[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66006-66007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Blood and Tissue Safety and 
Availability

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

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Advisory Committee on Blood and Tissue Safety and Availability 
(ACBTSA) will hold a meeting. The meeting will be open to the public.

DATES: The meeting will take place Wednesday, December 4 from 8:00 a.m. 
to 5:00 p.m. and Thursday, December 5, 2013 from 8:00 a.m. to 4:00 p.m.

ADDRESSES: NIH Conference Room, 5635 Fishers Lane, Rockville, MD 20892.

FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for 
Blood and Tissue Safety Policy, Office of the Assistant Secretary for 
Health, Department of Health and Human Services, 1101 Wootton Parkway, 
Suite 250, Rockville, MD 20852; phone: (240) 453-8803; fax: (240) 453-
8456; email: [email protected].

SUPPLEMENTARY INFORMATION: The ACBTSA shall provide advice to the 
Secretary through the Assistant Secretary for Health. The Committee 
advises on a range of policy issues to include: (1) Definition of 
public health parameters around safety and availability of blood and 
blood products as well as tissues and tissue products, (2) broad public 
health, ethical, and legal issues related to transfusion and 
transplantation safety, and (3) the implications for safety and 
availability of various economic factors affecting product cost and 
supply. The advisory committee has met regularly since its 
establishment in 1997.
    At the December 2013 meeting the ACBTSA will hear updates on recent 
activities of the Department and its agencies in support of previous 
Committee recommendations. Past recommendations made by the ACBTSA may 
be viewed at www.hhs.gov/bloodsafety.
    This meeting will serve as a continuation of the June 2013 ACBTSA 
meeting, which addressed whether the current construct of the blood 
collection center system in the United States is designed for optimal 
service delivery in the era of health care reform. In

[[Page 66007]]

particular, this meeting seeks to evaluate the cost recovery system of 
blood centers, their perceived capacity for product and services 
innovations, and to promote risk based decision making from donor to 
recipient. The Committee will also hear from the World Health 
Organization's NOTIFY Library Project and their efforts to improve 
vigilance and surveillance of adverse transplant events relating to 
human cells, tissues, and organs. Additionally, the Committee will 
receive updates on recommendations from the ACBTSA Subcommittees 
addressing Disaster Preparedness; Tissue and Blood Safety; and Informed 
Consent in Transfusion and Transplantation.
    The public will have the opportunity to present their views to the 
Committee during a public comment session scheduled for December 4, 
2013. Comments will be limited to five minutes per speaker and must be 
pertinent to blood and tissue safety and availability. Pre-registration 
is required for participation in the public comment session. Any member 
of the public who would like to participate in this session should to 
contact the designated Federal official to register prior to close of 
business on December 2, 2013. If it is not possible to provide 30 
copies of the material to be distributed, then individuals are 
requested to provide a minimum of one (1) copy of the document(s) to be 
distributed prior to the close of business on December 2, 2013. It is 
also requested that any member of the public who wishes to provide 
comments to the Committee utilizing electronic data projection to 
submit the necessary material to the Executive Secretary prior to the 
close of business on December 2, 2013.

    Dated: October 28, 2013.
James J. Berger,
Senior Advisor for Blood and Tissue Safety Policy.
[FR Doc. 2013-26292 Filed 11-1-13; 8:45 am]
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