thefederalregister.com

Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.
ACTION: This notice announces a forthcoming teleconference meeting of a public advisory committee of the Food and Drug Administration (FDA). At least oneportion 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.

DATES: Location:National Institutes of Health (NIH), Building 29A, Conference Room 1A09, 9000 Rockville Pike, Bethesda, MD 20892. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the internet athttp://www.nih.gov/about/visitor/index.htm.(FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in theFederal Register.) 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. Detailed information about security procedures is located athttp://www.nih.gov/about/visitorsecurity.htm.Due to the limited available parking, visitors are encouraged to use public transportation.

Contact Person:Gail Dapolito or Sheryl Clark, 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). A notice in theFederal Registerabout 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 athttp://www.fda.gov/AdvisoryCommittees/default.htmand scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Agenda:On November 29, 2012 the committee will meet in open session to hear updates of research programs in the Gene Transfer and Immunogenicity Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and the Laboratory of Immunology, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA.

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 athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.Scroll down to the appropriate advisory committee link.

Procedure:On November 29, 2012, from 1 p.m. to 4 p.m. (Eastern Time) 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 21, 2012. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 p.m. Those individuals interested in making 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 14, 2012. 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 November 15, 2012.

Closed Committee Deliberations:On November 29, 2012, from 4 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 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 Gail Dapolito 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 athttp://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htmfor 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).

Dated: October 9, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs.