E6-18472. 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 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: 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 by teleconference on November 20, 2006, from 2:15 p.m. to approximately 5 p.m.

Location: National Institutes of Health (NIH), Bldg. 29, rm. 121, 9000 Rockville Pike, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speakerphone will be provided at the specified location for public participation in the meeting. Important information about transportation, directions to the NIH campus, parking, and security procedures is available on the Internet at http://www.nih.gov/​about/​visitor/​index.htm. Visitors must show two forms of identification, one of which must be a Government-issued photo identification such as a Federal employee badge, driver's license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave. (the Medical Center Metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at http://www.nih.gov/​about/​visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

Contact Person: Gail Dapolito or Rosanna Harvey, 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 November 20, 2006, the committee will meet in open session to hear updates of research programs in the Laboratory of Immunobiology and the Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research.

Procedure: On November 20, 2006, from 2:15 p.m. to approximately 4:30 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 November 13, 2006. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Time allotted for each presentation may be limited. 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 November 13, 2006.

Closed Committee Deliberations: On November 20, 2006, from approximately 4:30 p.m. to 5 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 a report of intramural research programs.

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: October 27, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning