05-17149. Research Review Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 Cellular, Tissue and Gene Therapies 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 September 29, 2005, from 8 a.m. to 4 p.m.

Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person: Gail Dapolito or Sheila Langford, 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 3014512389. Please call the Information Line for up-to-date information on this meeting.

Agenda: On September 29, 2005, the subcommittee will listen to presentations about the research program at the Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OCTGT's regulatory mission and facilitate development of safe and effective biological products. The subcommittee will discuss the program and make recommendations to the Cellular Tissue and Gene Therapies Advisory Committee at a future open meeting of the full 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 September 29, 2005, from 8 a.m. to approximately 1:20 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 September 22, 2005. Oral presentations from the public will be scheduled between approximately 11:20 a.m. and 12:20 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by September 22, 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 September 29, 2005, from approximately 1:20 p.m. to 4 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 internal research programs in OCTGT, 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 Gail Dapolito 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).

Dated: August 18, 2005.

Scott Gottlieb,

Deputy Commissioner for Policy.