Determination of Public Health Emergency

AGENCY:

Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

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 February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that 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). On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of this novel coronavirus (2019-nCoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

DATES:

The determination and declaration took effect February 4, 2020.

FOR FURTHER INFORMATION CONTACT:

Robert P. Kadlec, M.D., MTM&H, MS, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

Under Section 564 of the FD&C Act, 21 U.S.C. 360bbb-3, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product. 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, of attack with (i) a biological, chemical, radiological, or nuclear 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 declare that circumstances exist that justify the EUA, at which point the FDA Commissioner may issue an EUA if the criteria for issuance of an authorization under section 564 of the FD&C Act are met.

The determination of a public health emergency, and the declaration that circumstances exist justifying emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) by the Secretary of HHS, as described below, enable the FDA Commissioner to issue EUAs for certain in vitro diagnostics for emergency use under section 564 of the FD&C Act. The Centers for Disease Control and Prevention (CDC) requested that the FDA issue an EUA for its in vitro diagnostic for detection of 2019-nCoV to allow the Department to take preparedness measures based on information currently available about 2019-nCoV.

II. Determination by the Secretary of Health and Human Services

On February 4, 2020, pursuant to section 564 of the FD&C Act, I determined that 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).

III. Declaration of the Secretary of Health and Human Services

Also on February 4, 2020, on the basis of my determination of 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 the novel (new) coronavirus (2019-nCoV), I declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

Notice of any EUAs issued by the FDA Commissioner pursuant to this determination and declaration will be provided promptly in the Federal Register as required under section 564 of the FD&C Act.