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, 68625-68636 [2024-18971]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness
(§ 314.162 (21 CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), is the subject of NDA
215252, held by Exela Pharma Sciences,
LLC, and initially approved on October
28, 2021. DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
is indicated for the following: (1)
temporary control of rapid ventricular
rate in atrial fibrillation or atrial flutter;
and (2) rapid conversion of paroxysmal
supraventricular tachycardias to sinus
rhythm.
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In previous
instances (see, e.g., 72 FR 9763 (March
5, 2007), 61 FR 25497 (May 21, 1996)),
the Agency has determined that, for
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Fresenius Kabi USA, LLC submitted a
citizen petition dated March 5, 2024
(Docket No. FDA–2024–P–1131), under
21 CFR 10.30, requesting that the
Agency determine whether DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that DILTIAZEM
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HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
DILTIAZEM HYDROCHLORIDE IN
DEXTROSE 5% (diltiazem HCl), 125
mg/125 mL (1 mg/mL) and 250 mg/250
mL (1 mg/mL), from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list DILTIAZEM
HYDROCHLORIDE IN DEXTROSE 5%
(diltiazem HCl), 125 mg/125 mL (1 mg/
mL) and 250 mg/250 mL (1 mg/mL), in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19233 Filed 8–26–24; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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68625
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 AllHazards 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.
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,
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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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 wellcontrolled 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 lifethreatening 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
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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is made by the Secretary of Defense; and
(5) that such other criteria as may be
prescribed by regulation are satisfied.
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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68627
Authorization are available on the
internet at https://www.regulations.gov.
BILLING CODE 4164–01–P
August 8, 2024
Octaphanna Pharmazeutika Produktionsges.m.b.H.
c/o Sergio Alegre
Octapharma USA Inc.
11 7 West Century Road
Paramus, NJ 07652
Dear Mr. Alegre,
This letter is in response to Octapharma Phannazeutika Produktionsges.m.b.H. 's (Octapharma)
request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization
(EUA) for emergency use of octaplasLG Powder (blood group types A and AB) 1 for U.S.
military forces 2 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, pursuant to section 564 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3)
On Jlll1e 7, 2018, pursuant to section 564(b)(l)(B) of the Act (21 US.C. § 360bbb-3(b)(l)(B)),
the Deputy Secretary of the Department of Defense (DoD) detennined 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.""' 4•5 Pursuant to section
564(b)(l) of the Act (21 U.S.C. § 360bbb-3(b)(l)), and on the basis of such determination, on
July 9, 2018, the Secretary of the Department of Health and Human Services (HHS) then
declared that circumstances exist justifying the authorization of emergency use of freeze dried
Hereafter octaplasLG Powder (blood group types A and AB) will be referred to as octaplasLG Powder.
For purposes of this EUA, the term "U.S. military forces" may include troops, civilians, contractors, and allied
military personnel operating with Department of Defense. Also, for purposes of this EUA, it is anticipated that U.S.
military medical pers01n1el trained in the use of octaplasLG Powder will administer the authorized octaplasLG
Powder to U.S. military forces. However, in the event the operational enviro11111ent prevents such administration, it is
possible that other trained U.S. military forces may need to administer the authorized octaplasLG Powder during an
emergency as set forth in this authorization.
3 DoD. Letter to the HHS Secretmy issuing a determination of a militmy eme1;f?ency, or significant potential for a
military emergency, and requesting a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act.
June 7, 2018.
•1 Under section 564(b)(1)(B) of the Act, the Secretary of Defense may make a determination 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 arc otherwise
associated with, an imminently life-threatening and specific risk to United States military forces.
5 When the DoD Secretary makes such a determination, the Secretary of Health and Human Services (HHS) shall
detertnine, within 45 calendar days of such detertnination, whether to make a declaration that circumstances exist to
justify EUA issuance and, if appropriate, shall promptly make such a declaration.
1
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Page 2 - Octapharma
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. 6
Octaphanna requested this EUA so that octaplasLG Powder, which is not FDA-approved, may
be acquired, distributed, and held by DoD for preparedness purposes in advance of an actual
threat of agents of military combat (e.g., firearms, projectiles, and explosive devices) that may
cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S.
military forces, with the intent that it may be administered by U.S. military medical personnel or
other Authorized Providers 7 during an event or post-event for the treatment of hemorrhage or
coagulopathy caused by exposure to agents of military combat when plasma is not available for
use Or when the use of plasma is not practical. An EUA is needed to facilitate DoD pre-event
planning and preparedness activities related to the acquisition and use of this non-FDA approved
product to enable activities to support rapid administration of treatment during an actual
emergency event involving the threat of agents of military combat (e.g., firearms, projectiles,
and explosive devices) that may cause, or are otherwise associated with, an imminently lifethreatening and specific risk to U.S. military forces.
This EUA is important for supporting military emergency response because it enables rapid
initiation of treatment with octaplasLG Powder during an emergency involving agents of military
combat (e.g., firearms, projectiles, and ex-plosive devices) that may cause, or are otherwise
associated with, an imminently life-threatening and specific risk to U.S. military forces, without
FDA or DoD having to take further action with respect to otherwise applicable requirements
under federal law.
Having concluded that the criteria for issuance of this authorization under section 564(c) of the
Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of octaplasLG
Powder (as described in the Scope of Authorization section of this letter (Section II)) in the
specified population for the treatment of hemorrhage or coagulopathy during an emergency
involving agents of military combat (e.g., firearms, projectiles, and explosive devices) that may
cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S.
military forces when plasma is not available for use or when the use of plasma is not practical,
subject to the tenns of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of octaplasLG Powder for the treatment of hemorrhage
or coagulopathy during an emergency involving agents of military combat (e.g., firearms,
projectiles, and explosive devices) that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces when plasma is not available
for use or when the use of plasma is not practical in the specified population, when administered
6 HHS. Declaration that Circumstances ExistJustifying an Authorization Pursuant to Section 564 of the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b). July 9, 2018.
Authorized Providers are medical personnel trained in the use of octaplasLG Powder who may administer 1he
authorized octaplasLG Powder to US. military forces. In 1he event 1he operational environment prevents such
administration, oilier trained US. military forces may need to administer 1he au1horized octaplasLG Powder as
Authorized Providers during an emergency as set forth in this authorization.
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68629
Page 3 - Octapharma
as described in the. Scope of Authorization (Section II), meets the criteria for issuance of an
authorization under section 564(/i) of the Act, because I have concluded that:
l. Agents ofmilitary combat (e.g., firearms, projectiles, and.explosivedevices)can cause,
or otherwise be associated with a serious. or life.fhreatening disease or condition to
humans exposed to these agents, specifically hemorrhage or coagulopathy during an
emergency when plasma is :not available for use or when the use of plasma is not
practical;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that octaplasLG Powder, when used in accordance with the Scope of Authorization, may
be effective 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 notavailable for use orwhentheuse of plasma is not practical, and that
the known and potential benefits of octaplasLG Powder for this. use outweigh the known
and potential risks of such product;
3. There is no adequate, approved, and available alternatlve to the emergency use of
octaplasLG Powder;. and
4, The Deputy Secretru:y of Defense ha:.-, requested emergency use of this product ror
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. 8
It Scope of Authorization
I have concluded, pursuant to section 564(d)(l) of the Act, that the scope ofthis authorization is
limited as follows:
• Octapharma will supply octa:plasLG Powder, either directly or through authorized
distributor(s) to DoD as directed by DoD, for use consistent with the terms and
conditions ofthis EUA.
• octaplasLG Powder will be used for U.S. military forces for the treatment ofheniorthage
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,
Product Description
octaplasLG Powder is a biological product to be used for U.S. 11111itaryforces forfreatrilertt of
hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g.,
fireatms, projectiles, and explosive devices) that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces when plasma is notavailable
for use or when the use of plasma is fiot practical.
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No other criteria ofissuance hav.e been prescribed by regulation under section 564(c)(4) of the Ai;L
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octaplasLG Powder is an unapproved lyophilized plasma product created from the FDA
approved, pooled, solvent/detergent treated plasma product, Octaplas. Octaplas is manufactured
from human plasma collected in US licensed plasma donation centers. All plasma donations are
tested for relevant transfusion-transmitted infections in accordance with U.S. federal regulations.
octaplasLG Powder is presented as a powder for solution for intravenous infusion, filled into and
freeze-dried in glass vials, with each product vial containing 9-14 g of A- or AB-blood group
specific human plasma protein and is reconstituted with 190 ml of water for injections (WFI)
solvent. Prior to reconstitution, octaplasLG Powder can be stored at +2°C to +25°C for 24
months.
octaplasLG Powder is authorized to be distributed with an FDA cleared or approved transfusion
filter set.
octaplasLG Powder is authorized to be distributed as directed by DoD for storage, distribution,
and administration, when packaged in the authorized packaging and with the authorized labeling
(e.g., carton and container labels, fact sheets).
octaplasLG Powder is authorized to be administered without a prescription and by U.S. military
medical professionals or other authorized providers under this EU A, despite the fact that it does
not meet certain requirements othenvise required by federal law.
octaplasLG Powder is authorized for emergency use with the following information required to
be made available to medical professionals or other authorized providers and recipients (to the
extent practicable given the emergency circumstances) when plasma is not available for use or
when the use of plasma is not practical.
•
Fact Sheet for Health Care Professionals or Other Authorized Providers
•
Fact Sheet for Recipients
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the
known and potential benefits of the authorized octaplasLG Powder in the specified population,
when used 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, when used consistently with the
Scope of Authorization of this letter (Section II), outweigh the known and potential risks of such
a product.
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I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that the authorized octaplasLG Powder
may be effective in 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, when used consistently with the
Scope of Authorization of this letter (Section II), pursuant to section 564(c)(2)(A) of the Act.
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
68631
Page 5 - Octaphanna
FDA has reviewed the. scientific infonnation available to FDA, including the information
supporting the conclusions described in Section I above, and concludes that the authorized
octaplasLG Powder, when used for the treatment of hemorrhage or coagulopathy during an
emergency involving agents of military combat (e.g., fireanns, projectiles, and explosive
devices) when plasma is not available for use or when the use of plasma is not practical in the
specified population (as described in the Scope of Authorization of this letter (Section II)), meets
the criteria set forth in section 564(c) ofthe Act concerning safety and potential effectiveness.
The emergency use of the authorized octaplasLG Powder product under this EUA must be
consistent with, and may not exceed, the tenns of this letter, including the Scope of
Authorization (Section II) and the Conditions of Authorization (Section IV). Subject to the
terms of this EUA and.under the circumstances set forth in the Deputy Secretary of Defense's
determination described above and the Secretary ofHHS's corresponding declaration under
section 564(b)(l), the octaplasLG Powder described above is authorized for the treatment of
hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g.,
fireanns, projectiles, and explosive devices) when plasma is not available for use or when the use
of plasma is not practical in the specified population.
III. Conditions of Authorization
Pursuant to section 564 of the Act, I ant establishing the following conditions on this
authorization:
Octapharma
A Octapharma will ensure that the authorized octaplasLG Powder will be distributed as
directed by DoD, and the authorized Fact Sheet for Health Care Professionals or Other
Authorized Providers, the authorized Fact Sheet for Recipients, and any other labeling
that FDA may authorize, as well as any authorized an1endments thereto will be made
available to applicable DoD components.
B. Octapharma, in consultation with DoD, may request changes to this authorization,
including the authorized Fact Sheet for Health Care Professionals or Other Authorized
Providers and the authorized Fact Sheet for Recipients, the authorized labeling (e.g.,
carton and container labels, label on.each packaged unit) and authorized packaging for
the authorized octaplasLG Powder, or to the manufacturing, labeling, and packaging
processes of Octaphanna or its authorized agent(s) for the authorized product. Any
request for changes to this EU A must be submitted to Office of Blood Research and
Review (OBRR)/Center for Biologics Evaluation and Research (CBER). Such changes
require appropriate authorization prior to implementation. 9
The following types of revisions may be authorized without reissuing this letter: (!) changes to the authorized
labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new
fact sheets; (4) new carton/container labels,. (5) expiration dating exte11,~ions; (6) changes to manufacturing
processes, including tests or other authc;,rized components of manufacturing; (7) new conditions of authorization to
require data collection or study. All changes to the authorization require review and concurrence from OBRR For
changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and
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9
68632
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
Page 6 - Octapharma
C. bctapharmil will ensure thatthe tenns ofthis EUAare made avajlable to DoD.
Octapharma will provide applicable IJoD components a>copy ofthis letter of
authorization and communicate to applicable DoD components any subsequent
:amendments that might be made to this letter of authorization and its authorized
accompanyingmaterials (e,g:; Fact Sheets).
D. Octapharma wiHinfonn applicable Doi) components about the need fohave a process in
place for perfonning adverse event monitoring designed to ensure that suspected adverse
reactions and all medication errors associated with the use ofthe authorized octaplasLG
Powder are reported to Octapharma£ Octapharma.will conduct any follow-up requested
by FDA regarding adverse events, to the extent feasible given the emergency
circumstances.
E. Octaphanna will ensure that the. authorized octaplasLffPowder is distributed within the
expiry dating period.
F. Octaphanna will ellsute thatthe authorizedoctaplasLQPowdeds distributed with.an
FDA cleared or approved transfusion filter set
G, ()ctapharma will.post on its website tlre following statement: ''For information aboutthe
FDA-authorized emergency use of octaplasLG Powder please see,
https://www.fda.gov/emergency0preparedness-and•response/mcm-legal-regulatocy-andpolicy-fuunewotk/emergency-use 0 anthorization."
H. Octapharmawill promptlynotify FDA of any suspected or confirmed quality,
manufacturing, distribution, and/or other issues with the authorized octaplasLG
Powder of Which it becomes aware.
L Octapharma will establish a Collaborative Research and DevelopmentA:greement
(CRADA) with DoD to collect data related to use ofoctaplasLG Powder under combat
conditions. These data will be collected wheneveroctaplasLG Powder is transfusedto
patients to the extent practicable given the emergency circumstances. Collected data
will incluqe suspected adverse reactions, including seriollS and unexpected adverse
reactions, and any medication errors associated with the use ofthe authorized
octaplasLG Powder. Octaphanna-Will report data to FDA on an annual basis,
l 6ctapharma must submit to the Emergency Use Authorization submission fife periodic
safetyreporls annuaHy, or at another appropriate interval determined by CBE'.R; in
accordance with a due date agreed upon with OBRR/CBER beginning after the first
full calendar month after authorization. Each. periodic safety report must contain
descriptive information which includes:
• A narrative. sumntary and analysis o:fsuspected adverse reactions submitted during
the reporting interval, includitig'intervaland cumulative counts by age groups;
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concurrence is required from the Preparedness and Response Team (P:REP)/Office-of:the Cente(Directot
(OD)/CBER.
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
68633
Page 7 - Octaphanna
•
•
•
•
A narrative summary and analysis of medication errors, whether or not associated
with an adverse event; that were identified since the last reporting interval;
Newly identified safety concerns in the interval;
Actions taken since the last report because of adverse experiences;
Cumulative doses distributed, and doses distrilmted. during the reporting interval.
K. Octapharmawill report to FDA, as soon as possible; any serious and.unexpected
suspected adverse reactionthat is not described under 'Risks and Adverse. Events' in the
authorized Fllct Sheetfor Health Care Professionals ot Other Authorized Providers. and
any susptlcted adverse reaction resulting in death. Octaphanna will conduct any followup requested by FDA regarding adverse events;to the extent feasible given the
emergency circumstances.
L. Upon request by FDA, Octaphanna will make available any records maintained in
connectionwith this letter.
DoD
M. DoD witl distribute the authorized octapfasLG f'owder under its direction to the extent
such decisions are consistent with and do not exceed the terms of this letter, including
distribution with the authorized labeling (e.g., Fact Sheets)i
N. Through a process of inventory conttol,J)JD will maintain records regatding
distribution under its direction of the authorized octaplasLG Powder(e.g., lot nurtibets,
quantity, receivingsite, receipt date).
h
DoD will ensure that the tetrns ofthls EDA ate made available to applicable bob
components through applicable DoD communication channels ai)d procedures. 10 DoD
will provide applicable DoD components a copy ofthis letter of authorization /llld
communicate to applicable DoD components any subsequent amendments that might
be made to this letter of authorization and its authorized accompanying materials (e.g.,
Fact Sheets).
P. DoD will inform applicable t>oD con1ponents that the authorized octaplasLG l>owder
may be used only by U.S. military forces forthetreatment ofhemorrhage or
coagulopathy during an emergency involving.agents of military combat (e.g., 11tearms,
projectiles, and explosive devices)when plasma is not available for use or when the
use of plasma is not practical.
Q: DoD will be responsiblefor authorizing components· actittgas partofaDoD response to
administer the authorized octaplasLG Powder in accordance with the terms.ofthis EUA,
including instructing such components about the terms of this EUA with regatd to
storage, distribution, and administration, and for. instructing about the means through
which they are to: obtain and use the authorized octaplasLG Powder.
°For example, through pre-deployineilttnlining, hard. copy, web posting, etc:
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68634
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
Page 8 - Octapharma
R. DoD will train applicable DoD components on the use of the authorized octaplasLG
Powder in accordance with this EUA and any applicable DoD procedures or protocols.
S. DoD will make available to applicable DoD components through applicable DoD
communication channels and procedures the authorized Fact Sheet for Health Care
Professional or Other Authorized Providers, the authorized Fact Sheet for Recipients, and
any other Fact Sheets that FDA may authorize, as well as any authorized amendments
thereto. 11 U.S. military medical personnel or other authorized providers administering the
authorized octaplasLG Powder will ensure that the authorized Fact Sheet for Recipients
has been made available to U.S. military forces that receive octaplasLG Powder through
appropriate means, to the extent feasible given the emergency circumstances. Under
exigent circumstances, other appropriate means for disseminating these Fact Sheets may
be used. 12
T. DoD will infonn applicable DoD components about the need to have a process in place
for performing adverse event monitoring designed to ensure that suspected adverse
reactions and all medication errors associated with the use of the authorized octaplasLG
Powder are report.ed to Octapharma, to the extent practicable given emergency
circumstances, in according with the conditions of the EUA. Submitted reports should
state that octaplasLG Powder was used under an EUA.
U. DoD will have a process in place for recording and reporting of data, as outlined in a
CRADA to be established between DoD and Octapharma. These data will be recorded
whenever octaplasLG Powder is transfused to patients to the extent reasonable and
practicable given the emergency circumstances. Collected data will include suspected
adverse reactions and any medication errors associated with the use of the authorized
octaplasLG Powder.
V. DoD will report to Octapharma, as soon as reasonably possible, any serious and
unexpected suspected adverse reaction that is not described under 'Risks and Adverse
Events' in the authorized Fact Sheet for Health Care Professionals or Other Authorized
Providers and any suspected adverse reaction resulting in death.
W. DoD will ensure that the authorized octaplasLG Powder is distributed for use under its
direction within the expiry dating on the manufacturer's labeling
X. Per the tenns ofthe CRADA with Octapharma, DoD will work with Octapharma to
ensure that any records a~sociated with the use of this product under this EU A are
maintained, to the extent practicable given the emergency circumstances, until notified
by FDA. Upon request by FDA7 DoD will make available these and any other records
maintained in connection with this letter.
For example, through pre-deployment training, hard copy, web posting, etc.
FDA recognizes that the complex environment in which octaplasLG Powder may be used may prevent
dissemination of Fact Sheets at the time of use of the octaplasLG Powder. Therefore, "other appropriate means" may
include activities such.as DoD components sharing the Fact Sheet for Recipients with US. military forces in predeployment or other training.
11
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12
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
68635
Page 9 - Octapharma
Y. DoD will promptly notify FDA of any suspected or conrmned quality, manufacturing,
distribution, and/or other issues with the OctaplasLG Powder of which it becomes
aware.
Conditions Related to Descriptive Printed Material
Z. All descriptive printed matter relating to the use of the authorized octaplasLG Powder
shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set
forth in this EUA and the applicable requirements set forth in the Act and FDA
regulations.
AA. All descriptive printed matter relating to the use of the authorized octaplastG Powder
shall clearly and conspicuously state that:
• This product has not been FDA approved or licensed;
• This product has been authorized by FDA under an EUA for use by DoD;
• This product has been authorized only 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; and
• This product is only authorized for the duration ofthe declaration that circumstances
exist justifying the. authorization of the emergency use of octaplasLG Powder 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, under section
564(b)(l)ofthe Act, 21 U.S.C. § 360bbb-3(b)(l), unless the.authorization.is
terminated or revoked sooner.
No descriptive printed matterrelating to the use of the authorized octaplasLG Powder
may represent or suggest that this product is safe or effective for the treatment of
hemorrhage or coagulopathy during an emergency involving agents ofmilitary combat
(e.g., firearms, projectiles, and explosive devices) when plasma is not available fot use
or when the use of plasma is not practical.
Page 1() -Octapharma
V. Duration ot:Anthorization
This EUA will be effe.ctive until the declara_tion that circ,umstances existjusti{yingthe
authorization of the emergency use•of octaplasLG Powder for the treatment ofhemorrhage or
coagulopathy during·an.emergency involving agents ofmilitary combat (e,g., firearms,
projeetiles,andexplosivedevices)when. plasma.is rtotavailabfofotuse orwhentheuseof
plasma isnot practfoalJs tennirtated uttdersectionS64(b)(2)ofthe Act or the EtJAis revoked
undersection 564(g}ofthe Act,
siricereiy,
¥:!:~iigiiedliyPeiei-W~
..,,i'~i:wo~oi4:~ura10;34,t4
EN27AU24.016</GPH>
PeterW.Marks,M.D., Ph;D.
Dir:ector
Gen~rfor: Bi◊logfos E:valuatio11: itjid Re$ear¢h
Enclosures
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PeterW.
M,rrks-S
68636
Federal Register / Vol. 89, No. 166 / Tuesday, August 27, 2024 / Notices
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2024–18971 Filed 8–26–24; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: 0937–0191–30D]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 26,
2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
SUMMARY:
When submitting comments or
requesting information, please include
the document identifier 0937–0191–30D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Type of Collection: Reinstatement,
with no change.
OMB No.: 0937–0191.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center, Federal Real Property
Assistance Program is requesting OMB
approval on a previously approved
information collection, 0937–0191. 40
U.S.C. 550 (the ‘‘Act’’), as amended,
provides authority to the Secretary of
Health and Human Services to convey
or lease surplus real property to States
and their political subdivisions and
instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which (except for
institutions which lease property to
assist the homeless) have been held
exempt from taxation under Section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health and
homeless assistance purposes. Transfers
are made to transferees at little or no
cost.
Type of Respondent: Responses are
dependent on when Federal surplus real
property is made available and is
desired by a respondent/applicant for
acquisition. Likely respondents include
State, local, or tribal units of
government or instrumentalities thereof,
and not-for-profit organizations.
ESTIMATED ANNUALIZED BURDEN TABLE
Total
burden
hours
Applications for surplus Federal real property ...............................
............................
10
1
200
2,000
Total ........................................................................................
............................
10
1
200
2,000
[FR Doc. 2024–19250 Filed 8–26–24; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7082–N–07]
60-Day Notice of Proposed Information
Collection: Disaster Recovery Grant
Reporting System (DRGR), OMB
Control No.: 2506–0165
Office of Community Planning
and Development, HUD.
ACTION: Notice.
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
Average
burden per
response
Respondents
(if necessary)
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
SUMMARY:
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Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
parties on the proposed collection of
information. The purpose of this notice
is to allow for 60 days of public
comment.
DATES: Comments Due Date: October 28,
2024.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Written comments and
recommendations for the proposed
information collection can be sent
within 60 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this information
collection by selecting ‘‘Currently under
60-day Review—Open for Public
Comments’’ or by using the search
function. Interested persons are also
invited to submit comments regarding
this proposal and comments should
refer to the proposal by name and/or
OMB Control Number and should be
sent to: Colette Pollard, Clearance
Officer, REE, Department of Housing
and Urban Development, 451 7th Street
SW, Room 8210, Washington, DC
PO 00000
Frm 00061
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20410–5000; email
PaperworkReductionActOffice@
hud.gov.
FOR FURTHER INFORMATION CONTACT:
Tennille Smith Parker, Director, Disaster
Recovery and Special Issues Division,
email Tennille.Parker@HUD.gov,
telephone (202) 402–4649 or Robert C.
Peterson, Director of State and Small
Cities, email Robert.C.Peterson@
hud.gov, Office of Block Grant
Assistance, telephone (202) 402–4211,
Department of Housing and Urban
Development, 451 7th Street SW,
Washington, DC 20410. HUD welcomes
and is prepared to receive calls from
individuals who are deaf or hard of
hearing, as well as individuals with
speech or communication disabilities.
To learn more about how to make an
accessible telephone call, please visit
https://www.fcc.gov/consumers/guides/
telecommunications-relay-service-trs.
Copies of available documents
submitted to OMB may be obtained
from Ms. Pollard.
E:\FR\FM\27AUN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 68626]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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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