The October 22-23, 2013 Cellular, Tissue and Gene Therapies Advisory Committee meeting has been postponed due to resource constraints arising from the government shutdown.
|CBER||October 22-23 2013||October 22 between |
8 a.m. and 5:30 p.m.
October 23 between
8 a.m. and 5 p.m.
|FDA White Oak Campus,|
White Oak Conference Center,
Great Room Room 1503
10903 New Hampshire Avenue
Silver Spring MD 20993
On October 22 from 8 a.m. to 5:30 p.m. and on October 23 from 8 a.m. to approximately 11:15 a.m. the Committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. On October 23 from approximately 11:15 a.m. to 11:30 a.m. the Committee will hear updates on guidance documents issued from the Office of Cellular Tissue and Gene Therapies Center for Biologics Evaluation and Research (CBER) FDA. On October 23 from 12:30 p.m. to approximately 5 p.m. the Committee will discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. CBER published a draft guidance on this topic on July 2 2013 and it is located at the Cellular Tissue and Gene Therapies Guidances page.
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 2013 Cellular Tissue and Gene Therapies meetings 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 October 15 2013.
- Oral presentations from the public will be scheduled between approximately 2:15 p.m. and 3:15 p.m. on October 22 and between approximately 1:15 p.m. and 1:45 p.m. on October 23. 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 October 7 2013. 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 October 8, 2013.
CBER plans to provide a free of charge live webcast of the October 22-23 2013 meeting of the Cellular Tissue and Gene Therapies Advisory Committee. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus there are instances where the webcast transmission is not successful staff will work to re-establish the transmission as soon as possible. The link for the webcast is available at: https://collaboration.fda.gov/ctgtac1013/
- Gail Dapolito 301-827-1289, Fax, 301-827-0294 e-mail: firstname.lastname@example.org
- 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.
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.
Information regarding ground transportation, airport information lodging driving directions; visitor parking and security can be accessed at the FDA White Oak Campus Public Meeting Attendee Information page.
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