Federal Register - February 16, 2021
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Fuente: Federal Register
9516
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices TABLE 2ESTIMATED ANNUAL RECORDKEEPING BURDEN 1Continued Number of recordkeepers
Activity; 21 CFR part
Number of records per recordkeeper
Average burden per recordkeeping
Total annual records
Total hours
Multiple distributor data and distributor tracking records 821.30c2 and d
22,000
1
22,000
1
22,000
Total
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
TABLE 3ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of respondents
Activity; 21 CFR part
Acquisition of tracked devices and final distributor data 821.30a and b
Multiple distributor data and distributor tracking records 821.30c2 and d
Total
1 There
Dated: February 9, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202103017 Filed 21221; 8:45 am BILLING CODE 416401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID19
Notice of amendment.
The Acting Secretary issues this amendment pursuant to section 319F3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.
SUMMARY:
This amendment to the Declaration is effective as of February 16, 2021.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Total annual disclosures
Average burden per disclosure
Total hours
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
23,100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this information collection has not changed since the last OMB approval.
ACTION:
Number of disclosures per respondent
L.
Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health andHuman Services, 200 Independence Avenue
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:04 Feb 12, 2021
Jkt 253001
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, section 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 Countermeasures under the PREP Act.
On January 31, 2020, former Secretary, Alex M. Azar II, declared a
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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, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 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
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