[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Page 22950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9230]


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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 [email protected].

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