[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-36]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). 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 February 9, 2006, from 8
a.m. to approximately 5:30 p.m. and on February 10, 2006, from 8 a.m.
to approximately 1 p.m.
Location: Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Gail Dapolito or Rosanna L. Harvey, Food and Drug
Administration, 1401 Rockville Pike (HFM-71), 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 301-451-2389. Please
call the Information Line for up-to-date information on this meeting.
Agenda: On February 9, 2006, in open session, the committee will
conduct a scientific discussion of potency measurements for cellular
and gene transfer products. On February 10, in open session, the
committee will (1) Discuss the National Toxicology Program on
Retroviral Mutagenesis and (2) receive a brief update on the recent
review of the research program of the Office of Cellular, Tissue and
Gene Therapies, FDA.
Procedure: On February 9, 2006, from 8 a.m. to approximately 5:30
p.m., and on February 10, 2006, from 8 a.m. to approximately 11:30
a.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 by February 2, 2006. Oral presentations from the public will be
scheduled between approximately 1:30 p.m. and 2 p.m. on February 9,
2006, and between approximately 9:40 a.m. and 10:10 a.m. on February
10, 2006. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before February 2, 2006, 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.
Closed Committee Deliberations: On February 10, 2006, from
approximately 11:30 a.m. to 1 p.m., the meeting will be closed to
permit discussion and review of trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)); and where disclosure would
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss the report of the Research
Subcommittee of the Cellular, Tissue and Gene Therapies Advisory
Committee related to a review of the research program in the Office of
Cellular, Tissue 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).
Dated: January 3, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-71 Filed 1-6-06; 8:45 am]
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