Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat; Correction, 36941-36942 [2018-16331]

Download as PDF Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES daltland on DSKBBV9HB2PROD with NOTICES National Committee on Vital and Health Statistics: Meeting Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics (NCVHS), Full Committee Meeting. Date and Times: Thursday, September 13, 2018: 9:00 a.m.–5:00 p.m. (EDT); Friday, September 14, 2018: 8:30 a.m.– 3:00 p.m. (EDT). Place: Melrose Georgetown Hotel, 2430 Pennsylvania Avenue NW, Washington, DC 20037. Status: Open. Purpose: At the September 13–14, 2018 meeting, the Committee will hear presentations, hold discussions on several health data policy topics and continue work on projects outlined in the NCVHS 2018 workplan. Anticipated action items during this meeting include an Environmental Scan Report on Health Terminologies and Vocabularies (T/V); and a summary report of the health T/V expert roundtable meeting held July 17–18, 2018. The NCVHS Population Health Subcommittee will hold a session with panelists to provide input to the Committee regarding strategies and resources/tools to increase access to small area data, and in general, the challenges in making relevant sub-national level health data more readily available. Subcommittee activities for discussion include the Predictability Roadmap as part of the Standards Subcommittee’s project to identify possible approaches to improve predictability and improvements in the adoption and processes related to updating standards and operating rules for electronic administrative transactions (e.g., claims, eligibility, electronic funds transfer). The Privacy, Confidentiality & Security Subcommittee will continue its focus on use cases that highlight the intersection of the regulated and unregulated domains for its ‘‘Health Information Privacy and Security Beyond HIPAA’’ project, and will propose a model that depicts the opportunities to address risks to individually identifiable information through improved stewardship for consideration by the full Committee. The Committee will initiate discussion regarding plans for the NCVHS Thirteenth Report to Congress. The agenda times and topics are subject to change. There will be a public VerDate Sep<11>2014 18:30 Jul 30, 2018 Jkt 244001 comment period on both meeting days. Please refer to the posted agenda for any updates. Contact Persons for More Information: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458–4715. Summaries of meetings and a roster of Committee members are available on the home page of the NCVHS website: www.ncvhs.hhs.gov, where further information including an agenda and instructions to access the audio broadcast of the meetings will be posted. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488–3210 as soon as possible. Dated: July 25, 2018. Laina Bush, Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2018–16361 Filed 7–30–18; 8:45 am] BILLING CODE 4151–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat; Correction Office of the Secretary, Department of Health and Human Services. ACTION: Notice, correction. AGENCY: 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, SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 36941 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). 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.’’ SUPPLEMENTARY INFORMATION: E:\FR\FM\31JYN1.SGM 31JYN1 36942 Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Meeting daltland on DSKBBV9HB2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Aging. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Aging. Date: September 13–14, 2018. Closed: September 13, 2018, 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, C Wing 6th Floor Conference Room 10, 9000 Rockville Pike, Bethesda, MD 20892. Open: September 14, 2018, 8:00 a.m. to 12:45 p.m. Agenda: Call to order and report from the Director; Discussion of future meeting dates; Consideration of minutes of last meeting; Reports from Task Force on Minority Aging Research, Working Group on Program; Council Speaker; Program Highlights. Place: National Institutes of Health, Building 31, C Wing 6th Floor Conference Room 10, 9000 Rockville Pike, Bethesda, MD 20892. Contact Person: Robin Barr, Director, National Institute on Aging, Office of Extramural Activities, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20814, (301) 496–9322, barrr@nia.nih.gov. VerDate Sep<11>2014 18:30 Jul 30, 2018 Jkt 244001 Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page:www.nia.nih.gov/about/naca, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: July 25, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–16294 Filed 7–30–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Microbiology, Infectious Diseases and AIDS Initial Review Group Acquired Immunodeficiency Syndrome Research Review Committee. Date: August 30–31, 2018. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: San Diego Marriott Mission Valley, 8757 Rio Diego Drive, San Diego, CA 92108. Contact Person: Robert C. Unfer, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3F40A, National Institutes of Health, PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892–9834, (240) 669–5035, robert.unfer@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: July 25, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–16296 Filed 7–30–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Quantitative Imaging Tools and Methods for Cancer Therapy Response Assessment (UG3/ UH3 & U01). Date: September 7, 2018. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 7W640, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Saejeong J. Kim, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W640, Bethesda, MD 20892–9750, 240–276–5179, saejeong.kim@ nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project II. Date: September 20–21, 2018. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852. Contact Person: Anita T. Tandle, Ph.D., Scientific Review Officer, Research Program E:\FR\FM\31JYN1.SGM 31JYN1

Agencies

[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]


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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
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