Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | May 14-15, 2009 | May 14, 2009 from 8:00 a.m. to approximately 6:00 p.m. and on May 15, 2009 from 8:00 a.m. to approximately 1:00 p.m. |
Hilton Hotel, Grand Ballroom, 620 Perry Parkway, Gaithersburg, Maryland |
Agenda
On May 14 in the morning, in open session, the Committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources. In the afternoon, in open session, the Committee will discuss animal models for porcine xenotransplantation products intended to treat Type 1 diabetes or acute liver failure. On May 15, in open session, the Committee will 1) receive an update on Guidance documents from the Office of Cellular, Tissue and Gene Therapies and the Center for Veterinary Medicine, 2) discuss clinical issues related to the FDA draft guidance “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.”
Meeting Materials
Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.
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 May 7, 2009.
- Oral presentation from the public will be scheduled on May 14 between approximately 11:00 a.m. and 11:20 a.m. and between approximately 2 p.m. and 2:20 p.m. and on May 15 between approximately 10 a.m. and 10:20 a.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 May 6, 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 May 7, 2009.
Contact Information
- Gail Dapolito or Danielle Cubbage
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-0314
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 3014512388
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 at http://www.fda.gov/oc/advisory/default.htm 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).