[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64424-64425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood and Tissue Safety and
Availability
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
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 Monday, November 9, 2015, from 8:00
a.m.-4:30 p.m. and Tuesday, November 10, 2015, from 8:00 a.m.-4:00 p.m.
ADDRESSES: Veterans' Health Administration National Conference Center,
2011 Crystal Drive, 1st floor Conference Center, Crystal City, VA
22202.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal
Officer for the ACBTSA, Senior Advisor for Blood and Tissue 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 provides advice to the Secretary
through the Assistant Secretary for Health. The Committee advises on a
range of policy issues to include: (1) Identification of public health
issues through surveillance of blood and tissue safety issues with
national biovigilance data tools; (2) identification of public health
issues that affect availability of blood, blood products, and tissues;
(3) broad public health, ethical and legal issues related to the safety
of blood, blood products, and tissues; (4) the impact of various
economic factors (e.g., product cost and supply) on safety and
availability of blood, blood products, and tissues; (5) risk
communications related to blood transfusion and tissue transplantation;
and (6) identification of infectious disease transmission issues for
blood, organs, blood stem cells and tissues. The Committee has met
regularly since its establishment in 1997.
In December 2013, the Committee made recommendations regarding the
blood system. At that time, the Committee expressed concern about the
ongoing reductions in blood use, the number of large scale
consolidations occurring, the cost recovery issues for blood centers,
and the potential effects on safety and innovation due to instability.
Past recommendations made by the ACBTSA may be viewed at www.hhs.gov/bloodsafety.
This meeting will provide a focused examination of the mechanisms
to fund recently approved blood safety innovations, such as pathogen
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reduction, bacterial testing, and infectious disease testing. It is
anticipated that the implementation of these blood safety innovations
will come with significant costs to blood collection centers, and it
remains unclear how or if the blood industry can afford such
implementation. Speakers will include a broad range of stakeholders
including blood banks, physicians, blood purchasers, and organizations
that reimburse for blood and blood products.
The public will have an opportunity to present their views to the
Committee during a public comment session scheduled for November 10,
2015. Comments will be limited to five minutes per speaker and must be
pertinent to the discussion. Pre-registration is required for
participation in the public comment session. Any member of the public
who would like to participate in this session is required to contact
the Designated Federal Officer at his/her earliest convenience to
register for time (limited to 5 minutes); registration must be
completed prior to close of business on November 2, 2015. If it is not
possible to provide 30 copies of the material to be distributed at the
meeting, 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 November 2, 2015. It is also requested that any member of
the public who wishes to provide comments to the Committee utilizing
electronic data projection submit the necessary material to the
Designated Federal Officer prior to the close of business on November
2, 2015.
Dated: October 16, 2015.
James J. Berger,
Senior Advisor for Blood and Tissue Safety Policy.
[FR Doc. 2015-26904 Filed 10-22-15; 8:45 am]
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