Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 4:45 p.m.
Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877, 301-977-8900.
Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.Start Printed Page 11377
Agenda: On April 1, 2009, the committee will hear updates on the following topics: National Biovigilance Data Collection and Analysis Program; a summary of the December 16 and 17, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; and a summary of the September 12, 2008, FDA Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted Babesiosis in the United States. The committee will then discuss blood donor screening and testing donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) for hepatitis B virus infection by nucleic acid testing. In the afternoon, the committee will discuss potential testing strategies for Trypanosoma cruzi infection in blood donors. On April 2, 2009, the committee will discuss FDA's current considerations on plasma obtained from a Whole Blood donor for further manufacturing use and in the afternoon will review the research programs in the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, CBER Site Visit held on October 22, 2008.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.
Procedure: On April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 3:45 p.m, the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 25, 2009. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12 noon and between approximately 4:15 p.m. and 4:45 p.m. on April 1, 2009, and between approximately 10:45 a.m. and 11:45 a.m. and between approximately 3:15 p.m. and 3:45 p.m. on April 2, 2009. Those desiring to make formal oral presentations should notify the contact person and 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 on or before March 23, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 24, 2009.
Closed Committee Deliberations: On April 2, 2009, between 4 p.m. and 4:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions.
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 William Freas or Pearline K. Muckelvene at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: March 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5734 Filed 3-16-09; 8:45 am]
BILLING CODE 4160-01-S