
Mental Health and Substance
Abuse Social Workers.
Home Health Aides.

The WWMC approach determines
resource use for each episode by
multiplying utilization (in terms of the
number of minutes of direct patient care
provided by each discipline) by the
corresponding opportunity cost of that
care (represented by wage and fringe
TABLE 29—BLS STANDARD OCCUPA- benefit rates from the BLS).24 Table 30
TION CLASSIFICATION (SOC) CODES shows the occupational titles and
corresponding mean hourly wage rates
FOR HOME HEALTH PROVIDERS
from the BLS. The employer cost per
hour worked shown in the fifth column
Standard
Occupation
Occupation
is calculated by adding together the
title
Code (SOC) No.
mean hourly wage rates and the fringe
29–1141 ................ Registered Nurses.
benefit rates from the BLS. For home
29–2061 ................ Licensed Practical and Lihealth disciplines that include multiple
censed Vocational Nurses.
occupations (such as skilled nursing),
29–1123 ................ Physical Therapists.
the opportunity cost is generated by
31–2021 ................ Physical Therapist Assistants.
31–2022 ................ Physical Therapist Aides.
weighting the employer cost by the
29–1122 ................ Occupational Therapists.
proportions of the labor mix.25
31–2011 ................ Occupational Therapist AssistOtherwise,
the opportunity cost is the
ants.
same as the employer cost per hour.
31–2012 ................ Occupational Therapist Aides.

TABLE 30—OCCUPATIONAL EMPLOYMENT AND WAGES PROVIDED BY THE FEDERAL BUREAU OF LABOR STATISTICS

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Occupation title

Registered Nurses ..............
Licensed Practical and Licensed Vocational Nurses.
Physical Therapists .............
Physical Therapist Assistants.
Occupational Therapists .....
Occupational Therapist Assistants.
Speech-Language Pathologists.
Medical and Public Health
Social Workers.
Mental Health and Substance Abuse Social
Workers.
Home Health Aides .............

National
employment
counts

Mean
hourly
wage

Estimate
of benefits
as
a % of
wages

Estimated
employer
cost
per hour
worked

Labor
mix

Home health discipline

Opportunity
cost

179,280
85,410

$33.34
22.03

43.85
43.85

$47.96
31.69

0.66
0.34

Skilled Nursing ...................

$42.42

24,810
7,330

47.23
31.43

40.92
35.79

66.55
42.68

0.66
0.34

Physical Therapy ................

58.55

10,760
2,270

45.27
33.83

40.92
35.79

63.79
45.94

0.79
0.21

Occupational Therapy ........

59.97

5,360

47.08

40.92

66.34

............

Speech Therapy .................

66.34

18,930

28.76

40.92

40.53

0.97

Medical Social Service .......

40.42

500

25.85

40.92

36.43

0.03

408,920

11.25

35.79

15.28

............

Home Health Aide ..............

15.28

Source: May 2016 National Industry-Specific Occupational Employment and Wage Estimates—NAICS 621600—Home Health Care Services.
23 Less than 0.1 percent of all visits were recorded
as having greater than 8 hours of service.
24 Opportunity costs represent the foregone
resources from providing each minute of care
versus using the resources for another purpose (the
next best alternative). Generally, opportunity costs

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represent more than the monetary costs, but in
these analyses, they are proxied using hourly wage
rates.
25 Labor mix represents the percentage of
employees with a particular occupational title (as
obtained from claims) within a home health

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discipline. Physical therapist aides and
occupational therapist aides were not included in
the labor mix.

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Home Health Agency Medicare Cost
Report (MCR) data for FY 2016 were
also used to construct a measure of
resource use after trimming out HHAs
whose costs were outliers (see section
III.F.2 of this proposed rule). These data
are used to provide a representation of
the average costs of visits provided by
HHAs in the six Medicare home health
disciplines: Skilled nursing; physical
therapy; occupational therapy; speechlanguage pathology; medical social
services; and home health aide services.
Cost report data are publicly available
at: https://www.cms.gov/ResearchStatistics-Data-and-Systems/
Downloadable-Public-Use-Files/CostReports/. More details regarding how
HHA MCR data were used in
constructing the CPM+NRS measure of
resource use can be found in section
III.F.2 of this proposed rule.
A comment submitted in response to
the CY 2018 HH PPS proposed rule
questioned the trimming process for the
Medicare cost report data used to
calculate the cost-per-minute plus nonroutine supplies (CPM+NRS)
methodology used to estimate resource
use (outlined in section III.F.2 of this
rule). The commenter stated that for
rebasing, CMS audited 100 cost reports
and the findings of such audits found
that costs were overstated by 8 percent
and that finding was attributed to the
entire population of HHA Medicare cost
reports. The commenter questioned if
CMS applied the 8 percent ‘‘adjustment
factor’’ in last year’s proposed rule,
requested CMS provide the number of
cost reports used for the proposed rule,
asked if only cost reports of freestanding
HHAs were used, and requested that
CMS describe what percentage of cost
reports did not list any costs for NRS,
yet listed NRS charges.
For the calculations in the CY 2018
HH PPS proposed rule, CMS applied the
trimming methodology described in
detail in the ‘‘Analyses in Support of
Rebasing & Updating Medicare Home
Health Payment Rates’’ Report available
at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HomeHealthPPS/Downloads/Analysesin-Support-of-Rebasing-and-Updatingthe-Medicare-Home-Health-PaymentRates-Technical-Report.pdf. This is also
the trimming methodology outlined in
the CY 2014 HH PPS proposed rule (78
FR 40284). Of note, for each discipline
and for NRS, we also followed the
methodology laid out in the ‘‘Rebasing
Report’’ by trimming out values that fell
in the top or bottom 1 percent of the
distribution across all HHAs. This
included the cost-per-visit values for
each discipline and NRS cost-to-charge
ratios that fell in the top or bottom 1

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percent of the distribution across all
HHAs. For this proposed rule, we
applied the same trimming
methodology.
We included both freestanding and
facility-based HHA Medicare cost report
data in our rebasing calculations as
outlined in the CY 2014 HH PPS
proposed and final rules and in our
analysis of FY 2015 HHA Medicare cost
report data for the CY 2018 HH PPS
proposed rule. We similarly included
both freestanding and facility-based
HHA Medicare cost report data in our
analysis of FY 2016 cost report data for
this proposed rule. We note that
although we found an 8 percent
overstatement of costs from the
Medicare cost reports audits performed
to support the rebasing adjustments, we
did not apply an 8 percent adjustment
to HHA costs in the CY 2014 HH PPS
proposed or final rules. We also did not
apply an 8 percent adjustment to the
costs in the CY 2018 HH PPS proposed
rule or in this proposed rule. The 8
percent overstatement was determined
using a small sample size of HHA
Medicare cost reports and the CY 2014
HH PPS proposed rule included this
information as illustrative only. The
information was not used in any cost
calculations past or present.
Before trimming, there were 10,394
cost reports for FY 2016. In this
proposed rule, we used 7,458 cost
reports. Of the 7,458 cost reports, 5,447
(73.4 percent) had both NRS charges
and costs, 1,672 (22.4 percent) had
neither NRS charges or costs, and 339
(4.5 percent) had NRS charges but no
NRS costs. There were no cost reports
with NRS costs, but no NRS charges.
The initial 2017 analytic file included
6,771,059 episodes. Of these, 959,410
(14.2 percent) were excluded because
they could not be linked to OASIS
assessments or because of the claims
data cleaning process reasons listed
above. This yielded a final analytic file
that included 5,811,649 episodes. Those
episodes are 60-day episodes under the
current payment system, but for the
PDGM those 60-day episodes were
converted into two 30-day periods. This
yielded a final PDGM analytic file that
included 10,160,226, 30-day periods.
Certain 30-day periods were excluded
for the following reasons:
• Inability to merge to certain OASIS
items to create the episode’s functional
level that is used for risk adjustment.
For all the periods in the analytic file,
there was a look-back through CY 2016
for a period with a Start of Care or
Resumption of Care assessment that
preceded the period being analyzed and
was in the same sequence of periods. If
such an assessment was found, it was

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used to impute responses for OASIS
items that were not included in the
follow-up assessment. Periods that were
linked to a follow-up assessment which
did not link to a Start of Care or
Resumption of Care assessment using
the process described above were
dropped (after exclusions, n =
9,471,529).
• No nursing visits or therapy visits
(after exclusions, n = 9,287,622).
• LUPAs were excluded from the
analysis. Periods that are identified as
LUPAs in the current payment system
were excluded in the creation of the
functional score. Following the creation
of the score (and the corresponding
levels), case-mix group specific LUPA
thresholds were created and episodes/
periods were excluded that were below
the new LUPA threshold when
computing the case-mix weights.26
Therefore, the final analytic sample
included 8,624,776 30-day periods that
were used for the analyses in the PDGM.
In response to the CY 2018 HH PPS
proposed rule, we received many
comments stating there was limited
involvement with the industry in the
development of the alternative case-mix
adjustment methodology. Commenters
also stated that they were unable to
obtain the necessary data in order to
replicate and model the effects on their
business. We note that, through notice
and comment rulemaking and other
processes, stakeholders always have the
opportunity to reach out to CMS and
provide suggestions for improvement in
the payment methodology under the HH
PPS. In the CY 2014 HH PPS final rule,
we noted that we were continuing to
work on improvements to our case-mix
adjustment methodology and welcomed
suggestions for improving the case-mix
adjustment methodology as we
continued in our case-mix research (78
FR 72287). The analyses and the
ultimate development of an alternative
case-mix adjustment methodology was
shared with stakeholders via technical
expert panels, clinical workgroups, and
special open door forums. We also
provided high-level summaries on our
case-mix methodology refinement work
in the HH PPS proposed rules for CYs
2016 and 2017 (80 FR 39839, and 81 FR
76702). A detailed technical report was
posted on the CMS website in December
of 2016, additional technical expert
panel and clinical workgroup webinars
were held after the posting of the
technical report, and a National
Provider call occurred in January 2017
26 The case-mix group specific LUPA thresholds
were determined using episodes that were
considered LUPAs under the current payment
system.

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to further solicit feedback from
stakeholders and the general public.27 28
As noted above, the CY 2018 HH PPS
proposed rule further solicited
comments on an alternative case-mix
adjustment methodology. Ultimately the
proposed alternative case-mix
adjustment methodology, including a
proposed change in the unit of payment
from 60 days to 30 days, was not
finalized in the CY 2018 HH PPS final
rule in order to allow CMS additional
time to consider public comments for
potential refinements to the model (82
FR 51676).
On February 1, 2018, CMS convened
another TEP, to gather perspectives and
identify and prioritize recommendations
from industry leaders, clinicians,
patient representatives, and researchers
with experience with home health care
and/or experience in home health
agency management regarding the casemix adjustment methodology
refinements described in the CY 2018
HH PPS proposed rule (82 FR 35270),
and alternative case-mix models
submitted during 2017 as comments to
the CY 2018 HH PPS proposed rule.
During the TEP, there was a description
and solicitation of feedback on the
components of the proposed case-mix
methodology refinement, such as
resource use, 30-day periods, clinical
groups, functional levels, comorbidity
groups, and other variables used to
group periods into respective case-mix
groups. Also discussed were the
comments received from the CY 2018
HH PPS proposed rule, the creation of
case-mix weights, and an open
discussion to solicit feedback and
recommendations for next steps. This
TEP satisfied the requirement set forth
in section 51001(b)(1) of the BBA of
2018, which requires that at least one
session of such a TEP be held between
January 1, 2018 and December 31, 2018.
Lastly, section 51001(b)(3) of the BBA of
2018 requires the Secretary to issue a
report to the Committee on Ways and
Means and Committee on Energy and
Commerce of the House of
Representatives and the Committee on
27 Abt Associates. ‘‘Overview of the Home Health
Groupings Model.’’ Medicare Home Health
Prospective Payment System: Case-Mix
Methodology Refinements. Cambridge, MA,
November 18, 2016. Available at https://
downloads.cms.gov/files/hhgm%20technical%20
report%20120516%20sxf.pdf.
28 Centers for Medicare & Medicaid Services
(CMS). ‘‘Certifying Patients for the Medicare Home
Health Benefit.’’ MLN ConnectsTM National
Provider Call. Baltimore, MD, December 16, 2016.
Slides, examples, audio recording and transcript
available at https://www.cms.gov/Outreach-andEducation/Outreach/NPC/National-Provider-Callsand-Events-Items/2017-01-18-HomeHealth.html?DLPage=2&DLEntries=10&DLSort=0&
DLSortDir=descending.

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Finance of the Senate on the
recommendations from the TEP
members, no later than April 1, 2019.
This report is available on the CMS
HHA Center web page at: https://
www.cms.gov/center/provider-Type/
home-Health-Agency-HHA-Center.html
and satisfies the requirement of section
51001(b)(3) of the BBA of 2018.
Finally, with respect to comments
regarding the availability of data to
replicate and model the effects of the
PDGM on HHAs, we note that generally
the data needed to replicate and model
the effects of the proposed PDGM are
available by request through the CMS
Data Request Center.29 Although claims
data for home health are available on a
quarterly and annual basis as Limited
Data Set (LDS) files and Research
Identifiable Files (RIFs); we note that
assessment data (OASIS) are not
available as LDS files through the CMS
Data Request Center. While CMS is able
to provide LDS files in a more expedited
manner, it may take several months for
CMS to provide RIFs. Therefore, we will
provide upon request a Home Health
Claims-OASIS LDS file to accompany
the CY 2019 HH PPS proposed and final
rules. We believe that in making a Home
Health Claims-OASIS LDS file available
upon request in conjunction with the
CY 2019 HH PPS proposed and final
rules, this would address concerns from
stakeholders regarding data access and
transparency in annual ratesetting.
The Home Health Claims-OASIS LDS
file can be requested by following the
instructions on the following CMS
website: https://www.cms.gov/ResearchStatistics-Data-and-Systems/Files-forOrder/Data-Disclosures-DataAgreements/DUA_-_NewLDS.html and a
file layout will be available. This file
will contain information from claims
data matched with assessment data for
CY 2017, both obtained from the
Chronic Conditions Data Warehouse
(CCW), and each observation in the file
will represent a 30-day period of care
with variables created that provide
information corresponding to both the
30-day period of care and the 60-day
episode of care. The file will also
contain variables that show the case-mix
group that a particular claim would be
grouped into under both the new PDGM
case-mix methodology and the current
case-mix adjustment methodology as
well as variables for all the assessment
items used for grouping the claim into
its appropriate case-mix group under
the PDGM and variables used for
calculating resource use. Because this
Home Health Claims-OASIS LDS file

includes variables used for calculating
resource use, this file will also include
publically available data from home
health cost reports and the BLS. Some
of the cost data in this file is trimmed
and imputed before being used as
outlined above. We note that much of
the content of the Home Health ClaimsOASIS LDS file will be derived from
CMS data sources. That is, many
elements of claims or elements of
OASIS will not be copied to the LDS file
as is. For example, we will have
variables in the data files that will
record the aggregated number of visits
and minutes of service by discipline
type. We will need to create those
aggregates from the line item data
available on the claims data. Because we
will be taking data from different
sources (claims, OASIS, and cost
reports/BLS), we will match the data
across those sources. Information from
claims and costs reports will be linked
using the CCN. OASIS assessment data
will be linked to those sources using
information available both on the claim
and OASIS. As noted earlier in this
section, any episodes that could not be
linked with an OASIS assessment were
excluded from the analysis file, as they
included insufficient patient-level data
to re-group such episodes into one of
the 216 case-mix groups under the
PDGM.
In addition, similar to the CY 2018
HH PPS proposed rule, we will again
provide a PDGM Grouper Tool in
conjunction with this proposed rule on
CMS’ HHA Center web page to allow
HHAs to replicate the PDGM
methodology using their own internal
data.30 In addition, in conjunction with
this proposed rule, we will post a file on
the HHA Center web page that contains
estimated Home Health Agency-level
impacts as a result of the proposed
PDGM.

29 https://www.resdac.org/cms-data/request/cmsdata-request-center.

30 https://www.cms.gov/center/provider-Type/
home-Health-Agency-HHA-Center.html.

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2. Methodology Used To Calculate the
Cost of Care
To construct the case-mix weights for
the PDGM proposal, the costs of
providing care needed to be determined.
A Wage-Weighted Minutes of Care
(WWMC) approach is used in the
current payment system based on data
from the BLS. However, we are
proposing to adopt a Cost-per-Minute
plus Non-Routine Supplies (CPM +
NRS) approach, which uses information
from HHA Medicare Cost Reports and
Home Health Claims.
• Home Health Medicare Cost Report
Data: All Medicare-certified HHAs must
report their own costs through publicly-

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available home health cost reports
maintained by the Healthcare Cost
Report Information System (HCRIS).
Freestanding HHAs report using a HHAspecific cost report while HHAs that are
hospital-based report using the HHA
component of the hospital cost reports.
These cost reports enable estimation of
the cost per visit by provider and the
estimated NRS cost to charge ratios. To
obtain a more robust estimate of cost, a
trimming process was applied to remove
cost reports with missing or
questionable data and extreme values.31
• Home Health Claims Data:
Medicare home health claims data are
used in both the previous WWMC
approach and in the CPM+NRS method
to obtain minutes of care by discipline
of care.
Under the proposed PDGM, we group
30-day periods of care into their casemix groups taking into account
admission source, timing, clinical
group, functional level, and comorbidity
adjustment. From there, the average
resource use for each case-mix group
dictates the group’s case-mix weight.
We propose that resource use be
estimated with the cost of visits
recorded on the home health claim plus
the cost of NRS recorded on the claims.
The cost of NRS is generated by taking
NRS charges on claims and converting
them to costs using a NRS cost to charge
ratio that is specific to each HHA. NRS
costs are then added to the resource use
estimates. That overall resource use
estimate is then used to establish the
case-mix weights. Similar to the current
system, NRS would still be paid
prospectively under the PDGM, but the
PDGM eliminates the separate case-mix
adjustment model for NRS.
Under the proposed alternative casemix methodology discussed in the CY
2018 HH PPS proposed rule, we
proposed to calculate resource use using
the CPM+NRS approach (82 FR 35270).
In response to the CY 2018 HH PPS
proposed rule, several commenters
expressed support for the proposed
change to the CPM+NRS methodology
used to measure resource use, noting
that such an approach incorporates a
wider variety of costs (such as
transportation) compared to the current
WWMC approach. Alternatively, other
commenters responding to last year’s
proposed rule objected to using
31 The trimming methodology is described in the
report ‘‘Analyses in Support of Rebasing &
Updating Medicare Home Health Payment Rates’’
(Morefield, Christian, and Goldberg 2013). See
https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/HomeHealthPPS/Downloads/
Analyses-in-Support-of-Rebasing-and-Updatingthe-Medicare-Home-Health-Payment-RatesTechnical-Report.pdf.

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Medicare cost report data rather than
Wage-Weighted Minutes of Care
(WWMC) to calculate resource use. The
commenters indicated that the strength
and utility of period-specific cost
depends on the accuracy and
consistency of agencies’ reported
charges, cost-to-charge ratios, and
period minutes and indicated that they
believe there are no incentives for
ensuring the accuracy of HHA cost
reports, which they believe may result
in erroneous data. Several commenters
also indicated that the use of cost report
data in lieu of WWMC favors facilitybased agencies because they believe that
facility-based agencies have the ability
to allocate indirect overhead costs from
their parent facilities to their service
cost and argued that the proposed
alternative case-mix methodology
would reward inefficient HHAs with
historically high costs. A few
commenters stated that Non-Routine
Supplies (NRS) should not be
incorporated into the base rate and then
wage-index adjusted (as would be the
case if CMS were to use the CPM+NRS
approach to estimate resource use). The
commenters stated that HHAs’ supply
costs are approximately the same
nationally, regardless of rural or urban
locations and regardless of the wageindex, and including NRS in the base
rate will penalize rural providers and
unnecessarily overpay for NRS in high
wage-index areas. We note that in
accordance with the requirement of
section 51001 of the BBA of 2018, a
Technical Expert Panel (TEP) convened
in February 2018 to solicit feedback and
identify and prioritize recommendations
from a wide variety of industry experts
and patient representatives regarding
the public comments received on the
proposed alternative case-mix
adjustment methodology. We received
similar comments on the approach to
calculating resource use using the
CPM+NRS approach, versus the WWMC
approach, bothin response to the CY
2018 HH PPS proposed rule and those
provided by the TEP participants.
We believe that using HHA Medicare
cost report data, through the CPM+NRS
approach, to calculate the costs of
providing care better reflects changes in
utilization, provider payments, and
supply amongst Medicare-certified
HHAs. Using the BLS average hourly
wage rates for the entire home health
care service industry does not reflect
changes in Medicare home health
utilization that impact costs, such as the
allocation of overhead costs when
Medicare home health visit patterns
change. Utilizing data from HHA
Medicare cost reports better represents

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the total costs incurred during a 30-day
period (including, but not limited to,
direct patient care contract labor,
overhead, and transportation costs),
while the WWMC method provides an
estimate of only the labor costs (wage
and fringe benefit costs) related to direct
patient care from patient visits that are
incurred during a 30-day period. With
regards to accuracy, we note that each
HHA Medicare cost report is required to
be certified by the Officer or Director of
the home health agency as being true,
correct, and complete with potential
penalties should any information in the
cost report be a misrepresentation or
falsification of information.
As noted above, and in the CY 2018
HH PPS proposed rule, we applied the
trimming methodology described in
detail in the ‘‘Analyses in Support of
Rebasing & Updating Medicare Home
Health Payment Rates’’ Report. This is
also the trimming methodology outlined
in the CY 2014 HH PPS proposed rule
(78 FR 40284) in determining the
rebased national, standardized 60-day
episode payment amount. For each
discipline and for NRS used in
calculating resource use using the
CPM+NRS approach, we also followed
the methodology laid out in the
‘‘Rebasing Report’’ by trimming out
values that fall in the top or bottom 1
percent of the distribution across all
HHAs. This included the cost per visit
values for each discipline and NRS costto-charge ratios that fall in the top or
bottom 1 percent of the distribution
across all HHAs. Normalizing data by
trimming out missing or extreme values
is a widely accepted methodology both
within CMS and amongst the health
research community and provides a
more robust measure of average costs
per visit that is reliable for the purposes
of establishing base payment amounts
and case-mix weights under the HH
PPS. Using HHA Medicare cost report
data to establish the case-mix weight
aligns with the use of this data in
determining the national, standardized
60-day episode payment amount under
the HH PPS.
In response to commenters’ concerns
regarding the allocation of overhead
costs by facility-based HHAs, we note
that a single HHA’s costs impact only a
portion of the calculation of the weights
and costs are blended together across all
HHAs. The payment regression was
estimated using 8,624,776 30-day
periods from 10,480 providers. On
average, each provider contributed 823
30-day periods to the payment
regression, which is only 0.010 percent
of all 30-day periods. Therefore,
including or excluding any single HHA,
on average, would not dramatically

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impact the results of the payment
regression. Further, facility-based HHAs
are only 8 percent of HHAs whereas 92
percent of HHAs are freestanding, and
coincidentally the percentage of 30-day
periods furnished by facility-based
versus freestanding HHAs is also 8 and
92 percent, respectively. Additionally,
in the PDGM, we estimate the payment
regression using provider-level fixed
effects; therefore we are looking at the
within provider variation in resource
use.
In the CY 2008 HH PPS final rule,
CMS noted that use of non-routine
medical supplies is unevenly
distributed across episodes of care in
home health. In addition, the majority of
episodes do not incur any NRS costs
and, at that time, the current payment
system overcompensated for episodes
with no NRS costs. In the CY 2008 HH
PPS proposed rule, we stated that
patients with certain conditions, many
of them related to skin conditions, were
more likely to require high non-routine
medical supply utilization (72 FR
49850), and that we would continue to
look for ways to improve our approach
to account for NRS costs and payments
in the future (72 FR 25428). We believe
that the proposed PDGM offers an
alternative method for accounting for
NRS costs and payments by grouping
patients more likely to require high NRS
utilization. For example, while the
Wound group and Complex Nursing
Interventions groups comprise about 9
percent and 4 percent of all 30-day
periods of care, respectively; roughly 27
percent of periods where NRS was
supplied were assigned to the Wound
and Complex Nursing Interventions
groups and 44 percent of NRS costs fall
into the Wound and Complex Nursing
groups. We note that CY 2017 claims
data indicates that about 60 percent of
60-day episodes did not provide any
NRS.
In using the CPM + NRS approach to
calculate the cost of proving care
(resource use), NRS costs are reflected
in the average resource use that drives

the case-mix weights. If there is a high
amount of NRS cost for all periods in a
particular group (holding all else equal),
the resource use for those periods will
be higher relative to the overall average
and the case-mix weight will
correspondingly be higher. Similar to
the current system, NRS would still be
paid prospectively under the PDGM, but
the PDGM eliminates the separate casemix adjustment model for NRS.
Incorporating the NRS cost into the
measure of overall resource use (that is,
the dependent variable of the payment
model) requires adjusting the NRS
charges submitted on claims based on
the NRS cost-to-charge ratio from cost
report data.
The following steps would be used to
generate the measure of resource use
under this CPM + NRS approach:
(1) From the cost reports, obtain total
costs for each of the six home health
disciplines for each HHA.
(2) From the cost reports, obtain the
number of visits by each of the six home
health disciplines for each HHA.
(3) Calculate discipline-specific cost
per visit values by dividing total costs
[1] by number of visits [2] for each
discipline for each HHA. For HHAs that
did not have a cost report available (or
a cost report that was trimmed from the
sample), imputed values were used as
follows:
• A state-level mean was used if the
HHA was not hospital-based. The statelevel mean was computed using all nonhospital based HHAs in each state.
• An urban nationwide mean was
used for all hospital-based HHAs
located in a Core-based Statistical Area
(CBSA). The urban nation-wide mean
was computed using all hospital-based
HHAs located in any CBSA.
• A rural nationwide mean was used
for all hospital-based HHAs not in a
CBSA. The rural nation-wide mean was
computed using all hospital-based
HHAs not in a CBSA.
(4) From the home health claims data,
obtain the average number of minutes of
care provided by each discipline across
all episodes for a HHA.

32387

(5) From the home health claims data,
obtain the average number of visits
provided by each discipline across all
episodes for each HHA.
(6) Calculate a ratio of average visits
to average minutes by discipline by
dividing average visits provided [5] by
average minutes of care [4] by discipline
for each HHA.
(7) Calculate costs per minute by
multiplying the HHA’s cost per visit [3]
by the ratio of average visits to average
minutes [6] by discipline for each HHA.
(8) Obtain 30-day period costs by
multiplying costs per minute [7] by the
total number of minutes of care
provided during a 30-day period by
discipline. Then, sum these costs across
the disciplines for each period.
This approach accounts for variation
in the length of a visit by discipline.
NRS costs are added to the resource use
calculated in [8] in the following way:
(9) From the cost reports, determine
the NRS cost-to-charge ratio for each
HHA. The NRS ratio is trimmed if the
value falls in the top or bottom 1
percent of the distribution across all
HHAs from the trimmed sample.
Imputation for missing or trimmed
values is done in the same manner as it
was done for cost per visit (see [3]
above).
(10) From the home health claims
data, obtain NRS charges for each
period.
(11) Obtain NRS costs for each period
by multiplying charges from the home
health claims data [10] by the cost-tocharge ratio from the cost reports [9] for
each HHA.
Resource use is then obtained by:
(12) Summing costs from [8] with
NRS costs from [11] for each 30-day
period.
Table 31 shows these costs for 30-day
periods in CY 2017 (n = 8,624,776). On
average, total 30-day period costs as
measured by resource use are $1,570.68.
The distribution ranges from a 5th
percentile value of $296.66 to a 95th
percentile value of $3,839.91.

TABLE 31—DISTRIBUTION OF AVERAGE RESOURCE USE USING CPM + NRS APPROACH

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[30 Day periods]
Statistics

Mean

N

5th
Percentile

10th
Percentile

25th
Percentile

50th
Percentile

75th
Percentile

90th
Percentile

95th
Percentile

Average Resource Use (CPM +
NRS) ......................................

$1,570.68

8,624,776

$296.66

$394.31

$679.12

$1,272.18

$2,117.47

$3,107.93

$3,839.91

The distributions and magnitude of
the estimates of costs for the CPM +
NRS method versus the WWMC method
are very different. The differences arise
because the CPM + NRS method

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incorporates HHA-specific costs that
represent the total costs incurred during
a 30-day period (including overhead
costs), while the WWMC method
provides an estimate of only the labor

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costs (wage + fringe) related to direct
patient care from patient visits that are
incurred during a 30-day period. Those
costs are not HHA-specific and do not
account for any non-labor costs (such as

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transportation costs) or the non-direct
patient care labor costs (such as,
administration and general labor costs).
Because the costs estimated using the
two approaches are measuring different
items, they cannot be directly
compared. However, if the total cost of
a 30-day period is correlated with the
labor that is provided during visits, the
two approaches should be highly
correlated. The correlation coefficient

(estimated by comparing a 30-day
period’s CPM + NRS resource use to the
same period’s WWMC resource use)
between the two approaches to
calculating resource use is equal to
0.8512 (n = 8,624,776). Therefore, the
relationship in relative costs is similar
between the two methods.
Using cost report data to develop
case-mix weights more evenly weights
skilled nursing services and therapy

services than the BLS data. Table 32
shows the ratios between the estimated
costs per hour for each of the home
health disciplines compared with
skilled nursing resulting from the CPM
+ NRS versus WWMC methods. Under
the CPM + NRS methodology, the ratio
for physical therapy costs per hour to
skilled nursing is 1.14 compared with
1.36 using the WWMC method.

TABLE 32—RELATIVE VALUES IN COSTS PER HOUR BY DISCIPLINE
[Skilled nursing is base]
Estimated cost per hour

Skilled nursing

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CPM + NRS .............................................
WWMC .....................................................

1.00
1.00

In response to the CY 2018 HH PPS
proposed rule (82 FR 35270), a few
commenters, stated that based on their
operational experiences with clinical
staffing labor costs, HHA cost report
data suggests more parity exists between
skilled nursing (‘‘SN’’) versus physical
therapist (‘‘PT’’) costs than in fact exists.
Commenters stated that BLS data
showing a 40 percent difference
between SN and PT costs are more
reflective of the human resources
experiences in the markets where they
operate. As such, commenters believe
the use of cost report data would cause
the proposed alternative case-mix
methodology to overpay for nursing
services and underpay for therapy
services, although it was not clear from
the comments why the relative
relationship in cost between disciplines
would necessarily mean that nursing
would be overpaid or underpaid relative
to therapy.
We note that the HHA Medicare cost
report data reflects all labor costs,
including contract labor costs. The BLS
data only reflects employed staff. This
may partially explain why a 40 percent
variation between SN and PT costs is
not evident in the cost report data.
However, the comparison is somewhat
inappropriate because the BLS data only
reflects labor costs whereas the HHA
Medicare cost report data includes labor
and non-labor costs. As noted earlier in
Table 32, there is only a 14 percent
variation using the CPM + NRS
methodology. Moreover, in aggregate,
about 15 percent of compensation costs
are contract labor costs and this varies
among the disciplines with contract
labor costs accounting for a much higher
proportion of therapy visit costs
compared to skilled nursing visit costs.
Utilization also varies among
freestanding providers with smaller

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Physical
therapy

Occupational
therapy

1.14
1.36

1.15
1.38

providers having a higher proportion of
contract labor costs, particularly for
therapy services compared to larger
providers. The decision of whether to/
or what proportion of contract labor to
use is at the provider’s discretion.
Finally, we note that in order to be
eligible for Medicare HH PPS payments,
providers must complete the HHA
Medicare cost report and certify the
report by the Officer or Director of the
home health agency as being true,
correct, and complete; therefore, such
data can and should be used to calculate
the cost of care.
We have determined that using cost
report data to calculate the cost of home
health care better aligns the case-mix
weights with the total relative cost for
treating various patients. In addition,
using cost report data allows us to
incorporate NRS into the case-mix
system, rather than maintaining a
separate payment system. Therefore, we
are re-proposing to calculate the cost of
a 30-day period of home health care
under the proposed PDGM using the
cost per minute plus non-routine
supplies (CPM + NRS) approach
outlined above, as also outlined in the
CY 2018 proposed rule. We invite
comments on the proposed
methodology for calculating the cost of
a 30-day period of care under the
PDGM.
3. Change From a 60-Day to a 30-Day
Unit of Payment
a. Background
Currently, HHAs are paid for each 60day episode of home health care
provided. In the CY 2018 HH PPS
proposed rule, CMS proposed a change
from making payment based on 60-day
episodes to making payment based on
30-day periods, effective for January 1,

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Speech
therapy
1.25
1.56

Medical
social service
1.39
0.94

Home
health aide
0.40
0.35

2019. Examination of the resources used
within a 60-day episode of care
identified differences in resources used
between the first 30-day period within
a 60-day episode and the second 30-day
period within a 60-day episode.
Episodes have more visits, on average,
during the first 30 days compared to the
last 30 days and costs are much higher
earlier in the episode and lesser later on;
therefore, dividing a single 60-day
episode into two 30-day periods more
accurately apportioned payments. In
addition, with the proposed removal of
therapy thresholds from the case-mix
adjustment methodology under the HH
PPS, a shorter period of care reduced
the variation and improved the accuracy
of the case-mix weights generated under
the PDGM. CMS did not finalize the
implementation of a 30-day unit of
payment in the CY 2018 HH PPS final
rule (82 FR 51676).
Section 1895(b)(2)(B) of the Act, as
added by section 51001(a)(1) of the BBA
of 2018, requires the Secretary to apply
a 30-day unit of service for purposes of
implementing the HH PPS, effective
January 1, 2020. We note that we
interpret the term ‘‘unit of service’’ to be
synonymous with ‘‘unit of payment’’
and will henceforth refer to ‘‘unit of
payment’’ in this proposed rule with
regards to payment under the HH PPS.
We propose to make HH payments
based on a 30-day unit of payment
effective January 1, 2020. While we are
proposing to change to a 30-day unit of
payment, we note that the
comprehensive assessment would still
be completed within 5 days of the start
of care date and completed no less
frequently than during the last 5 days of
every 60 days beginning with the start
of care date, as currently required by
§ 484.55, Condition of participation:
Comprehensive assessment of patients.

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In addition, the plan of care would still
be reviewed and revised by the HHA
and the physician responsible for the
home health plan of care no less
frequently than once every 60 days,
beginning with the start of care date, as
currently required by § 484.60(c),
Condition of participation: Care
planning, coordination of services, and
quality of care.
b. 30-Day Unit of Payment
Under section 1895(b)(3)(A)(iv) of the
Act, we are required to calculate a 30day payment amount for CY 2020 in a
budget neutral manner such that
estimated aggregate expenditures under
the HH PPS during CY 2020 are equal
to the estimated aggregate expenditures
that otherwise would have been made
under the HH PPS during CY 2020 in
the absence of the change to a 30-day
unit of payment. Furthermore, as also
required by section 1895(b)(3)(A)(iv) of
the Act, to calculate a 30-day payment
amount in a budget-neutral manner, we
are required to make assumptions about
behavior changes that could occur as a
result of the implementation of the 30day unit of payment. In addition, in
calculating a 30-day payment amount in
a budget-neutral manner, we must take
into account behavior changes that
could occur as a result of the case-mix
adjustment factors that are implemented
in CY 2020. We are also required to
calculate a budget-neutral 30-day
payment amount before the provisions
of section 1895(b)(3)(B) of the Act are
applied, that is, the home health
applicable percentage increase, the
adjustment for case-mix changes, the
adjustment if quality data is not
reported, and the productivity
adjustment.
In calculating the budget-neutral 30day payment amount, we propose to
make three assumptions about behavior
change that could occur in CY 2020 as
a result of the implementation of the 30day unit of payment and the
implementation of the PDGM case-mix
adjustment methodology outlined in
this proposed rule:
• Clinical Group Coding: A key
component of determining payment
under the PDGM is the 30-day period’s
clinical group assignment, which is
based on the principal diagnosis code
for the patient as reported by the HHA
on the home health claim. Therefore, we
assume that HHAs will change their
documentation and coding practices
and would put the highest paying
diagnosis code as the principal
diagnosis code in order to have a 30-day
period be placed into a higher-paying
clinical group. While we do not support
or condone coding practices or the

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provision of services solely to maximize
payment, we often take into account
expected behavioral effects of policy
changes related to the implementation
of the proposed rule.
• Comorbidity Coding: The PDGM
further adjusts payments based on
patients’ secondary diagnoses as
reported by the HHA on the home
health claim. While the OASIS only
allows HHAs to designate 1 primary
diagnosis and 5 secondary diagnoses,
the home health claim allows HHAs to
designate 1 principal diagnosis and 24
secondary diagnoses. Therefore, we
assume that by taking into account
additional ICD–10–CM diagnosis codes
listed on the home health claim (beyond
the 6 allowed on the OASIS), more 30day periods of care will receive a
comorbidity adjustment than periods
otherwise would have received if we
only used the OASIS diagnosis codes for
payment. The comorbidity adjustment
in the PDGM can increase payment by
up to 20 percent.
• LUPA Threshold: Rather than being
paid the per-visit amounts for a 30-day
period of care subject to the lowutilization payment adjustment (LUPA)
under the proposed PDGM, we assume
that for one-third of LUPAs that are 1 to
2 visits away from the LUPA threshold
HHAs will provide 1 to 2 extra visits to
receive a full 30-day payment.32 LUPAs
are paid when there are a low number
of visits furnished in a 30-day period of
care. Under the PDGM, the LUPA
threshold ranges from 2–6 visits
depending on the case-mix group
assignment for a particular period of
care (see section F.9 of this proposed
rule for the LUPA thresholds that
correspond to the 216 case-mix groups
under the PDGM).
Table 33 includes estimates of what
the 30-day payment amount would be
for CY 2019 (using CY 2017 home
health utilization data) in order to
achieve budget neutrality both with and
without behavioral assumptions and
including the application of the
proposed home health payment update
percentage of 2.1 percent outlined in
section C.2 of this proposed rule. We
note that these are only estimates to
illustrate the 30-day payment amount if
we had proposed to implement the 30day unit of payment and the proposed
PDGM for CY 2019. However, because
we are proposing to implement the 30day unit of payment and proposed
32 Current data suggest that what would be about
⁄ of the LUPA episodes with visits near the LUPA
threshold move up to become non-LUPA episodes.
We assume this experience will continue under the
PDGM, with about 1⁄3 of those episodes 1 or 2 visits
below the thresholds moving up to become nonLUPA episodes.

13

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32389

PDGM for CY 2020, we would propose
the actual 30-day payment amount in
the CY 2020 HH PPS proposed rule
calculated using CY 2018 home health
utilization data, and we would calculate
this amount before application of the
proposed home health update
percentage required for CY 2020 (as
required by section 1895(b)(3)(iv) of the
Act). In order to calculate the budget
neutral 30-day payment amounts in this
proposed rule, both with and without
behavioral assumptions, we first
calculated the total, aggregate amount of
expenditures that would occur under
the current case-mix adjustment
methodology (as described in section
III.B. of this rule) and the 60-day
episode unit of payment using the
proposed CY 2019 payment parameters
(e.g., proposed 2019 payment rates,
proposed 2019 case-mix weights, and
outlier fixed-dollar loss ratio). That
resulted in a total aggregate
expenditures target amount of $16.1
billion.33 We then calculated what the
30-day payment amount would need to
be set at in CY 2019, with and without
behavior assumptions, while taking into
account needed changes to the outlier
fixed-dollar loss ratio under the PDGM
in order to pay out no more than 2.5
percent of total HH PPS payments as
outlier payments (refer to section
III.F.12 of this proposed rule) and in
order for Medicare to pay out $16.1
billion in total expenditures in CY 2019
with the application of a 30-day unit of
payment under the PDGM.

33 The initial 2017 analytic file included
6,771,059 60-day episodes ($18.2 billion in total
expenditures). Of these, 959,410 (14.2 percent) were
excluded because they could not be linked to
OASIS assessments or because of the claims data
cleaning process reasons listed in section III.F.1 of
this proposed rule. We note that of the 959,410
claims excluded, 620,336 were excluded because
they were RAPs without a final claim or they were
claims with zero payment amounts, resulting in
$17.4 billion in total expenditures. After removing
all 959,410 excluded claims, the 2017 analytic file
consisted of 5,811,649 60-day episodes ($16.4
billion in total expenditures). 60-day episodes of
duration longer than 30 days were divided into two
30-day periods in order to calculate the 30-day
payment amounts. As noted in section III.F.1 of this
proposed rule, there were instances where 30-day
periods were excluded from the 2017 analytic file
(for example, we could not match the period to a
start of care or resumption of care OASIS to
determine the functional level under the PDGM, the
30-day period did not have any skilled visits, or
because information necessary to calculate payment
was missing from claim record). The final 2017
analytic file used to calculate budget neutrality
consisted of 9,285,210 30-day periods ($16.1 billion
in total expenditures) drawn from 5,456,216 60-day
episodes.

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TABLE 33—ESTIMATES OF 30-DAY BUDGET-NEUTRAL PAYMENT AMOUNTS
30-day budget
neutral (BN)
standard
amount

Behavioral assumption

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No Behavioral Assumptions ....................................................................................................................................
LUPA Threshold (1⁄3 of LUPAs 1–2 visits away from threshold get extra visits and become case-mix adjusted)
Clinical Group Coding (among available diagnoses, one leading to highest payment clinical grouping classification designated as principal) ..........................................................................................................................
Comorbidity Coding (assigns comorbidity level based on comorbidities appearing on HHA claims and not just
OASIS) .................................................................................................................................................................
Clinical Group Coding + Comorbidity Coding .........................................................................................................
Clinical Group Coding + Comorbidity Coding + LUPA Threshold ..........................................................................

If no behavioral assumptions were
made, we estimate that the 30-day
payment amount needed to achieve
budget neutrality would be $1,873.91.
The clinical group and comorbidity
coding assumptions would result in the
need to decrease the budget-neutral 30day payment amount to $1,786.54 (a
4.66 percent decrease from $1,873.91).
Adding the LUPA assumption would
require us to further decrease that
amount to $1,753.68 (a 6.42 percent
decrease from $1,873.91).
We note that we are also required
under section 1895(b)(3)(D)(i) of the Act,
as added by section 51001(a)(2)(B) of the
BBA of 2018, to analyze data for CYs
2020 through 2026, after
implementation of the 30-day unit of
payment and new case-mix adjustment
methodology, to annually determine the
impact of differences between assumed
behavior changes and actual behavior
changes on estimated aggregate
expenditures. We interpret actual
behavior change to encompass both
behavior changes that were outlined
above, as assumed by CMS when
determining the budget-neutral 30-day
payment amount for CY 2020, and other
behavior changes not identified at the
time the 30-day payment amount for CY
2020 is determined. The data from CYs
2020 through 2026 will be available to
determine whether a prospective
adjustment (increase or decrease) is
needed no earlier than in years 2022
through 2028 rulemaking. As noted
previously, under section
1895(b)(3)(D)(ii) of the Act, we are
required to provide one or more
permanent adjustments to the 30-day
payment amount on a prospective basis,
if needed, to offset increases or
decreases in estimated aggregate
expenditures as calculated under
section 1895(b)(3)(D)(i) of the Act.
Clause (iii) of section 1895(b)(3)(D) of
the Act requires the Secretary to make
temporary adjustments to the 30-day
payment amount, on a prospective
basis, in order to offset increases or
decreases in estimated aggregate

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expenditures, as determined under
clause (i) of such section. The temporary
adjustments allow us to recover excess
spending or give back the difference
between actual and estimated spending
(if actual is less than estimated) not
addressed by permanent adjustments.
For instance, if expenditures are
estimated to be $18 billion in CY 2020,
but expenditures are actually $18.25
billion in CY 2020, then we can reduce
payments (temporarily) in the future to
recover the $250 million.
As noted above, section
1895(b)(3)(A)(iv) of the Act requires the
Secretary to calculate a budget-neutral
30-day payment amount to be paid for
home health units of service that are
furnished and end during the 12-month
period beginning January 1, 2020. For
implementation purposes, we propose
that the 30-day payment amount would
be paid for home health services that
start on or after January 1, 2020. More
specifically, for 60-day episodes that
begin on or before December 31, 2019
and end on or after January 1, 2020
(episodes that would span the January 1,
2020 implementation date), payment
made under the Medicare HH PPS
would be the CY 2020 national,
standardized 60-day episode payment
amount. For home health units of
service that begin on or after January 1,
2020, the unit of service would now be
a 30-day period and payment made
under the Medicare HH PPS would be
the CY 2020 national, standardized
prospective 30-day payment amount.
For home health units of service that
begin on or after December 2, 2020
through December 31, 2020 and end on
or after January 1, 2021, the HHA would
be paid the CY 2021 national,
standardized prospective 30-day
payment amount.
We are soliciting comments on our
proposals, including the proposed
behavior change assumptions outlined
above to be used in determining the 30day payment amount for CY 2020 and
the corresponding regulation text

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Percent
change from
no behavioral
assumptions

$1,873.91
1,841.05

........................
¥1.75

1,793.69

¥4.28

1,866.76
1,786.54
1,753.68

¥0.38
¥4.66
¥6.42

changes outlined in section III.F.13 and
IX. of this proposed rule.
c. Split Percentage Payment Approach
for a 30-Day Unit of Payment
In the current HH PPS, there is a split
percentage payment approach to the 60day episode. The first bill, a Request for
Anticipated Payment (RAP), is
submitted at the beginning of the initial
episode for 60 percent of the anticipated
final claim payment amount. The
second, final bill is submitted at the end
of the 60-day episode for the remaining
40 percent. For all subsequent episodes
for beneficiaries who receive continuous
home health care, the episodes are paid
at a 50/50 percentage payment split.
In the CY 2018 HH PPS proposed rule
(82 FR 35270), we solicited comments
as to whether the split payment
approach would still be needed for
HHAs to maintain adequate cash flow if
the unit of payment changes from 60day episodes to 30-day periods of care.
In addition, we solicited comments on
ways to phase-out the split percentage
payment approach in the future.
Specifically, we solicited comments on
reducing the percentage of the upfront
payment over a period of time and if in
the future the split percentage approach
was eliminated, we solicited comments
on the need for HHAs to submit a notice
of admission (NOA) within 5 days of the
start of care to assure being established
as the primary HHA for the beneficiary
and so that the claims processing system
is alerted that a beneficiary is under a
HH period of care to enforce the
consolidating billing edits as required
by law. Commenters generally
expressed support for continuing the
split percentage payment approach in
the future under the proposed
alternative case-mix model. While we
solicited comments on the possibility of
phasing-out the split percentage
payment approach in the future and the
need for a NOA, commenters did not
provide suggestions for a phase-out
approach, but stated that they did not
agree with requiring a NOA given the

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experience with such a process under
the Medicare hospice benefit.
While CMS did not finalize the
implementation of a 30-day unit of
payment in the CY 2018 HH PPS final
rule (82 FR 51676), the BBA of 2018
now requires a change to the unit of
payment from a 60-day episode to a 30day period of care, as outlined in
section F.3.b above, effective January 1,
2020. We continue to believe that as a
result of the reduced timeframe for the
unit of payment, that a split percentage
approach to payment may not be needed
for HHAs to maintain adequate cash
flow. Currently, about 5 percent of
requests for anticipated payment are not
submitted until the end of a 60-day
episode of care and the median length
of days for RAP submission is 12 days
from the start of the 60-day episode. As
such, we are reevaluating the necessity
of RAPs for existing and newly-certified
HHAs versus the risks they pose to the
Medicare program.
RAP payments can result in program
integrity vulnerabilities. For example, a
final claim was never submitted for
$321 million worth of RAP payments
between July 1, 2015 and July 31, 2016.
While CMS typically can recoup RAP
overpayments from providers that
continue to submit final claims to the
Medicare program, some fraud schemes
have involved collecting these RAP
payments, never submitting final
claims, and closing the HHA before
Medicare can take action. Below are two
examples of HHAs that were identified
for billing large amounts of RAPs with
no final claim:
• Provider 1 is a Home Health Agency
located in Michigan. It was identified
for submitting home health claims for
beneficiaries located in California and
Florida. Further analysis found that the
HHA was submitting RAPs with no final
claims. CMS discovered that the address
on record for the HHA was vacant for
an extended period of time. In addition,
CMS determined that although Provider
1 had continued billing and receiving
payments for RAP claims, it had not
submitted a final claim in 10 months.
Ultimately, the HHA submitted a total of
$50,234,430.36 in RAP payments and
received $37,204,558.80 in RAP
payments. In addition to the large
amount of money paid to the HHA,
Medicare beneficiaries were also
impacted by the HHA’s billing behavior.
For example, a Florida beneficiary who
needed home health services was
unable to receive the care required due
to the RAP submission by this Provider.
• Provider 2 is a Home Health Agency
that is also located in Michigan that
submitted a significant number of RAPs
with no final claim. While the majority

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of these beneficiaries were located in
Michigan, data analysis identified
beneficiaries who were not likely
homebound or qualified for home health
services. CMS discovered that the
address on record for the HHA was
vacant. Provider 2 had not submitted
any final claims in more than one year
and was no longer billing the Medicare
program. However, the HHA was paid a
total of $5,765,261.04 in RAP payments
that had no final claim.
Given the program integrity concerns
outlined above and the reduced
timeframe for the unit of payment (30days rather than 60-days), we are
proposing not to allow newly-enrolled
HHAs, that is HHAs certified for
participation in Medicare effective on or
after January 1, 2019, to receive RAP
payments beginning in CY 2020. This
would allow newly-enrolled HHAs to
structure their operations without
becoming dependent on a partial,
advanced payment and take advantage
of receiving full payments for every 30day period of care. We are proposing
that HHAs, that are certified for
participation in Medicare effective on or
after January 1, 2019, would still be
required to submit a ‘‘no pay’’ RAP at
the beginning of care in order to
establish the home health episode, as
well as every 30-days thereafter. RAP
submissions are currently operationally
significant as the RAP establishes the
HHA as the primary HHA for the
beneficiary during that timeframe and
alerts the claims processing system that
a beneficiary is under the care of an
HHA to enforce the consolidating billing
edits required by law under section
1842(b)(6)(F) of the Act. Without such
notification, there would be an increase
in denials of claims subject to the home
health consolidated billing edits that are
prevented when an episode/period is
established in the common working file
(CWF) by the RAP, potentially resulting
in increases in appeals, and increases in
situations where other providers,
including other HHAs, would not have
easy information on whether a patient
was already being served by an HHA.
CMS invites comments on whether the
burden of submitting a ‘‘no-pay’’ RAP
by newly-enrolled HHAs outweighs the
risks to the Medicare program and
providers associated with not
submitting them.
We propose that existing HHAs, that
is HHAs certified for participation in
Medicare with effective dates prior to
January 1, 2019, would continue to
receive RAP payments upon
implementation of the 30-day unit of
payment and the proposed PDGM casemix adjustment methodology in CY
2020. However, we are again soliciting

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comments on ways to phase-out the
split percentage payment approach in
the future given that CMS is required to
implement a 30-day unit of payment
beginning on January 1, 2020 as
outlined above. Specifically, we are
soliciting comments on reducing the
percentage of the upfront payment
incrementally over a period of time. If
in the future the split percentage
approach was eliminated, we are also
soliciting comments on the need for
HHAs to submit a NOA within 5 days
of the start of care to assure being
established as the primary HHA for the
beneficiary during that timeframe and
so that the claims processing system is
alerted that a beneficiary is under a HH
period of care to enforce the
consolidating billing edits as required
by law. As outlined above, there are
significant drawbacks to both Medicare
and providers of not establishing a NOA
process upon elimination of RAPs.
In summary, we invite comments on
the change in the unit of payment from
a 60-day episode of care to a 30-day
period of care; the proposed calculation
of the 30-day payment amount in a
budget-neutral manner and behavior
change assumptions for CY 2020; the
proposed interpretation of the statutory
language regarding actual behavior
change; the proposal not to allow
newly-enrolled HHAs (HHAs certified
for participation in Medicare effective
on or after January 1, 2019) to receive
RAP payments upon implementation of
the 30-day unit of payment in CY 2020,
yet still require the submission of a ‘‘no
pay’’ RAP at the beginning of care; the
proposal to maintain the split
percentage payment approach for
existing HHAs and applying such policy
to 30-day periods of care; and the
associated regulations text changes
outlined in section III.F.13 and IX of
this proposed rule. We are also
soliciting comments on ways the split
percentage payment approach could be
phased-out and whether to implement a
NOA process if the split percentage
payment approach is eliminated in the
future.
4. Timing Categories
In the CY 2018 HH PPS proposed
rule, we described analysis showing the
impact of timing on home health
resource use and proposed to classify
the 30-day periods under the proposed
alternative case-mix adjustment
methodology as ‘‘early’’ or ‘‘late’’
depending on when they occur within
a sequence of 30-day periods (82 FR
35307). Under the current HH PPS, the
first two 60-day episodes of a sequence
of adjacent 60-day episodes are
considered early, while the third 60-day

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episode of that sequence and any
subsequent episodes are considered late.
Under the alternative case-mix
adjustment methodology, we proposed
that the first 30-day period would be
classified as early and all subsequent
30-day periods in the sequence (second
or later) would be classified as late.
Similar to the current payment system,
we proposed that a 30-day period could
not be considered early unless there was
a gap of more than 60 days between the
end of one period and the start of
another, or it was the first period in a
sequence of periods in which there was
no more than 60 days between the end
of that period and the start of the next
period.
In response to the CY 2018 HH PPS
proposed rule, several commenters were
supportive of the inclusion of the timing
category in the alternative case-mix
adjustment methodology, stating that
this differentiation would reflect that
HHA costs are typically highest during
the first 30 days of care. However, other
commenters expressed concerns
regarding timing, stating that HHAs may
modify the ways in which they provide

care, that the change would cause a
decrease in overall payment to HHAs
and an increase in hospital
readmissions, and that the categories
would not account for increased costs in
the later periods of care. Several
commenters described concerns
regarding the potential for problematic
provider behavior due to financial
incentives as well as the potential for
problems with operational aspects of the
timing element of the alternative casemix adjustment methodology.
Additionally, some commenters
suggested that we modify the definition
of an ‘‘early’’ 30-day period to either the
first two 30-day periods or the first four
30-days of care, stating that those
definitions would more closely mirror
the current payment system’s definition
of ‘‘early’’ and that HHAs would
otherwise experience a payment
decrease when compared to the current
60-day episode payment amount.
As described in detail in the CY 2018
HH PPS proposed rule, our proposal
regarding the timing element of the
alternative case-mix adjustment
methodology was intended to refine and

to better fit costs incurred by agencies
for patients with differing
characteristics and needs under the HH
PPS (82 FR 35270). Analysis of home
health data demonstrates that under the
current payment system, when analyzed
by 30-day periods, HHAs provide more
resources in the first 30-day period of
home health (‘‘early’’) than in later
periods of care. The differences in the
average resource use during early and
late home health episodes when divided
into 30-day periods are presented in
Table 34, and shows the first 30-day
periods in a home health sequence have
significantly higher average resource use
at $2,113.66 as compared with
subsequent 30-day periods. Specifically,
the later 30-day periods showed an
average resource use of $1,311.73, a
difference of more than $800 or a 38
percent decrease. Table 34 also shows a
significant difference between the early
and late median values of resource use.
The median for the first 30-day period
is $1,866.79, while the median for
subsequent 30-day periods is $987.94, a
difference of more than $878 or an
approximately 47 percent decrease.

TABLE 34—AVERAGE RESOURCE USE BY TIMING
[30-Day periods]
Average
resource
use

Timing

Frequency
of periods

Percent
of periods

Standard
deviation of
resource
use

25th
percentile of
resource
use

Median
resource
use

75th
percentile of
resource
use

Early 30-Day Periods ................................................................
Late 30-Day Periods .................................................................

$2,113.66
1,311.73

2,785,039
5,839,737

32.3
67.7

$1,236.30
1,125.44

$1,232.23
534.82

$1,866.79
987.94

$2,707.04
1,735.69

Total ...................................................................................

1,570.68

8,624,776

100.0

1,221.38

679.12

1,272.18

2,117.47

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Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

There is significant difference in the
resource utilization between early and
late 30-day periods as demonstrated in
Table 34. Moreover, the predictive
power of the proposed PDGM in terms
of estimating resource utilization
improved when separating episodes into
30-day periods rather than 60-day
periods (that is, the first and second 30day periods). We believe that a PDGM
that accounts for the demonstrated
increase in resource utilization in the
first 30-day period better captures the
variations in resource utilization and
further promotes the goal of payment
accuracy within the HH PPS.
Moreover, we note that the resource
cost estimates are derived from a very
large, representative dataset. Therefore,
we expect that the proposal reflects
agencies’ average costs for all home
health service delivered in the period
examined. We have constructed the
revised case-mix adjustment model
based upon the actual resources
expended by home health agencies for

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Medicare beneficiaries, which show that
typically HHAs provide more visits
during the first 30 days of care and
utilize less resources thereafter. We
reiterate that the timing categories are
reflective of the utilization patterns
observed in the data analyzed for the
purposes of constructing the PDGM. The
weights of the two timing categories are
driven by the mix of services provided,
the costs of services provided as
determined by cost report data, the
length of the visits, and the number of
visits provided. The categorization of
30-day periods as ‘‘early’’ and ‘‘late’’
serves to better align payments with
already existing resource use patterns.
This alignment of payment with
resource use is not to be interpreted as
placing a value judgment on particular
care patterns or patient populations.
Our goal in developing the PDGM is to
provide an appropriate payment based
on the identified resource use of
different patient groups, not to

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encourage, discourage, value, or devalue
one type of skilled care over another.
For the reasons described above, we
are proposing to classify the 30-day
periods under the proposed PDGM as
‘‘early’’ or ‘‘late’’ depending on when
they occur within a sequence of 30-day
periods. For the purposes of defining
‘‘early’’ and ‘‘late’’ periods for the
proposed PDGM, we are proposing that
only the first 30-day period in a
sequence of periods be defined as
‘‘early’’ and all other subsequent 30-day
periods would be considered ‘‘late’’.
Additionally, we are proposing that the
definition of a ‘‘home health sequence’’
(as currently described in § 484.230)
will remain unchanged relative to the
current system, that is, 30-day periods
are considered to be in the same
sequence as long as no more than 60
days pass between the end of one period
and the start of the next, which is
consistent with the definition of a
‘‘home health spell of illness’’ described
at section 1861(tt)(2) of the Act. We note

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that because section 1861(tt)(2) of the
Act is a definition related to eligibility
for home health services as described at
section 1812(a)(3) of the Act, it does not
affect or restrict our ability to
implement a 30-dayunit of payment.
At this time, the data do not support
the notion that the first two 30-day
periods should be defined as early, as
only the first 30-day period presents
marked increase in resource use. We
believe the PDGM’s definition of ‘‘early’’
as the first 30-day period most
accurately reflects agencies’ average
costs for patients with characteristics
measured on the OASIS and used in
defining payment groups and supports
the shift from the current ‘‘early’’
category as defined by two 60-day
episodes. We continue to believe that a
PDGM that accounts for the actual,
demonstrated increase in resource
utilization in the first 30-day period
better captures the variations in
resource utilization.
Additionally, in our CY 2008 HH PPS
final rule, we implemented an ‘‘early’’
and ‘‘late’’ distinction in the HH PPS in
which the late episode groupings were
weighted more heavily than those
episodes designated as early due to
heavier resource use during later
episodes (72 FR 49770). At that time,
commenters expressed concerns that
this heavier weighting for later episodes
could lead to gaming by providers, with
patients on service longer than would be
appropriate, and providers not
discharging patients when merited.
During our analysis in support of
subsequent refinements to the HH PPS
in 2015, we analyzed the utilization
patterns observed in the CY 2013 claims
data and observed that the resource use
for later episodes had indeed shifted
such that later episodes had less
resource use than earlier periods, which
was the opposite of the pattern observed
prior to CY 2008. Furthermore, in its
2016 Report to Congress, MedPAC noted
that, between 2002 and 2014, a pattern
in home health emerged where the
number of episodes of care provided to
home health beneficiaries trended
upwards, with the average number of
episodes per user increasing by 18
percent, rising from 1.6 to 1.9 episodes
per user.34 MedPAC noted that this
upward trajectory coincided with,
among other changes, higher payments
for the third and later episodes in a
consecutive spell of home health
episodes. Given the longitudinal
variation in terms of resource provision
during home health episodes, we
34 http://www.medpac.gov/docs/default-source/
reports/chapter-8-home-health-care-services-march2016-report-.pdf.

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believe that restricting the ‘‘early’’
definition to the first 30-day period is
most appropriate for this facet of the
PDGM. Our analysis of home health
resource use as well as comments from
the public that confirm that more
resources are provided in the first 30
days provide compelling evidence to
limit the definition of early to the first
30-day period.
Moreover, the public comments we
received in response to the CY 2018 HH
PPS proposed rule presented conflicting
predictions regarding anticipated
provider behavior in response to the
implementation of the alternative casemix adjustment methodology. Several
commenters stated that they expected
providers to discharge patients after the
first 30-days of care, given that the casemix weights are, on average, higher for
the first 30-days of care. Other
commenters expressed concern that
providers may attempt to keep home
health beneficiaries on service for as
long as possible. Additionally, meeting
the requirement of section 51001 of the
BBA of 2018, a Technical Expert Panel
(TEP) was convened in February 2018 to
solicit feedback and identify and
prioritize recommendations from a wide
variety of industry experts and patient
representatives regarding the public
comments received on the proposed
alternative case-mix adjustment
methodology. Comments on the timing
categories and suggestions for
refinement to this adjustment were very
similar between those received on the
CY 2018 HH PPS proposed rule and
those made by the TEP participants. We
note the PDGM case-mix weights reflect
existing patterns of resource use
observed in our analyses of CY 2016
home health claims data. Since we
propose to recalibrate the PDGM casemix weights on an annual basis to
ensure that the case-mix weights reflect
the most recent utilization data
available at the time of rulemaking,
future recalibrations of the PDGM casemix weights may result in changes to
the case-mix weights for early versus
late 30-day periods of care as a result of
changes in utilization patterns.
Several commenters responding to the
CY 2018 HH PPS proposed rule
suggested that we revise the model such
that a readmission to home health
within the 60-day gap period results in
an ‘‘early’’ instead of a ‘‘late’’ 30-day
period. However, we note that the
PDGM also includes a category
determined specifically by source of
admission, which would account for
any readmission to home health. Under
the PDGM we already account for
whether the patient was admitted to
home health care from the community

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or following an institutional stay,
including inpatient stays that occur after
the commencement of a home health
care. For example, if the original home
health stay was categorized as
community and subsequently the
patient experienced an inpatient stay,
the subsequent home health stay would
reset to institutional upon discharge
from the inpatient setting. Similarly, we
note that for the purposes of the timing
component of the PDGM, an intervening
hospital stay would not trigger recategorization to an ‘‘early’’ period
unless there were a 60-day gap in home
health care. Therefore, we do not
believe that the timing element of the
PDGM would create a financial
incentive to inappropriately encourage
the admission of home health patients
to an acute care setting in order to
receive a subsequent home health
referral in the higher-paid ‘‘early’’
category. Our proposal was intended to
refine and to better fit costs incurred by
agencies for patients with differing
characteristics and needs under the
prospective payment system. Therefore,
we expect that the addition of both the
source of admission, as well as the
timing categories do reflect agencies’
average costs for home health patients
and used in defining payment groups.
We believe that crafting a multi-pronged
case-mix adjustment model, which
includes adjustments based both on
timing within a home health sequence
as well as the source of the beneficiary
admission, will serve to more accurately
account for resources required for
Medicare beneficiaries and similarly
provide a differentiated payment
amount for care.
Several commenters responding to the
CY 2018 HH PPS proposed rule
expressed concern regarding the
operational aspects of the timing
element of the alternative case-mix
adjustment methodology. As we
described in the CY 2018 HH PPS
proposed rule, and as we are proposing
in this rule, we would use Medicare
claims data and not the OASIS
assessment in order to determine if a 30day period is considered ‘‘early’’ or
‘‘late’’ (82 FR 35309). We have
developed claims processing procedures
to reduce the amount of administrative
burden associated with the
implementation of the PDGM. Providers
would not have to determine whether a
30-day period is early (the first 30-day
period) or later (all adjacent 30-day
periods beyond the first 30-day period)
if they choose not to. Information from
Medicare systems would be used during
claims processing to automatically
assign the appropriate timing category.

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To identify the first 30-day period
within a sequence, the Medicare claims
processing system would verify that the
claim ‘‘From date’’ and ‘‘Admission
date’’ match. If this condition were to be
met, our systems would send the
‘‘early’’ indicator to the HH Grouper for
the 30-day period of care. When the
claim was received by CMS’s Common
Working File (CWF), the system would
look back 60 days to ensure there was
not a prior, related 30-day period. If not,
the claim would continue to be paid as
‘‘early.’’ If another related 30-day period
were to be identified, that is an earlier
30-day period in the sequence, the claim
would be flagged as ‘‘late’’ and returned
to the shared systems for subsequent
regrouping and re-pricing. Those
periods that are not the first 30-day
period in a sequence of adjacent
periods, separated by no more than a 60
day gap, would be categorized as ‘‘late’’
periods and placed in corresponding
PDGM categories.
Early 30-day periods are defined as
the initial 30-day period in a sequence
of adjacent 30-day periods. Late 30-day
periods are defined as all subsequent
adjacent periods beyond the first 30-day
period. Periods are considered to be
adjacent if they are contiguous, meaning
that they are separated by no more than
a 60-day period between 30-day periods
of care. In determining a gap, we only
consider whether the beneficiary was
receiving home health care from
traditional fee-for-service Medicare.
For example, if the beneficiary has not
received home health care through
traditional Medicare for at least 60 days,
and then receives home health care from
agency A, that is an early 30-day period.
If that 30-day period receives a PEP
adjustment and agency B recertifies the
beneficiary for a second 30-day period,
that second 30-day period is now
considered a late 30-day period.
However, the beneficiary could have
received home health care from other
traditional Medicare providers within
60 days before coming to agency A. The
designation of early or late would
depend upon how many adjacent
periods of care were received prior to
coming to agency A. The CWF will
examine claims upon receipt in
comparison to all previously processed
30-day period to verify that the period
is correctly designated as early or later.
The 60-day period to determine a gap
that will begin a new sequence of 30day periods will be counted in most
instances from the calculated end date
of the 30-day period. That is, in most
cases CWF will count from ‘‘day 30’’ of
a 30-day period without regard to an
earlier discharge date. The exception to
this is for 30-day periods that were

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subject to PEP adjustment. In PEP cases,
CWF will count 60 days from the date
of the last billable home health visit
provided. Under the current HH PPS,
the partial episode payment (PEP)
adjustment is a proportion of the
episode payment that is based on the
span of days, including the start-of-care
date or first billable service date,
through and including the last billable
service date under the original plan of
care, before the intervening event in a
home health beneficiary’s care, which is
defined as: A beneficiary elected
transfer, or a discharge and return to
home health that would warrant, for
purposes of payment, a new OASIS
assessment, physician certification of
eligibility, and a new plan of care.
Because PEPs are paid based upon the
last billable service date and not
necessarily based on the last day of a 60day episode, we would consider the end
of the PEP HH episode as the last
billable home health visit provided and
begin the count of gap days from the
date of the last billable home health
visit and not ‘‘day 30’’ of a 30-day
period.
Regarding PEP adjustments, consider
the following example: A 30-day period
is opened on January 1, 2020 which
would normally span until January 30,
2020. If this 30-day period were not
subject to a PEP adjustment, any 30-day
period beginning within 60 days
following January 30, 2020 would be
considered an adjacent 30-day period.
In the case of a PEP adjustment, the
determination of an adjacent 30-day
period would no longer be based on day
60, but would instead be based on the
latest billable visit in the 30-day period.
Assume in the example, the patient is
transferred to another HHA (triggering
the PEP adjustment) on January 15, 2020
but the last billable visit is provided on
January 13, 2020. In this case, any 30day period beginning within 60 days
following the January 13, 2020 visit
would be considered an adjacent 30-day
period.
Intervening stays in inpatient
facilities will not create any special
considerations in counting the 60-day
gap. If an inpatient stay occurred within
a period, it would not be a part of the
gap, as counting would begin at ‘‘day
60’’ which in this case would be later
than the inpatient discharge date. If an
inpatient stay occurred within the time
after the end of the HH period and
before the beginning of the next one,
those days would be counted as part of
the gap just as any other days would.
If periods are received after a
particular claim is paid that change the
sequence initially assigned to the paid
period (for example, by service dates

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falling earlier than those of the paid
period, or by falling within a gap
between paid periods), Medicare
systems will initiate automatic
adjustments to correct the payment of
any necessary periods.
Upon receipt of a HH period coded to
represent the early 30-day period in a
sequence, Medicare systems will search
the period history records that are
maintained for each beneficiary. If an
existing 30-day period is found on that
history, the claim for the new period
will be recoded to represent its
sequence correctly and paid according
to the changed code. In addition, when
any new 30-day period is added to those
history records for each beneficiary, the
coding representing period sequence on
previously paid periods will be checked
to see if the presence of the newly
added period causes the need for
changes to those periods. If the need for
changes is found, Medicare systems will
initiate automatic adjustments to those
previously paid periods.
For example, a given 30-day period is
initially determined to be and paid as
the early period in a sequence of
periods. After some amount of time, a
claim is submitted by another HHA that
occurs before the previously designated
first period in the sequence of adjacent
periods and is less than 60 days before
the beginning of that previously
designated first period. In such a case,
the 30-day period corresponding to the
newly submitted claim becomes the first
30-day period of this sequence of
adjacent 30-day periods and thus is
considered to be an early period. The
30-day period previously designated as
the first 30-day period in the sequence
of periods now becomes the second 30day period in the sequence of adjacent
periods, thus changing its status from
that of an early period to that of a late
period.
We plan to develop materials
regarding timing categories, including
such topics as claims adjustments and
resolution of claims processing issues.
We will also update guidance in the
Medicare Claims Processing Manual, as
well as the Medicare Benefit Manual as
appropriate with detailed procedures.
We will also work with our Medicare
Administrative Contractors (MACs) to
address any concerns regarding the
processing of home health claims as
well as develop training materials to
facilitate all aspects of the transition the
PDGM, including the unique aspects of
the timing categories.
Several commenters responding to the
CY 2018 HH PPS proposed rule had
concerns regarding the potential for
problematic provider behavior due to
financial incentives. We note that we

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fully intend to monitor provider
behavior in response to the new PDGM.
As we receive and evaluate new data
related to the provision of Medicare
home health care under the PDGM, we
will reassess the appropriateness of the
payment levels for ‘‘early’’ and ‘‘late’’
periods in a sequence of periods.
Additionally, we will share any
concerning behavior or patterns with
the Medicare Administrative Contracts
(MACs) as well as our Center for
Program Integrity. We plan to monitor
for and identify any variations in the
patterns of care provided to home health
patients, including both increased and
decreased provision of care to Medicare
beneficiaries. We note that an increase
in the volume of Medicare beneficiaries
receiving home health care may, in fact,
represent a positive outcome of the
PDGM, signaling increased access to
care for the Medicare population, so
long as said increase in volume of
beneficiaries is appropriate and in
keeping with eligibility guidelines for
the Medicare home health benefit.
We invite public comments on the
timing categories in the proposed PDGM
and the associated regulations text
changes outlined in section III.F.13. of
this proposed rule.
5. Admission Source Category
In the CY 2018 HH PPS proposed
rule, we described analysis showing the
impact of the source of admission on
home health resource use and proposed
to classify periods into one of two
admission source categories—
community or institutional—depending
on what healthcare setting was utilized
in the 14 days prior to home health (82
FR 35309). We proposed that a 30-day
period would be categorized as
institutional if an acute or post-acute
care (PAC) stay occurred in the 14 days
prior to the start of the 30-day period of
care. We also proposed that a 30-day
period would be categorized as
community if there was no acute or PAC
stay in the 14 days prior to the start of
the 30-day period of care. We proposed

to adopt this categorization by
admission source with the
implementation of alternative case-mix
adjustment methodology refinements.
The proposed admission source
category was discussed in detail in the
CY 2018 HH PPS proposed rule and we
solicited public comments on the
admission source component of the
proposed alternative case-mix
adjustment methodology. Several
commenters expressed their support for
the admission categories within the
framework of the alternative case-mix
adjustment methodology refinements, as
they believe that these groups would be
meaningful and would more
appropriately align the cost of Medicare
home health care with payments,
thereby improving the accuracy of the
HH payment system under the
alternative case-mix adjustment
methodology refinements. Commenters
also expressed a variety of concerns
regarding admission source, stating that
the source of a home health admission
may not always correspond with home
health beneficiary needs and associated
provider costs, that the categories would
discourage the admission of community
entrants due to lower reimbursement,
that the differentiation may encourage
HHAs to favor hospitalization during an
episode of home health care, that
agencies’ ability to provide the care for
beneficiaries in the community would
be reduced, and that small HHAs with
no hospital affiliation would be
negatively impacted. Several
commenters recommended that CMS
consider incorporating other clinical
settings into the definition of the
institutional category, including
hospices and outpatient facilities.
Several commenters also expressed
concern regarding the operational
aspects of the admission source
category, requesting guidance for
retroactive adjustments, plans for the
claims readjustment process due to
institutional claim issues, definitions for
timely filing, and guidance regarding

when occurrence codes may be utilized.
Moreover, in accordance with the
requirement of section 51001 of the BBA
of 2018, a Technical Expert Panel (TEP)
convened in February 2018 to solicit
feedback and identify and prioritize
recommendations from a wide variety of
industry experts and patient
representatives regarding the public
comments received on the proposed
alternative case-mix adjustment
methodology. Comments on the
admission source categories and
suggestions for refinement to this
element of the alternative case-mix
system were very similar between those
received in response to the CY 2018 HH
PPS proposed rule and those provided
by the TEP participants.
We appreciate commenters’ feedback
regarding the admission source element
of the alternative case-mix adjustment
methodology. The intention of the
proposal included in the CY 2018 HH
PPS proposed rule, including the
admission source component, was to
refine and to better fit costs incurred by
agencies for patients with differing
characteristics and needs under the HH
prospective payment system, and we
believe that the differing weights for
source of admission will serve to
promote appropriate alignment between
costs and payment within the HH PPS.
As described in the CY 2018 HH PPS
proposed rule, our analytic findings
demonstrate that institutional
admissions have higher average
resource use when compared with
community admissions, which
ultimately led to the inclusion of the
admission source category within the
framework of the alternative case-mix
adjustment methodology refinements
(82 FR 35309). The differences in care
needs during home health based on
admission source are illustrated in the
resource utilization figures presented in
Table 35, which shows the distribution
of admission sources as well as average
resource use for 30-day periods by
admission source.

TABLE 35—AVERAGE RESOURCE USE BY ADMISSION SOURCE (14 DAY LOOK-BACK; 30 DAY PERIODS) ADMISSION
SOURCE, COMMUNITY AND INSTITUTIONAL ONLY

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Average
resource
use

Frequency
of periods

Percent
of periods

Standard
deviation of
resource
use

25th
percentile of
resource
use

Median
resource
use

75th
percentile of
resource
use

Community ................................................................................
Institutional ................................................................................

$1,363.11
2,171.00

6,408,805
2,215,971

74.3
25.7

$1,119.20
1,303.24

$570.26
1,246.05

$1,062.05
1,920.06

$1,817.75
2,791.91

Total ...................................................................................

1,570.68

8,624,776

100.0

1,221.38

679.12

1,272.18

2,117.47

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

Institutional admissions have
significantly higher average resource use

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at $2,171.00 compared with community
admissions at $1,363.11, a difference of

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$807.89. Median values of resource use
also show a significant difference

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between sources of admission, with
institutional resource use at $1,920.06
while community resource use is at
$1,062.05, a difference of $858.01. The
pattern of higher resource use for
institutional admissions as compared to
community admissions remains
consistent for the 25th and 75th
percentiles, with a difference of
approximately $675 and $974,
respectively.
Additionally, we note that we do not
show preference to any particular
patient profile, but rather aim to better
align home health payment with the
costs associated with providing care. As
discussed in our CY 2018 HH PPS
proposed rule, current research around
those patients who are discharged from
acute and PAC settings shows that these
beneficiaries tend to be sicker upon
admission, are being discharged rapidly
back to the community, and are more
likely to be re-hospitalized after
discharge due to the acute nature of
their illness.35 Additionally, as further
described in the CY 2018 HH PPS
proposed rule, research studies indicate
that patients admitted to home health
from institutional settings are
vulnerable to adverse effects and injury
because of the functional decline that
occurs due to their institutional stay,
indicating that the patient population
referred from an institutional setting
requires more concentrated resources
and supports to account for and mitigate
this functional decline.36 Moreover, as
described in the CY 2018 HH PPS
proposed rule, research suggests that the
reduction in monitoring from the level
typically experienced in an inpatient
facility to that in the home environment
can potentially cause gaps in care and
consequently increased risk for adverse
events for the newly-admitted home
health beneficiary, and any negative
impacts of the transition to the home
setting can be reduced by an appropriate
increase in care for the beneficiary,
particularly through more frequent
assessment of their condition and
ongoing monitoring once transferred to
the home environment.37 Furthermore,
research discussed in our CY 2018 HH
PPS proposed rule shows that
35 O’Connor, M. (2012, February). Hospitalization
Among Medicare-Reimbursed Skilled Home Health
Recipients. Retrieved March 02, 2017, from https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC4690459.
36 Rosati, R. J., Huang, L., Navaie-Waliser, M., &
Feldman, P. H. (2003). Risk Factors for Repeated
Hospitalizations Among Home Healthcare
Recipients. Journal For Healthcare Quality, 25(2),
4–11. doi:10.1111/j.1945–1474.2003.tb01038.x.
37 Forster, A. J. (2003). The Incidence and
Severity of Adverse Events Affecting Patients after
Discharge from the Hospital. Annals of Internal
Medicine, 138(3), 161. doi:10.7326/0003–4819–
138–3–200302040–00007.

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beneficiaries discharged from
institutional settings are more
vulnerable because of, among other
factors, the need to manage new health
care issues, major modifications to
medication interventions, and the
coordination of follow-up
appointments, which could lead to the
risk for adverse drug events, for errors
in a beneficiary’s medication regimen,
and for the need to readmit to the
hospital due to deterioration of the
patient’s condition.38 Additionally, we
note that the goal of the admission
source variable is not to identify or
evaluate for increases in rehospitalization in the home health
beneficiary population but rather to
align payment with the costs of
providing home health care. Other CMS
initiatives such as the HH QRP as well
as the HH VBP demonstration take into
account readmissions, among other
measures of quality. However, because
this population is at higher risk for
possible readmission to an institutional
setting, we believe that more intensive
supports, partnered with differentiated
payment weights, are appropriate in
crafting a payment system that better
reflects the costs incurred by HHAs
while also promoting the delivery of
quality care to the Medicare population.
In summary, clinical research continues
to indicate that the needs of the
institutional population are intensive.
Likewise, our analysis of home health
data shows that costs sustained by home
health agencies for those beneficiaries
admitted from institutional settings are
higher than community entrants.
Therefore, we believe that accounting
for these material differences in the care
needs of the beneficiary population
admitted from institutional settings and
their resultant, differentiated resource
use, will serve to better align payments
with actual costs incurred by HHAs
when caring for Medicare beneficiaries.
We expect that HHAs will continue to
provide the most appropriate care to
Medicare home health beneficiaries,
regardless of admission source or any
other category related to home health
payment. As we noted in the CY 2018
HH PPS proposed rule, the primary goal
of home health care is to provide
restorative care when improvement is
expected, maintain function and health
status if improvement is not expected,
slow the rate of functional decline to
avoid institutionalization in an acute or
38 Meyers, A. G., Salanitro, A., Wallston, K. A.,
Cawthon, C., Vasilevskis, E. E., Goggins, K. M., . . .
Kripalani, S. (2014). Determinants of health after
hospital discharge: Rationale and design of the
Vanderbilt Inpatient Cohort Study (VICS). BMC
Health Services Research, 14(1). doi:10.1186/1472–
6963–14–10.

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post-acute care setting, and/or facilitate
transition to end-of-life care as
appropriate (82 FR 35348). The primary
goal of the HH PPS is to align payment
with the costs of providing home health
care. Furthermore, in our CY 2000 HH
PPS final rule, commenters asserted that
patients admitted to home health from
the hospital were often more acutely ill
and resource-intensive than other
patients, particularly when compared
with beneficiaries who had no
institutional care prior to admission (64
FR 41147). We appreciate the concerns
expressed in response to the CY 2018
HH PPS proposed rule regarding
possible behavioral changes by
providers given the perceived incentives
created by the admission source
categories within the alternative casemix adjustment methodology. However,
we continue to expect that HHAs will
provide the appropriate care needed by
all beneficiaries who are eligible for the
home health benefit, including those
beneficiaries with medically-complex
conditions who are admitted from the
community. We will carefully monitor
the outcomes of the proposed change,
including any impacts to community
entrants, and make further refinements
as necessary.
Regarding the incorporation of other
clinical settings into the definition of
the institutional category under the
alternative case-mix adjustment
methodology that some commenters
raised in response to the CY 2018 HH
PPS proposed rule, such as emergency
department (ED) use and observational
stays, we propose to only include those
stays that are considered institutional
stays in other Medicare settings. For
example, observational stays do not
count towards the 3-day window for an
admission to a SNF because they are not
categorized as inpatient. Additionally,
in our analysis of 2017 HH claims data,
we identified those HH stays that,
within the 14 days prior to admission to
HH, had been preceded by ED visits or
outpatient observational stays and
isolated these stays from stays that
would otherwise be grouped into the
community admission source category.
As demonstrated in Table 36, 30-day
periods of care for beneficiaries with a
preceding ED visit (which would
otherwise be grouped into the
community admission source category)
do not show higher resource use when
compared to those beneficiaries entering
from acute or PAC settings, with an
average resource use at $1,660.64 per
home health period as compared to
$2,171.00 for institutional admits. When
compared with those patients admitted
from the community, admissions from

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the ED show somewhat higher resource
use at $1,660.64 per home health period
as compared to $1,337.73 for

community admits. We note that the
volume of patients with preceding ED

visits is relatively low, at about 5.8
percent of total home health periods.

TABLE 36—AVERAGE RESOURCE USE BY ADMISSION SOURCE (14 DAY LOOK-BACK, 30 DAY PERIODS) ADMISSION
SOURCE: COMMUNITY, INSTITUTIONAL, AND EMERGENCY DEPARTMENT
Average
resource
use

Number of
30-day
periods

Percent of
30-day
periods

Standard
deviation of
resource
use

25th
percentile of
resource
use

Median
resource
use

75th
percentile of
resource
use

Community ................................................................................
Institutional ................................................................................
Emergency Department ............................................................

$1,337.73
2,171.00
1,660.64

5,905,217
2,215,971
503,588

68.5
25.7
5.8

$1,108.57
1,303.24
1,197.60

$558.54
1,246.05
782.63

$1,035.34
1,920.06
1,396.50

$1,779.73
2,791.91
2,225.38

Total ...................................................................................

1,570.68

8,624,776

100.0

1,221.38

679.12

1,272.18

2,117.47

Similarly, 30-day periods for
beneficiaries with preceding
observational stays (which would
otherwise be grouped into the

community admission source category)
also do not show higher resource use
when compared to those beneficiaries
entering from acute or PAC settings, as

described in Table 37, with average
resource use at $1,820.06 per home
health period as compared to $2,171.00
for institutional admits.

TABLE 37—AVERAGE RESOURCE USE BY ADMISSION SOURCE (14 DAY LOOK-BACK; 30 DAY PERIODS) ADMISSION
SOURCE: COMMUNITY, INSTITUTIONAL, AND OBSERVATIONAL STAYS

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Average
resource
use

Number of
30-day
periods

Percent of
30-day
periods

Standard
deviation
of resource
use

25th
percentile
of resource
use

Median
resource
use

75th
percentile
of resource
use

Community ................................................................................
Institutional ................................................................................
Observational Stays ..................................................................

$1,350.90
2,171.00
1,820.06

6,242,043
2,215,971
166,762

72.4%
25.7%
1.9%

$1,114.94
1,303.24
1,180.96

$564.31
1,246.05
960.15

$1,048.86
1,920.06
1,589.08

$1,799.27
2,791.91
2,399.68

Total ...................................................................................

1,570.68

8,624,776

100.0%

1,221.38

679.12

1,272.18

2,117.47

When compared with those patients
admitted from the community,
admissions from observational stays
show higher resource use at $1,820.06
per home health period as compared to
$1,350.90 for community admits.
However, the volume of patients with
preceding observational stays is very
low, at about 2 percent of total home
health periods.
In summary, home health stays with
preceding observational stays and ED
visits show resource use that falls
between that of the institutional and
community categories. However, the
resource use is not equivalent to that of
the institutional settings; therefore, we
do not believe it appropriate to include
observational stays and ED visits in the
institutional category for the purposes of
the PDGM. Additionally, including
these stays in the institutional category
would lead to a small reduction in the
overall average resource use and related
case mix weights for groups admitted
from acute and PAC settings. Moreover,
including ED or observational stays with
discharges from acute care hospitals,
LTCHs, IRFs and SNFs would be
inconsistent with section 1861(tt)(1) of
the Act, which defines the term ‘‘postinstitutional home health services’’ as
discharges from hospitals (which
include IRFs and LTCHs) and SNFs

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within 14 days of when home health
care is initiated.
We explored the option of creating a
third admission source category
specifically for observational stays/ED
visits. In order to more fully understand
the potential impact of a third category,
we analyzed the overall impact of the
creation of such a category. For the
purposes of this analysis, in the event
that a home health stay was preceded by
both an institutional stay and an
observation stay or ED visit, the case
would be grouped into the institutional
category. Our findings indicate for those
HH stays with a preceding outpatient
observational stay/ED visit, the overall
payment weight for associated groups
for ‘‘early’’ 30-day periods (as defined in
section III.F.4 of this rule) would be
approximately 6 percent higher than the
community admission counterparts,
whereas institutional stays would see
weights that are approximately 19
percent higher than community
admissions. When examining the
overall payment weights for ‘‘late’’ 30day periods (as defined in section III.F.4
of this rule), HH stays with a preceding
outpatient admission would observe
weights that are approximately 10
percent higher than the community
admission counterparts, whereas
institutional stays would see weights

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that are approximately 43 percent
higher than community admissions.
However, we are concerned that a third
admission source category for
observational stays and ED visits could
create an incentive for providers to
encourage outpatient encounters both
prior to a 30-day period of care or
within a 30-day period of care within 14
days of the start of the next 30-day
period, thereby potentially
inappropriately increasing costs to the
Medicare program overall. The clinical
threshold for an observational stay or an
ED visit is not as high as that required
for an institutional admission, and we
are concerned that home health agencies
may encourage beneficiaries to engage
with emergency departments before
initiating a home health stay.
For example, in the FY 2014 IPPS/
LTCH PPS final rule and also the
Medicare Benefit Policy Manual Chapter
1—Inpatient Hospital Services Covered
Under Part A, CMS clarified and
specified in the regulations that an
individual becomes an inpatient of a
hospital, including a long term care
hospital or a Critical Access Hospital,
when formally admitted as such
pursuant to an order for inpatient
admission by a physician or other
qualified practitioner described in the
final regulations (78 FR 50495). The

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order is required for payment of hospital
inpatient services under Medicare Part
A. CMS also specified that for those
hospital stays in which the physician
expects the beneficiary to require care
that crosses two midnights and admits
the beneficiary based upon that
expectation, Medicare Part A payment is
generally appropriate. Additionally, for
the purposes of admissions to skilled
nursing facilities, the Medicare Benefit
Policy Manual Chapter 8—Coverage of
Extended Care (SNF) Services Under
Hospital Insurance states that in order to
qualify for post-hospital extended care
services, the individual must have been
an inpatient of a hospital for a medically
necessary stay of at least three
consecutive calendar days and that time
spent in observation or in the
emergency room prior to (or in lieu of)
an inpatient admission to the hospital
does not count toward the 3-day
qualifying inpatient hospital stay, as a
person who appears at a hospital’s
emergency room seeking examination or
treatment or is placed on observation
has not been admitted to the hospital as
an inpatient; instead, the person
receives outpatient services.
Furthermore, admission to an inpatient
rehabilitation facility (IRF) requires that
for IRF care to be considered reasonable
and necessary, the documentation in the
patient’s IRF medical record must
demonstrate a reasonable expectation
that the patient must require active and
ongoing intervention of multiple
therapy disciplines, at least one of
which must be PT or OT; require an
intensive rehabilitation therapy
program, generally consisting of 3 hours
of therapy per day at least 5 days per
week; or in certain well-documented
cases, at least 15 hours of intensive
rehabilitation therapy within a 7consecutive day period, beginning with
the date of admission; reasonably be
expected to actively participate in, and
benefit significantly from the intensive
rehabilitation therapy program; require
physician supervision by a
rehabilitation physician, with face-toface visits at least 3 days per week to
assess the patient both medically and
functionally and to modify the course of
treatment as needed; and require an
intensive and coordinated
interdisciplinary team approach to the
delivery of rehabilitative care, as
described in detail in Medicare Benefit
Policy Manual, Chapter 1—Inpatient
Hospital Services Covered Under Part A
110.2—Inpatient Rehabilitation Facility
Medical Necessity Criteria.
Conversely, CMS specified that for
hospital stays in which the physician
expects the patient to require care less

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than two midnights, payment under
Medicare Part A is generally
inappropriate. (However, we note that
in the CY 2016 Outpatient Prospective
Payment System final rule, CMS
adopted a policy such that for stays for
which the physician expects the patient
to need less than two midnights of
hospital care (and the procedure is not
on the inpatient-only list or otherwise
listed as a national exception), an
inpatient admission may be payable
under Medicare Part A on a case-by-case
basis based on the judgment of the
admitting physician (80 FR 70297).)
Regarding emergency department
visits by Medicare beneficiaries,
services are generally covered by
Medicare Part B in instances where a
beneficiary experiences an injury, a
sudden illness, or an illness that quickly
worsens. In the case of observational
stays, as described in the Medicare
Claims Processing Manual, Chapter 12,
observation care is a well-defined set of
specific, clinically appropriate services,
which include ongoing short term
treatment, assessment, and reassessment
before a decision can be made regarding
whether patients will require further
treatment as hospital inpatients or if
they are able to be discharged from the
hospital. As described in the Medicare
Benefit Policy Manual, Chapter 6—
Hospital Services Covered Under Part B
20.6—Outpatient Observation Services,
observation services are commonly
ordered for patients who present to the
emergency department and who then
require a significant period of treatment
or monitoring in order to make a
decision concerning their admission or
discharge. Moreover, the Medicare
Claims Processing Manual in Chapter
4—Part B Hospital, 290—Outpatient
Observation Services states that
observation services are covered by
Medicare only when provided by the
order of a physician or another
individual authorized by state licensure
law and hospital staff bylaws to admit
patients to the hospital or to order
outpatient tests. In the majority of cases,
the decision whether to discharge a
patient from the hospital following
resolution of the reason for the
observation care or to admit the patient
as an inpatient can be made in less than
48 hours, usually in less than 24 hours.
In only rare and exceptional cases do
reasonable and necessary outpatient
observation services span more than 48
hours. In summary, the clinical
thresholds for coverage and payment for
an admission to institutional settings are
higher when compared with ED visits
and observational stays. Finally, we
note that the proportion of home health

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periods with admissions from ED visits
and observational stays is low relative to
community and institutional
counterparts. Creating a third
community admission source category
for observational stays and ED visits
would potentially introduce added
complexity into the payment system for
a small portion of home health stays,
which could lead to the creation of
payment groups that contain very few
stays with very little difference in casemix weights across the landscape of
groups.
For all of these reasons, we believe
that incorporating HH stays with
preceding observational stays and ED
visits into the community admission
category is most appropriate at this
time. However, we note that as we
receive and evaluate new data related to
the provision of Medicare home health
care under the PDGM, we will continue
to assess the appropriateness of the
payment levels for admission source
within a home health period and give
consideration to any cost differentiation
evidenced by the resources required by
those home health patients with a
preceding outpatient event.
Regarding the operational aspects of
the admission source category, as
described in the CY 2018 HH PPS
proposed rule, we have developed
automated claims processing procedures
with the goal of reducing the amount of
administrative burden associated with
the admission source category of the
alternative case-mix adjustment
methodology (82 FR 35309). For
example, Medicare systems will
automatically determine whether a
beneficiary has been discharged from an
institutional setting for which Medicare
paid the claim, using information used
during claims processing to
systematically identify admission
source and address this issue. When the
Medicare claims processing system
receives a Medicare home health claim,
the systems will check for the presence
of a Medicare acute or PAC claim for an
institutional stay. If such an
institutional claim is found, and the
institutional stay occurred within 14
days of the home health admission, our
systems will trigger an automatic
adjustment of the corresponding HH
claim to the appropriate institutional
category. Similarly, when the Medicare
claims processing system receives a
Medicare acute or PAC claim for an
institutional stay, the systems will
check for the presence of a subsequent
HH claim with a community payment
group. If such a HH claim is found, and
the institutional stay occurred within 14
days of the home health admission, our
systems will trigger an automatic

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adjustment of the HH claim to the
appropriate institutional category. This
process may occur any time within the
12-month timely filing period for the
acute or PAC claim. The OASIS
assessment will not be utilized in
evaluating for admission source
information.
Moreover, as we also proposed in the
CY 2018 HH PPS proposed rule, we
propose in this rule that newly-created
occurrence codes would also be
established, allowing HHAs to manually
indicate on Medicare home health
claims that an institutional admission
had occurred prior to the processing of
an acute or PAC Medicare claim, if any,
in order to receive the higher payment
associated with the institutional
admission source sooner (82 FR 35312).
However, the usage of the occurrence
codes is limited to situations in which
the HHA has information about the
acute or PAC stay. We also noted that
the use of these occurrence codes would
not be limited to home health
beneficiaries for whom the acute or PAC
claims were paid by Medicare. HHAs
would also use the occurrence codes for
beneficiaries with acute or PAC stays
paid by other payers, such as the
Veterans Administration (VA).
If a HHA does not include on the HH
claim the occurrence code indicating
that a home health patient had a
previous institutional stay, processed
either by Medicare or other institutions
such as the VA, such an admission will
be categorized as ‘‘community’’ and
paid accordingly. However, if later a
Medicare acute or PAC claim for an
institutional stay occurring within 14
days of the home health admission is
submitted within the timely filing
deadline and processed by the Medicare
systems, the HH claim would be
automatically adjusted and recategorized as an institutional
admission and appropriate payment
modifications would be made. If there
was a non-Medicare institutional stay
occurring within 14 days of the home
health admission but the HHA was not
aware of such a stay, upon learning of
such a stay, the HHA would be able to
resubmit the HH claim that included an
occurrence code, subject to the timely
filing deadline, and payment
adjustments would be made
accordingly.
We note that the Medicare claims
processing system will check for the
presence of an acute or PAC Medicare
claim for an institutional stay occurring
within 14 days of the home health
admission on an ongoing basis and
automatically assign the home health
claim as ‘‘community’’ or
‘‘institutional’’ appropriately. As a

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result, with respect to a HH claim with
a Medicare institutional stay occurring
within 14 days of home health
admission, we will not require the
submission of an occurrence code in
order to appropriately categorize the HH
claim to the applicable admission
source. With respect to a HH claim with
a non-Medicare institutional stay
occurring with 14 days of home health
admission, a HHA would need to
submit an occurrence code on the HH
claim in order to have the HH claim
categorized as ‘‘institutional’’ and paid
the associated higher amount.
Additionally, we plan to provide
education and training regarding all
aspects of the admission source process
and to develop materials for guidance
on claims adjustments, for resolution of
claims processing issues, for defining
timely filing windows, and for
appropriate usage of occurrence codes
through such resources as the Medicare
Learning Network. We will also update
guidance in the Medicare Claims
Processing Manual as well as the
Medicare Benefit Policy Manual as
appropriate with detailed procedures.
We will also work with our Medicare
Administrative Contractors (MACs) to
address any concerns regarding the
processing of home health claims as
well as develop training materials to
facilitate all aspects of the transition to
the PDGM, including the unique aspects
of the admission source categories.
With regards to the length of time for
resubmission of home health claims that
reflect a non-Medicare institutional
claim, all appropriate Medicare rules
regarding timely filing of claims will
still apply. Procedures required for the
resubmission of home health claims will
apply uniformly for those claims that
require editing due to the need to add
or remove occurrence codes. Details
regarding the timely filing guidelines for
the Medicare program are available in
the Medicare Claims Processing Manual,
Chapter 1—General Billing
Requirements, which is available at the
following website: https://
www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/clm104c01.pdf.
Additionally, adjustments to any resubmitted home health claims will be
processed in the same manner as other
edited Medicare home health claims.
Additionally, we plan to perform robust
testing within the Medicare claims
processing system to optimize and
streamline the payment process.
Regarding the process by which HHAs
should verify a non-Medicare
institutional stay, as we noted in in the
CY 2018 HH PPS proposed rule, we
expect home health agencies would

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utilize discharge summaries from all
varieties of institutional providers (that
is, Medicare and non-Medicare) to
inform the usage of these occurrence
codes, and these discharge documents
should already be part of the
beneficiary’s home health medical
record used to support the certification
of patient eligibility as outlined in
§ 424.22(c) (82 FR 35309). Providers
should utilize existing strategies and
techniques for verification of such stays
and incorporate relevant clinical
information into the plan of care, as is
already required by our Conditions of
Participation.
Our evaluation process within the
Medicare claims processing system will
check for the presence of an acute or
PAC Medicare claim for an institutional
stay occurring within 14 days of the
home health admission on an ongoing
basis. Under this approach, the
Medicare systems would only evaluate
for whether an acute or PAC Medicare
claim for an institutional stay occurring
within 14 days of the home health
admission was processed by Medicare,
not whether it was paid. Therefore, we
do not expect that a home health claim
will be denied due to unpaid Medicare
claims for preceding acute or PAC
admissions. Moreover, as previously
stated above, we note that providers
would have the option to submit the
occurrence code indicating a preceding
institutional stay in order to categorize
the home health admission as
‘‘institutional.’’ In the case of a HHA
submitting an occurrence code because
of a preceding Medicare institutional
stay, if upon medical review after
finding no Medicare acute or PAC
claims in the National Claims History,
and there is documentation of a
Medicare acute or PAC stay within the
14 days prior to the home health
admission, but the institutional setting
did not submit its claim in a timely
fashion, or at all, we would permit the
institutional categorization for the
payment of the home health claim
through appropriate administrative
action. Similarly, in the case of a HHA
submitting an occurrence code because
of a preceding non-Medicare
institutional stay, if documentation of a
non-Medicare acute or PAC stay within
the 14 days prior to the home health
admission, is found, we would permit
the categorization of the home health
claim as ‘‘institutional’’.
However, if upon medical review after
finding no acute or PAC Medicare
claims in the National Claims History,
and there is no documentation of an
acute or PAC stay, either a Medicare or
non-Medicare stay, within 14 days of
the home health admission, we would

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correct the overpayment. If upon
medical review after finding no
Medicare acute or PAC claims in the
National Claims History and we find
that an HHA is systematically including
occurrence codes that indicate the
patient’s admission source was
‘‘institutional,’’ but no documentation
exists in the medical record of Medicare
or non-Medicare stays, we would refer
the HHA to the zone program integrity
contractor (ZPIC) for further review.
Moreover, we intend to consider
targeted approaches for medical review
after the implementation of the
admission source element of the PDGM,
including potentially identifying HHAs
that have claims that are consistently
associated with acute or PAC denials,
whose utilization pattern of acute or
PAC occurrence codes is aberrant when
compared with their peers, or other
such metrics that would facilitate any
targeted reviews.
For all of the reasons described above,
we are proposing to establish two
admission source categories for
grouping 30-day periods of care under
the PDGM—institutional and
community—as determined by the
healthcare setting utilized in the 14 days
prior to home health admission. We are
proposing that 30-day periods for
beneficiaries with any inpatient acute
care hospitalizations, skilled nursing
facility (SNF) stays, inpatient
rehabilitation facility (IRF) stays, or long
term care hospital (LTCH) stays within
the 14 days prior to a home health
admission would be designated as
institutional admissions. We are
proposing that the institutional
admission source category would also
include patients that had an acute care
hospital stay during a previous 30-day
period of care and within 14 days prior
to the subsequent, contiguous 30-day
period of care and for which the patient
was not discharged from home health
and readmitted (that is, the admission
date and from date for the subsequent
30-day period of care do not match) as
we acknowledge that HHAs have
discretion as to whether they discharge
the patient due to a hospitalization and
then readmit the patient after hospital
discharge. However, we are proposing
that we would not categorize PAC stays
(SNF, IRF, LTCH stays) that occur
during a previous 30-day period and
within 14 days of a subsequent,
contiguous 30-day period of care (that
is, the admission date and from date for
the subsequent 30-day period of care do
not match) as institutional, as we would
expect the HHA to discharge the patient
if the patient required PAC in a different
setting and then readmitted the patient,

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if necessary, after discharge from such
setting. If the patient was discharged
and then readmitted to home health, the
admission date and ‘‘from’’ date on the
30-day claim would match and the
claims processing system will look for
an acute or a PAC stay within 14 days
of the home health admission date. This
admission source designation process
would be applicable to institutional
stays paid by Medicare or any other
payer. All other 30-day periods would
be designated as community
admissions.
For the purposes of a RAP, we would
only adjust the final home health claim
submitted for source of admission. For
example, if a RAP for a community
admission was submitted and paid, and
then an acute or PAC Medicare claim
was submitted for that patient before the
final home health claim was submitted,
we would not adjust the RAP and would
only adjust the final home health claim
so that it reflected an institutional
admission. Additionally, HHAs would
only indicate admission source
occurrence codes on the final claim and
not on any RAPs submitted.
We invite public comments on the
admission source component of the
proposed PDGM payment system.
6. Clinical Groupings
In the CY 2018 HH PPS proposed rule
(82 FR 35307), we discussed the
findings of the Home Health Study
Report to Congress, which indicates that
the current payment system may
encourage HHAs to select certain types
of patients over others.39 Patients with
a higher severity of illness, including
those receiving a greater level of skilled
nursing care; for example, patients with
wounds, with ostomies, or who are
receiving total parenteral nutrition or
mechanical ventilation were associated
with higher resource use and lower
margins. This may have produced a
disincentive for providing care for
patients with higher clinical acuity, and
thereby may have limited access of
home health services to these vulnerable
patient populations.40 We noted that
payment should be predicated on
resource use and proposed that
adjusting payment based on identified
39 Report to Congress. Medicare Home Health
Study: An Investigation on Access to Care and
Payment for Vulnerable Patient Populations.
Available at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HomeHealthPPS/Downloads/HH-Report-toCongress.pdf.
40 Report to the Congress: Medicare Payment
Policy. (2015)Home health care services: Assessing
payment adequacy and updating payments. Ch.9
http://www.medpac.gov/docs/default-source/
reports/chapter-9-home-health-care-services-march2015-report-.pdf?sfvrsn=0.

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clinical characteristics and associated
services would better align payment
with resource use.
For these reasons, we propose
grouping 30-day periods of care into six
clinical groups: Musculoskeletal
Rehabilitation, Neuro/Stroke
Rehabilitation, Wounds—Post-Op
Wound Aftercare and Skin/NonSurgical Wound Care, Behavioral Health
Care (including Substance Use
Disorder), Complex Nursing
Interventions, Medication Management,
Teaching and Assessment (MMTA).
These clinical groups are designed to
capture the most common types of care
that HHAs provide. We propose
placement of each 30-day period of care
into a specific clinical group based on
the primary reason the patient is
receiving home health care as
determined by the principal diagnosis
reported on the claim. Although the
principal diagnosis code is the basis for
the clinical grouping, secondary
diagnosis codes and patient
characteristics would then be used to
case-mix adjust the period further
through the comorbidity adjustment and
functional level. A complete list of ICD–
10–CM codes and their assigned clinical
groupings is posted on the CMS HHA
Center web page (https://www.cms.gov/
center/provider-Type/home-HealthAgency-HHA-Center.html). More
information on the analysis and
development of the groupings can be
found in the CY 2018 HH PPS proposed
rule as well as the HHGM technical
report from December 2016, also
available on the HHA Center webpage.
In the CY 2018 HH PPS proposed
rule, we solicited comments on the
clinical groups and the assigned clinical
groupings of the ICD–10–CM codes.
Additionally, in February 2018, a
Technical Expert Panel (TEP) was held
in order to gain insight from industry
leaders, clinicians, patient
representatives, and researchers with
experience in home health care and/or
experience in home health agency
management. Many commenters and
TEP members supported the patientcentered approach to grouping patients
by clinical characteristics, and several
commenters felt that the clinical
groupings did capture the majority of
characteristics of the home health
population. Specifically, commenters
generally approved of the higherweighted complex nursing and wound
groups, and agreed with the
‘‘importance the HHGM places on these
complex patients through its proposed
payment rate.’’ One commenter stated
that ‘‘the most complex and costly
beneficiaries for a HHA are those that
require intensive nursing care, while

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those that require intensive therapy
produce a significant margin with less
cost.’’ Additional comments on the
clinical groups generally included the
following: Concern that some diagnosis
codes are not used to group claims into
the six clinical groups; concern about
reduced therapy use in the clinical
groups that aren’t specifically for
musculoskeletal or neurological
rehabilitation; concern that the groups
do not capture clinically complex
patients that require multiple home
health disciplines; suggestions that the
clinical groups should be based on
impairments rather than diagnoses; and
concern that the MMTA clinical group
encompasses too many diagnosis codes.
Several commenters expressed concern
that certain ICD 10–CM diagnosis codes
were not used for payment (for example,
codes that were not used to group
claims into the six clinical groupings),
which could possibly restrict access to
the benefit or force beneficiaries to seek
care in institutional settings. Others had
concerns regarding specific diagnosis
codes they felt should be reassigned to
different clinical groups.
As outlined in the HHGM technical
report from December 2016 and in the
CY 2018 HH PPS proposed rule (82 FR
35314), there were several reasons why
a diagnosis code was not assigned to
one of the six clinical groups. These
included if the diagnosis code was too
vague, meaning the code does not
provide adequate information to support
the need for skilled home health
services (for example H57.9,
Unspecified disorder of eye and
adnexa); the code, based on ICD 10–CM,
American Hospital Association (AHA)
Coding Clinic, or Medicare Code Edits
(MCE) would indicate a non-home
health service (for example, dental
codes); the code is a manifestation code
subject to a manifestation/etiology
convention, meaning that the etiology
code must be reported as the principal
diagnosis, or the code is subject to a
code first sequencing convention (for
example, G99.2 myelopathy in diseases
classified elsewhere); the code identifies
a condition which would be unlikely to
require home health services (for
example, L81.2, Freckles); the code is
restricted to the acute care setting per
ICD 10–CM/AHA Coding Clinic, or the
diagnosis indicates death as the
outcome (for example S06.1X7A,
Traumatic cerebral edema with loss of
consciousness of any duration with
death due to brain injury prior to
regaining consciousness). We did,
however, review and re-group certain
codes based on commenter feedback.
For example, with regard to the

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classification of N39.0, Urinary tract
infection, site not specified as an invalid
code to group the home health period of
care, we do agree that absent definitive
information provided by the referring
physician, a home health clinician
would not know the exact site of a
urinary tract infection (UTI). As such,
Urinary tract infection, site not specified
(N39.0) will be grouped under MMTA,
as the home health services required
would most likely involve teaching
about the treatment for the UTI, as well
as evaluating the effectiveness of the
medication regimen. We encourage
HHAs to review the list of diagnosis
codes in the PDGM Grouping Tool
posted on the HHA Center web page at:
https://www.cms.gov/center/providerType/home-Health-Agency-HHACenter.html. Additionally, the ICD–10–
CM code set exceeds the ICD–9–CM in
the number of diagnoses and conditions
and contains codes that are much more
granular. Therefore, we disagree that
excluding certain codes from payment
will restrict access, considering the
increase in diagnoses potentially
requiring home health.
With regard to commenter concern
that the HHGM clinical groups did not
account for the need for therapy in
home health periods that are not
specifically grouped into
musculoskeletal or neurological
rehabilitation, we continue to expect the
ordering physician, in conjunction with
the therapist to develop and follow a
plan of care for any home health patient,
regardless of clinical group, as outlined
in the skilled service requirements at
§ 409.44, when therapy is deemed
reasonable and necessary. Although the
principal diagnosis is a contributing
factor in the PDGM and determines the
clinical group, it is not the only
consideration in determining what
home health services are needed in a
patient’s plan of care. It is the
responsibility of the patient’s treating
physician to determine if and what type
of therapy the patient needs regardless
of clinical grouping. In accordance with
§ 409.44(c)(1)(i), the therapy goals must
be established by a qualified therapist in
conjunction with the physician when
determining the plan of care. As such,
therapy may likely be included in the
plan of care for a patient in any of the
six clinical groupings. Any therapy
indicated in the plan of care is expected
to meet the requirements outlined in
§ 409.44, which states that all therapy
services must relate directly and
specifically to a treatment regimen
(established by the physician, after any
needed consultation with the qualified
therapist). Additional requirements

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dictate that the amount, frequency, and
duration of the services must be
reasonable and necessary, as determined
by a qualified therapist and/or
physician, using accepted standards of
clinical practice. One goal in developing
the PDGM is to provide an appropriate
payment based on the identified
resource use of different patient groups,
not to encourage, discourage, value, or
devalue one type of skilled care over
another.
Likewise, for patients requiring two or
three home health disciplines, the
PDGM takes into account the functional
level and comorbidities of the patient
after the primary reason for the period
is captured by the clinical grouping.
Decreasing functional status, as
indicated by a specific set of OASIS
items, and the presence of certain
comorbid conditions, is associated with
increased resource use. Here is where,
when combined with the clinical
grouping, any multi-disciplinary
therapy patients would be captured. For
instance, a patient grouped into the
Neuro-Rehabilitation clinical grouping
with a high Functional Level (meaning
high functional impairment) indicates
increased therapy needs, potentially
utilizing all skilled therapy disciplines.
Additionally, the comorbidity
adjustment further case mixes the
period and increases payment to capture
the additional resource use for a patient
regardless of whether the services are
skilled nursing or therapy based.
Therefore, a patient with complex
needs, including multiple therapy
disciplines and medical management, is
captured by the combination of the
different levels of the PDGM.
Furthermore, the current case-mix
adjustment methodology does not
differentiate between utilization of
therapy disciplines and whether or not
all three are utilized for the same
patient. We have determined that the
PDGM’s functional level when
combined with the clinical grouping
and comorbidity adjustment actually
provides a much clearer picture of the
patient’s needs, particularly in relation
to therapy services.
Comments on the CY 2018 HH PPS
proposed rule and at the 2018 TEP
indicated that diagnosis does not always
correlate with need and that
impairments and functional limitations
are better predictors of therapy services.
Additionally, some commenters stated
that clinicians are more likely to focus
on impairments and functional
limitations when conceptualizing
overall patient care, and suggested using
them as the basis for the clinical groups
rather than diagnosis codes. We do
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provide the entire clinical picture of the
home health patient; however, in the
same way the clinical group is one
aspect of the PDGM, therapy services
are only one aspect of home health. In
fact, the multidisciplinary nature of the
benefit is precisely the reason that
diagnosis should be an important aspect
of the clinical groupings model. The
various home health disciplines have
different but overlapping roles in
treating the patient; however, a
diagnosis is used across disciplines and
has important implications for patient
care. A patient’s diagnosis consists of a
known set of signs and symptoms
agreed upon by the medical community.
Each different healthcare discipline uses
these identifiable signs and symptoms
to apply its own approach and skill set
to treat the patient. However, it remains
a patient centered approach.
Several commenters and TEP
participants alike, stated that the MMTA
clinical group is too broad and should
be divided into more clinical groups or
subgroups. One commenter questioned
whether it made sense to assign patients
to different clinical groupings if roughly
60 percent of 30-day periods will fall
into the MMTA category. Others
considered it an ‘‘other’’ category that
was counter to the goal of clarifying the
need for home health.
A significant goal of the PDGM is to
clearly define what types of services are
provided in home health and accurately
ascribe payment to resource use. Our
analysis showed that there are four very

broad categories of interventions
frequently provided in the home that are
not attributable to one specific
intervention or diagnosis: Health
teaching; guidance and counseling; case
management; treatments and
procedures; and surveillance. These
categories cross the spectrum of
diagnoses, medications, and
interventions, which understandably is
why this clinical grouping represents
the majority of home health episodes.
We believe that these four broad
categories of interventions in MMTA
cannot be underestimated in
importance. We stated in the CY 2018
HH PPS proposed rule that many home
health patients have multi-morbidity
and polypharmacy, making education
and surveillance crucial in the
management of the home health patient
in order to prevent medication errors
and adverse effects. However, the
principal diagnosis necessitating home
care for these patients may not involve
a complex nursing intervention,
behavioral health, rehabilitation, or
wound care. This group represents a
broader, but no less important reason for
home care. We believe MMTA is not so
much an ‘‘other’’ category as much as it
appears to represent the foundation of
home health. Many commenters
highlighted the complexity of home
health patients; pointing to multimorbidity, ‘‘quicker and sicker’’
discharges, and polypharmacy as
important factors in maintaining home

health access. CMS agrees that these
issues alone are important reasons for
ordering home health services and
necessitate their own clinical grouping.
When initially developing the model,
we looked at breaking MMTA into
subgroups in order to account for
differences amongst diagnoses within
the broader category of this group. We
found that the variation in resource use
was similar across those subgroups and
determined separating diagnoses further
would only serve to make the model
more complex and without significant
variations in case-mix. However, in
response to public comments and the
discussion at the 2018 TEP,20 we
performed further analysis on the
division of MMTA into subgroups in
order to estimate the payment regression
if these groups were separated from
MMTA. We conducted a thorough
review of all the diagnosis codes
grouped into MMTA. We then grouped
the codes into subgroups based on
feedback from public comments, which
mainly focused on cardiac, oncology,
infectious, and respiratory diagnoses.
We created the additional subgroups
(Surgical/Procedural Aftercare, Cardiac/
Circulatory, Endocrine, GI/GU,
Infectious Diseases/Neoplasms,
Respiratory, and Other) based on data
that showed above-average resource use
for the codes in those groups, and then
combined certain groups that had a
minimal number of codes. Those results
are shown in Table 38.

TABLE 38—DISTRIBUTION OF RESOURCE USE BY 30-DAY PERIODS
[MMTA subgroups]

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Subgroup

N

Mean

Median

Aftercare ......................................................................................................................................
Cardiac/Circulatory ......................................................................................................................
Endocrine .....................................................................................................................................
GI/GU ...........................................................................................................................................
Infectious Diseases/Neoplasms/Blood-forming Diseases ...........................................................
Respiratory ...................................................................................................................................
Other ............................................................................................................................................

304,871
1,594,149
425,077
402,322
347,755
724,722
1,226,750

$1,605.43
1,433.02
1,524.45
1,414.44
1,400.65
1,411.61
1,366.56

$1,326.03
1,121.27
1,062.41
1,115.29
1,077.58
1,122.23
1,035.76

Total ......................................................................................................................................

5,025,646

1,428.17

1,105.20

Table 39 shows the impact each
MMTA variable has on case-mix weight.
The impact is calculated by taking the
regression coefficient for each variable
(unreported here) and dividing by the
average resource use of the 30-day
periods in the model. Model 1 shows
the result when MMTA clinical group is
not separated into subgroups. Model 1
shows that all else equal, being in

MMTA—Low Functional impairment
causes no increase in case-mix weight
(for example, a 30-day period’s case-mix
weight would be calculated with the
coefficients from the constant of the
model plus the admission source/timing
of the period plus the comorbidity
adjustment). A 30-day period in
MMTA—Medium Functional would
increase the case-mix weight by 0.1560.

A 30-day period in MMTA—High
Functional would increase the case-mix
weight by 0.2731. Model 2 shows the
same information but now includes the
MMTA subgroups. In any given
functional level, many of the MMTA
subgroups have an impact on the casemix weight that is similar to what is
found in Model 1. For example, a period
in MMTA (Other)—Medium Functional

20 https://www.cms.gov/center/provider-Type/
home-Health-Agency-HHA-Center.html.

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has an increase in case-mix of 0.1568
(which is very similar to the 0.1560
value found in Model 1). There are some
groups like Aftercare, Endocrine, and
GI/GU which show different impacts
than Model 1. Also, to a lesser extent

these differences also exist for the
‘‘Infectious Diseases/Neoplasms/Blood
forming Diseases’’ and ‘‘Respiratory’’
subgroups. Some of these differences are
driven by periods which are paid using
an outlier adjustment. Model 3 removes

32403

outliers and the corresponding results
for the Endocrine subgroup are very
similar to Model 1. Some differences
(for example in Aftercare) persist;
however, the change in case-mix weight
remains similar to Model 1.

TABLE 39—CHANGE IN CASE-MIX WEIGHT ASSOCIATED WITH MMTA VARIABLES

Variable
MMTA—Low Functional .......................................................................................................
MMTA—Medium Functional .................................................................................................
MMTA—High Functional ......................................................................................................
MMTA (Other)—Low Functional ...........................................................................................
MMTA (Other)—Medium Functional ....................................................................................
MMTA (Other)—High Functional ..........................................................................................
MMTA (Aftercare)—Low Functional .....................................................................................
MMTA (Aftercare)—Medium Functional ...............................................................................
MMTA (Aftercare)—High Functional ....................................................................................
MMTA (Cardiac/Circulatory)—Low Functional .....................................................................
MMTA (Cardiac/Circulatory)—Medium Functional ...............................................................
MMTA (Cardiac/Circulatory)—High Functional ....................................................................
MMTA (Endocrine)—Low Functional ...................................................................................
MMTA (Endocrine)—Medium Functional .............................................................................
MMTA (Endocrine)—High Functional ...................................................................................
MMTA (GI/GU)—Low Functional .........................................................................................
MMTA (GI/GU)—Medium Functional ...................................................................................
MMTA (GI/GU)—High Functional .........................................................................................
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)—Low Functional ..........
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)—Medium Functional ....
MMTA (Infectious Diseases/Neoplasms/Blood forming Diseases)—High Functional .........
MMTA (Respiratory)—Low Functional .................................................................................
MMTA (Respiratory)—Medium Functional ...........................................................................
MMTA (Respiratory)—High Functional ................................................................................

The results show that the change in
case-mix weight was minimal for the 30day periods assigned to these subgroups
compared to the case-mix weights
without the subgroups. Additionally,
the impact of other variables in the
model (admission source/timing,
comorbidity adjustment) on the final
case-mix weights were similar whether
or not MMTA subgroups were used.

Overall, using the MMTA subgroup
model would result in more payment
groups but not dramatic differences in
case-mix weights across those groups.
For this reason, we are not proposing to
divide the MMTA clinical group into
subgroups and to leave them as is
shown in Table 40. However, we are
soliciting comments from the public on
whether there may be other compelling
reasons why MMTA should be broken

Model 1

Model 2

Change in
case-mix
weight

Change in
case-mix
weight

0.000
0.1560
0.2731
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................

........................
........................
........................
0.000
0.1568
0.2896
¥0.1082
0.0798
0.2588
¥0.0239
0.1371
0.2737
0.1105
0.2859
0.4071
¥0.0751
0.0997
0.1992
¥0.0452
0.1068
0.2281
¥0.0501
0.1027
0.2241

Model 3
(outliers
excluded)
Change in
case-mix
weight
........................
........................
........................
0.000
0.1523
0.2748
¥0.1196
0.0701
0.2491
¥0.0050
0.1652
0.2952
0.0282
0.1833
0.3086
¥0.0639
0.1256
0.2231
¥0.0472
0.1128
0.2379
¥0.0488
0.1163
0.2400

out into subgroups as shown in Table
38, even if the additional subgroups do
not result in significant differences in
case-mix weights across those
subgroups. We note that we also plan
continue to examine trends in reporting
and resource utilization to determine if
future changes to the clinical groupings
are needed after implementation of the
PDGM.

TABLE 40—PROPOSED CLINICAL GROUPS USED IN THE PDGM

amozie on DSK3GDR082PROD with PROPOSALS2

Clinical groups

The primary reason for the home health encounter is to provide:

Musculoskeletal Rehabilitation ............................
Neuro/Stroke Rehabilitation ................................
Wounds—Post-Op Wound Aftercare and Skin/
Non-Surgical Wound Care.
Behavioral Health Care .......................................
Complex Nursing Interventions ...........................
Medication Management, Teaching and Assessment (MMTA).

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Therapy (physical, occupational or speech) for a musculoskeletal condition.
Therapy (physical, occupational or speech) for a neurological condition or stroke.
Assessment, treatment & evaluation of a surgical wound(s); assessment, treatment & evaluation of non-surgical wounds, ulcers, burns, and other lesions.
Assessment, treatment & evaluation of psychiatric conditions, including substance use disorders.
Assessment, treatment & evaluation of complex medical & surgical conditions including IV,
TPN, enteral nutrition, ventilator, and ostomies.
Assessment, evaluation, teaching, and medication management for a variety of medical and
surgical conditions not classified in one of the above listed groups.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

7. Functional Levels and Corresponding
OASIS Items

amozie on DSK3GDR082PROD with PROPOSALS2

As part of the overall payment
adjustment under an alternative casemix adjustment methodology, in the CY
2018 Home Health Prospective Payment
System proposed rule (82 FR 35317), we
proposed including a functional level
adjustment to account for the resource
costs associated with providing home
health care to those patients with
functional impairments. Research has
shown a relationship exists between
functional status, rates of hospital
readmission, and the overall costs of
health care services.42 Functional status
is defined in a number of ways, but
generally, functional status reflects an
individual’s ability to carry out
activities of daily living (ADLs) and to
participate in various life situations and
in society.43 CMS currently requires the
collection of data on functional status in
home health through a standardized
assessment instrument: The Outcome
and Assessment Information Set
(OASIS). Under the current HH PPS, a
functional status score is derived from
the responses to those items and this
score contributes to the overall case-mix
adjustment for a home health episode
payment.
Including functional status in the
case-mix adjustment methodology
allows for higher payment for those
patients with higher service needs. As
functional status is commonly used for
risk adjustment in various payment
systems, including in the current HH
PPS, we proposed that the alternative
case-mix adjustment methodology
would also adjust payments based on
responses to selected functional OASIS
items that have demonstrated higher
resource use. Therefore, we examined
every OASIS item for potential
inclusion in the alternative case-mix
adjustment methodology including
those items associated with functional
status.
Generally, worsening functional
status is associated with higher resource
use, indicating that the responses to
functional OASIS items may be useful
as adjustors to construct case-mix
weights for an alternative case-mix
adjustment methodology. However, due
42 Burke, R. MD, MS, Whitfield, E. Ph.D., Hittle,
D. Ph.D., Min, S. Ph.D., Levy, C. MD, Ph.D.,
Prochazka, A. MD, MS, Coleman, E. MD, MPH,
Schwartz, R. MD, Ginde, A. (2016). ‘‘Hospital
Readmission From Post-Acute Care Facilities: Risk
Factors, Timing, and Outcomes’’. The Journal of
Post-Acute Care and Long Term Care Medicine.
(17), 249–255.
43 Clauser, S. Ph.D., and Arlene S. Bierman, M.D.,
M.S. (2003). ‘‘Significance of Functional Status Data
for Payment and Quality’’. Health Care Financing
Review. 24(3), 1–12.

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to the lack of variation in resource use
across certain responses and because
certain responses were infrequently
chosen, we combined some responses
into larger response categories to better
capture the relationship between
worsening functional status and
resource use. The resulting
combinations of responses for these
OASIS items are found at Exhibit 7–2 in
the HHGM technical report, ‘‘Overview
of the Home Health Groupings Model,’’
on the HHA Center web page.44
Each OASIS item included in the final
model has a positive relationship with
resource use, meaning as functional
status declines (as measured by a higher
response category), periods have more
resource use, on average. As such, in the
CY 2018 HH PPS proposed rule, we
proposed that the following OASIS
items would be included as part of the
functional level adjustment under an
alternative case-mix adjustment
methodology:
• M1800: Grooming.
• M1810: Current Ability to Dress
Upper Body.
• M1820: Current Ability to Dress
Lower Body.
• M1830: Bathing.
• M1840: Toilet Transferring.
• M1850: Transferring.
• M1860: Ambulation/Locomotion.
• M1033 Risk of Hospitalization (at
least four responses checked, excluding
responses #8, #9, and #10).45
In the CY 2018 HH PPS proposed
rule, we discussed how under the
HHGM a home health period of care
receives points based on each of the
responses associated with the proposed
functional OASIS items which are then
converted into a table of points
corresponding to increased resource
use. That is, the higher the points, the
higher the functional impairment. The
sum of all of these points’ results in a
functional impairment score which is
used to group home health periods into
a functional level with similar resource
use. We proposed three functional
impairment levels of low, medium, and
high with approximately one third of
home health periods from each of the
clinical groups within each level. This
means home health periods in the low
impairment level have responses for the
proposed functional OASIS items that
are associated with the lowest resource
use on average. Home health periods in
the high impairment level have
44 https://downloads.cms.gov/files/
hhgm%20technical%20report%20120516
%20sxf.pdf.
45 Exclusions of the OASIS C–1 Item M1033
include, response #8: ‘‘currently reports
exhaustion’’; response #9: ‘‘other risk(s) not listed
in 1–8; response #10: None of the above.

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responses for the proposed functional
OASIS items that are associated with
the highest resource use on average. We
also proposed that the functional
impairment level thresholds would vary
between the clinical groups to account
for the patient characteristics within
each clinical group associated with
increased resource costs affected by
functional impairment. We provided a
detailed analysis of the development of
the functional points and the functional
impairment level thresholds by clinical
group in the HHGM technical report 46
and in Tables 36 and 37 in the CY 2018
HH PPS proposed rule (82 FR 35321).
In the CY 2018 HH PPS proposed
rule, we solicited comments on the
proposed functional OASIS items, the
associated points, and the thresholds by
clinical group used to group patients
into three functional impairment levels
under the HHGM, as outlined above.
The majority of comments received
were from physical therapists, physical
therapy assistants, occupational
therapists, and national physical,
occupational, and speech-language
pathology associations. Likewise, a
Technical Expert Panel (TEP) was
convened in February 2018 to collect
perspectives, feedback, and identify and
prioritize recommendations from a wide
variety of industry experts and patient
representatives regarding the public
comments received on the proposed
HHGM. Comments were very similar
between those received on the CY 2018
HH PPS proposed rule and those made
by the TEP participants.
Most commenters agreed that the
level of functional impairment should
be included as part of the overall casemix adjustment in a revised case-mix
model. Likewise, commenters were
generally supportive of the OASIS items
selected to be used in the functional
level payment adjustment. Commenters
noted that the role of patient
characteristics and functional status as
an indicator of resource use is a wellestablished principle in rehabilitation
care. Some commenters stated that
adopting a similar component in the
home health payment system will help
to remove the incentive to provide
unnecessary therapy services to reach
higher classifications for payment but
will also move the HH PPS toward
greater consistency with other postacute care prospective payment systems.
Other comments received on the
functional impairment level adjustment
46 ‘‘Medicare Home Health Prospective Payment
System: Case-Mix Methodology Refinements
Overview of the Home Health Groupings Model’’
located at https://downloads.cms.gov/files/
hhgm%20technical%20report%20
120516%20sxf.pdf.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
encompassed several common themes:
The effect of the IMPACT Act
provisions on the HHGM; adequacy of
the functional impairment thresholds
and corresponding payment
adjustments; potential HHA behavioral
changes to the provision of home health
services; the impact of the removal of
therapy thresholds on HHAs; and
recommendations for the inclusion of
other OASIS items into the functional
impairment level adjustment.
We note that the analysis presented in
the CY 2018 HH PPS proposed rule was
based on CY 2016 home health episodes
using version OASIS–C1/ICD–10 data
set, which did not include the
aforementioned IMPACT Act functional
items. To accommodate new data being
collected for the Home Health Quality
Reporting Program in support of the
IMPACT Act, CMS has proposed to add
the functional items, Section GG,
‘‘Functional Abilities and Goals’’, to the
OASIS data set effective January 1,
2019. Because these GG functional items
are not required to be collected on the
OASIS until January 1, 2019, we do not
have the data to determine the effect, if
any, of these newly added items on
resource costs during a home health
period of care. However, if the
alternative case-mix adjustment
methodology, is implemented in CY
2020, we would continue to examine
the effects of all OASIS items, including
the ‘‘GG’’ functional items, on resource
use to determine if any refinements are
warranted.
Addressing those comments regarding
the use and adequacy of the functional
impairment thresholds to adjust
payment, we remind commenters that
the structure of categorizing functional
impairment into Low, Medium, and
High levels has been part of the home
health payment structure since the
implementation of the HH PPS. The
current HH PPS groups’ scores are based
on functional OASIS items with similar
average resource use within the same
functional level, with approximately a
third of episodes classified as low
functional score, a third of episodes are
classified as medium functional score,
and a third of episodes are classified as
high functional score. Likewise, the
PDGM groups’ scores would be based on
functional OASIS items with similar
resource use and would have three
levels of functional impairment severity:
Low, medium and high. However, the
three functional impairment thresholds
vary between the clinical groups to
account for the patient characteristics
within that clinical group associated
with increased resource costs affected
by functional impairment. This is to
further ensure that payment is more

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accurately aligned with actual patient
resource needs. As such, we believe the
more granular structure of these
functional levels provides the
information needed on functional
impairment and allows greater
flexibility for clinicians to tailor a more
patient-centered home health plan of
care to meet the individualized needs of
their patients. As HHA-reported OASIS
information determines the functional
impairment levels, accurate reporting on
the OASIS will help to ensure that the
case-mix adjustment is in alignment
with the actual level of functional
impairment.
Concerns regarding HHAs changing
the way they provide services to eligible
beneficiaries, specifically therapy
services, should be mitigated by the
more granular functional impairment
level adjustment (for example,
functional thresholds which vary
between each of the clinical groups).
The functional impairment level casemix payment adjustment is reflective of
the resource costs associated with these
reported OASIS items and therefore
ensures greater payment accuracy based
on patient characteristics. We believe
that this approach will help to maintain
and could potentially increase access to
needed therapy services. We remind
HHAs that the provision of home health
services should be based on patient
characteristics and identified care
needs. This could include those patients
with complex and/or chronic care
needs, or those patients requiring home
health services over a longer period of
time or for which there is no
measureable or expected improvement.
While the majority of commenters
agreed that the elimination of therapy
thresholds is appropriate because of the
financial incentive to overprovide
therapy services, some commenters
indicated that the reductions in
payment for therapy visits could result
in a decrease in HHA viability and
could force some HHAs to go out of
business, such as those HHAs that
provide more therapy services than
nursing. We note that section
51001(a)(3) of the BBA of 2018 amended
section 1894(b)(4)(B) of the Act to
prohibit the use of therapy thresholds as
part of the overall case-mix adjustment
for CY 2020 and subsequent years.
Consequently, we have no regulatory
discretion in this matter.
Several commenters provided
recommendations for additional OASIS
items for inclusion to account for
functional impairment. Most notably,
commenters suggested adding OASIS
items associated with cognition,
instrumental activities of daily living
(IADLs), and caregiver support. The

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32405

current HH PPS does not use OASIS
items associated with cognition, IADLs,
or caregiver support to case-mix adjust
for payment. Nonetheless, the
relationship between cognition and
functional status is important and welldocumented in health care literature so
we included them in our analysis
because they generally have clinical
significance based on research and
standards of practice. As described in
the CY 2018 HH PPS proposed rule and
the technical report, we examined every
single OASIS item and its effect on
costs. These included those OASIS
items associated with cognition, IADLs,
and caregiver support. Only those
OASIS items associated with higher
resource costs were considered for
inclusion in the functional level
adjustment in the HHGM. Despite
commenters’ recommendations, the
variables suggested were only
minimally helpful in explaining or
predicting resource use and most
reduced the amount of actual payment.
As such, we excluded variables
associated with cognition, IADLs, and
caregiver support because they would
decrease payment for a home health
period of care which is counter to the
purpose of a case-mix adjustment under
the HHGM. The complete analysis of all
of the OASIS items can be found in the
HHGM technical report on the HHA
Center web page.47
After careful consideration of all
comments received on the functional
level adjustment as part of an alternative
case-mix adjustment methodology, we
believe that the three PDGM functional
impairment levels in each of the six
clinical groups are designed to capture
the level of functional impairment. We
believe that the more granular nature of
the levels of functional impairment by
clinical group would encourage
therapists to determine the appropriate
services for their patients in accordance
with identified needs rather than an
arbitrary threshold of visits. While the
functional level adjustment is not meant
to be a direct proxy for the therapy
thresholds, the PDGM has other casemix variables to adjust payment for
those patients requiring multiple
therapy disciplines or those chronically
ill patients with significant functional
impairment. We believe that also
accounting for timing, source of
admission, clinical group (meaning the
primary reason the patient requires
home health services), and the presence
of comorbidities will provide the
necessary adjustments to payment to
ensure that care needs are met based on
47 https://downloads.cms.gov/files/hhgm%20
technical%20report%20120516%20sxf.pdf.

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

actual patient characteristics. Therefore,
we continue to uphold that the
functional impairment level adjustment
is sufficient and along with the other
case-mix adjustments, payment will
better align with the costs of providing
services.
In summary, we are proposing that
the OASIS items identified in the CY
2018 HH PPS proposed rule would be
included as part of the functional
impairment level payment adjustment
under the proposed PDGM. These items
are:
• M1800: Grooming.

• M1810: Current Ability to Dress
Upper Body.
• M1820: Current Ability to Dress
Lower Body.
• M1830: Bathing.
• M1840: Toilet Transferring.
• M1850: Transferring.
• M1860: Ambulation/Locomotion.
• M1033: Risk of Hospitalization.48
We are proposing that a home health
period of care receives points based on
each of the responses associated with
the proposed functional OASIS items
which are then converted into a table of
points corresponding to increased
resource use (See Table 41). The sum of
all of these points results in a functional

score which is used to group home
health periods into a functional level
with similar resource use. We are
proposing three functional levels of low
impairment, medium impairment, and
high impairment with approximately
one third of home health periods from
each of the clinical groups within each
functional impairment level (See Table
42). The CY 2018 HH PPS Proposed rule
(82 FR 35320) and the technical report
posted on the HHA Center web page
provide a more detailed explanation as
to the construction of these functional
impairment levels using the proposed
OASIS items.

TABLE 41—OASIS POINTS TABLE FOR THOSE ITEMS ASSOCIATED WITH INCREASED RESOURCE USE USING A REDUCED
SET OF OASIS ITEMS, CY 2017

Points
(2017)

Response category

M1800: Grooming ......................................................................................
M1810: Current Ability to Dress Upper Body ............................................
M1820: Current Ability to Dress Lower Body ............................................
2 .................................................................................................................
M1830: Bathing ..........................................................................................

M1840: Toilet Transferring ........................................................................
M1850: Transferring ..................................................................................
M1860: Ambulation/Locomotion ................................................................

M1033: Risk of Hospitalization ..................................................................

1 .......................................................
1 .......................................................
1 .......................................................
11 .....................................................
1 .......................................................
2 .......................................................
3 .......................................................
1 .......................................................
1 .......................................................
2 .......................................................
1 .......................................................
2 .......................................................
3 .......................................................
4 or more items checked ................

4
6
5
20.9
3
13
21
4
4
8
11
13
25
11

Percent
of periods
in 2017
with this
response
category
56.9
60.0
59.3
18.0
53.1
23.6
32.1
37.8
59.2
25.2
52.8
14.8
17.8

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017(as of March 2, 2018).

TABLE 42—THRESHOLDS FOR FUNCTIONAL LEVELS BY CLINICAL GROUP, CY 2017
Clinical group

Level of impairment

MMTA ...........................................................................................................................

Low ...........................................................
Medium .....................................................
High ...........................................................
Low ...........................................................
Medium .....................................................
High ...........................................................
Low ...........................................................
Medium .....................................................
High ...........................................................
Low ...........................................................
Medium .....................................................
High ...........................................................
Low ...........................................................
Medium .....................................................
High ...........................................................
Low ...........................................................
Medium .....................................................
High ...........................................................

Behavioral Health .........................................................................................................

Complex Nursing Interventions ....................................................................................

Musculoskeletal Rehabilitation .....................................................................................

amozie on DSK3GDR082PROD with PROPOSALS2

Neuro Rehabilitation .....................................................................................................

Wound ..........................................................................................................................

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).
48 In Version OASIS C–2 (effective 1/1/2018),
three responses are excluded: #8:‘‘currently reports

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exhaustion’’, #9: ‘‘other risks not listed in 1–8’’, and
#10: ‘‘None of the above’’.

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Points
(2017 data)
0–37
38–53
54+
0–38
39–53
54+
0–36
37–57
58+
0–39
40–53
54+
0–45
46–61
62+
0–43
44–63
64+

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32407

Table 43 shows the average resource
use by clinical group and functional
level for CY 2017:

TABLE 43—AVERAGE RESOURCE USE BY CLINICAL GROUP AND FUNCTIONAL LEVEL, CY 2017
Mean
resource use
MMTA—Low ................
MMTA—Medium ..........
MMTA—High ................
Behavioral Health—Low
Behavioral Health—Medium ..........................
Behavioral Health—
High ..........................
Complex—Low .............
Complex—Medium .......
Complex—High ............
MS Rehab—Low ..........
MS Rehab—Medium ....
MS Rehab—High .........
Neuro—Low .................
Neuro—Medium ...........
Neuro—High ................
Wound—Low ................
Wound—Medium .........
Wound—High ...............
Total ......................

Frequency of
periods

Percent of
periods

Standard
deviation of
resource use

25th
Percentile of
resource use

Median
resource use

75th
Percentile of
resource use

$1,236.05
1,487.24
1,667.38
971.26

1,650,146
1,709,484
1,402,299
98,193

19.1
19.8
16.3
1.1

$1,076.20
1,162.37
1,274.53
845.25

$511.06
628.29
719.29
397.45

$907.38
1,202.12
1,371.99
686.39

$1,632.74
2,020.73
2,265.39
1,285.36

1,309.40

93,145

1.1

990.34

557.57

1,064.55

1,784.48

1,485.06
1,313.78
1,668.06
1,771.05
1,545.07
1,731.15
1,900.89
1,591.74
1,833.25
1,945.49
1,663.25
1,893.35
2,044.09
1,570.68

96,899
104,504
104,717
97,779
587,873
536,444
469,117
308,011
287,788
303,787
275,383
238,063
261,144
8,624,776

1.1
1.2
1.2
1.1
6.8
6.2
5.4
3.6
3.3
3.5
3.2
2.8
3.0
100.0

1,092.42
1,194.16
1,415.99
1,527.71
1,048.07
1,111.26
1,243.84
1,163.69
1,271.31
1,420.56
1,271.45
1,370.79
1,520.35
1,221.38

653.44
553.50
694.35
704.28
779.96
931.97
1,009.66
744.21
900.27
899.47
790.83
927.26
975.19
679.12

1,233.97
953.84
1,275.32
1,336.79
1,323.12
1,527.46
1,672.76
1,323.86
1,568.22
1,618.16
1,328.52
1,550.78
1,644.10
1,272.18

2,027.14
1,669.45
2,202.65
2,361.61
2,055.60
2,293.96
2,520.57
2,127.18
2,467.92
2,629.54
2,152.26
2,475.29
2,669.06
2,117.47

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

Like the annual recalibration of the
case-mix weights under the current HH
PPS, we expect that annual
recalibrations would also be made to the
PDGM case-mix weights. If the PDGM is
finalized for CY 2020, we will update
the functional points and thresholds
using the most current claims data
available. Likewise, we would continue
to analyze all of the components of the
case-mix adjustment, including
adjustment for functional status, and
would make refinements as necessary to
ensure that payment for home health
periods are in alignment with the costs
of providing care. We invite comments
on the proposed OASIS items and the
associated points and thresholds used to
group patients into three functional
impairment levels under the PDGM, as
outlined above.

amozie on DSK3GDR082PROD with PROPOSALS2

8. Comorbidity Adjustment
The alternative case-mix adjustment
methodology proposed in the CY 2018
HH PPS proposed rule, groups home
health periods based on the primary
reason for home health care (principal
diagnosis), functional level, admission
source, and timing. To further account
for differences in resource use based on
patient characteristics, in the CY 2018
HH PPS proposed rule, we proposed to
use the presence of comorbidities as
part of the overall case-mix adjustment
under the alternative case-mix
adjustment methodology. Specifically,

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we proposed a home health specific list
of comorbidities further refined into
broader, body system-based categories
and more granular subcategories to
capture those conditions that affect
resource costs during a home health
period of care. The proposed
comorbidities included those conditions
that represent more than 0.1 percent of
periods and had at least as high as the
median resource use as they indicate a
direct relationship between the
comorbidity and resource utilization.
Specifically, we proposed a list based
on the principles of patient assessment
by body systems and their associated
diseases, conditions, and injuries to
develop larger categories of conditions
that identified clinically relevant
relationships associated with increased
resource use. The broad, body systembased categories we proposed to use to
group comorbidities within the HHGM
included the following:
• Heart Disease
• Respiratory Disease
• Circulatory Disease and Blood
Disorders
• Cerebral Vascular Disease
• Gastrointestinal Disease
• Neurological Disease and Associated
Conditions
• Endocrine Disease
• Neoplasms
• Genitourinary and Renal Disease
• Skin Disease
• Musculoskeletal Disease or Injury

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• Behavioral Health (including
Substance Use Disorders)
• Infectious Disease
These broad categories used to group
comorbidities within the alternative
case-mix adjustment methodology were
further refined by grouping similar
diagnoses within the broad categories
into statistically and clinically
significant subcategories which would
receive the comorbidity adjustment in
the alternative case-mix adjustment
methodology (for example, Heart
Disease 1; Cerebral Vascular Disease 4).
All of the comorbidity diagnoses
grouped into the aforementioned
categories and subcategories are posted
on the Home Health Agency web page
and listed in the HHGM technical report
at the following link: https://
www.cms.gov/Center/Provider-Type/
Home-Health-Agency-HHA-Center.html.
We originally proposed that if a 30day period of care had at least one
secondary diagnosis reported on the
home health claim that fell into one of
the subcategories, that 30-day period of
care would receive a comorbidity
adjustment to account for higher costs
associated with the comorbidity.
Therefore, the payment adjustment for
comorbidities would be predicated on
the presence of one of the identified
diagnoses within the subcategories
associated with increased resource use
at or above the median. The comorbidity
adjustment amount would be the same

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

across all of the subcategories. A 30-day
period of care would receive only one
comorbidity adjustment regardless of
the number of secondary diagnoses
reported on the home health claim that
fell into one of the subcategories
associated with higher resource use. If
there is no reported diagnosis that meets
the comorbidity adjustment criteria, the
30-day period of care would not qualify
for the payment adjustment.
We solicited comments on the
proposed comorbidity adjustment in the
CY 2018 HH PPS proposed rule,
including the proposed comorbidity
diagnoses and their associated
subcategories, as part of the overall
alternative case-mix adjustment
methodology. While all commenters
supported the inclusion of a
comorbidity adjustment, most
commenters said that a single
comorbidity payment amount as part of
the overall case-mix adjustment is
insufficient to fully capture the home
health needs and resource costs
associated with the presence of
comorbidities. Meeting the requirement
of section 51001 of the BBA of 2018, a
Technical Expert Panel (TEP) was
convened in February 2018 to collect
perspectives, feedback, and identify and
prioritize recommendations from a wide
variety of industry experts and patient
representatives regarding the public
comments received on the proposed
alternative case-mix adjustment
methodology. Comments on the
comorbidity adjustment and suggestions
for refinement to this adjustment were
very similar between those received on
the CY 2018 HH PPS proposed rule and
those made by the TEP participants.
Specifically, the majority of commenters
stated that the presence of multiple
comorbidities has more of an effect on
home health resource use than a single
comorbidity and that any case-mix
adjustment should account for multiple
comorbidities. There was general
agreement that most home health
patients have multiple conditions which
increase the complexity of their care
and affects the ability to care for one’s
self at home. Several suggested that
CMS should let the data help determine
how many comorbidity adjustment
levels there should be and what
percentage of 30-day periods should be
in each level. Some commenters stated
they preferred specificity and
complexity over simplicity if the
complexity improved accuracy. Others
suggested including interactions
between comorbidities in the model,
specifically interactions of comorbid
conditions with the principal diagnosis
and with other comorbidities.

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Commenters and TEP members alike
focused on those conditions they saw as
most impactful on the provision of care
to home health beneficiaries. These
conditions included chronic respiratory
and cardiac conditions, as well as
psychological and diabetes-related
conditions. Most encouraged CMS to
continue to develop a system to allow
for appropriate changes to be made over
time to the list of comorbidity
subcategories that would assign a
comorbidity adjustment to a 30-day
period of care.
We agree with commenters that the
relationship between comorbidities and
resource use can be complex and that a
single adjustment, regardless of the type
or number of comorbidities, may be
insufficient to fully capture the resource
use of a varied population of home
health beneficiaries. However, we also
recognize that adjusting payment based
on the number of reported comorbidities
may encourage HHAs to inappropriately
report comorbid conditions in order to
increase payment, regardless of any true
impact on the home health plan of care.
Currently, OASIS instructions state that
clinicians must list each diagnosis for
which the patient is receiving home care
and to enter the level of highest
specificity as required by ICD–10 CM
coding guidelines. These instructions
state that clinicians should list
diagnoses in the order that best reflects
the seriousness of each condition and
supports the disciplines and services
provided.49 We also note that CMS
currently uses interaction items as part
of the HH PPS case-mix adjustments. In
the CY 2008 HH PPS final rule (72 FR
49772), we added secondary diagnoses
and their interactions with the principal
diagnosis as part of the clinical
dimension in the overall case-mix
adjustment. However, analysis since
then has shown that nominal case-mix
growth became an ongoing issue
resulting from the incentive in the
current HH PPS to code only those
conditions associated with clinical
points even though the data did not
show an associated increase in resource
utilization. Likewise, when we looked at
a multi-morbidity approach to the
overall case-mix adjustment to a home
health period of care, for the CY 2018
HH PPS proposed rule our analysis
showed that the reporting of secondary
diagnoses on home health claims was
not robust enough to support a payment
adjustment based on the presence of
49 ‘‘Outcome and Assessment I OASIS
Information Set C2 Guidance Manual Effective
January 1, 2018 accessed at https://www.cms.gov/
Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HomeHealthQualityInits/Downloads/
OASIS–C2-Guidance-Manual-Effective_1_1_18.pdf.

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multiple comorbidities. This means that
the data did not show significant
variations in resource use with an
increase in reported comorbidities.
In spite of concerns of potential
manipulation of coding patterns to
increase payment due to the
comorbidity adjustment, the results of
our most recent analyses for this
proposed rule show compelling
evidence that patients with certain
comorbidities and interactions of certain
comorbid conditions (as described later
in this section) have home health
episodes with higher resource use than
home health episodes without those
comorbidities or interactions. The goal
of our analyses was to identify those
clinically and statistically significant
comorbidities and interactions that
could be used to further case-mix adjust
a 30-day home health period of care. As
a result of these analyses, we identified
that there were certain individual
comorbidity subgroups and interactions
of the comorbidity subgroups (for
example, having diagnoses associated
with two of the comorbidity subgroups)
which could be used as part of the
comorbidity case-mix adjustment in the
PDGM.
To identify these relationships with
resource utilization, we looked at all
diagnoses reported on the OASIS
(M1021, M1023, and M1025) for each
30-day period of care. These fields
represent 18 different diagnoses which
could be reported on the OASIS. In the
PDGM, the principal diagnosis assigns
each 30-day period of care into a
clinical group which identifies the
primary reason the patient requires
home health services. During our
analysis, this usually was the reported
principal diagnosis, but in cases where
the diagnosis did not link to a clinical
group (for example, the diagnosis could
not be reported as a principal diagnosis
in accordance with ICD–10 CM coding
guidelines), we used a secondary
diagnosis to assign the 30-day period of
care into a clinical group. Any other
diagnoses, except the one used to link
the 30-day period of care into a clinical
group, were considered comorbidities.
However, if one of those comorbid
diagnoses was in the same ICD–10 CM
block of codes as the diagnosis used to
place the 30-day period of care into a
clinical group, then that comorbid
diagnosis was excluded (for example, if
the reported principal diagnosis was
I63.432, Cerebral infarction due to
embolism of left post cerebral artery,
and the reported secondary diagnosis
was I65.01, Occlusion and stenosis of
right vertebral artery, I65.01 would be
excluded as a comorbidity as both codes
are in the same block of ICD–10

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diagnosis codes, Cerebrovascular
Diseases, and both would group into the
Neuro clinical group if reported as the
principal diagnosis). Then, we checked
those reported comorbid diagnoses
against the home health-specific
comorbidity subgroup list to see if any
reported secondary diagnoses are listed
in a subgroup (for example, if a reported
secondary diagnosis was I50.9, Heart
Failure, unspecified, this diagnosis is
found in the Heart 11 subgroup).
We went through the following steps
to determine which individual
comorbidity subgroups would be used
as part of the comorbidity adjustment:
• After dropping the comorbidity
subgroups with a small number of 30-

day periods of care (for example, those
that made up fewer than 0.1 percent of
30-day periods of care), this left 59
different comorbidity subgroups.
• Of those, there are 56 comorbidity
subgroups with a p-value less than or
equal to 0.05.
• Of those 56 subgroups, there are 22
comorbidity subgroups that have a
positive coefficient when regressing
resource use on the comorbidity
subgroups (and the interactions as
described below) and indicators for the
clinical group, functional level,
admission source, and timing. We
determine the median coefficient of
those 22 comorbidity subgroups to be
$60.67.

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• There are 11 comorbidity subgroups
with coefficients that are at or above the
median (for example, $60.67 or above).
This is a decrease from the 15 subgroups
presented in the CY 2018 HH PPS
proposed rule. Potential reasons for this
decrease include the use of CY 2017
data in this analysis, whereas the 2018
HH PPS proposed rule used CY 2016
data; the combination and/or addition of
comorbidity groups; and the inclusion
of the interactions between the
comorbidities.
Those 11 individual comorbidity
subgroups that are statistically and
clinically significant for potential
inclusion in the comorbidity case-mix
adjustment are listed below in Table 44:

TABLE 44—INDIVIDUAL SUBGROUPS FOR COMORBIDITY ADJUSTMENT
Comorbidity
subgroup

Description

Neuro 11 ...............
Neuro 10 ...............
Circulatory 9 ..........
Heart 11 ................
Cerebral 4 .............
Neuro 5 .................
Skin 1 ....................
Neuro 7 .................
Circulatory 10 ........
Skin 3 ....................
Skin 4 ....................

Includes diabetic retinopathy and other blindness ..........................................................................................
Includes diabetic neuropathies ........................................................................................................................
Includes acute and chronic embolisms and thrombosis ..................................................................................
Includes heart failure ........................................................................................................................................
Includes sequelae of cerebrovascular diseases ..............................................................................................
Includes Parkinson’s Disease ..........................................................................................................................
Includes cutaneous abscess, cellulitis, and lymphangitis ................................................................................
Includes hemiplegia, paraplegia, and quadriplegia .........................................................................................
Includes varicose veins with ulceration ...........................................................................................................
Include diseases of arteries, arterioles and capillaries with ulceration and non-pressure chronic ulcers ......
Includes stages Two-Four and unstageable pressure ulcers by site ..............................................................

Coefficient
$61.23
67.98
86.62
101.57
128.78
144.99
174.93
204.42
215.67
365.78
484.83

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

Next, we examined the impact of
interactions between the various
comorbidity subgroups on resource use.
The following steps show how we
identified which interactions (for
example, diagnoses from two different
comorbidity subgroups) had a clinically
and statistically significant relationship
with increased resource utilization and
could be used for the comorbidity
adjustment:
• After dropping the combinations of
comorbidity subgroups and interactions
with a small number of 30-day periods
of care (that is, those that made up fewer
than 0.1 percent of 30-day periods of

care), there are 343 different
comorbidity subgroup interactions (for
example, comorbidity subgroup
interaction Skin 1 plus Skin 3). As
mentioned previously, we regressed
resource use on the comorbidity
subgroups, the interactions, and
indicators for the clinical group,
functional level, admission source, and
timing.
• From that regression, we found 187
comorbidity subgroup interactions with
a p-value less than or equal to 0.05.
• Of those 187 comorbidity subgroup
interactions, there are 27 comorbidity
subgroup interactions where the

coefficient on the comorbidity subgroup
interaction term plus the coefficients on
both single comorbidity variables equals
a value that exceeds $150. We used
$150 as the inclusion threshold as this
amount is approximately three times
that of the median value for the
individual comorbidity subgroups and
we believe is appropriate to reflect the
increased resource use associated with
comorbidity interactions. The 27
comorbidity subgroup interactions that
are statistically and clinically significant
for potential inclusion in the
comorbidity adjustment are listed in
Table 45.

amozie on DSK3GDR082PROD with PROPOSALS2

TABLE 45—COMORBIDITY SUBGROUP INTERACTIONS FOR COMORBIDITY ADJUSTMENT
Sum of
interaction
term plus
single
comorbidity
coefficients

Comorbidity
subgroup
interaction

Comorbidity
subgroup

Description

Comorbidity
subgroup

Description

1 ..................
2 ..................
3 ..................

Circulatory 4 ....
Endocrine 3 .....
Neuro 3 ...........

Hypertensive Chronic Kidney Disease ........
Diabetes with Complications ........................
Dementia in diseases classified elsewhere

Neuro 11 .........
Neuro 7 ...........
Skin 3 ..............

$151.98
162.35
190.30

4 ..................
5 ..................
6 ..................

Circulatory 4 ....
Cerebral 4 .......
Neuro 7 ...........

Skin 1 ..............
Heart 11 ..........
Renal 3 ............

7 ..................
8 ..................

Circulatory 10 ..
Heart 11 ..........

Hypertensive Chronic Kidney Disease ........
Sequelae of Cerebrovascular Diseases ......
Includes hemiplegia, paraplegia, and quadriplegia.
Includes varicose veins with ulceration .......
Heart Failure ................................................

Includes diabetic retinopathy and other blindness ....
Includes hemiplegia, paraplegia, and quadriplegia ...
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Cutaneous abscess, cellulitis, and lymphangitis .......
Heart Failure ..............................................................
Nephrogenic Diabetes Insipidus ................................

Endocrine 3 .....
Neuro 5 ...........

Diabetes with Complications ......................................
Parkinson’s Disease ...................................................

205.52
212.88

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195.55
202.44

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Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 45—COMORBIDITY SUBGROUP INTERACTIONS FOR COMORBIDITY ADJUSTMENT—Continued

Comorbidity
subgroup
interaction

Comorbidity
subgroup

9 ..................

Description

Comorbidity
subgroup

Description

Heart 12 ..........

Other Heart Diseases ..................................

Skin 3 ..............

10 ................

Neuro 3 ...........

Dementia in diseases classified elsewhere

Skin 4 ..............

11 ................

Behavioral 2 ....

Mood Disorders ............................................

Skin 3 ..............

12 ................
13 ................

Circulatory 10 ..
Circulatory 4 ....

Includes varicose veins with ulceration .......
Hypertentive Chronic Kidney Disease .........

Heart 11 ..........
Skin 3 ..............

14 ................

Renal 1 ............

Chronic kidney disease and ESRD .............

Skin 3 ..............

15 ................

Respiratory 5 ...

COPD and Asthma ......................................

Skin 3 ..............

16 ................

Skin 1 ..............

Skin 3 ..............

17 ................

Renal 3 ............

Cutaneous abscess, cellulitis, and lymphangitis.
Nephrogenic Diabetes Insipidus ..................

Skin 4 ..............

18 ................

Heart 11 ..........

Heart Failure ................................................

Skin 3 ..............

19 ................

Heart 12 ..........

Other Heart Diseases ..................................

Skin 4 ..............

20 ................

Respiratory 5 ...

COPD and Asthma ......................................

Skin 4 ..............

21 ................

Circulatory 7 ....

Atherosclerosis .............................................

Skin 3 ..............

22 ................

Renal 1 ............

Chronic kidney disease and ESRD .............

Skin 4 ..............

23 ................

Endocrine 3 .....

Diabetes with Complications ........................

Skin 4 ..............

24 ................

Endocrine 3 .....

Diabetes with Complications ........................

Skin 3 ..............

25 ................

Circulatory 4 ....

Hypertensive Chronic Kidney Disease ........

Skin 4 ..............

26 ................

Heart 11 ..........

Heart Failure ................................................

Skin 4 ..............

27 ................

Skin 3 ..............

Diseases of arteries, arterioles and capillaries with ulceration and non-pressure
chronic ulcers.

Skin 4 ..............

Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Stages Two-Four and unstageable pressure ulcers
by site.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Heart Failure ..............................................................
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Stages Two-Four and unstageable pressure ulcers
by site.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Stages Two-Four and unstageable pressure ulcers
by site.
Stages Two-Four and unstageable pressure ulcers
by site.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Stages Two-Four and unstageable pressure ulcers
by site.
Stages Two-Four and unstageable pressure ulcers
by site.
Diseases of arteries, arterioles and capillaries with
ulceration and non-pressure chronic ulcers.
Stages Two-Four and unstageable pressure ulcers
by site.
Stages Two-Four and unstageable pressure ulcers
by site.
Stages Two-Four and unstageable pressure ulcers
by site.

Sum of
interaction
term plus
single
comorbidity
coefficients
260.83
274.16
287.42
292.39
296.70
300.31
306.63
390.47
422.34
422.20
423.08
428.02
432.46
436.39
487.96
504.54
509.63
529.47
750.85

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Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

In order to be considered a
comorbidity subgroup interaction, at
least two reported diagnoses, must
occur in the above corresponding
combinations, as shown in Table 45. For
example, one diagnosis from Heart 11
must be reported along with at least one
diagnosis from Neuro 5 in order to
qualify for comorbidity subgroup
interaction 8. In other words, the
comorbidity subgroups are not
interchangeable between the interaction
groups (for example, reported
conditions from the Renal 1 and
Respiratory 5 subgroups would not be
considered an interaction for purposes
of the comorbidity adjustment).
For illustrative purposes, this would
mean that if a 30-day period of care had
the following secondary diagnoses
reported, I50.22, chronic systolic
(congestive) heart failure and G20,
Parkinson’s Disease (these diagnoses fall
under comorbidity subgroups Heart 11
and Neuro 5 respectively and are in the
same comorbidity subgroup interaction),
this interaction of comorbid conditions
results in a higher level of resource use

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than just having a comorbid diagnosis
classified in Heart 11 or in Neuro 5.
There will be an updated PDGM
Grouper Tool posted on the HHA Center
web page that HHAs can access to
simulate the HIPPS code and case-mix
weight under the PDGM.50 This Grouper
Tool allows providers to fill in
information, including the
comorbidities, to determine whether a
home health period of care would
receive a comorbidity adjustment under
the PDGM.
The comorbidity interactions identify
subgroup combinations of comorbidities
that are associated with higher levels of
resource use. As such, we believe that
the comorbidity adjustment payment
should be dependent on whether the 30day period of care has an individual
comorbidity subgroup associated with
higher resource use or there is a
comorbidity subgroup interaction
resulting in higher resource use.
Therefore, we propose to have three
50 https://www.cms.gov/Center/Provider-Type/
Home-Health-Agency-HHA-Center.html.

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levels in the PDGM comorbidity casemix adjustment: No Comorbidity
Adjustment, Low Comorbidity
Adjustment, and High Comorbidity
Adjustment. This means that depending
on if and which secondary diagnoses are
reported, a 30-day period of care may
receive no comorbidity adjustment
(meaning, no secondary diagnoses exist
or do not meet the criteria for a
comorbidity adjustment), a ‘‘low’’
comorbidity adjustment, or a ‘‘high’’
comorbidity adjustment. We propose
that home health 30-day periods of care
can receive a comorbidity payment
adjustment under the following
circumstances:
• Low comorbidity adjustment: There
is a reported secondary diagnosis that
falls within one of the home-health
specific individual comorbidity
subgroups, as listed in Table 44, (for
example, Heart Disease 11, Cerebral
Vascular Disease 4, etc.) associated with
higher resource use, or;
• High comorbidity adjustment:
There are two or more secondary
diagnoses reported that fall within the

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same comorbidity subgroup interaction,
as listed in Table 45, (for example, Heart
11 plus Neuro 5) that are associated
with higher resource use.
Under the PDGM, a 30-day period of
care can receive payment for a low
comorbidity adjustment or a high
comorbidity adjustment, but not both. A
30-day period of care can receive only
one low comorbidity adjustment
regardless of the number of secondary
diagnoses reported on the home health
claim that fell into one of the individual

comorbidity subgroups or one high
comorbidity adjustment regardless of
the number of comorbidity group
interactions, as applicable. The low
comorbidity adjustment amount would
be the same across all 11 individual
comorbidity subgroups. Similarly, the
high comorbidity adjustment amount
would be the same across all 27
comorbidity subgroup interactions. See
Table 48 in section III.F.10 of this
proposed rule for the coefficient
amounts associated with both the low

32411

and high comorbidity adjustment, as
well as for all of the case-mix variables
in the PDGM. If a 30-day home health
period of care does not have any
reported comorbidities that fall into one
of the payment adjustments described
above, there would be no comorbidity
adjustment applied. Table 46 illustrates
the average resource use for each of the
comorbidity levels as described in this
section.

TABLE 46—AVERAGE RESOURCE USE BY COMORBIDITY ADJUSTMENT, CY 2017
Mean
resource use
No Comorbidity Adjustment ..........................
Comorbidity Adjustment—Has at least
one comorbidity from
comorbidity list, no
interaction from interaction list ..................
Comorbidity Adjustment—Has at least
one interaction from
interaction list ...........
Total ......................

Frequency
of periods

Percent
of periods

Standard
deviation of
resource use

25th
percentile of
resource use

Median
resource use

75th
percentile of
resource use

$1,539.92

5,402,694

62.6

$1,183.86

$673.27

$1,253.95

$2,078.68

1,575.12

2,721,969

31.6

1,248.71

658.77

1,262.47

2,131.92

1,878.84

500,113

5.8

1,412.06

880.07

1,523.87

2,469.93

1,570.68

8,624,776

100.0

1,221.38

679.12

1,272.18

2,117.47

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Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018).

Changing to three comorbidity levels
results in 216 possible case-mix groups
for the purposes of adjusting payment in
the PDGM. While this is more case-mix
groups than the 144 case-mix groups
proposed in the CY 2018 HH PPS
proposed rule, this change is responsive
to the comments received regarding
refinements to the comorbidity
adjustment without being unduly
complex. We believe that this method
for adjusting payment for the presence
of comorbidities is more robust,
reflective of patient characteristics,
better aligns payment with actual
resource use, and addresses comments
received from the CY 2018 HH PPS
proposed rule and recommendations
from TEP members. The comorbidity
payment adjustment takes into account
the presence of individual comorbid
conditions, as well as the interactions
between multiple comorbid conditions,
and reflects the types of conditions most
commonly seen in home health patients.
Similar to monitoring of nominal casemix growth under the current HH PPS,
upon implementation of the PDGM,
CMS will monitor the reporting of
secondary diagnoses to determine
whether adjustments to payment based
on the number of reported comorbidities
is resulting in HHAs inappropriately

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reporting comorbid conditions solely for
the purpose of increased payment and
appropriate program integrity actions
will be taken.
As mentioned previously in this
section, there will be an updated PDGM
Grouper Tool posted on the HHA Center
web page which will be key to
understanding whether a 30-day home
health period of care would receive a
no, low, or high comorbidity adjustment
under the PDGM. If implemented, we
would continue to examine the
relationship of reported comorbidities
on resource utilization and make the
appropriate payment refinements to
help ensure that payment is in
alignment with the actual costs of
providing care. We invite comments on
the change to the comorbidity case-mix
adjustment in the PDGM including the
three comorbidity levels: No
Comorbidity, Low Comorbidity, and
High Comorbidity Adjustment. We also
invite comments on the payment
associated with the Low Comorbidity
and High Comorbidity Adjustment to
account for increased resource
utilization resulting from the presence
of certain comorbidities and
comorbidity interactions.

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9. Change in the Low-Utilization
Payment Adjustment (LUPA) Threshold
Currently, a 60-day episode with four
or fewer visits is paid the national per
visit amount by discipline, adjusted by
the appropriate wage index based on the
site of service of the beneficiary, instead
of the full 60-day episode payment
amount. Such payment adjustments are
called Low Utilization Payment
Adjustments (LUPAs). While the
alternative case-mix model proposed in
the CY 2018 HH PPS proposed rule still
included LUPAs, the approach to
calculating the LUPA thresholds needed
to change due to the proposed change in
the unit of payment to 30-day periods of
care from 60-day episodes. The 30-day
periods of care have substantially more
episodes with four or fewer visits than
60-day episodes. To create LUPA
thresholds we proposed in the CY 2018
HH PPS proposed rule to set the LUPA
threshold at the 10th percentile value of
visits or 2, whichever is higher, for each
payment group, (82 FR 35324).
We received comments in response to
the CY 2018 HH PPS proposed rule on
maintaining the use of a single LUPA
threshold instead of varying the
thresholds at the subgroup level. Other
commenters expressed concern that the
variable LUPA thresholds will add

E:\FR\FM\12JYP2.SGM

12JYP2

32412

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

additional administrative burden and
create additional opportunity for error.
After analyzing the data to evaluate the
potential impact, we believe that the
change to a 30-day period of care under
the proposed PDGM from the current
60-day episode warrants variable LUPA
thresholds depending on the payment
group to which it is assigned. We
believe that the proposed LUPA
thresholds that vary based on the casemix assignment for the 30-day period of
care in the proposed PDGM is an
improvement over the current 5 visit
threshold that does not vary by case-mix
assignment. This is the same approach
proposed in the CY 2018 proposed rule
where LUPA thresholds would vary by
case-mix group. LUPA thresholds that
vary by case-mix group take into
account different resource use patterns
based on beneficiaries’ clinical

characteristics. Additionally, we do not
believe that the case-mix-specific LUPA
thresholds would result in additional
administrative burden as LUPA visits
are billed the same as non-LUPA
periods. Likewise, the PDGM will not be
implemented until January 1, 2020,
giving HHAs and vendors sufficient
time to make necessary changes to their
systems and to ensure that appropriate
quality checks are in place to minimize
any claims errors. Therefore, we
propose to vary the LUPA threshold for
a 30-day period of care under the PDGM
depending on the PDGM payment group
to which it is assigned.
We note that in the current payment
system, approximately 8 percent of
episodes are LUPAs. Under the PDGM,
consistent with the CY 2018 HH PPS
proposed rule, we propose the 10th
percentile value of visits or 2 visits,

whichever is higher, in order to target
approximately the same percentage of
LUPAs (approximately 7.1 percent of
30-day periods would be LUPAs
(assuming no behavior change)). For
example, for episodes in the payment
group corresponding to ‘‘MMTA–
Functional Level Medium—Early
Timing—Institutional Admission—No
Comorbidity’’ (HIPPS code 2AB1 in
Table 47), the threshold is four visits. If
a home health 30-day period of care is
assigned to that particular payment
group had three or fewer visits the HHA
would be paid using the national pervisit rates in section III.C.4 of this
proposed rule instead of the case-mix
adjusted 30-day period of care payment
amount. The LUPA thresholds for the
PDGM payment group with the
corresponding HIPPS code is listed in
Table 47.

TABLE 47—PROPOSED LUPA THRESHOLDS FOR THE PROPOSED PDGM PAYMENT GROUPS

amozie on DSK3GDR082PROD with PROPOSALS2

HIPPS

1AA11
1AA21
1AA31
1AB11
1AB21
1AB31
1AC11
1AC21
1AC31
1BA11
1BA21
1BA31
1BB11
1BB21
1BB31
1BC11
1BC21
1BC31
1CA11
1CA21
1CA31
1CB11
1CB21
1CB31
1CC11
1CC21
1CC31
1DA11
1DA21
1DA31
1DB11
1DB21
1DB31
1DC11
1DC21
1DC31
1EA11
1EA21
1EA31
1EB11
1EB21
1EB31

Clinical group and functional level

...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............

VerDate Sep<11>2014

MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—High ...........................................
MMTA—High ...........................................
MMTA—High ...........................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—High ...........................................
Neuro—High ...........................................
Neuro—High ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—High ..........................................
Wound—High ..........................................
Wound—High ..........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—High .......................................
Complex—High .......................................
Complex—High .......................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................

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Timing and admission source

Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community
Early—Community

Fmt 4701

Sfmt 4702

Comorbidity
adjustment
(0 = none,
1 = single
comorbidity,
2 = interaction)

..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
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..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................
..................................

E:\FR\FM\12JYP2.SGM

Visit
threshold
(10th percentile
or 2—whichever
is higher)
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2

12JYP2

4
4
4
4
4
5
4
4
4
4
5
5
5
5
5
4
5
5
4
4
4
5
5
5
4
5
4
3
2
4
3
3
4
3
3
3
5
5
5
5
5
5

32413

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 47—PROPOSED LUPA THRESHOLDS FOR THE PROPOSED PDGM PAYMENT GROUPS—Continued

amozie on DSK3GDR082PROD with PROPOSALS2

HIPPS

1EC11
1EC21
1EC31
1FA11
1FA21
1FA31
1FB11
1FB21
1FB31
1FC11
1FC21
1FC31
2AA11
2AA21
2AA31
2AB11
2AB21
2AB31
2AC11
2AC21
2AC31
2BA11
2BA21
2BA31
2BB11
2BB21
2BB31
2BC11
2BC21
2BC31
2CA11
2CA21
2CA31
2CB11
2CB21
2CB31
2CC11
2CC21
2CC31
2DA11
2DA21
2DA31
2DB11
2DB21
2DB31
2DC11
2DC21
2DC31
2EA11
2EA21
2EA31
2EB11
2EB21
2EB31
2EC11
2EC21
2EC31
2FA11
2FA21
2FA31
2FB11
2FB21
2FB31
2FC11
2FC21
2FC31
3AA11
3AA21

...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............

VerDate Sep<11>2014

Clinical group and functional level

Timing and admission source

MS Rehab—High ....................................
MS Rehab—High ....................................
MS Rehab—High ....................................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—High .........................
Behavioral Health—High .........................
Behavioral Health—High .........................
MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—High ...........................................
MMTA—High ...........................................
MMTA—High ...........................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—High ...........................................
Neuro—High ...........................................
Neuro—High ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—High ..........................................
Wound—High ..........................................
Wound—High ..........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—High .......................................
Complex—High .......................................
Complex—High .......................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—High ....................................
MS Rehab—High ....................................
MS Rehab—High ....................................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—High .........................
Behavioral Health—High .........................
Behavioral Health—High .........................
MMTA—Low ...........................................
MMTA—Low ...........................................

Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Community ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Early—Institutional ..................................
Late—Community ...................................
Late—Community ...................................

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E:\FR\FM\12JYP2.SGM

Comorbidity
adjustment
(0 = none,
1 = single
comorbidity,
2 = interaction)

Visit
threshold
(10th percentile
or 2—whichever
is higher)
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1

12JYP2

5
5
5
3
3
3
4
4
4
4
4
4
3
4
4
4
5
5
4
4
4
5
5
5
6
6
6
5
5
5
4
4
4
5
5
5
4
5
4
3
3
4
4
4
5
4
4
4
5
5
5
6
6
6
6
6
6
3
3
4
4
4
5
4
4
5
2
2

32414

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 47—PROPOSED LUPA THRESHOLDS FOR THE PROPOSED PDGM PAYMENT GROUPS—Continued

amozie on DSK3GDR082PROD with PROPOSALS2

HIPPS

3AA31
3AB11
3AB21
3AB31
3AC11
3AC21
3AC31
3BA11
3BA21
3BA31
3BB11
3BB21
3BB31
3BC11
3BC21
3BC31
3CA11
3CA21
3CA31
3CB11
3CB21
3CB31
3CC11
3CC21
3CC31
3DA11
3DA21
3DA31
3DB11
3DB21
3DB31
3DC11
3DC21
3DC31
3EA11
3EA21
3EA31
3EB11
3EB21
3EB31
3EC11
3EC21
3EC31
3FA11
3FA21
3FA31
3FB11
3FB21
3FB31
3FC11
3FC21
3FC31
4AA11
4AA21
4AA31
4AB11
4AB21
4AB31
4AC11
4AC21
4AC31
4BA11
4BA21
4BA31
4BB11
4BB21
4BB31
4BC11

Clinical group and functional level

...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
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...............

VerDate Sep<11>2014

MMTA—Low ...........................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—High ...........................................
MMTA—High ...........................................
MMTA—High ...........................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—High ...........................................
Neuro—High ...........................................
Neuro—High ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—High ..........................................
Wound—High ..........................................
Wound—High ..........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—High .......................................
Complex—High .......................................
Complex—High .......................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—High ....................................
MS Rehab—High ....................................
MS Rehab—High ....................................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—High .........................
Behavioral Health—High .........................
Behavioral Health—High .........................
MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Low ...........................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—Medium .....................................
MMTA—High ...........................................
MMTA—High ...........................................
MMTA—High ...........................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Low ............................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—Medium ......................................
Neuro—High ...........................................

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Timing and admission source

Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Community
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional

Fmt 4701

Comorbidity
adjustment
(0 = none,
1 = single
comorbidity,
2 = interaction)

...................................
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...................................
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...................................
...................................
...................................
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Sfmt 4702

E:\FR\FM\12JYP2.SGM

Visit
threshold
(10th percentile
or 2—whichever
is higher)
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0
1
2
0

12JYP2

3
2
2
3
2
2
3
2
2
2
2
2
3
2
2
2
2
3
3
3
3
3
3
3
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
3
2
2
2
2
2
2
2
2
2
3
3
3
3
3
4
3
3
4
3
4
3
4
4
5
4

32415

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules
TABLE 47—PROPOSED LUPA THRESHOLDS FOR THE PROPOSED PDGM PAYMENT GROUPS—Continued

HIPPS

4BC21
4BC31
4CA11
4CA21
4CA31
4CB11
4CB21
4CB31
4CC11
4CC21
4CC31
4DA11
4DA21
4DA31
4DB11
4DB21
4DB31
4DC11
4DC21
4DC31
4EA11
4EA21
4EA31
4EB11
4EB21
4EB31
4EC11
4EC21
4EC31
4FA11
4FA21
4FA31
4FB11
4FB21
4FB31
4FC11
4FC21
4FC31

Clinical group and functional level

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Neuro—High ...........................................
Neuro—High ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Low ...........................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—Medium ....................................
Wound—High ..........................................
Wound—High ..........................................
Wound—High ..........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Low ........................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—Medium ..................................
Complex—High .......................................
Complex—High .......................................
Complex—High .......................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Low .....................................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—Medium ...............................
MS Rehab—High ....................................
MS Rehab—High ....................................
MS Rehab—High ....................................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Low .........................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—Medium ...................
Behavioral Health—High .........................
Behavioral Health—High .........................
Behavioral Health—High .........................

amozie on DSK3GDR082PROD with PROPOSALS2

In summary, we propose to vary the
LUPA threshold for a 30-day period of
care under the PDGM depending on the
PDGM payment group to which it is
assigned. We also propose that the
LUPA thresholds for each PDGM
payment group would be re-evaluated
every year based on the most current
utilization data available. We invite
public comments on the LUPA
threshold methodology proposed for the
PDGM and the associated regulations
text changes in section III.F.13 of this
proposed rule.
10. HH PPS Case-Mix Weights Under
the PDGM
Section 1895(b)(4)(B) requires the
Secretary to establish appropriate case
mix adjustment factors for home health
services in a manner that explains a
significant amount of the variation in
cost among different units of services. In
the CY 2018 HH PPS proposed rule (82

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Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
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Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
Late—Institutional
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Late—Institutional
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FR 35270), we proposed an alternative
case-mix adjustment methodology to
better align payment with patient care
needs. The proposed alternative casemix adjustment methodology places
patients into meaningful payment
categories based on patient
characteristics (principal diagnosis,
functional level, comorbid conditions,
referral source and timing). We did not
finalize the alternative case-mix
adjustment methodology in the CY 2018
final rule in order to consider comments
and feedback for any potential
refinements to the model. Refinements
were made to the comorbidity case-mix
adjustment while all other variables
remain as proposed in the CY 2018 HH
PPS proposed rule (for example, clinical
group, functional level, admission
source, and episode timing). As outlined
in previous sections of this proposed
rule, we are again proposing an
alternative case-mix adjustment

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adjustment
(0 = none,
1 = single
comorbidity,
2 = interaction)

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is higher)
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methodology, called the PDGM, but this
methodology now results in 216 unique
case-mix groups. These 216 unique
case-mix payment groups are called
Home Health Resource Groups
(HHRGs). In accordance with the BBA of
2018, the proposed PDGM will be
implemented in a budget neutral
manner.
To generate PDGM case-mix weights,
we utilized a data file based on home
health episodes of care, as reported in
Medicare home health claims. The
claims data provide episode-level data
as well as visit-level data. The claims
also provide data on whether nonroutine supplies (NRS) was provided
during the episode and the total charges
for NRS. We used CY 2017 home health
claims data with linked OASIS
assessment data to obtain patient
characteristics. We determined the casemix weight for each of the different
PDGM payment groups by regressing

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32416

Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Proposed Rules

resource use on a series of indicator
variables for each of the categories using
a fixed effects model. The regression
measures resource use with the Cost per
Minute (CPM) + NRS approach outlined
in section III.F.2 of this proposed rule.
The model used in the PDGM payment
regression generates outcomes that are
statistically significant and consistent
with findings.
We received comments in response to
the proposed alternative case-mix
adjustment methodology in the CY 2018
HH PPS proposed rule on the standards
for subsequent case-mix weight
recalibration (nature and timing).
Similar to the annual recalibration of
the case-mix weights under the current
HH PPS, annual recalibration will be
made to the PDGM case-mix weights.
We will make refinements as necessary
to ensure that payment for home health
periods are in alignment with costs. We
note that this includes a re-calculation
of the proposed PDGM case-mix weights
for CY 2020 in the CY 2020 HH PPS
proposed rule using CY 2018 home
health claims data linked with OASIS
assessment data. In other words, the
table below represents the PDGM casemix weights if we were to implement
the PDGM in CY 2019. However, since
we are proposing to implement the
PDGM on January 1, 2020, the actual
PDGM case-mix weights for CY 2020
will be updated in the CY 2020 HH PPS

proposed rule. We also received a
comment from MedPAC about the
development of alternative case-mix
adjustment methodology using the
regression approach, which is a
statistical estimate of the cost associated
with a payment group instead of the
actual cost. MedPAC stated that this
approach results in estimated payments
that may not equal the actual costs
experienced by HHAs. As noted, CMS
has used a regression approach since the
inception of the HH PPS in 2000. The
regression smoothens weights compared
to a system where each payment group
receives a weight that is based solely on
the average resource use of all 30-day
periods in a payment group compared to
the overall average resource use across
all 30 day periods. Smoothing the
weights helps to see relationships
between variables and foresee trends. In
addition, using a regression approach to
calculate case-mix weights allows CMS
to use a fixed effects model, which will
estimate the variation observed within
individual HHAs and opposed to
estimating the variation across HHAs.
With the fixed effects, the coefficients
should better estimate the relationship
the regression variables have with
resource use compared to not
accounting for fixed effects. We
continue to believe that using a
regression approach for the calculation

of the HH PPS case-mix weights is most
appropriate.
After best fitting the model on home
health episodes from 2017 data, we used
the estimated coefficients of the model
to predict the expected average resource
use of each episode based on the five
PDGM categories. In order to normalize
the results, we have divided the
regression predicted resource use of
each episode by the overall average
resource use of all episodes used to
estimate the model in order to calculate
the case mix weight of all episodes
within a particular payment group,
where each payment group is defined as
the unique combination of the
subgroups within the five PDGM
categories (admission source, timing of
the 30-day period, clinical grouping,
functional level, and comorbidity
adjustment). The case-mix weight is
then used to adjust the base payment
rate to determine each period’s
payment. Table 48 shows the
coefficients of the payment regression
used to generate the weights, and the
coefficients divided by average resource
use. Information can be found in section
III.F.6 of this rule for the clinical groups,
section III.F.7 of this rule for the
functional levels, section III.F.5 for
admission source, section III.F.4 for
timing, and section III.F.8 for the
comorbidity adjustment.

TABLE 48—COEFFICIENT OF PAYMENT REGRESSION AND COEFFICIENT DIVIDED BY AVERAGE RESOURCE USE FOR PDGM
PAYMENT GROUP
Variable

Coefficient

Coefficient
divided
by average
resource use

amozie on DSK3GDR082PROD with PROPOSALS2

Clinical Group and Functional Level (MMTA—Low is excluded)
MMTA—Medium Functional ....................................................................................................................................
MMTA—High Functional ..........................................................................................................................................
Behavioral Health—Low Functional ........................................................................................................................
Behavioral Health—Medium Functional ..................................................................................................................
Behavioral Health—High Functional ........................................................................................................................
Complex—Low Functional .......................................................................................................................................
Complex—Medium Functional .................................................................................................................................
Complex—High Functional ......................................................................................................................................
MS Rehab—Low Functional ....................................................................................................................................
MS Rehab—Medium Functional ..............................................................................................................................
MS Rehab—High Functional ...................................................................................................................................
Neuro—Low Functional ...........................................................................................................................................
Neuro—Medium Functional .....................................................................................................................................
Neuro—High Functional ..........................................................................................................................................
Wound—Low Functional ..........................................................................................................................................
Wound—Medium Functional ...................................................................................................................................
Wound—High Functional .........................................................................................................................................

$237.83
416.75
¥116.39
169.86
309.97
¥27.39
331.88
476.69
141.37
338.96
558.95
329.19
593.98
711.48
368.43
628.37
822.84

0.1514
0.2653
¥0.0741
0.1081
0.1974
¥0.0174
0.2113
0.3035
0.0900
0.2158
0.3559
0.2096
0.3782
0.4530
0.2346
0.4001
0.5239

¥646.84
278.85
45.71

¥0.4118
0.1775
0.0291

Referral Source With Timing (Community Early excluded)
Community—Late ....................................................................................................................................................
Institutional—Early ...................................................................................................................................................
Institutional—Late ....................................................................................................................................................

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TABLE 48—COEFFICIENT OF PAYMENT REGRESSION AND COEFFICIENT DIVIDED BY AVERAGE RESOURCE USE FOR PDGM
PAYMENT GROUP—Continued
Variable

Coefficient
divided
by average
resource use

Coefficient

Comorbidity Adjustment (No Comorbidity Adjustment Group is excluded)
Comorbidity Adjustment—Has at least one comorbidity from comorbidity list, no interaction from interaction list
Comorbidity Adjustment—Has at least one interaction from interaction list ...........................................................

92.44
345.20

0.0589
0.2198

Constant ...................................................................................................................................................................
Average Resource Use ...........................................................................................................................................
N ..............................................................................................................................................................................
Adj. R-Squared ........................................................................................................................................................

$1,560.37
$1,570.68
8,624,776
0.2925

0.9934
........................
........................
........................

Source: CY 2017 Medicare claims data for episodes ending on or before December 31, 2017 (as of March 2, 2018) for which we had a linked
OASIS assessment. LUPA episodes, outlier episodes, and episodes with PEP adjustments were excluded.

Table 49 presents the case-mix weight
for each HHRG in the regression model
(Table 48). LUPA episodes, outlier
episodes, and episodes with PEP
adjustments were excluded. Please find
LUPA information in section III.F.9 of
this rule. Weights are determined by
first calculating the predicted resource
use for episodes with a particular
combination of admission source,
episode timing, clinical grouping,
functional level, and comorbidity
adjustment. This combination specific
calculation is then divided by the
average resource use of all the episodes
that were used to estimate the standard

30-day payment rate, which is
$1,570.68. The resulting ratio represents
the case-mix weight for that particular
combination of a HHRG payment group.
The adjusted R-squared value for this
model is 0.2925 which is slightly higher
than the adjusted R-squared value of
0.2704 that we proposed in CY 2018 by
using the CY 2016 claims data. The
adjusted R-squared value provides a
measure of how well observed outcomes
are replicated by the model, based on
the proportion of total variation of
outcomes explained by the model.
As noted above, there are 216
different HHRG payment groups under

the PDGM. There are 15 HHRG payment
groups that represent roughly 50.2
percent of the total episodes. There are
61 HHRG payment groups that represent
roughly 1.0 percent of total episodes.
The HHRG payment group with the
smallest weight has a weight of 0.5075
(community admitted, late, behavioral
health, low functional impairment level,
with no comorbidity adjustment). The
HHRG payment group with the largest
weight has a weight of 1.9146
(institutional admitted, early, wound,
high functional impairment level, with
interactive comorbidity adjustment).

TABLE 49—CASE MIX WEIGHTS FOR EACH HHRG PAYMENT GROUP

amozie on DSK3GDR082PROD with PROPOSALS2

HIPPS
1AA11
1AA21
1AA31
1AB11
1AB21
1AB31
1AC11
1AC21
1AC31
1BA11
1BA21
1BA31
1BB11
1BB21
1BB31
1BC11
1BC21
1BC31
1CA11
1CA21
1CA31
1CB11
1CB21
1CB31
1CC11
1CC21
1CC31
1DA11

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VerDate Sep<11>2014

Timing and
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Clinical group and functional level
MMTA—Low ...................................................
MMTA—Low ...................................................
MMTA—Low ...................................................
MMTA—Medium .............................................
MMTA—Medium .............................................
MMTA—Medium .............................................
MMTA—High ...................................................
MMTA—High ...................................................
MMTA—High ...................................................
Neuro—Low ....................................................
Neuro—Low ....................................................
Neuro—Low ....................................................
Neuro—Medium ..............................................
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Wound—Low ...................................................
Wound—Low ...................................................
Wound—Low ...................................................
Wound—Medium ............................................
Wound—Medium ............................................
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Wound—High ..................................................
Complex—Low ................................................

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Proposed
CY 2019
weight

Comorbidity
adjustment

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0.9934
1.0523
1.2132
1.1449
1.2037
1.3646
1.2588
1.3176
1.4785
1.2030
1.2619
1.4228
1.3716
1.4305
1.5914
1.4464
1.5053
1.6662
1.2280
1.2869
1.4478
1.3935
1.4523
1.6133
1.5173
1.5762
1.7371
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32418

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TABLE 49—CASE MIX WEIGHTS FOR EACH HHRG PAYMENT GROUP—Continued

amozie on DSK3GDR082PROD with PROPOSALS2

HIPPS
1DA21
1DA31
1DB11
1DB21
1DB31
1DC11
1DC21
1DC31
1EA11
1EA21
1EA31
1EB11
1EB21
1EB31
1EC11
1EC21
1EC31
1FA11
1FA21
1FA31
1FB11
1FB21
1FB31
1FC11
1FC21
1FC31
2AA11
2AA21
2AA31
2AB11
2AB21
2AB31
2AC11
2AC21
2AC31
2BA11
2BA21
2BA31
2BB11
2BB21
2BB31
2BC11
2BC21
2BC31
2CA11
2CA21
2CA31
2CB11
2CB21
2CB31
2CC11
2CC21
2CC31
2DA11
2DA21
2DA31
2DB11
2DB21
2DB31
2DC11
2DC21
2DC31
2EA11
2EA21
2EA31
2EB11
2EB21
2EB31
2EC11
2EC21

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Timing and
admission source

Clinical group and functional level
Complex—Low ................................................
Complex—Low ................................................
Complex—Medium ..........................................
Complex—Medium ..........................................
Complex—Medium ..........................................
Complex—High ...............................................
Complex—High ...............................................
Complex—High ...............................................
MS Rehab—Low .............................................
MS Rehab—Low .............................................
MS Rehab—Low .............................................
MS Rehab—Medium .......................................
MS Rehab—Medium .......................................
MS Rehab—Medium .......................................
MS Rehab—High ............................................
MS Rehab—High ............................................
MS Rehab—High ............................................
Behavioral Health—Low .................................
Behavioral Health—Low .................................
Behavioral Health—Low .................................
Behavioral Health—Medium ...........................
Behavioral Health—Medium ...........................
Behavioral Health—Medium ...........................
Behavioral Health—High .................................
Behavioral Health—High .................................
Behavioral Health—High .................................