Professional Documents
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51076 Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices
Therefore, under section 505(e) of the Tissue and Gene Therapies Advisory between approximately 11:20 a.m. and
Federal Food, Drug, and Cosmetic Act Committee. 12:20 p.m. Time allotted for each
(21 U.S.C. 355(e)) and under authority presentation may be limited. Those
delegated to the Director, Center for General Function of the Committee: desiring to make formal oral
Drug Evaluation and Research (21 CFR To provide advice and presentations should notify the contact
5.105(a)), approval of the ANDAs listed recommendations to the agency on person by September 22, 2005, and
in the table of this document, and all FDA’s regulatory issues. submit a brief statement of the general
amendments and supplements thereto, Date and Time: The meeting will be
nature of the evidence or arguments
is withdrawn, effective August 29, 2005. held on September 29, 2005, from 8 a.m.
to 4 p.m. they wish to present, the names and
Thereafter, distribution of the products addresses of proposed participants, and
in interstate commerce without Location: Holiday Inn Select, 8120
Wisconsin Ave., Bethesda, MD. an indication of the approximate time
approved applications is illegal and requested to make their presentation.
subject to regulatory action. Also, on the Contact Person: Gail Dapolito or
basis of the circumstances described in Sheila Langford, Center for Biologics Closed Subcommittee Deliberations:
this document that led to the recall of Evaluation and Research (HFM–71), On September 29, 2005, from
the products and their subsequent Food and Drug Administration, 1401 approximately 1:20 p.m. to 4 p.m. the
removal from the market, the agency Rockville Pike, Rockville, MD 20852, meeting will be closed to the public.
will remove the products from the 301–827–0314, or FDA Advisory The meeting will be closed to permit
agency’s list of drug products with Committee Information Line, 1–800– discussion where disclosure would
effective approvals, published under the 741–8138 (301–443–0572 in the constitute a clearly unwarranted
title ‘‘Approved Drug Products With Washington, DC area), code
invasion of personal privacy (5 U.S.C.
Therapeutic Equivalence Evaluations.’’ 3014512389. Please call the Information
552b(c)(6)) and to permit discussion and
This document serves as notice of the Line for up-to-date information on this
review of trade secret and/or
removal of the products covered by the meeting.
Agenda: On September 29, 2005, the confidential information (5 U.S.C.
ANDAs listed in this document from the 552b(c)(4)). The subcommittee will
subcommittee will listen to
list of approved drug products. discuss internal research programs in
presentations about the research
Distribution of these products in OCTGT, CBER.
program at the Office of Cellular, Tissue
interstate commerce without approved
and Gene Therapies (OCTGT), Center Persons attending FDA’s advisory
applications is illegal and subject to
for Biologics Evaluation and Research committee meetings are advised that the
regulatory action (see sections 505(a)
(CBER). The program is intended to agency is not responsible for providing
and 301(d) of the act (21 U.S.C. 355(a)
provide dynamic, responsive, cutting access to electrical outlets.
and 331(d)).
edge research to contribute to OCTGT’s
Dated: August 15, 2005. FDA welcomes the attendance of the
regulatory mission and facilitate
Steven Galson, development of safe and effective public at its advisory committee
Director, Center for Drug Evaluation and biological products. The subcommittee meetings and will make every effort to
Research. will discuss the program and make accommodate persons with physical
[FR Doc. 05–17151 Filed 8–26–05; 8:45 am] recommendations to the Cellular Tissue disabilities or special needs. If you
BILLING CODE 4160–01–S and Gene Therapies Advisory require special accommodations due to
Committee at a future open meeting of a disability, please contact Gail Dapolito
the full Committee. Information at least 7 days in advance of the
DEPARTMENT OF HEALTH AND regarding CBER’s scientific program is meeting.
HUMAN SERVICES outlined in its Strategic Plan of 2004
and is available to the public on the
Food and Drug Administration Notice of this meeting is given under
Internet at: http://www.fda.gov/cber/
the Federal Advisory Committee Act (5
inside/mission.htm. Information
Research Review Subcommittee of the U.S.C. app. 2).
regarding FDA’s Critical Path to New
Cellular, Tissue and Gene Therapies
Medical Products is available to the Dated: August 18, 2005.
Advisory Committee; Notice of Meeting
public on the Internet at: http:// Scott Gottlieb,
AGENCY: Food and Drug Administration, www.fda.gov/oc/initiatives/ Deputy Commissioner for Policy.
HHS. criticalpath/.
[FR Doc. 05–17149 Filed 8–26–05; 8:45 am]
ACTION: Notice. Procedure: On September 29, 2005,
from 8 a.m. to approximately 1:20 p.m., BILLING CODE 4160–01–S
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