[Federal Register Volume 83, Number 147 (Tuesday, July 31, 2018)]
[Notices]
[Pages 36941-36942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16331]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Emergency Use of Treatment for Uncontrolled Hemorrhage Due to 
Agents of Military Combat; Correction

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice, correction.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services is correcting a 
notice that appeared in the Federal Register on July 16, 2018. The 
notice announced the Secretary's Declaration Regarding Emergency Use of 
Treatment for Uncontrolled Hemorrhage During an Emergency Involving 
Agents of Military Combat pursuant to section 564 of the Federal Food, 
Drug & Cosmetic (FD&C) Act. On July 9, 2018, the Secretary declared 
that circumstances exist justifying the authorization of emergency use 
of freeze dried plasma (FDP) 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 FD&C Act, subject to the terms of any 
authorization issued under that section. This notice is correcting the 
July 16, 2018 notice to correctly state the Secretary's declaration.

FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, 
Assistant Secretary for Preparedness and Response, Office of the 
Secretary, Department of Health and Human Services, 200 Independence 
Avenue SW, Washington, DC 20201, Telephone (202) 205-2882 (this is not 
a toll free number).

SUPPLEMENTARY INFORMATION: In the Federal Register of July 16, 2018 (83 
FR 32884) appearing on page 32884 in FR Doc. 2018-15152 the following 
corrections are made:
    1. Title, change the title of the notice to ``Declaration Regarding 
Emergency Use of Treatment for Hemorrhage or Coagulopathy During an 
Emergency Involving Agents of Military Combat.''
    2. Summary section, change the second paragraph to: '' On the basis 
of this determination, on July 9, 2018, the Secretary declared that 
circumstances exist justifying the authorization of emergency use of 
freeze dried plasma (FDP) 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 FD&C Act, subject to the terms of any 
authorization issued under that section.''
    3. Supplementary Information section, subpart I, Background, second 
paragraph second sentence, delete ``French'' before ``FDP.''
    4. Supplementary Information section, subpart III, Determination of 
the Secretary of Health and Human Services, change paragraph 1 to: ``On 
July 9, 2018, on the basis of the Deputy Secretary of Defense's 
determination 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, I declared that circumstances exist 
justifying the authorization of emergency use of FDP 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 FD&C Act, subject to the 
terms of any authorization issued under that section.''


[[Page 36942]]


    Dated: July 25, 2018.
Ann Agnew,
Executive Secretary to the Department, U.S. Department of Health and 
Human Services.
[FR Doc. 2018-16331 Filed 7-30-18; 8:45 am]
BILLING CODE P