[Federal Register Volume 72, Number 243 (Wednesday, December 19, 2007)]
[Notices]
[Pages 71922-71923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24629]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0471]
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
[[Page 71923]]
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 April 10, 2008, from 9
a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to
approximately 12 noon.
Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select ``2007N-0471--Scientific
Considerations for Safety Testing for Cellular Therapy Products Derived
From Human Embryonic Stem Cell'' 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 26, 2008. All comments received will be posted without change,
including any personal information provided. Comments received on or
before March 26, 2008, will be provided to the committee before or at
the meeting.
Location: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Gail Dapolito or Danielle Cubbage, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
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. 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.
Agenda: On April 10, 2008, the committee will meet to discuss
scientific considerations for safety testing for cellular therapy
products derived from human embryonic stem cells. On April 11, 2008,
the committee will meet to discuss updates on the following topics: (1)
Research management related to the September 29, 2005, review of
research programs of the Office of Cellular, Tissue and Gene Therapies,
Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell
Therapy Letter; and (3) recently released FDA guidance documents.
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. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
Procedure: 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
April 3, 2008. Oral presentations from the public will be scheduled on
April 10, 2008, between approximately 1:45 p.m. and 2:15 p.m. and on
April 11, 2008, between approximately 10:15 a.m. and 10:45 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 March 26, 2008. 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 27, 2008.
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.
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).
Dated: December 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-24629 Filed 12-18-07; 8:45 am]
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