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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 agencys 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. 202116597 Filed 8321; 8:45 am BILLING CODE 416515P

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 COVID19
ACTION:

Notice of amendment.

The Secretary issues this amendment pursuant to section 319F3
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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SW, Washington, DC 20201; 202260
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 319F3, which addresses liability immunity, and section 319F4, which creates a compensation program.
These sections are codified at 42 U.S.C.
247d6d and 42 U.S.C. 247d6e, respectively. Section 319F3 of the PHS
Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act PAHPRA, Public Law 1135, enacted on March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security CARES Act, Public Law 116136, 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 nations health care community to the COVID19 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 COVID19 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 COVID19 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 Secretarys Declaration and authorizations issued by the Departments 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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