[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40059-40070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3009]


Authorization of Emergency Use of a Freeze Dried Plasma Treatment 
for Hemorrhage or Coagulopathy During an Emergency Involving Agents of 
Military Combat; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of an Emergency Use Authorization (EUA) (the Authorization) 
for a freeze dried plasma treatment for hemorrhage or coagulopathy 
during an emergency involving agents of military combat (e.g., 
firearms, projectiles, and explosive devices) when plasma is not 
available for use or when the use of plasma is not practical. FDA 
issued this Authorization under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), as requested by the U.S. Department of Defense (DoD). 
The Authorization contains, among other things, conditions on the 
emergency use of the authorized treatment. The Authorization follows 
the June 7, 2018, determination by the Deputy 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 of Defense 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. On the basis of such 
determination, the Department of Health and Human Services (HHS) 
Secretary declared on July 9, 2018, that circumstances exist justifying 
the authorization of emergency use of freeze dried plasma for the 
treatment of hemorrhage or coagulopathy during an emergency involving 
agents of military combat (e.g., firearms, projectiles, and explosive 
devices) when plasma is not available for use or when the use of plasma 
is not practical, subject to the terms of any authorization issued 
under the FD&C Act. The Authorization, which includes an explanation of 
the reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 9, 2018.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the 
Project BioShield Act of 2004 (Pub. L. 108-276), the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5), 21st 
Century Cures Act (Pub. L. 114-255), and Public Law 115-92 (2017), 
allows FDA to strengthen the public health protections against 
biological, chemical, nuclear, and radiological agents and other agents 
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces. Among other 
things, section 564 of the FD&C Act allows FDA to authorize the use of 
an unapproved medical product or an unapproved use of an approved 
medical product in certain situations. With this EUA authority, FDA can 
help assure that medical countermeasures may be used in emergencies to 
diagnose, treat, or prevent serious or life-threatening diseases or 
conditions caused by biological, chemical, nuclear, or radiological 
agents and other agents that may cause, or are otherwise associated 
with, an imminently life-threatening and specific risk to U.S. military 
forces when there are no adequate, approved, and available 
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (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 agent or agents; (2) 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 U.S. military forces, including personnel operating under the 
authority of title 10 or title 50, United States Code, 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 U.S. military 
forces; \1\ (3) a determination by the Secretary of HHS 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 U.S. citizens living 
abroad, and that involves a biological, chemical, radiological, or 
nuclear agent or agents, or a disease or condition that may be 
attributable to such agent or agents; or (4) the identification of a 
material threat by the Secretary of Homeland Security under section 
319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) 
sufficient to affect national security or the health and security of 
U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine, within 45 calendar days of 
such determination, whether to make a declaration under section 
564(b)(1) of the FD&C Act, and, if appropriate, shall promptly make 
such a declaration.
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    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section

[[Page 40060]]

564(h)(1) of the FD&C Act, FDA is required to publish in the Federal 
Register a notice of each authorization, and each termination or 
revocation of an authorization, and an explanation of the reasons for 
the action. Section 564 of the FD&C Act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use when the Secretary of HHS has declared that 
circumstances exist justifying the authorization of emergency use. 
Products appropriate for emergency use may include products and uses 
that are not approved, cleared, or licensed under sections 505, 510(k), 
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, and 360e) or 
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved 
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an 
EUA only if, after consultation with the HHS Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health, and the Director of the Centers for Disease Control and 
Prevention (to the extent feasible and appropriate given the applicable 
circumstances), FDA \2\ concludes: (1) That an agent referred to in a 
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of 
scientific evidence available to FDA, including data from adequate and 
well-controlled clinical trials, if available, it is reasonable to 
believe that: (A) The product may be effective in diagnosing, treating, 
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under 
section 564, approved or cleared under the FD&C Act, or licensed under 
section 351 of the PHS Act, for diagnosing, treating, or preventing 
such a disease or condition caused by such an agent; and (B) the known 
and potential benefits of the product, when used to diagnose, prevent, 
or treat such disease or condition, outweigh the known and potential 
risks of the product, taking into consideration the material threat 
posed by the agent or agents identified in a declaration under section 
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no 
adequate, approved, and available alternative to the product for 
diagnosing, preventing, or treating such disease or condition; (4) in 
the case of a determination described in section 564(b)(1)(B)(ii), that 
the request for emergency use is made by the Secretary of Defense; and 
(5) that such other criteria as may be prescribed by regulation are 
satisfied.
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    \2\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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    No other criteria for issuance have been prescribed by regulation 
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. EUA Request for a Freeze Dried Plasma Treatment for Hemorrhage or 
Coagulopathy During an Emergency Involving Agents of Military Combat 
When Plasma Is Not Available for Use or When the Use of Plasma Is Not 
Practical

    On June 7, 2018, the Deputy Secretary of Defense determined 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 of Defense further stated that, 
``[m]ore specifically, U.S. [f]orces 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 July 9, 2018, 
under section 564(b)(1) of the FD&C Act, and on the basis of such 
determination, the Secretary of HHS declared that circumstances exist 
justifying the authorization of emergency use of freeze dried plasma 
for the treatment of hemorrhage or coagulopathy during an emergency 
involving agents of military combat (e.g., firearms, projectiles, and 
explosive devices) when plasma is not available for use or when the use 
of plasma is not practical, subject to the terms of any authorization 
issued under section 564 of the FD&C Act. Notice of the declaration of 
the Secretary of HHS was published in the Federal Register on July 16, 
2018 (83 FR 32884) and a correction was published in the Federal 
Register on July 31, 2018 (83 FR 36941). On July 9, 2018, DoD 
requested, and on July 9, 2018, FDA issued, an EUA for Pathogen-Reduced 
Leukocyte-Depleted Freeze Dried Plasma manufactured by the Centre de 
Transfusion Sanguine des Arm[eacute]es (CTSA) (for purposes of this 
EUA, ``French FDP''), subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the 
Authorization are available on the internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the 
Authorization under section 564(c) of the FD&C Act are met, FDA has 
authorized the emergency use of a freeze dried plasma treatment for the 
treatment of hemorrhage or coagulopathy during an emergency involving 
agents of military combat (e.g., firearms, projectiles, and explosive 
devices) when plasma is not available for use or when the use of plasma 
is not practical, subject to the terms of the Authorization. The 
Authorization in its entirety (not including the authorized versions of 
the fact sheets and other written materials) follows and provides an 
explanation of the reasons for issuance, as required by section 
564(h)(1) of the FD&C Act.

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    Dated: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17303 Filed 8-10-18; 8:45 am]
 BILLING CODE 4164-01-C