[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Pages 13907-13908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04823]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Emergency Use Declaration

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). The 
virus is now named SARS-CoV-2, which causes the illness COVID-19.
    On the basis of this determination, he also declared that 
circumstances exist justifying the authorization of emergency use of 
personal respiratory protective devices during the COVID-19 outbreak, 
pursuant to section 564 of the FD&C Act, subject to the terms of any 
authorization issued under that section.

DATES: The determination was effective February 4, 2020, and this 
declaration is effective March 2, 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, 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,\1\ 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.\2\
---------------------------------------------------------------------------

    \1\ 42 U.S.C. 247d-6b.
    \2\ As amended by the Pandemic and All-Hazards Preparedness 
Reauthorization Act, Public Law 113-5, the Secretary may make 
determination of a public health emergency, or a significant 
potential for a public health emergency, under section 564 of the 
FD&C Act. The Secretary is no longer required to make a 
determination of a public health emergency in accordance with 
section 319 of the PHS Act, 42 U.S.C. 247d to support a 
determination or declaration made under section 564 of the FD&C Act.
---------------------------------------------------------------------------

    Based on any of these four determinations, the Secretary of HHS may 
then declare that circumstances

[[Page 13908]]

exist that justify the EUA, at which point the FDA Commissioner may 
issue an EUA if the criteria for issuance of such an authorization 
under section 564 of the FD&C Act are met.
    The Centers for Disease Control and Prevention (CDC), HHS, 
requested that the FDA, HHS, issue an EUA for personal respiratory 
protective devices to allow the Department to take preparedness 
measures, based on information currently available about the virus that 
causes COVID-19. The determination of a public health emergency, and 
the declaration that circumstances exist justifying emergency use of 
personal respiratory protective devices by the Secretary of HHS, as 
described below, enable the FDA Commissioner to issue an EUA for 
respiratory protective devices for emergency use under section 564 of 
the FD&C Act.

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). The virus is now named SARS-CoV-2, 
which causes the illness COVID-19.

III. Declaration of the Secretary of Health and Human Services

    On March 2, 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, I declared that 
circumstances exist justifying the authorization of emergency use of 
personal respiratory protective devices during the COVID-19 outbreak, 
pursuant to section 564 of the FD&C Act, subject to the terms of any 
authorization issued under that section.
    Notice of the 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.

Alex M. Azar II,
Secretary.
[FR Doc. 2020-04823 Filed 3-9-20; 8:45 am]
 BILLING CODE P