60-day FRN

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pertaining to ACF programs, key
stakeholder groups involved in ACF
projects and programs, individuals

engaged in program re-design or
demonstration development for
evaluation, state or local government

officials, or others involved in or
prospectively involved in ACF
programs.

ANNUAL BURDEN ESTIMATES
Estimated
number of
responses
per
respondent

Estimated
total number
of
respondents

Instrument type

Average
burden hours
per response

Estimated
total burden
hours

Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
Templates and Open-ended requests .............................................................

2,000
1,000
1,000
250

1
1
* 1.5
1

2
1
.5
10

4,000
1,000
750
2,500

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

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

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

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

8,250

* We have estimated 1.5 responses to account for rapid cycle testing, which will require multiple responses.
Authority: Social Security Act, Sec. 1110.
[42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–12801 Filed 6–17–19; 8:45 am]
BILLING CODE 4184–79–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request Information
Request Title: 340B Drug Pricing
Program Reporting Requirements,
OMB Number 0915–0176—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.

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AGENCY:

SUMMARY: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate or
any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than August 19, 2019.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft

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instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Drug Pricing Program Reporting
Requirements OMB No. 0915–0176—
[Extension].
Abstract: Section 340B of the Public
Health Service Act (PHS Act
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities’’)
instructs HHS to enter into a
Pharmaceutical Pricing Agreement
(PPA) with manufacturers of covered
outpatient drugs. Manufacturers are
required by section 1927(a)(5)(A) of the
Social Security Act to enter into
agreements with the Secretary of HHS to
comply with section 340B of the PHS
Act if they participate in the Medicaid
Drug Rebate Program. When a drug
manufacturer signs a PPA, it is opting
into the 340B Drug Pricing Program
(340B Program) and it agrees to the
statutory requirement that prices
charged for covered outpatient drugs to
covered entities will not exceed defined
340B ceiling prices, which are based on
quarterly pricing data reported by
manufacturers to the Centers for
Medicare & Medicaid Services (CMS).
When an eligible covered entity
voluntarily decides to enroll and
participate in the 340B Program, it
accepts responsibility for ensuring
compliance with all provisions of the
340B Program, including all associated
costs. Covered entities that choose to
participate in the 340B Program must
comply with the requirements of section
340B(a)(5) of the PHS Act. Section
340B(a)(5)(A) prohibits a covered entity
from accepting a discount for a drug that

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would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits
a covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
covered entity.
Section 340B(a)(5)(C) of the PHS Act
permits the Secretary of HHS and
manufacturers of a covered outpatient
drug to conduct audits of covered
entities in accordance with procedures
established by the Secretary related to
the number, duration, and scope of the
audits. Manufacturers are permitted to
conduct an audit only when there is
reasonable cause to believe a violation
of section 340B(a)(5)(A) or (B) has
occurred. The manufacturer notifies the
covered entity in writing when it
believes the covered entity has violated
these provisions of the 340B Program. If
the problem cannot be resolved, the
manufacturer will then submit an audit
work plan describing the audit and
evidence in support of the reasonable
cause standard to the HRSA, Healthcare
Systems Bureau, Office of Pharmacy
Affairs (OPA) for review. OPA will
review the documentation to determine
if reasonable cause exists. Once the
audit is completed, the manufacturer
will submit copies of the audit report to
OPA for review and resolution of the
findings, as appropriate. The
manufacturer will also submit an
informational copy of the audit report to
the HHS Office of Inspector General
(OIG).
In response to the statutory mandate
of section 340B(a)(5)(C) to permit the
Secretary or manufacturers to conduct
audits of covered entities and because of
the potential for disputes involving
covered entities and participating drug
manufacturers, OPA developed an
informal voluntary dispute resolution
process for manufacturers and covered
entities who, prior to filing a request for
resolution of a dispute with OPA,

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Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices
should attempt in good faith to resolve
the dispute. All parties involved in the
dispute should maintain written
documentation as evidence of a good
faith attempt to resolve the dispute. To
request voluntary dispute resolution of
an unresolved dispute, a party submits
a written request for a review of the
dispute to OPA. A committee appointed
to review the documentation will send
a letter to the party alleged to have
committed a violation. The party will be
asked to provide a response to or a
rebuttal of the allegations.
HRSA published a notice in 1996 and
a policy release in 2011 on
manufacturer audit guidelines and the
informal dispute resolution process (61
FR 65406 (December 12, 1996) and
‘‘Clarification of Manufacturer Audits of
340B Covered Entities,’’ Release No.
2011–3).
Need and Proposed Use of the
Information: HRSA is proposing the
collection of information related to the
manufacturer audit guidelines. These

guidelines contain the following
reporting/notification elements:
1. Manufacturers should notify the
covered entity in writing when it
believes a violation has occurred;
2. manufacturers should submit
documentation to OPA as evidence of
good faith of attempts to resolve a
dispute;
3. manufacturers must submit an
audit work plan to OPA;
4. manufacturers should submit the
audit report to the OPA and
informational copies to the HHS OIG;
and
5. the covered entity should provide
a written response to the audit report.
This information is necessary to
ensure the orderly conduct of
manufacturer audits. Also, the informal
dispute resolution process requires the
participating manufacturer or covered
entity requesting dispute resolution to
provide OPA with a written request.
The party alleged to have committed a
340B Program violation may provide a
response or rebuttal to OPA. This

information is necessary to ensure that
the dispute will be resolved in a fair and
equitable manner.
Likely Respondents: Drug
manufacturers and 340B covered
entities.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested during an audit. This includes
the time needed to review instructions,
to develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information for both covered entities
and manufacturers. The total annual
burden hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Audits
Good faith Resolution 1 ........................................................
Audit Notification to Entity 1 .................................................
Audit Workplan 1 ..................................................................
Audit Report 1 .......................................................................
Entity Response ...................................................................

10
10
43
14
14

1
1
1
1
1

10
10
43
14
14

60
6
12
12
12

600
60
516
168
168

Dispute Resolution
Mediation Request ...............................................................
Rebuttal ................................................................................

10
10

4
1

40
10

15
28

600
280

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

111

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

120

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

2,392

Recordkeeping requirement

Number of
recordkeepers

Hours of
recordkeeping

Total burden

Dispute Records ..........................................................................................................................

50

1

50

1 Prepared

by the manufacturer.

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Recordkeeping Burden:

HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the

estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information

technology to minimize the information
collection burden.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–12894 Filed 6–17–19; 8:45 am]
BILLING CODE 4165–15–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Health Resources and Services
Administration

Substance Abuse and Mental Health
Services Administration, HHS

Senior Executive Service Performance
Review Board

Meeting of the the Substance Abuse
and Mental Health Services
Administration’s National Advisory
Council

Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

jbell on DSK3GLQ082PROD with NOTICES

SUMMARY: HRSA, an Operating Division
of HHS, is publishing a list of persons
appointed to serve on the Performance
Review Board that oversees the
evaluation of performance appraisals for
Senior Executive Service members
within HRSA for the Fiscal Year 2019
and 2020 review period.
FOR FURTHER INFORMATION CONTACT:
Georgia Lyons, Executive Resources,
Office of Human Resources, 5600
Fishers Lane, Rm. 12N06C, Rockville,
Maryland 20857, Telephone (301) 443–
4618.
SUPPLEMENTARY INFORMATION: Title 5,
U.S.C. 4314(c)(4) of the Civil Service
Reform Act of 1978, Public Law 95–454,
requires that the appointment of
Performance Review Board Members be
published in the Federal Register. The
following are persons appointed to serve
on the HRSA Performance Review
Board:
Leslie Atkinson
Tonya Bowers
Adriane Burton
Tina Cheatham
Laura Cheever
Natasha Coulouris
Cheryl Dammons
Elizabeth DeVoss
Diana Espinosa
Catherine Ganey
Alexandra Garcia
Heather Hauck
Laura Kavanagh
Martin Kramer
Rimas Liogys
Torey Mack
James Macrae
Susan Monarez
Thomas Morris
Kerry Nesseler
Luis Padilla
Wendy Ponton
Michael Warren

George Sigounas,
Administrator.
[FR Doc. 2019–12819 Filed 6–17–19; 8:45 am]
BILLING CODE 4165–15–P

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Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:

Notice is hereby given of the
meeting on July 1, 2019, of the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
National Advisory Council (SAMHSA
NAC). This notice may publish with less
than 15 days prior to the meeting due
to a change in schedule for the
committee chair and unexpected
calendar changes. The meeting is open
to the public and can be accessed via
telephone only. Agenda with call-in
information will be posted on the
SAMHSA website prior to the meeting
at: https://www.samhsa.gov/about-us/
advisory-councils/meetings. The
meeting will include remarks and
dialogue from the Assistant Secretary
for Mental Health and Substance Use;
updates from the SAMHSA Centers
Directors, and a council discussion with
SAMHSA NAC members.
DATES: July 1, 2019, 9:00 a.m. to 12:00
p.m. (EDT)/Open.
ADDRESSES: The meeting will be held
(virtually) at SAMHSA Headquarters,
5600 Fishers Lane, Rockville, Maryland
20857.
FOR FURTHER INFORMATION CONTACT:
Carlos Castillo, Committee Management
Officer and Designated Federal Official,
SAMHSA National Advisory Council,
Room 18E05C, 5600 Fishers Lane,
Rockville, Maryland 20857 (mail),
Telephone: (240) 276–2787, Email:
[email protected].
SUPPLEMENTARY INFORMATION: The
SAMHSA NAC was established to
advise the Secretary, Department of
Health and Human Services (HHS), and
the Assistant Secretary for Mental
Health and Substance Use, SAMHSA, to
improve the provision of treatments and
related services to individuals with
respect to substance use and to improve
prevention services, promote mental
health, and protect legal rights of
individuals with mental illness and
individuals who are substance users.
SUMMARY:

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Interested persons may present data,
information, or views orally or in
writing, on issues pending before the
Council. Written submissions must be
forwarded to the contact person by June
26, 2019. Oral presentations from the
public will be scheduled at the
conclusion of the meeting. Individuals
interested in making oral presentations
must notify the contact person by June
26, 2019. Up to 3 minutes will be
allotted for each presentation.
To obtain the call-in number, access
code, and/or web access link; submit
written or brief oral comments; or
request special accommodations for
persons with disabilities, please register
on-line at: http://nac.samhsa.gov/
Registration/meetingsRegistration.aspx,
or communicate with SAMHSA’s
Committee Management Officer, CAPT
Carlos Castillo.
Meeting information and a roster of
Council members may be obtained
either by accessing the SAMHSA
Council’s website at http://
www.samhsa.gov/about-us/advisorycouncils/ or by contacting Carlos
Castillo.
Council Name: Substance Abuse and
Mental Health Services Administration
National Advisory Council.
Dated: June 12, 2019.
Carlos Castillo,
Committee Management Officer, SAMHSA.
[FR Doc. 2019–12797 Filed 6–17–19; 8:45 am]
BILLING CODE 4162–20–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4421–
DR; Docket ID FEMA–2019–0001]

Iowa; Amendment No. 5 to Notice of a
Major Disaster Declaration
Federal Emergency
Management Agency, DHS.

AGENCY:
ACTION:

Notice.

SUMMARY: This notice amends the notice
of a major disaster declaration for the
State of Iowa (FEMA–4421–DR), dated

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