60Day FRN

Att2. MIDRS_60D_FRN.pdf

Maritime Illness Database and Reporting System (MIDRS)

60Day FRN

OMB: 0920-1260

Document [pdf]
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58915

Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices
data used for the dose reconstruction.
Signing this form does not indicate that
the claimant agrees with the outcome of
the dose reconstruction. The dose
reconstruction results will be supplied

to the claimant and to the DOL, the
agency that will utilize them as one part
of its determination of whether the
claimant is eligible for compensation
under the Act.

Total annualized burden is estimated
to be 3900 hours. There is no cost to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Claimant ..........................................................
Claimant ..........................................................

Initial Interview ...............................................
Conclusion Form OCAS–1 .............................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–23182 Filed 10–22–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–1260; Docket No. CDC–2021–
0114]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled ‘‘Maritime Illness Database and
Reporting System (MIDRS).’’ The
purpose of this data collection is to
provide U.S.-bound passenger vessel
operators an electronic reporting system
to assist with their legal requirement to
notify CDC of the number of passengers
and crew members onboard their ship
who have reportable acute
gastroenteritis (AGE) as defined by
federal quarantine regulations.

SUMMARY:

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Number of
respondents

Type of respondents

CDC must receive written
comments on or before December 27,
2021.

DATES:

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You may submit comments,
identified by Docket No. CDC–2021–
0114 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329; phone:
404–639–7118; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
ADDRESSES:

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3600
3600

Number of
responses per
respondent
1
1

Average
burden per
response
(in hours)
1
5/60

1. Evaluate whether the proposed
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 the
agency’s estimate of the burden of the
proposed 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;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Maritime Illness Database and
Reporting System (MIDRS) (OMB
Control No. 0920–1260, Exp. 04/30/
2022)—Extension—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The purpose of this Extension
Information Collection Request (ICR) is
to request a three-year Paperwork
Reduction Act (PRA) clearance for
CDC’s Maritime Illness Database and
Reporting System (MIDRS) surveillance
system.
Operationally, CDC has divided the
responsibilities for enforcing foreign
quarantine regulations between the
Vessel Sanitation Program (VSP) and the
Division of Global Migration and
Quarantine (DGMQ). VSP takes the lead
on overseeing acute gastroenteritis
(AGE) illness surveillance and outbreak
investigation activities on passenger
ships using MIDRS, while DGMQ
monitors all non-AGE illnesses and

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58916

Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices

deaths on passenger vessels as well as
all diseases of public health concern on
all other conveyances with international
itineraries bound for the U.S. under
‘‘Foreign Quarantine Regulations (42
CFR part 71)’’ (OMB Control No. 0920–
0134, Exp. 03/31/2022).
The MIDRS data collection system
consists of a surveillance system that
receives information electronically
through a web-based reporting portal;
data can also be submitted by phone,
email, or fax, and entered into MIDRS
by VSP. AGE cases reported to MIDRS
are totals for the entire voyage and do
not represent the number of active AGE
cases at any given port of call or at

food/activity histories. Of note, VSP will
not receive any information from or
about the AGE cases; this information is
collected and owned by the cruise line
and maintained on the ship as part of
the AGE case’s medical record. VSP
reviews these records during
operational inspections to confirm they
are available if needed, and if there is
an AGE outbreak or report of unusual
AGE illness for a particular voyage.
The total annualized time burden
requested is 1,537 burden hours. A
summary of the estimated annualized
burden hours is shown in the table
below. There are no costs to
respondents other than their time.

disembarkation. The AGE log, 72-hour
food/activity history and other required
documentation are completed and
maintained on the ship.
Data collected will allow VSP to
quickly detect AGE outbreaks, provide
epidemiologic and sanitation guidance
to stop the outbreak, craft public health
recommendations to prevent future
outbreaks, and monitor AGE illness
trends to identify important changes
over time.
There are two types of respondents for
this data collection: Cruise ship medical
staff or other designated personnel who
report AGE cases, and AGE cases who
provide information for the 72-hour

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Cruise ship medical staff
or other designated
personnel.

AGE passenger and
crew cases.

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

Number of
respondents

Form name

Number of
responses per
respondent

Total burden
(in hours)

71.21(c) Gastrointestinal Illnesses reports 24
and 4 hours before arrival (MIDRS).

250

10

3/60

125

71.21(c) Recordkeeping—Gastrointestinal Illnesses reports 24 and 4 hours before arrival
(MIDRS).
71.21(c) AGE Logs ..............................................
71.21(c) Recordkeeping—medical records (AGE
Logs).
71.21(c) Interviews with AGE crew case cabin
mates and immediate contacts to determine
AGE illness status and documentation of
interview dates/times.
71.21(c) Recordkeeping—medical records
(Interviews with AGE crew case cabin mates
and immediate contacts to determine AGE illness status and documentation of interview
dates/times).
71.21(c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew
members.
71.21(c) Recordkeeping—medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members).
71.21(c) Documentation of date/time of last
symptom and clearance to return to work for
food and nonfood employees.
71.21(c) Recordkeeping—medical records (Documentation of date/time of last symptom and
clearance to return to work for food and
nonfood employees).
71.21(c) Recordkeeping—medical records (72
hour food/activity histories).
71.21(c) 72-hour food/activity history ..................

250

1

1/60

4

250
250

10
1

10/60
1/60

417
4

250

3

5/60

63

250

1

1/60

4

250

5

3/60

63

250

1

1/60

4

250

1

3/60

12

250

1

1/60

4

250

1

1/60

4

5,000

1

10/60

833

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

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

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

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

1,537

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of
Science,Centers for Disease Control and
Prevention.
[FR Doc. 2021–23187 Filed 10–22–21; 8:45 am]
BILLING CODE 4163–18–P

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Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–6091–N]
RIN 0938–ZB70

Medicare, Medicaid, and Children’s
Health Insurance Programs; Provider
Enrollment Application Fee Amount for
Calendar Year 2022
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:

This notice announces a
$631.00 calendar year (CY) 2022
application fee for institutional
providers that are initially enrolling in
the Medicare or Medicaid program or
the Children’s Health Insurance
Program (CHIP); revalidating their
Medicare, Medicaid, or CHIP
enrollment; or adding a new Medicare
practice location. This fee is required
with any enrollment application
submitted on or after January 1, 2022
and on or before December 31, 2022.
DATES: The application fee announced
in this notice is effective on January 1,
2022.
FOR FURTHER INFORMATION CONTACT:
Frank Whelan, (410) 786–1302.
SUPPLEMENTARY INFORMATION:
SUMMARY:

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I. Background
In the February 2, 2011 Federal
Register (76 FR 5862), we published a
final rule with comment period titled
‘‘Medicare, Medicaid, and Children’s
Health Insurance Programs; Additional
Screening Requirements, Application
Fees, Temporary Enrollment Moratoria,
Payment Suspensions and Compliance
Plans for Providers and Suppliers.’’ This
rule finalized, among other things,
provisions related to the submission of
application fees as part of the Medicare,
Medicaid, and CHIP provider
enrollment processes. As provided in
section 1866(j)(2)(C)(i) of the Social
Security Act (the Act) and in 42 CFR
424.514, ‘‘institutional providers’’ that
are initially enrolling in the Medicare or
Medicaid programs or CHIP,
revalidating their enrollment, or adding
a new Medicare practice location are
required to submit a fee with their
enrollment application. An
‘‘institutional provider’’ for purposes of
Medicare is defined at § 424.502 as ‘‘any
provider or supplier that submits a

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paper Medicare enrollment application
using the CMS–855A, CMS–855B (not
including physician and non-physician
practitioner organizations), CMS–855S,
CMS–20134, or associated internetbased PECOS enrollment application.’’
As we explained in the February 2, 2011
final rule (76 FR 5914), in addition to
the providers and suppliers subject to
the application fee under Medicare,
Medicaid-only and CHIP-only
institutional providers would include
nursing facilities, intermediate care
facilities for persons with intellectual
disabilities (ICF/IID), psychiatric
residential treatment facilities; they may
also include other institutional provider
types designated by a state in
accordance with their approved state
plan.
As indicated in § 424.514 and
§ 455.460, the application fee is not
required for either of the following:
• A Medicare physician or nonphysician practitioner submitting a
CMS–855I.
• A prospective or revalidating
Medicaid or CHIP provider—
++ Who is an individual physician or
non-physician practitioner; or
++ That is enrolled as an institutional
provider in Title XVIII of the Act or
another state’s Title XIX or XXI plan
and has paid the application fee to a
Medicare contractor or another state.
II. Provisions of the Notice
Section 1866(j)(2)(C)(i)(I) of the Act
established a $500 application fee for
institutional providers in calendar year
(CY) 2010. Consistent with section
1866(j)(2)(C)(i)(II) of the Act,
§ 424.514(d)(2) states that for CY 2011
and subsequent years, the preceding
year’s fee will be adjusted by the
percentage change in the consumer
price index (CPI) for all urban
consumers (all items; United States city
average, CPI–U) for the 12-month period
ending on June 30 of the previous year.
Each year since 2011, accordingly, we
have published in the Federal Register
an announcement of the application fee
amount for the forthcoming CY based on
the formula noted previously. Most
recently, in the November 23, 2020
Federal Register (85 FR 74724), we
published a notice announcing a fee
amount for the period of January 1, 2021
through December 31, 2021 of $599.00.
The $599.00 fee amount for CY 2021
was used to calculate the fee amount for
2022 as specified in § 424.514(d)(2).
According to Bureau of Labor
Statistics (BLS) data, the CPU–U
increase for the period of July 1, 2020

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through June 30, 2021 was 5.4 percent.
As required by § 424.514(d)(2), the
preceding year’s fee of $599 will be
adjusted by 5.4 percent. This results in
a CY 2022 application fee amount of
$631.35 ($599 × 1.054). As we must
round this to the nearest whole dollar
amount, the resultant application fee
amount for CY 2022 is $631.00.
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
However, it does reference previously
approved information collections. The
Forms CMS–855A, CMS–855B, and
CMS–855I are approved under OMB
control number 0938–0685; the Form
CMS–855S is approved under OMB
control number 0938–1056.
IV. Regulatory Impact Statement
A. Background and Review
Requirements
We have examined the impact of this
notice 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
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.
A regulatory impact analysis (RIA) must
be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). As
explained in this section of the notice,
we estimate that the total cost of the
increase in the application fee will not
exceed $100 million. Therefore, this
notice does not reach the $100 million

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