Research Review Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 51076 [05-17149]

Download as PDF 51076 Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices ANDA No. Drug 75–838 Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/ 650 mg 76–032 Methylphenidate HCl Exended-Release Tablets USP, 20 mg Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research (21 CFR 5.105(a)), approval of the ANDAs listed in the table of this document, and all amendments and supplements thereto, is withdrawn, effective August 29, 2005. Thereafter, distribution of the products in interstate commerce without approved applications is illegal and subject to regulatory action. Also, on the basis of the circumstances described in this document that led to the recall of the products and their subsequent removal from the market, the agency will remove the products from the agency’s list of drug products with effective approvals, published under the title ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations.’’ This document serves as notice of the removal of the products covered by the ANDAs listed in this document from the list of approved drug products. Distribution of these products in interstate commerce without approved applications is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the act (21 U.S.C. 355(a) and 331(d)). Dated: August 15, 2005. Steven Galson, Director, Center for Drug Evaluation and Research. [FR Doc. 05–17151 Filed 8–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Research Review Subcommittee of the 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 subcommittee 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 Subcommittee: Research Review Subcommittee of the Cellular, VerDate Aug<18>2005 15:17 Aug 26, 2005 Jkt 205001 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 September 29, 2005, from 8 a.m. to 4 p.m. Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD. Contact Person: Gail Dapolito or Sheila Langford, 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. Agenda: On September 29, 2005, the subcommittee will listen to presentations about the research program at the Office of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OCTGT’s regulatory mission and facilitate development of safe and effective biological products. The subcommittee will discuss the program and make recommendations to the Cellular Tissue and Gene Therapies Advisory Committee at a future open meeting of the full Committee. Information regarding CBER’s scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the Internet at: https://www.fda.gov/cber/ inside/mission.htm. Information regarding FDA’s Critical Path to New Medical Products is available to the public on the Internet at: https:// www.fda.gov/oc/initiatives/ criticalpath/. Procedure: On September 29, 2005, from 8 a.m. to approximately 1:20 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 subcommittee. Written submissions may be made to the contact person by September 22, 2005. Oral presentations from the public will be scheduled PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 between approximately 11:20 a.m. and 12:20 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by September 22, 2005, 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 Subcommittee Deliberations: On September 29, 2005, from approximately 1:20 p.m. to 4 p.m. the meeting will be closed to the public. 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)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The subcommittee will discuss internal research programs in OCTGT, CBER. 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: August 18, 2005. Scott Gottlieb, Deputy Commissioner for Policy. [FR Doc. 05–17149 Filed 8–26–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 70, Number 166 (Monday, August 29, 2005)]
[Notices]
[Page 51076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Research Review Subcommittee of the 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 subcommittee 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 Subcommittee: Research Review Subcommittee of the 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 September 29, 2005, from 
8 a.m. to 4 p.m.
    Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.
    Contact Person: Gail Dapolito or Sheila Langford, 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.
    Agenda: On September 29, 2005, the subcommittee will listen to 
presentations about the research program at the Office of Cellular, 
Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and 
Research (CBER). The program is intended to provide dynamic, 
responsive, cutting edge research to contribute to OCTGT's regulatory 
mission and facilitate development of safe and effective biological 
products. The subcommittee will discuss the program and make 
recommendations to the Cellular Tissue and Gene Therapies Advisory 
Committee at a future open meeting of the full Committee. Information 
regarding CBER's scientific program is outlined in its Strategic Plan 
of 2004 and is available to the public on the Internet at: https://
www.fda.gov/cber/inside/mission.htm. Information regarding FDA's 
Critical Path to New Medical Products is available to the public on the 
Internet at: https://www.fda.gov/oc/initiatives/
criticalpath/.
    Procedure: On September 29, 2005, from 8 a.m. to approximately 1:20 
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 subcommittee. Written submissions may be made to the contact 
person by September 22, 2005. Oral presentations from the public will 
be scheduled between approximately 11:20 a.m. and 12:20 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person by September 
22, 2005, 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 Subcommittee Deliberations: On September 29, 2005, from 
approximately 1:20 p.m. to 4 p.m. the meeting will be closed to the 
public. 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)) and to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The 
subcommittee will discuss internal research programs in OCTGT, CBER.
    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: August 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17149 Filed 8-26-05; 8:45 am]
BILLING CODE 4160-01-S

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