Department of Health and Human Services, Office of the Secretary.
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 Tuesday December 16 and Wednesday December 17, 2008.
The meeting will take place Tuesday December 16 and Wednesday December 17, 2008 from 9 a.m. to 5 p.m.
The Hilton Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852, Phone: (301) 468-1100.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
Blood and plasma donations are critical to provide blood products necessary for maintaining health delivery. Over the years the safety of the blood and plasma supply has increased through vigilant review of processes and adherence to layers of safeguards. While safety and availability is paramount to the intended recipient of blood and plasma products, the pre and post donation care of the donor is also important. Commitment to donor health as well as to transfusion recipient is necessary to build a robust and healthy donor based nationally.
The Nation's potential donor population is approximately 37% of those medically eligible to donate. Approximately 16 million units of blood were collected in 2006 which exceeded demand by 7.8%. First time whole blood donors represented approximately 28.5% of the donors, while the remaining 71.5% of the donors had given previously an equivalent of 1.7 whole blood donations in the year. As the American population ages, dependence on the younger generation is more critical. In some states, donors may be 16-years-old to be eligible.
Donor selection processes have the potential to detect health abnormalities or risks which could affect the donor and even public health. Adverse events to the donor either as a result of the process of donating blood (e.g. injury, syncope, or loss of iron) or discovery of abnormal screening results can impact the donor's health. For example, iron loss can be from 220 to 290 mg in whole blood donations and from 20 to 25 mg in plasmapheresis.
Informed consent is required by FDA regulation or recommended in guidance for apheresis procedures (source plasma and platelet collections) prior to donations to include the donation procedure, the risk of the procedure, and laboratory screenings performed to reduce the risk of transmission of infectious diseases to the recipient. A written statement of understanding for whole blood donations is proposed in the Food and Drug Administration's Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use, November 2007.
During the December 2008 meeting of the ACBSA, the Committee will be asked to comment on the responsibility of blood and plasma centers to donor and public health. Public comment will be solicited on both December 16 and 17, 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 December 12, 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 December 12, 2008.Start Signature
Dated: November 18, 2008.
Jerry A. Holmberg,
Executive Secretary, Advisory Committee on Blood Safety and Availability.
[FR Doc. E8-27852 Filed 11-21-08; 8:45 am]
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