[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32884-32885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Declaration Regarding Emergency Use of Treatment for Uncontrolled 
Hemorrhage Due to Agents of Military Combat

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

ACTION: Notice.

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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing 
this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) 
Act. On June 7, 2018, Patrick M. Shanahan, Deputy Secretary of Defense, 
determined in accordance with the Federal Food, Drug and Cosmetic Act, 
as delegated by the Secretary of Defense, that there is a military 
emergency or significant potential for a military emergency, involving 
a heightened risk to U.S. military forces of an attack with an agent or 
agents that may cause, or are otherwise associated with an imminently 
life-threatening and specific risk to those forces. More specifically, 
U.S. Forces are now deployed in multiple locations where they serve at

[[Page 32885]]

heightened risk of an enemy attack with agents of military combat, 
including firearms, projectiles, and explosive devices, that may cause 
major and imminently life-threatening combat casualties involving 
uncontrolled hemorrhage.
    On the basis of this determination, on July 9, 2018 the Secretary 
declared that circumstances exist justifying the authorization of 
emergency use of Freeze Dried Plasma (FDP) to treat uncontrolled 
hemorrhage due to agents of military combat (e.g., firearms, 
projectiles, and explosive devices) in emergency situations when plasma 
is not available for use or its use is not practical, pursuant to 
section 564 of the FD&C Act, subject to the terms of any authorization 
issued under that section.

DATES: The declaration is effective July 9, 2018.

FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, 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 biological, chemical, 
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.
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    \1\ 42 U.S.C. 247d-6b, which states: ``[t]he Homeland Security 
Secretary, in consultation with the Secretary and the heads of other 
agencies as appropriate, shall on an ongoing basis--(i) assess 
current and emerging threats of chemical, biological, radiological, 
and nuclear agents; and (ii) determine which of such agents present 
a material threat against the United States population sufficient to 
affect national security.''
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    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 military emergency or significant potential for 
a military emergency by the Deputy Secretary of Defense, and the 
declaration that circumstances exist justifying emergency use of French 
FDP by the Secretary of HHS, as described below, enable the FDA 
Commissioner to issue an EUA for FDP in emergency situations when 
plasma is not available for use or its use is not practical for 
emergency use under section 564 of the FD&C Act.

II. Determination of a Military Emergency or Significant Potential for 
a Military Emergency by the Deputy Secretary of Defense

    On June 7, 2018, Patrick M. Shanahan, Deputy Secretary of Defense, 
determined in accordance with section 564(b)(1)(B) of the Federal Food, 
Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1)(B), as delegated by the 
Secretary of Defense, that there is a military emergency or significant 
potential for a military emergency, involving a heightened risk to U.S. 
military forces of an attack with an agent or agents that may cause, or 
are otherwise associated with an imminently life-threatening and 
specific risk to those forces. The Deputy Secretary further stated 
that, more specifically, U.S. Forces are now deployed in multiple 
locations where they serve at heightened risk of an enemy attack with 
agents of military combat, including firearms, projectiles, and 
explosive devices, that may cause major and imminently life-threatening 
combat casualties involving uncontrolled hemorrhage.

III. Declaration of the Secretary of Health and Human Services

    On July 9, 2018, on the basis of the Deputy Secretary of Defense's 
determination that there is a military emergency or significant 
potential for a military emergency involving a heightened risk to U.S. 
military forces of an attack with an agent or agents that may cause, or 
are otherwise associated with an imminently life-threatening and 
specific risk to those forces, I declared that circumstances exist 
justifying the authorization of emergency use of FDP to treat 
uncontrolled hemorrhage due to agents of military combat (e.g., 
firearms, projectiles, and explosive devices) in emergency situations 
when plasma is not available for use or its use is not practical, 
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.

Alex M. Azar II,
Secretary.
[FR Doc. 2018-15152 Filed 7-13-18; 8:45 am]
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