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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices

technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–16591 Filed 8–3–21; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Amendment for the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In accordance with the
Federal Advisory Committee Act
(FACA) and section 1111 of the Public
Health Service (PHS) Act, HHS is
hereby giving notice that the charter for
the Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC) has been amended to set the
time period for appointment of members
to a term of up to 4 years. The effective
date of the amendment is July 30, 2021.
FOR FURTHER INFORMATION CONTACT: Mia
Morrison (DFO), Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–2521; or [email protected].
SUPPLEMENTARY INFORMATON: The
ACHDNC provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
concerning certain activities described
in section 1111 of the PHS Act (42
U.S.C. 300b–10), as further described
below. The ACHDNC is also governed
by the provisions of the FACA, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of advisory committees. The
ACHDNC advises the Secretary of HHS
about aspects of newborn and childhood
screening and technical information for
the development of policies and
priorities that will enhance the ability of
the state and local health agencies to
provide for newborn and child
screening, counseling and health care
services for newborns and children
having, or at risk for, heritable
disorders. The ACHDNC will review
and report regularly on newborn and
childhood screening practices,
recommend improvements in the
national newborn and childhood
screening programs, and fulfill
responsibilities described in section

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1111 of the PHS Act. In addition, the
ACHDNC’s recommendations regarding
inclusion of additional conditions for
screening, following adoption by the
Secretary, are considered evidenceinformed 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 PHS Act (42 U.S.C. 300gg–13).
Under this provision, non-grandfathered
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, co-insurance, 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.
The filing date of the ACHDNC
charter remains November 10, 2020. A
copy of the ACHDNC charter is
available on the ACHDNC website at
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
index.html. A copy of the charter also
can be obtained by accessing the FACA
database that is maintained by the
Committee Management Secretariat
under the General Services
Administration. The website address for
the FACA database is http://
www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–16618 Filed 8–3–21; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: National
Health Service Corps Scholar/Students
To Service Travel Worksheet, OMB No.
0915–0278—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:

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

SUMMARY:

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(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 4, 2021.
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
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:
National Health Service Corps Scholar/
Students to Service Travel Worksheet,
OMB No. 0915–0278—Extension.
Abstract: Clinicians participating in
the HRSA National Health Service
Corps (NHSC) Scholarship Program (SP)
and the Students to Service (S2S) Loan
Repayment Program (LRP) use the
online Travel Request Worksheet to
request and receive travel funds from
the federal government to visit eligible
NHSC sites to which they may be
assigned in accordance with the Public
Health Service Act, section 331(c)(1).
The travel approval process is
initiated when an NHSC scholar or S2S
participant notifies the NHSC of an
impending interview at one or more
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after a
NHSC scholar or S2S participant has
successfully been matched to an
approved practice site in accordance
with the Public Health Service Act,
section 331(c)(3). Upon receipt of a
completed Travel Request Worksheet,
the NHSC will review and approve or
disapprove the request and promptly
notify the scholar or S2S participant and
the NHSC logistics contractor regarding
travel arrangements and authorization of
the funding for the site visit or
relocation.
Need and Proposed Use of the
Information: This information will
facilitate NHSC scholar and S2S
participants’ receipt of federal travel
funds that are used to visit high-need
NHSC-approved practice sites. The
Travel Request Worksheet is also used
to initiate the relocation process after a
NHSC scholar or S2S participant has

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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
requested. 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

successfully been matched to an
approved practice site.
Likely Respondents: Clinicians
participating in the NHSC SP and the
S2S LRP.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information

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. 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

Total
responses

Average
burden
per response
(in hours)

Total burden
hours

Travel Request Worksheet ..................................................

300

2

600

.0667

40.02

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

300

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

600

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

40.02

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, Executive Secretariat.
[FR Doc. 2021–16597 Filed 8–3–21; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Eighth Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19
ACTION:

Notice of amendment.

The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
clarify and expand the authority for
certain Qualified Persons authorized to
prescribe, dispense, and administer
covered countermeasures under section
VI of this Declaration.
DATES: This amendment is effective as
of August 4, 2021.
FOR FURTHER INFORMATION CONTACT: L.
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SUMMARY:

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Number of
responses per
respondent

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SW, Washington, DC 20201; 202–260–
0365, [email protected].
SUPPLEMENTARY INFORMATION: The
Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of Health and Human
Services (the Secretary) to issue a
Declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
manufacture, distribution,
administration, or use of medical
countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, § 2. It amended the
Public Health Service (PHS) Act, adding
section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified at 42 U.S.C.
247d–6d and 42 U.S.C. 247d–6e,
respectively. Section 319F–3 of the PHS
Act has been amended by the Pandemic
and All-Hazards Preparedness
Reauthorization Act (PAHPRA), Public
Law 113–5, enacted on March 13, 2013,
and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public
Law 116–136, enacted on March 27,
2020, to expand Covered
Countermeasures under the PREP Act.
On January 31, 2020, the former
Secretary, Alex M. Azar II, declared a
public health emergency pursuant to
section 319 of the PHS Act, 42 U.S.C.
247d, effective January 27, 2020, for the
entire United States to aid in the
response of the nation’s health care
community to the COVID–19 outbreak.
Pursuant to section 319 of the PHS Act,

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the Secretary renewed that declaration
effective on April 26, 2020, July 25,
2020, October 23, 2020, January 21,
2021, April 21, 2021 and July 20, 2021.
On March 10, 2020, former Secretary
Azar issued a Declaration under the
PREP Act for medical countermeasures
against COVID–19 (85 FR 15198, Mar.
17, 2020) (the Declaration). On April 10,
the former Secretary amended the
Declaration under the PREP Act to
extend liability immunity to covered
countermeasures authorized under the
CARES Act (85 FR 21012, Apr. 15,
2020). On June 4, the former Secretary
amended the Declaration to clarify that
covered countermeasures under the
Declaration include qualified
countermeasures that limit the harm
COVID–19 might otherwise cause. (85
FR 35100, June 8, 2020). On August 19,
the former Secretary amended the
declaration to add additional categories
of Qualified Persons and amend the
category of disease, health condition, or
threat for which he recommended the
administration or use of the Covered
Countermeasures. (85 FR 52136, August
24, 2020). On December 3, 2020, the
former Secretary amended the
declaration to incorporate Advisory
Opinions of the General Counsel
interpreting the PREP Act and the
Secretary’s Declaration and
authorizations issued by the
Department’s Office of the Assistant
Secretary for Health as an Authority
Having Jurisdiction to respond; added
an additional category of qualified
persons under Section V of the
Declaration; made explicit that the
Declaration covers all qualified
pandemic and epidemic products as
defined under the PREP Act; added a
third method of distribution to provide
liability protections for, among other
things, private distribution channels;
made explicit that there can be

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