Notice2024-18971
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 27, 2024
Effective
August 8, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 166 (Tuesday, August 27, 2024)</title>
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[Federal Register Volume 89, Number 166 (Tuesday, August 27, 2024)]
[Notices]
[Pages 68625-68636]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on August 27, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.