[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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]
BILLING CODE 4150-37-P