41976 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 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: 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 mmorrison@hrsa.gov. 

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 

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 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

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, 

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 

paperwork@hrsa.gov 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 paperwork@hrsa.gov 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41977 

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 

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 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

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. 

SUMMARY: 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 

SW, Washington, DC 20201; 202–260– 

0365, paige.ezernack@hhs.gov. 

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, 

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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