[Federal Register Volume 89, Number 166 (Tuesday, August 27, 2024)]
[Notices]
[Pages 68625-68636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3925]


Authorization of Emergency Use of a Freeze-Dried Plasma Product 
for Treatment of 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) 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use of a 
freeze-dried plasma product, octaplasLG Powder, for emergent 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.

DATES: The Authorization is effective as of August 8, 2024.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the 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: Andrew C. Harvan, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

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 
actions, 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 ensure 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

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and specific risk to U.S. military forces when there are no adequate, 
approved, and available alternatives (among other criteria).

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Department of Health and Human Services (HHS) Secretary 
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 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. Under section 564(h)(1) of the FD&C Act, revisions to 
an authorization shall be made available on the internet website of 
FDA. 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) of the FD&C Act, 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.

III. The Authorization

    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 February 22, 2024, Octapharma Pharmazeutika 
Produktionsges.m.b.H. (Octapharma) submitted a complete EUA request for 
octaplasLG Powder. Having concluded that the criteria for issuance of 
the Authorization under section 564(c) of the FD&C Act are met, on 
August 8, 2024, FDA issued an EUA for octaplasLG Powder, manufactured 
by Octapharma, 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.

IV. Electronic Access

    An electronic version of this document and the full text of the

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Authorization are available on the internet at https://www.regulations.gov.
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    Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18971 Filed 8-26-24; 8:45 am]
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