October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement

October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement

Agenda
On October 9, 2009, in open session, the Committee will discuss, ISOLAGEN THERAPY, BLA 125348, Isolagen Technologies, Inc., for moderate to severe nasolabial fold wrinkles. Nasolabial fold wrinkles are the two skin folds that run from each side of the nose to the corners of the mouth.

Meeting Materials
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 2, 2009.
Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. 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 October 1, 2009. 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 2, 2009.
Contact Information
Gail Dapolito or Danielle Cubbage
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1289
FAX: 301-827-0294
e-mail: gail.dapolito@fda.hhs.gov email: danielle.cubbage@fda.hhs.gov
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.
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.

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 or Danielle Cubbage 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).

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October 9, 2009: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement