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U.S. Department of Health and Human Services

Advisory Committees

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September 18, 2014: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement

Center Date Time Location
CBER September 18, 2014 1 p.m. to 4 p.m. FDA White Oak Campus, White Oak Conference Center, Building 31, Rm. 1506-IR, 10903 New Hampshire Avenue, Silver Spring, MD  20993

Agenda
On September 18, 2014, from 1 p.m. to approximately 3:20 p.m., the meeting is open to the public.  The committee will meet by teleconference.  In open session, the committee will hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, FDA.

From approximately 3:20 p.m. to 4 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 the intramural research programs and make recommendations regarding personnel staffing decisions.

Meeting Materials
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.

Materials for this meeting will be available at the 2014 Cellular, Tissue and Gene Therapies Advisory Committee Meeting main page.   

Public Participation Information
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 September 11, 2014.
  • Oral presentations from the public will be scheduled between approximately 2:20 p.m. and 3:20 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 September 3, 2014. 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 September 4, 2014.

Contact Information

  • Gail Dapolito, 240-402-8046, E-mail: gail.dapolito@fda.hhs.gov
  • FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington, DC, area)
    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.

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. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus."  Please note that visitors to the White Oak Campus must enter through Building 1.

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 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). Official FR Notice