Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a subcommittee 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 Subcommittee: Research Review Subcommittee of the Blood Products Advisory CommitteeStart Printed Page 37863
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 July 22, 2005, from 8 a.m. to 5 p.m.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879.
Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, (HFM-71), Food and Drug Administration, 1401 Rockville Pike, 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.
Agenda: On July 22, 2005, the subcommittee will listen to presentations to further a dynamic, responsive, and cutting edge research program at the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), that facilitates development of safe and effective biological products. The subcommittee's recommendations will be publicly discussed at a future meeting of the Blood Products Advisory Committee. Information regarding CBER's scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the Internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA's Critical Path to New Medical Products is available to the public on the Internet at: http://www.fda.gov/oc/initiatives/criticalpath/.
Procedure: On July 22, 2005, from 8 a.m. to 1:15 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 subcommittee. Written submissions may be made to the contact person by July 14, 2005. Oral presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by July 14, 2005, 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.
Closed Subcommittee Deliberations: On July 22, 2005, from 2:15 p.m. to 5 p.m., the meeting will be closed to the public. 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)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The subcommittee will discuss the internal research programs in the Office of Blood Research and Review, CBER.
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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-12962 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S