Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.
Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 29, 2007, from 8 a.m. to approximately 6:30 p.m. and on March 30, 2007 from 8 a.m. to approximately 3 p.m.
Address: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select Docket No. 2007N-0061, “Sipuleucel-T Dendreon,” and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on March 22, 2007. All comments received will be posted without change, including any personal information provided. Comments received on or before March 22, 2007, will be provided to the committee before or at the meeting.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD, Grand Ballroom.
Contact Person: Gail Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1289, FAX: 301-827-0294, or 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.
Agenda: On March 29, 2007, in open session, the committee will discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the treatment of men with asymptomatic metastatic hormone refractory prostate cancer. The committee will also hear overviews of research programs in the Division of Cellular and Gene Therapies, Center for Biologics Evaluation and Research. On March 30, 2007, in open session, the committee will discuss the draft document entitled “Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.” For a copy of the draft guidance visit http://www.fda.gov/cber/gdlns/cordbld.pdf. The committee will also discuss scientific issues regarding minimally manipulated, unrelated allogeneic peripheral blood stem cells.
FDA intends to make background material available to the public no later than 1 business day 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. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link.
Procedure: On March 29, 2007, from 8 a.m. to approximately 5:30 p.m., and on March 30, 2007, from 8 a.m. to approximately 3 p.m., the meeting is open to the public. 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 March 15, 2007. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. on March 29, 2007, and between 10 a.m. and 11 a.m. on March 30, 2007. 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 March 7, 2007. 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 March 8, 2007.
Closed Committee Deliberations: On March 29, 2007, at approximately 5:30 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 a report of intramural research programs in the Division of Cellular and Gene Therapies.
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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-3712 Filed 3-2-07; 8:45 am]
BILLING CODE 4160-01-S