83 FR 32884 - Declaration Regarding Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range		32884-32885
FR Document		2018-15152

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 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.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018)

[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32884-32885]
From the Federal Register Online  [www.thefederalregister.org]
[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]
BILLING CODE 4150-37-P

32884 Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices

Guidance for Industry and FDA Staff— FD&C Act should be included in the CFR part 814, subpart E, including the
Class II Special Controls Guidance annual report. Also, a manufacturer of a submission of periodic reports under 21
Document: Automated Blood Cell device determined to be substantially CFR 814.84.
Separator Device Operating by equivalent to the centrifugal or Collecting or transfusing facilities, the
Centrifugal or Filtration Separation filtration-based automated cell separator intended users of the device, and the
Principle device intended for the routine device manufacturers have certain
collection of blood and blood responsibilities under the Federal
OMB Control Number 0910–0594—
components should comply with the regulations. For example, collecting or
Extension
same general and special controls. transfusing facilities are required to
Under the Safe Medical Devices Act The annual report should include, at maintain records of any reports of
of 1990 (Pub. L. 101–629), FDA may a minimum, a summary of anticipated complaints of adverse reactions (21 CFR
establish special controls, including and unanticipated adverse events that 606.170), while the device manufacturer
performance standards, postmarket have occurred and that are not required is responsible for conducting an
surveillance, patient registries, to be reported by manufacturers under investigation of each event that is
guidelines, and other appropriate Medical Device Reporting (MDR) (part reasonably known to the manufacturer
actions it believes necessary to provide 803 (21 CFR part 803)). The reporting of and evaluating the cause of the event
reasonable assurance of the safety and adverse device events summarized in an (§ 803.50(b) (21 CFR 803.50(b))). In
effectiveness of the device. The special annual report will alert FDA to trends addition, manufacturers of medical
control guidance serves as the special or clusters of events that might be a devices are required to submit to FDA
control for the automated blood cell safety issue otherwise unreported under individual adverse event reports of
separator device operating by the MDR regulation. The report should death, serious injury, and malfunctions
centrifugal or filtration separation also include any subsequent change to (§ 803.50).
principle intended for the routine the preamendments class III device In the special control guidance
collection of blood and blood requiring a 30-day notice in accordance document, FDA recommends that
components (§ 864.9245 (21 CFR with 21 CFR 814.39(f). manufacturers include in their three
864.9245)). Reclassification of this device from annual reports a summary of adverse
For currently marketed products not class III to class II relieves reactions maintained by the collecting
approved under the premarket approval manufacturers of the burden of or transfusing facility or similar reports
process, the manufacturer should file complying with the premarket approval of adverse events collected.
with FDA for 3 consecutive years an requirements of section 515 of the FD&C In the Federal Register of February
annual report on the anniversary date of Act (21 U.S.C. 360e) and may permit 22, 2018, (83 FR 7745), FDA published
the device reclassification from class III small potential competitors to enter the a 60-day notice requesting public
to class II or on the anniversary date of marketplace by reducing the burden. comment on the proposed collection of
the 510(k) of the Federal Food, Drug, Although the special control guidance information. One comment was received
and Cosmetic Act (FD&C Act) (21 U.S.C. recommends that manufacturers of these but did not respond to any of the four
360(k)) clearance. Any subsequent devices file with FDA an annual report information collection topics solicited
change to the device requiring the for 3 consecutive years, this would be and is therefore not discussed here.
submission of a premarket notification less burdensome than the current We estimate the burden of the
in accordance with section 510(k) of the postapproval requirements under 21 information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Reporting activity responses per burden per
respondents responses hours
respondent response

Annual Report ...................................................................... 3 1 3 5 15
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA records, there are Dated: July 9, 2018. SUMMARY: The Secretary of Health and
approximately three manufacturers of Leslie Kux, Human Services (HHS) is issuing this
automated blood cell separator devices. Associate Commissioner for Policy. notice pursuant to the Federal Food,
We estimate that the manufacturers will [FR Doc. 2018–15089 Filed 7–13–18; 8:45 am] Drug, and Cosmetic (FD&C) Act. On
spend approximately 5 hours preparing BILLING CODE 4164–01–P June 7, 2018, Patrick M. Shanahan,
and submitting the annual report. The Deputy Secretary of Defense,
total burden hours are reduced from determined in accordance with the
previous collections due to a decrease in DEPARTMENT OF HEALTH AND Federal Food, Drug and Cosmetic Act,
the number of manufacturers. HUMAN SERVICES as delegated by the Secretary of Defense,
that there is a military emergency or
Other burden hours required for Declaration Regarding Emergency Use significant potential for a military
§ 864.9245 are reported and approved of Treatment for Uncontrolled emergency, involving a heightened risk
sradovich on DSK3GMQ082PROD with NOTICES

under OMB control number 0910–0120 Hemorrhage Due to Agents of Military to U.S. military forces of an attack with
(premarket notification submission Combat an agent or agents that may cause, or are
510(k), 21 CFR part 807, subpart E), and otherwise associated with an
AGENCY: Office of the Secretary,
OMB control number 0910–0437 (MDR, imminently life-threatening and specific
Department of Health and Human
part 803). Services. risk to those forces. More specifically,
U.S. Forces are now deployed in
ACTION: Notice.
multiple locations where they serve at

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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32885

heightened risk of an enemy attack with affect national security or the health and specifically, U.S. Forces are now
agents of military combat, including security of United States citizens living deployed in multiple locations where
firearms, projectiles, and explosive abroad; (3) a determination by the they serve at heightened risk of an
devices, that may cause major and Secretary of Defense that there is a enemy attack with agents of military
imminently life-threatening combat military emergency, or a significant combat, including firearms, projectiles,
casualties involving uncontrolled potential for a military emergency, and explosive devices, that may cause
hemorrhage. involving a heightened risk to United major and imminently life-threatening
On the basis of this determination, on States military forces, including combat casualties involving
July 9, 2018 the Secretary declared that personnel operating under the authority uncontrolled hemorrhage.
circumstances exist justifying the of title 10 or title 50, of attack with (i)
a biological, chemical, radiological, or III. Declaration of the Secretary of
authorization of emergency use of
nuclear agent or agents; or (ii) an agent Health and Human Services
Freeze Dried Plasma (FDP) to treat
uncontrolled hemorrhage due to agents or agents that may cause, or are On July 9, 2018, on the basis of the
of military combat (e.g., firearms, otherwise associated with, an Deputy Secretary of Defense’s
projectiles, and explosive devices) in imminently life-threatening and specific determination that there is a military
emergency situations when plasma is risk to United States military forces; or emergency or significant potential for a
not available for use or its use is not (4) a determination by the Secretary that military emergency involving a
practical, pursuant to section 564 of the there is a public health emergency, or a heightened risk to U.S. military forces of
FD&C Act, subject to the terms of any significant potential for a public health an attack with an agent or agents that
authorization issued under that section. emergency, that affects, or has a may cause, or are otherwise associated
DATES: The declaration is effective July significant potential to affect, national with an imminently life-threatening and
9, 2018. security or the health and security of specific risk to those forces, I declared
United States citizens living abroad, and that circumstances exist justifying the
FOR FURTHER INFORMATION CONTACT:
that involves a CBRN agent or agents, or authorization of emergency use of FDP
Robert P. Kadlec, MD, MTM&H, MS,
a disease or condition that may be to treat uncontrolled hemorrhage due to
Assistant Secretary for Preparedness
attributable to such agent or agents. agents of military combat (e.g., firearms,
and Response, Office of the Secretary, Based on any of these four
Department of Health and Human projectiles, and explosive devices) in
determinations, the Secretary of HHS emergency situations when plasma is
Services, 200 Independence Avenue may then declare that circumstances
SW, Washington, DC 20201, Telephone not available for use or its use is not
exist that justify the EUA, at which practical, pursuant to section 564 of the
(202) 205–2882 (this is not a toll free point the FDA Commissioner may issue
number). FD&C Act, subject to the terms of any
an EUA if the criteria for issuance of an authorization issued under that section.
SUPPLEMENTARY INFORMATION: authorization under section 564 of the Notice of any EUAs issued by the
FD&C Act are met. The determination of FDA Commissioner pursuant to this
I. Background
a military emergency or significant determination and declaration will be
Under Section 564 of the FD&C Act, potential for a military emergency by provided promptly in the Federal
the Commissioner of the Food and Drug the Deputy Secretary of Defense, and the Register as required under section 564
Administration (FDA), acting under declaration that circumstances exist of the FD&C Act.
delegated authority from the Secretary justifying emergency use of French FDP
of HHS, may issue an Emergency Use by the Secretary of HHS, as described Alex M. Azar II,
Authorization (EUA) authorizing (1) the below, enable the FDA Commissioner to Secretary.
emergency use of an unapproved drug, issue an EUA for FDP in emergency [FR Doc. 2018–15152 Filed 7–13–18; 8:45 am]
an unapproved or uncleared device, or situations when plasma is not available BILLING CODE 4150–37–P
an unlicensed biological product; or (2) for use or its use is not practical for
an unapproved use of an approved drug, emergency use under section 564 of the
approved or cleared device, or licensed FD&C Act. DEPARTMENT OF HOMELAND
biological product. Before an EUA may SECURITY
be issued, the Secretary of HHS must II. Determination of a Military
declare that circumstances exist Emergency or Significant Potential for a U.S. Customs and Border Protection
justifying the authorization based on Military Emergency by the Deputy
Secretary of Defense [Docket No. USCBP–2018–0026]
one of four determinations: (1) A
determination by the Secretary of On June 7, 2018, Patrick M. Commercial Customs Operations
Homeland Security that there is a Shanahan, Deputy Secretary of Defense, Advisory Committee (COAC)
domestic emergency, or a significant determined in accordance with section
potential for a domestic emergency, 564(b)(1)(B) of the Federal Food, Drug AGENCY: U.S. Customs and Border
involving a heightened risk of attack and Cosmetic Act, 21 U.S.C. 360bbb– Protection (CBP), Department of
with a biological, chemical, radiological, 3(b)(1)(B), as delegated by the Secretary Homeland Security (DHS).
or nuclear (‘‘CBRN’’) agent or agents; (2) of Defense, that there is a military ACTION: Committee management; notice
the identification of a material threat by emergency or significant potential for a of Federal Advisory Committee meeting.
the Secretary of Homeland Security military emergency, involving a
pursuant to section 319F–2 of the Public heightened risk to U.S. military forces of SUMMARY: The Commercial Customs
Operations Advisory Committee (COAC)
sradovich on DSK3GMQ082PROD with NOTICES

Health Service (PHS) Act 1 sufficient to an attack with an agent or agents that
may cause, or are otherwise associated will hold its public meeting on
1 42 U.S.C. 247d–6b, which states: ‘‘[t]he
with an imminently life-threatening and Wednesday, August 1, 2018 via
Homeland Security Secretary, in consultation with specific risk to those forces. The Deputy webinar. The meeting will be open to
the Secretary and the heads of other agencies as
Secretary further stated that, more the public.
appropriate, shall on an ongoing basis—(i) assess
DATES: The COAC will meet on
current and emerging threats of chemical,
biological, radiological, and nuclear agents; and (ii) threat against the United States population Wednesday, August 1, 2018 from 1:00
determine which of such agents present a material sufficient to affect national security.’’ p.m. to 4:00 p.m. EST. Please note that

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Document Created: 2018-07-14 00:53:42
Document Modified: 2018-07-14 00:53:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The declaration is effective July 9, 2018.
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).
FR Citation		83 FR 32884