Notice of upcoming Blood Products Safety Advisory Committee meeting
The Food and Drug Administration (FDA) is announcing a meeting of its Blood Products Advisory Committee (BPAC) to discuss important issues that include an approach for home-use rapid HIV test kits. The Committee will hear a proposal by OraSure Technologies, Inc. for over-the-counter (OTC) availability of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid specimens, including:
- Proposed studies to validate adequate performance in the hands of intended users, and
- The ability of informational materials to provide counseling and other information regarding accuracy of testing, correct test interpretation, management of psychological and social issues, and medical referral.
The BPAC will also hear presentations addressing the role of rapid HIV tests in CDC's Advancing HIV Prevention initiative and CDC's current HIV test counseling recommendations, the role of quality systems in diagnostic testing, psychological and social issues associated with HIV testing, and prior experience with approved home-use test kits.
In addition, the committee will hear updates on the following topics: (1) West Nile Virus; (2) draft guidance on nucleic acid testing (NAT) for human immunodeficiency virus (HIV)-1 and hepatitis C virus (HCV): Testing, product disposition, and donor deferral and re-entry; (3) summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability held on September 19 and 20, 2005; and (4) re-entry of donors deferred based on hepatitis B core antigen (anti-HBc) test results.
The meeting is scheduled for November 3, 2005, from 8:00 a.m. to 5:30 p.m. at:
Holiday Inn Gaithersburg
2 Montgomery Village Ave.
The meeting is open to the public, and no registration is required. Please contact the hotel directly at 301.948.8900 for directions or information about accommodations.
Background materials for this meeting are posted on the FDA website at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4190b1.htm
A draft agenda is available at http://www.fda.gov/ohrms/dockets/ac/05/agenda/2005-4190A1_draft.htm
Interested persons may present data, information, or views - orally or in writing - on issues pending before the committee during the open public hearing. Written submissions may be made by October 25, 2005 to Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314.
Those desiring to make formal oral presentations should, by October 25, 2005, submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation to Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314.
Oral presentations from the public will be scheduled on November 3, 2005, between approximately 2 p.m. and 3:45 p.m. Time allotted for each presentation may be limited, depending on the number of requests to speak.
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting.
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516.
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration