[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Notices]
[Page 22950]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap08-56]
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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.
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 Safety and Availability (ACBSA) will
hold a meeting. The meeting will be open to the public on both
Thursday, May 29 and Friday, May 30, 2008.
DATES: The meeting will take place Thursday, May 29 and Friday, May 30,
2008 from 9 a.m. to 5 p.m.
ADDRESSES: The Hilton Rockville Hotel, 1750 Rockville Pike, Rockville,
MD 20852 Phone: (301) 468-1100.
FOR FURTHER INFORMATION CONTACT: Jerry A. Holmberg, PhD, Executive
Secretary, Advisory Committee on Blood Safety and Availability, Office
of Public Health and Science, Department of Health and Human Services,
1101 Wootton Parkway, Suite 250, Rockville, MD 20852, (240) 453-8803,
Fax (240) 453-8456, e-mail ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION: Updates will be provided to the Committee on
previous recommendations as follows:
At the January 2003 meeting of the ACBSA, the Committee recognized
that the leading causes of transfusion related fatalities were:
bacterial contamination of platelets; hemolysis, primarily due to
errors in release and administration of incorrect blood; and
transfusion related acute lung injury (TRALI). Progress has been made
on all three of these causes of transfusion related fatalities. Updates
will be provided on the rate of bacterial contamination and reports of
sepsis associated with 5 day and 7 day dating of apheresis platelets
and on the use of improved methods to reduce errors in the
identification of patients and transfusion products. In addition, the
Committee will review progress made to reduce the risk of TRALI. In
2007, the AABB recommended to its institutional members to devise
strategies to reduce the risk of TRALI in transfused patients. Total
voluntary implementation was to be complete by November 2008. To this
end, many blood centers and hospitals have implemented strategies to
decrease the adverse risk of TRALI by using male only apheresis
platelets and plasma donors. Various strategies will be presented and
discussed as well as messaging to potential donors.
The Committee will also hear an update from the Food and Drug
Administration's sponsored public workshop entitled: ``Hemoglobin Based
Oxygen Carriers: Current Status and Future Directions,'' which will be
held on April 29 and 30, 2008. The Committee will also hear an update
from Health Resources and Services Administration (HRSA) regarding its
April 4, 2008 meeting on potential rulemaking with respect to
vascularized composite allografts and whether vascularized composite
allografts should be included within the definition of organs covered
by the regulations governing the operation of the Organ Procurement and
Transplantation Network and covered by section 301 of the National
Organ Transplant Act of 1984.
The Committee will then be asked to discuss and make
recommendations on reports of adverse outcomes associated with
transfusion of older red cells. There have been additional studies and
peer reviewed publications reporting adverse outcomes associated with
the administration of red cells older than 14 days of storage.
Currently human red cells for transfusion are good for up to 42 days of
storage depending on the anticoagulant and additive solutions used in
storage. Presentations and discussions will review current blood
distribution and transfusion practices as well as available outcome
data related to clinical studies with older red cells.
Public comment will be solicited on both May 29 and 30, 2008.
Comments will be limited to five minutes per speaker and must be
pertinent to the discussion. Anyone planning to comment is encouraged
to contact the Executive Secretary at his/her earliest convenience.
Those who wish to have printed material distributed to Advisory
Committee members should submit thirty (30) copies to the Executive
Secretary prior to close of business May 27, 2008. Likewise, those who
wish to utilize electronic data projection to the Committee must submit
their materials to the Executive Secretary prior to close of business
May 27, 2008.
Dated: April 22, 2008.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on Blood Safety and
Availability.
[FR Doc. E8-9230 Filed 4-25-08; 8:45 am]
BILLING CODE 4150-41-P