|CBER||November 6, 2014||9 a.m. to approximately 4:30 p.m.||FDA White Oak Campus, White Oak Conference Center, Building 31, Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993|
The committee will discuss the draft guidance for industry entitled "Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products" and the Dear Gene Therapy IND or Master File Sponsor Letter.
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 committee 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 23, 2014.
- Oral presentations from the public will be scheduled between approximately 11:05 a.m. and 12:05 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 October 15, 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 October 16, 2014.
CBER plans to provide a free of charge, live webcast of the November 6, 2014 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:
- Gail Dapolito, 240-402-8046, 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 Public meetings at White Oak main page.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at 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