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is withdrawn, effective August 29, 2005.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, 

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: http://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: http:// 

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