[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Page 1432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-71]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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]
BILLING CODE 4160-01-S