Public Health Service (PHS) Blood Safety Committee
The PHS Blood Safety Committee (BSC), chaired by the Assistant Secretary for Health, is composed of senior PHS representatives including the Director, NIH; the Director, CDC; and the Commissioner, FDA. The BSC, as the highest level policy group regarding blood safety, is the direct advisor to the Secretary concerning blood safety issues.
DHHS Advisory Committee on Blood Safety and Availability (ACBSA)
The Secretary established the ACBSA in October 1996 in response to the Institute of Medicine report on HIV and the Blood Supply: An Analysis of Crisis Decision Making. The ACBSA advises the Secretary through the BSC. It addresses both scientific and societal issues (e.g., cost-benefit ratios, conflicting interests of patient groups, effects of decisions on product availability). At its first meeting in April 1997, the ACBSA considered such issues as the theoretical risk of blood transmission of CJD and direct notification of individuals who had received transfused blood from donors later testing positive for HCV, both of which concern hemophilia patients. Subsequent meetings considered product shortages, product recall policies, and preferential use of recombinant (as opposed to plasma-derived) proteins.
Trans-Agency Hepatitis Working Group
The Trans-Agency Hepatitis Working Group includes the NIH, the CDC, the Department of Defense, and the Veteran's Administration. Its goal is to facilitate or develop collaborative research activities in HCV and to develop uniform and consistent guidelines for screening and treatment.
Trans-NIH Hepatitis C Virus Working Group
Eight NIH institutes and centers1 participate in the Trans-NIH Hepatitis C Virus Working Group. The charge of this group is to develop an integrated NIH-wide plan for research in HCV that addresses basic, translational, and clinical aspects of HCV infection aiming at the prevention and cure of the disease.
Other Coordinating Groups
The PHS Interagency Working Group on Blood Safety and Availability, which functions through the BSC and is chaired by an FDA official, holds a monthly conference call. Federal agencies with an interest in blood safety issues, including the NIH and the CDC, are members of the Working Group. The telephone conferences provide an opportunity to exchange information among agencies and offer early warning regarding potential new threats to the blood supply. Participants discuss newly identified threats and methods for determining whether a new infectious agent is transmitted by blood, is detectable by a test, and produces disease. In addition, the NIH, the FDA, and the CDC often form ad hoc groups to study such issues further. The Working Group also follows up on tasks assigned to it by the BSC.
Additional collaborative opportunities are provided by two FDA advisory committees: the Blood Products Advisory Committee, and the Transmissible Spongiform Encephalopathy Advisory Committee. NIH and CDC members play key roles on both of these committees.
1The NHLBI, NIAID, NIDDK, NCI, National Institute of Drug Abusae, National Institute on Alcohol Abuse and Alcoholism, National Center for Research Resources, and the NIH Center for Scientific Review.