Office of the National Security Assistant Deputy Secretary of National Security Statement of Delegation of Authority, 16644 [2023-05637]

Download as PDF 16644 Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Notices 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: March 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–05641 Filed 3–17–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Security Assistant Deputy Secretary of National Security Statement of Delegation of Authority Notice is hereby given that I have delegated to the Assistant Deputy Secretary for National Security within the Office of the Secretary (OS), Immediate Office of the Secretary (IOS), Office of National Security (ONS), the authorities vested in me as the Secretary of Health and Human Services for managing the Controlled Unclassified Information Program under Executive Order 13556, now and hereafter. This authority may be redelegated, but only within ONS. Exercise of this authority shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the E.O. 13556 and 32 CFR part 2002 ‘‘Controlled Unclassified Information.’’ This delegation of authority is effective immediately upon signature. Dated: March 15, 2023. Xavier Becerra, Secretary. [FR Doc. 2023–05637 Filed 3–17–23; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary COVID–19 Emergency Use Authorization Declaration ACTION: Notice of amendment. VerDate Sep<11>2014 17:19 Mar 17, 2023 Jkt 259001 The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On March 15, 2023, the Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019–nCoV, or SARS–CoV–2). DATES: The section 564(b)(1)(C) determination that was originally issued on February 4, 2020, is amended as of March 15, 2023. FOR FURTHER INFORMATION CONTACT: Paige Ezernack: 202–260–0365, paige.ezernack@hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Under section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an EUA authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, an unlicensed biological product, or an unapproved animal drug; or (2) an unapproved use of an approved drug, approved or cleared device, licensed biological product, or conditionally approved animal drug. Before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of four determinations: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (‘‘CBRN’’) agent or agents; (2) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act sufficient to affect national security or the health and security of United States citizens living abroad; (3) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 of attack with (i) a CBRN agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces; or (4) a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents. Based on any of these four determinations, the Secretary of HHS may then issue a declaration(s) that circumstances exist that justify the issuance of an EUA(s), at which point the FDA Commissioner may issue an EUA(s) for certain products if the criteria for issuance under section 564 of the FD&C Act are met. The section 564 declaration(s) terminate only when the Secretary of HHS determines that the termination requirements of section 564(b)(2)(A) of the FD&C Act are met. Additionally, section 564(b)(3) provides that the Secretary shall provide advance notice, by publication in the Federal Register, that a declaration(s) under section 564 will be terminated. II. Determination by the Secretary of Health and Human Services On February 4, 2020, pursuant to his authority under section 564 of the FD&C Act, the Secretary of HHS determined that the circumstances in section 564(b)(1) exist because ‘‘there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019–nCoV).’’ 85 FR 7316. It is now well established that SARS– CoV–2 is constantly evolving and continues to be an ongoing challenge. As of January 30, 2023, SARS–CoV–2 has led to over 753 million cases of COVID–19, including 6.8 million deaths worldwide. This is due, in part, to variations in the virus that may allow it to spread more easily or make it resistant to treatments or decreased vaccine effectiveness. There is also a risk that eventually a variant will emerge that will escape the protection provided by the current generation of vaccines against severe disease. For example, the SARS–CoV–2 Omicron variant has continued to evolve into sublineages with additional mutations in the spike glycoprotein and the E:\FR\FM\20MRN1.SGM 20MRN1

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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Page 16644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Office of the National Security Assistant Deputy Secretary of 
National Security Statement of Delegation of Authority

    Notice is hereby given that I have delegated to the Assistant 
Deputy Secretary for National Security within the Office of the 
Secretary (OS), Immediate Office of the Secretary (IOS), Office of 
National Security (ONS), the authorities vested in me as the Secretary 
of Health and Human Services for managing the Controlled Unclassified 
Information Program under Executive Order 13556, now and hereafter.
    This authority may be redelegated, but only within ONS. Exercise of 
this authority shall be in accordance with established policies, 
procedures, guidelines, and regulations as prescribed by the E.O. 13556 
and 32 CFR part 2002 ``Controlled Unclassified Information.''
    This delegation of authority is effective immediately upon 
signature.

    Dated: March 15, 2023.
Xavier Becerra,
Secretary.
[FR Doc. 2023-05637 Filed 3-17-23; 8:45 am]
BILLING CODE P
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