[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Page 26300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood 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 (HHS) is hereby giving notice
that the Advisory Committee on Blood Safety and Availability (ACBSA)
will hold a meeting. The meeting will be open to the public.
DATES: The meeting will take place Tuesday, June 7, and Wednesday June
8, 2011, from 8:30 a.m. to 5 p.m.
ADDRESSES: National Institute of Health, Building 31, Conference Room
6, Bethesda, MD 20892.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Associate Public
Health Advisor for Blood, Organ and Tissue Safety, Office of the
Assistant Secretary for Health, Department of Health and Human
Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240)
453-8803, Fax (240) 453-8456, e-mail [email protected].
SUPPLEMENTARY INFORMATION: The ACBSA shall provide advice to the
Secretary through the Assistant Secretary for Health. The Committee
shall advise on a range of policy issues to include: (1) Definition of
public health parameters around safety and availability of the blood
supply and blood 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.
In keeping with its established mission, the Committee will also be
asked to review and provide comments to the Department on two World
Health Assembly (WHA) resolutions related to transfusion, and
transplantation safety. http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf On June 7, 2011, the Committee will be asked to review
the WHA 63.22 on human organ and tissue transplantation and if
appropriate, make recommendations on areas of enhanced safety.
Specifically areas of collecting data including adverse events and
reactions on the practices, safety, quality, efficacy, epidemiology and
ethics of donations and transplantation will be considered as it
relates to safety. Concerns for a globally consistent coding system for
human cells, tissues and organs to facilitate national and
international traceability of materials of human origin for
transplantation will be solicited. In addition, the Committee will be
asked for comments or recommendations on developing and promoting
international best practices.
On June 8, 2011, the Committee will be asked to review and comment
on WHA 63.12 regarding the availability, safety and quality of blood
products. http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R12-en.pdf
Specifically the Committee will be asked to review the current status
of safe and rational use of blood products in patient blood management
and assess the current status in the U.S.
In addition, the Committee will be asked to comment on the areas of
safety and sustainability of providing blood and blood products that
should be addressed by the Committee in future meetings.
The public will have the opportunity to present their views to the
Committee during a public comment session scheduled for June 7, 2011.
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 encouraged to contact
the Executive Secretary at his/her earliest convenience to register for
time (limited to 5 minutes) and registration must be prior to close of
business on June 3, 2011. 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 11:30 a.m. Eastern Daylight Time on June 6, 2011. 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 June 6, 2011. Electronic comments must adhere to disability
accessibility guidelines (Section 508 compliance).
Dated: May 3, 2011.
James J. Berger,
Associate Public Health Advisor for Blood, Organ and Tissue Safety.
[FR Doc. 2011-11128 Filed 5-5-11; 8:45 am]
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