Federal Register - February 2, 2021
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Fuente: Federal Register
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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices
Agenda: To review and evaluate grant applications.
For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S1078, Atlanta, Georgia 30341, Telephone 770
4886511, JRaman@cdc.gov.
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Jaya Raman, Ph.D., Scientific Review Officer, National Center for Chronic Disease Prevention and Health Promotion, CDC, 4770 Buford Highway, Mailstop S1078, Atlanta, Georgia 30341, Telephone 770
4886511, JRaman@cdc.gov.
The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.
Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention.
FR Doc. 202102164 Filed 2121; 8:45 am
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BILLING CODE 416318P
BILLING CODE 416318P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and Prevention
Office of the Secretary
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Notice of Closed Meeting Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, Title 5 U.S.C., as amended, and the Determination of the Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel SEP
SIP21003, Evaluating Alternative Delivery Models for ArthritisAppropriate Evidence-Based Physical Activity and Self-Management Interventions.
Date: April 29, 2021.
Time: 11:00 a.m.6:00 p.m., EDT.
Place: Teleconference.
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Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID19
ACTION:
Notice of amendment.
SUMMARY: 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 COVID19
vaccines that are covered countermeasures under section VI of this Declaration.
DATES: This amendment to the Declaration is effective as of February 2, 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; Telephone:
2022600365; 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,
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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 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, 2121.
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 51236, 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
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