83_FR_40215 83 FR 40059 - Authorization of Emergency Use of a Freeze Dried Plasma Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability

83 FR 40059 - Authorization of Emergency Use of a Freeze Dried Plasma Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 156 (August 13, 2018)

Page Range40059-40070
FR Document2018-17303

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.

Federal Register, Volume 83 Issue 156 (Monday, August 13, 2018) 
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40059-40070]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40059 organizations with common interests are major and imminently life-threatening used in emergencies to diagnose, treat, urged to consolidate or coordinate, and combat casualties involving or prevent serious or life-threatening request time for a joint presentation. No uncontrolled hemorrhage. On the basis diseases or conditions caused by commercial or promotional material of such determination, the Department biological, chemical, nuclear, or will be permitted to be presented or of Health and Human Services (HHS) radiological agents and other agents that distributed at the public workshop. Secretary declared on July 9, 2018, that may cause, or are otherwise associated Transcripts: As soon as a transcript is circumstances exist justifying the with, an imminently life-threatening available, FDA will post it at https:// authorization of emergency use of freeze and specific risk to U.S. military forces www.fda.gov/Drugs/NewsEvents/ dried plasma for the treatment of when there are no adequate, approved, ucm607276.htm. hemorrhage or coagulopathy during an and available alternatives. emergency involving agents of military Section 564(b)(1) of the FD&C Act Dated: August 8, 2018. combat (e.g., firearms, projectiles, and provides that, before an EUA may be Leslie Kux, explosive devices) when plasma is not issued, the Secretary of HHS must Associate Commissioner for Policy. available for use or when the use of declare that circumstances exist [FR Doc. 2018–17272 Filed 8–10–18; 8:45 am] plasma is not practical, subject to the justifying the authorization based on BILLING CODE 4164–01–P terms of any authorization issued under one of the following grounds: (1) A the FD&C Act. The Authorization, determination by the Secretary of which includes an explanation of the Homeland Security that there is a DEPARTMENT OF HEALTH AND reasons for issuance, is reprinted in this domestic emergency, or a significant HUMAN SERVICES document. potential for a domestic emergency, DATES: The Authorization is effective as involving a heightened risk of attack Food and Drug Administration with a biological, chemical, radiological, of July 9, 2018. [Docket No. FDA–2018–N–3009] ADDRESSES: Submit written requests for or nuclear agent or agents; (2) a single copies of the EUA to the Office determination by the Secretary of Authorization of Emergency Use of a of Counterterrorism and Emerging Defense that there is a military Freeze Dried Plasma Treatment for Threats, Food and Drug Administration, emergency, or a significant potential for Hemorrhage or Coagulopathy During 10903 New Hampshire Ave., Bldg. 1, a military emergency, involving a an Emergency Involving Agents of Rm. 4338, Silver Spring, MD 20993– heightened risk to U.S. military forces, Military Combat; Availability 0002. Send one self-addressed adhesive including personnel operating under the label to assist that office in processing authority of title 10 or title 50, United AGENCY: Food and Drug Administration, States Code, of attack with (i) a HHS. your request or include a fax number to which the Authorization may be sent. biological, chemical, radiological, or ACTION: Notice. nuclear agent or agents; or (ii) an agent See the SUPPLEMENTARY INFORMATION section for electronic access to the or agents that may cause, or are SUMMARY: The Food and Drug otherwise associated with, an Administration (FDA) is announcing the Authorization. imminently life-threatening and specific issuance of an Emergency Use FOR FURTHER INFORMATION CONTACT: risk to U.S. military forces; 1 (3) a Authorization (EUA) (the Authorization) Michael Mair, Office of determination by the Secretary of HHS for a freeze dried plasma treatment for Counterterrorism and Emerging Threats, that there is a public health emergency, hemorrhage or coagulopathy during an Food and Drug Administration, 10903 or a significant potential for a public emergency involving agents of military New Hampshire Ave., Bldg. 1, Rm. health emergency, that affects, or has a combat (e.g., firearms, projectiles, and 4340, Silver Spring, MD 20993–0002, significant potential to affect, national explosive devices) when plasma is not 301–796–8510 (this is not a toll-free security or the health and security of available for use or when the use of number). U.S. citizens living abroad, and that plasma is not practical. FDA issued this SUPPLEMENTARY INFORMATION: involves a biological, chemical, Authorization under the Federal Food, radiological, or nuclear agent or agents, Drug, and Cosmetic Act (FD&C Act), as I. Background or a disease or condition that may be requested by the U.S. Department of Section 564 of the FD&C Act (21 attributable to such agent or agents; or Defense (DoD). The Authorization U.S.C. 360bbb–3) as amended by the (4) the identification of a material threat contains, among other things, Project BioShield Act of 2004 (Pub. L. by the Secretary of Homeland Security conditions on the emergency use of the 108–276), the Pandemic and All- under section 319F–2 of the Public authorized treatment. The Authorization Hazards Preparedness Reauthorization Health Service (PHS) Act (42 U.S.C. follows the June 7, 2018, determination Act of 2013 (Pub. L. 113–5), 21st 247d–6b) sufficient to affect national by the Deputy Secretary of Defense that Century Cures Act (Pub. L. 114–255), security or the health and security of there is a military emergency or and Public Law 115–92 (2017), allows U.S. citizens living abroad. significant potential for a military FDA to strengthen the public health Once the Secretary of HHS has emergency, involving a heightened risk protections against biological, chemical, declared that circumstances exist to U.S. military forces of an attack with nuclear, and radiological agents and justifying an authorization under an agent or agents that may cause, or are other agents that may cause, or are section 564 of the FD&C Act, FDA may otherwise associated with an otherwise associated with, an authorize the emergency use of a drug, imminently life-threatening and specific imminently life-threatening and specific device, or biological product if the risk to those forces. The Deputy risk to U.S. military forces. Among other sradovich on DSK3GMQ082PROD with NOTICES Agency concludes that the statutory Secretary of Defense further stated that, things, section 564 of the FD&C Act criteria are satisfied. Under section more specifically, U.S. forces are now allows FDA to authorize the use of an deployed in multiple locations where unapproved medical product or an 1 In the case of a determination by the Secretary they serve at heightened risk of an unapproved use of an approved medical of Defense, the Secretary of HHS shall determine, within 45 calendar days of such determination, enemy attack with agents of military product in certain situations. With this whether to make a declaration under section combat, including firearms, projectiles, EUA authority, FDA can help assure 564(b)(1) of the FD&C Act, and, if appropriate, shall and explosive devices, that may cause that medical countermeasures may be promptly make such a declaration. VerDate Sep<11>2014 20:42 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1

40060 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 564(h)(1) of the FD&C Act, FDA is prevent, or treat such disease or determination, the Secretary of HHS required to publish in the Federal condition, outweigh the known and declared that circumstances exist Register a notice of each authorization, potential risks of the product, taking justifying the authorization of and each termination or revocation of an into consideration the material threat emergency use of freeze dried plasma authorization, and an explanation of the posed by the agent or agents identified for the treatment of hemorrhage or reasons for the action. Section 564 of the in a declaration under section coagulopathy during an emergency FD&C Act permits FDA to authorize the 564(b)(1)(D) of the FD&C Act, if involving agents of military combat introduction into interstate commerce of applicable; (3) that there is no adequate, (e.g., firearms, projectiles, and explosive a drug, device, or biological product approved, and available alternative to devices) when plasma is not available intended for use when the Secretary of the product for diagnosing, preventing, for use or when the use of plasma is not HHS has declared that circumstances or treating such disease or condition; (4) practical, subject to the terms of any exist justifying the authorization of in the case of a determination described authorization issued under section 564 emergency use. Products appropriate for in section 564(b)(1)(B)(ii), that the of the FD&C Act. Notice of the emergency use may include products request for emergency use is made by declaration of the Secretary of HHS was and uses that are not approved, cleared, the Secretary of Defense; and (5) that published in the Federal Register on or licensed under sections 505, 510(k), such other criteria as may be prescribed July 16, 2018 (83 FR 32884) and a 512, or 515 of the FD&C Act (21 U.S.C. by regulation are satisfied. correction was published in the Federal 355, 360(k), 360b, and 360e) or section No other criteria for issuance have Register on July 31, 2018 (83 FR 36941). 351 of the PHS Act (42 U.S.C. 262), or been prescribed by regulation under On July 9, 2018, DoD requested, and on conditionally approved under section section 564(c)(4) of the FD&C Act. July 9, 2018, FDA issued, an EUA for 571 of the FD&C Act (21 U.S.C. 360ccc). Because the statute is self-executing, Pathogen-Reduced Leukocyte-Depleted FDA may issue an EUA only if, after regulations or guidance are not required Freeze Dried Plasma manufactured by consultation with the HHS Assistant for FDA to implement the EUA the Centre de Transfusion Sanguine des Secretary for Preparedness and authority. Armées (CTSA) (for purposes of this Response, the Director of the National EUA, ‘‘French FDP’’), subject to the Institutes of Health, and the Director of II. EUA Request for a Freeze Dried terms of the Authorization. the Centers for Disease Control and Plasma Treatment for Hemorrhage or Prevention (to the extent feasible and Coagulopathy During an Emergency III. Electronic Access appropriate given the applicable Involving Agents of Military Combat An electronic version of this circumstances), FDA 2 concludes: (1) When Plasma Is Not Available for Use document and the full text of the That an agent referred to in a or When the Use of Plasma Is Not Authorization are available on the declaration of emergency or threat can Practical internet at https://www.regulations.gov. cause a serious or life-threatening On June 7, 2018, the Deputy Secretary disease or condition; (2) that, based on IV. The Authorization of Defense determined that ‘‘there is a the totality of scientific evidence military emergency or significant Having concluded that the criteria for available to FDA, including data from potential for a military emergency, issuance of the Authorization under adequate and well-controlled clinical involving a heightened risk to U.S. section 564(c) of the FD&C Act are met, trials, if available, it is reasonable to military forces of an attack with an FDA has authorized the emergency use believe that: (A) The product may be agent or agents that may cause, or are of a freeze dried plasma treatment for effective in diagnosing, treating, or otherwise associated with an the treatment of hemorrhage or preventing (i) such disease or condition; coagulopathy during an emergency imminently life-threatening and specific or (ii) a serious or life-threatening involving agents of military combat risk to those forces.’’ The Deputy disease or condition caused by a (e.g., firearms, projectiles, and explosive Secretary of Defense further stated that, product authorized under section 564, devices) when plasma is not available ‘‘[m]ore specifically, U.S. [f]orces are approved or cleared under the FD&C for use or when the use of plasma is not now deployed in multiple locations Act, or licensed under section 351 of the practical, subject to the terms of the where they serve at heightened risk of PHS Act, for diagnosing, treating, or Authorization. The Authorization in its an enemy attack with agents of military preventing such a disease or condition entirety (not including the authorized combat, including firearms, projectiles, caused by such an agent; and (B) the versions of the fact sheets and other and explosive devices, that may cause known and potential benefits of the written materials) follows and provides major and imminently life-threatening product, when used to diagnose, an explanation of the reasons for combat casualties involving uncontrolled hemorrhage.’’ On July 9, issuance, as required by section 2 The Secretary of HHS has delegated the 2018, under section 564(b)(1) of the 564(h)(1) of the FD&C Act. authority to issue an EUA under section 564 of the FD&C Act to the Commissioner of Food and Drugs. FD&C Act, and on the basis of such BILLING CODE 4164–01–P sradovich on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 20:42 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1

mA U.S.FOOD & prug A D NHNESTRATECH July 9, 2018 Robert E. Miller, Ph.D. Senior Regulatory Affairs Advisor Office of Regulated Activities Department of the Army Headquarters, U.S. Army Medical Research and Materiel Command 1430 Veterans Drive Fort Detrick, MD 21702—5009 Dear Dr. Miller: This letter is in response to your request that the Food and Drug Administration {FDAy issue an Emergency Use Authorization (EUA) for emergency use of Pathogen—Reduced Leukocyte— Depleted Freeze Dried Plasma manufactured by the Centre de Transfusion Sanguine des Armées (CTSA) (for purposes of this EVUA, "French FDP"Y for U.S. military forces* for the treatment of hemorrhage or coagulopathy daoring an emergency involving agents of military combat (e4., 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 Actf (21 U.S.C. § 360bb6b—39.3 On June 7, 2018, pursuant to section 564(bYTHB) of the Act{21 U.S.C. § 360bbb—3(b) 1 YB), the Deputy Secretary of the Department of Defense (DoD) 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 fife—threatening and specific:risk to those forees."*"** Pursuant to section *Oin the date of issuance of this EUA, the authorized French FDP product under this EUA refers specifically to French FDP product that is manufactured using French—derived, pathopgen—reduced, Leukocyte—Depleted freah frozen plasima (FFP). As discussed in Section II of this letter, at this time the authorized Freach FDP product unider this EUA does not include French FDP that is manufactured vsing Department of Defense (DoDYderived plasma or other U.S.—derived plasma. *For purposes of this EL A, to meet DoD military need$ "ULS. military forces" may include U.S, troops and military members of an allied force or other personnel sperating with DoD. Also, for purposes of this EUA, it is anticipated that U.8, military medical personnel trained in the use of Freach FDP will administer the authorized Freach FDP to U:S —milftary forces. However, in the event the operational environment prevents such administration, it is possible that othertrained U.S. military forees may need to administer the authoriged French FDP during an emergency as set forth in this authorization. * At the time of fsxuance of this EUA, Freach FDOP was approved in at least onc country (he., France) but not approved in the U;8. This EUA, including its Conditions of Authorization in Section IV, applics only to French FDFP product that is manufactured and distributed by Centre de Transfusion Sunguine des Armées (CT SA )Jand its authorized agent(s) specifically for DoD procurementand further DoB distribution; stockpiling, and use during an emergency as set forth in this authorization; * oD. Lefter to the HHS Secretaiy issuing a determination ofa milttary emergency, or significant potentialfor a milttary emergency, and requesting a declaration under section 364 ofthe Federal Food, Drug, and Cosmetic Act. June 7. 2018.

Page 2 —Dr. Miller, DoD 564(b)(1) of the Act (211.S5.C; $360bbb—3(b)(1)), and on the basis of such determination, on July 9, 2018, the Secretary ofthe Department of Health and Human Services (HHS) then declared that circumstances exist justifying the authori¥ation of emergency use of FDP for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (eg., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, subject to the terms of any authorization issued under 21 USKC. § 360bbb—3(a)." DoD requested this EUA so that French FDFP, which is not FDA—approved, may be distributed and held by DoD for preparedness purposes in advance of an actual threat of agents of military combat (e.g., firearms, projectiles, and explosive devices) that may cause, or are otherwise associated with, an imminently hfe—threatening and specific risk to U.S. military forces, with the intent that it may be administered by U:.S. military medical personnel during an event or post— event for the treatment of hemorrhage or coagulopathy caused by exposure to such agents when plasma is not available for use or when the use of plasma is not practical. An EUA is needed to facilitate DoD pre—event planning and preparedness activities related to the use ofthis unapproved product to enable activities to support raplid administration. of treatment during an actual emergency event involving the threat of agents of military combat (e_g., firearms, projectiles, and explosive devices) that may cause, or are otherwise associated with, an imminently life—threatening ind specific risk to U.S, military forces. This EUA is important for supporting military emergency response because it enables rapid initiation oftreatment with French FDP during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) that may cause, or are otherwise associated with, an imminently life—threatening and specificrisk to U.$. military forees, without FDA or DoD having to take further action with respect to otherwise applicable requirements under federal faw. Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act{(2] ULSXLL, § 360bbbh—3(c)) are met, 1 am anthonzmg the emergency use of French FDP {as described in the Scope of Authorization section ofthis letter (Section 11)) 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 Hfe—threatemng and specifi¢c riak to U.S. military forces when plasma is not available for use or when the use of plasma is not practical, subject to the terms of this authorization. * Acamended by H.R, 4374 (Pub L. No: 115—93, December 12; 2017}, under section $64(B)(D(B) of the Act, the Secretary of Defense may make a determination that there is a rilitary emergency, or a significant potential for a anliary emergency; involving a heightened risk to United States military forces. including personnel operating under the authority oftitle 10 ortitle 50; of attack with—(f} a biological, chentical, radiological, ormuclear agent or agents; or (i) an agent or agents that may cause, or are otherwise associated. with, an inmmminently iHo—threatening and specific risk to United States military forces, * When the DoD Secretary makes such a determination, the Seeretary of Health and Human Services (HHS) shall determine, within 45 calendar days ofsuch determination, whether to make a declaration that circumstances exist 10 justify EUA issuance and, if appropriate, shall prompily make such a declaration. ‘HHS. Declgration that Ciroumstances Exist Justifying on Authorization Pursuant to Section 264 ofthe Federal Foad, Drug. and Cosmetic Act, 21 USC. $ 260bbb—3(b) July 9, 2018.

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40064 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices The sradovich on DSK3GMQ082PROD with NOTICES EN13AU18.004</GPH> VerDate Sep<11>2014 20:42 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4725 E:\FR\FM\13AUN1.SGM 13AUN1

Page 5 —BDr. Miller, DoD accompanied by the following information pertaining to the emergency use, which is authorized to be made available to U.S. military medical personnel and U.8. military forces ("recipients") to facilitate understanding of the treatment of hemorrhage or coagulopathy durmg 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 plasima is not practical, the risks and benefits of French FDP, and proper administration: * Fact Sheet for ULS. Military Medical Personnel * Fact Sheet for Recipients Other Fact Sheets developed by DoD in consultation with, and with concurrence of, OBRR/CBER, CT/ODVCBER, and OCET/OCS/OC may be authorized to accompany the above described French FDP and to be made available to U.S, military medical personnel and LLS. milifary forces, as appropriate. As described in Section TV below, Do is also authorized to make available additional information relating to the emergency use of the authorized French FDP that is reasonably consistent with, and does not exeeed, the terms of this lefter of authorization. Authorized French FDP is authorized to have its manufacturer labeled expiry dating extended by OBRR/CBER, CTHOD/CBER, and QOCET/OCS/OC based on scientific data supporting such an extension. 1 have concluded, pursuant to section 564(d){2) of the Act, that it is reasonable to believe that the known and potential benefits ofthe authorized French FDP in the specified population, when used for the treatment ofhemorrhage or coagulopathy during an emergency imvolving 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 H), outweigh the known and potential risks ofsuch a product. Ubave concluded, pursuant to section 564(d)(3) of the Act, based on the totality ofscientific evidence available‘to FDA, that it is reasonable—to believe that the authorized French FDP 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 ofplasma is not practical, when used consistently with the Scope of Authorization ofthis letter (Section (), pursuant to section §564(c¥7XA) ofthe Act. FDA has reviewed the scientific information available to FDA, incloding the information supporting the conclusions described in Section T above, and concludes that the authorized French FDP, when used for the treatment of hemorrhage or coagulopathy during an emergency involving agents of milftary combat (e.g., firearms, 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 [1y), meets the criteria set forth in section 564(c) of the Act—concerning safety and potential effectiveness.

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Page 8 — Dr. Miller, DoBD development of additional Fact Sheets. Such requests will be made by Dold in consultation with, and require concurrence of, OBRR/CBER, CTYODVCBER, and OcETOCs/OC. L._ DoD is authorized to issue additional recommendations and instructions related to the emergency use ofthe authorized French FDP as described in this letter of authorization, to the extrent that additional recommendations and instructions are necessary to meet military needs during an emergency involving agents of military combat (e.g., firearms, projectites, and explosgive devices) when plasma is not available for use or when the: use of plasma is not practical when they are reasonably consistent with the guthorized emergency use of the product. 1. DoD may request changes to the authorized labeling (e.g.. carton and container labels, label on each packaged unit, technical notice and summary ofproduct characteristics) and authorized packaging for the authorized French FDP, of to the manufacturing, labeling, and packaging processes of CTSA or its authorized agent(s) for the authorized product. Such requests will be made by DoD in consultation with, and require concurrence of, OBRRCRBER, ODV/CT/ACBER, and OCET/OCSOC. K. DoD may request the authorization of additional sources ofplasma (e.g., DoD—derived or other U.S.—derived) of the authorized French FDP under this EUA. Such requests will be made by DoD in consultation with, and require concurrence of, OHRR/CBER, OB/CT/ACRBER, and OCET/OCS/OC. L. DoD will inform applicable DoD components about the need to have a process in place for performing adverse event monitorimg and compliance activities designed to ensure that adverse events and all medication errors associated with the use of the authorized French FDP are:reported to FDA, to the extent practicable given emergency cireumstances, as follows: complete the MedWatch FDA Form 3500 online at wiwoy. cdg. ooy rmuhvatecl, by using a postage—paid MedWatch Form 3500 (available at hi nvoscocecels tdpey seripts medwstch ndexatin"ache itrg.henl, or by calling 1—800—FDA—1088. Submitted reports should state that French FDP was used under an EUA DoD will conduct any follow—up requested by FDA regarding adverse events, to the extent feasible given the emergency circumstances, M. DoD will ensure that the authorized Freanch FDP is distributed for use underits direction within the expiry dating on the manufacturer‘s fabeling. If FDA authorizes any expiry dating extensions of the authorized Freach FDP underthis EUA, DoD will inform applicable DoD components holding and/or receiving the authorized French FDP of such extensions and any conditions related to such extensions under this EUA. DoD will maintain adequate records regarding the expiry dates by which authorized Freach FDP may be used. N. DoD will inform CTSA about this EUA and its Conditions of Authorization, including the Conditions Related to Descriptive Printed Material outlined below.

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40070 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices Dated: August 7, 2018. ACTION: Notice. Ave., Bldg. 75, Rm. 1671, Silver Spring, Leslie Kux, MD 20993–0002, 240–402–7945, Associate Commissioner for Policy. SUMMARY: The Food and Drug Trang.Tran@fda.hhs.gov. [FR Doc. 2018–17303 Filed 8–10–18; 8:45 am] Administration (FDA or Agency) is withdrawing approval of 20 abbreviated SUPPLEMENTARY INFORMATION: The BILLING CODE 4164–01–C new drug applications (ANDAs) from holders of the applications listed in the multiple applicants. The holders of the table have informed FDA that these drug DEPARTMENT OF HEALTH AND applications notified the Agency in products are no longer marketed and HUMAN SERVICES writing that the drug products were no have requested that FDA withdraw longer marketed and requested that the approval of the applications under the Food and Drug Administration approval of the applications be process described in § 314.150(c) (21 withdrawn. CFR 314.150(c)). The applicants have [Docket No. FDA–2018–N–2876] DATES: Approval is withdrawn as of also, by their requests, waived their Fougera Pharmaceuticals, Inc., et al.; September 12, 2018. opportunity for a hearing. Withdrawal Withdrawal of Approval of 20 of approval of an application or FOR FURTHER INFORMATION CONTACT: Abbreviated New Drug Applications abbreviated application under Trang Tran, Center for Drug Evaluation § 314.150(c) is without prejudice to AGENCY: Food and Drug Administration, and Research, Food and Drug HHS. Administration, 10903 New Hampshire refiling. Application No. Drug Applicant ANDA 060133 ...................... Chloramphenicol Ophthalmic Ointment, 1% ................... Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. ANDA 060572 ...................... Mycolog II (nystatin and triamcinolone acetonide) Oint- Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., ment USP, 100,000 units/gram (g) and 0.1%. P.O. Box 4310, Morgantown, WV 26504. ANDA 061107 ...................... Hydrocortisone Acetate and Neomycin Sulfate Oint- Fougera Pharmaceuticals, Inc.. ment, 0.5%/0.5% and 1.5%/0.5%. ANDA 061988 ...................... Polycillin (ampicillin) Capsules, 250 milligrams (mg) and Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 500 mg. 08543. sradovich on DSK3GMQ082PROD with NOTICES ANDA 072097 ...................... Cap-Profen (ibuprofen) Tablets USP, 200 mg (White) ... L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010. ANDA 072098 ...................... Ibuprofen Tablets, 200 mg (Brown) ................................ Do. ANDA 074334 ...................... Vecuronium Bromide for Injection, 10 mg/vial and 20 Watson Laboratories, Inc., Subsidiary of Teva Pharma- mg/vial. ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074874 ...................... Pentoxifylline Extended-Release Tablets, 400 mg ......... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. EN13AU18.010</GPH> VerDate Sep<11>2014 21:07 Aug 10, 2018 Jkt 244001 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 E:\FR\FM\13AUN1.SGM 13AUN1


Document Created: 2018-08-11 00:27:20
Document Modified: 2018-08-11 00:27:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe Authorization is effective as of July 9, 2018.
ContactMichael 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).
FR Citation83 FR 40059 
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