E8-9230. Meeting of the Advisory Committee on Blood Safety and Availability

AGENCY:

Department of Health and Human Services, Office of the Secretary.

ACTION:

Notice.

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: [phone].

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, [phone], Fax [phone], e-mail [e-mail].

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.