Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices 51075 

specifications/statements of work and 

grants announcements; (4) participates 

with top program management in 

program planning, policy 

determination, evaluation, and 

directions concerning acquisition and 

grants strategies and execution; (5) 

provides innovative program-solving 

methods in the coordination of 

international procurement and grants 

for a wide range plan with partners in 

virtually all major domestic and 

international health agencies dealing 

with the United Nations Foundation 

health priorities/issues, to include 

resolution of matters with the 

Department of State; (6) executes 

contracts and grants in support of 

international activities; (7) provides 

business management oversight for 

contracts and assistance awards; (8) 

participates with top program 

management in program planning, 

policy determination, evaluation, and 

directions concerning acquisition and 

assistance strategies and execution; (9) 

maintains branch’s official contract and 

assistance files; (10) maintains a close 

working relationship with CDC program 

office components in carrying out their 

missions; (11) establishes branch goals, 

objectives, and priorities, and assures 

their consistency and coordination with 

the overall objectives of PGO. 

Acquisition and Assistance Branch 

VIII (CAJHV). This branch supports the 

CDC Office of the Director acquisition 

requirements by performing the 

following: (1) Plans, directs, and 

conducts the acquisition of nonpersonal services, supplies, equipment, 

research and development, studies, and 

data collection for CDC through a 

variety of contractual mechanisms 

(competitive and non-competitive); (2) 

reviews statements of work from a 

management point of view for 

conformity to laws, regulations, and 

policies, and negotiates and issues 

contracts; (3) provides continuing 

surveillance of financial and 

administrative aspects of acquisitionsupported activities to assure 

compliance with appropriate DHHS and 

CDC policies; (4) gives technical 

assistance, where indicated, to improve 

the management of acquisition 

activities, and responds to requests for 

management information from the 

Office of the Director, headquarters, 

regional staffs, CDC program offices and 

the public; (5) performs contract and 

purchasing administrative activities 

including coordination and negotiation 

of contract modifications, reviewing and 

approving contractor billings, resolving 

audit findings, and performing closeout/termination activities; (6) provides 

for the collection and reporting of 

business management and 

programmatic data, and analyzes and 

monitors business management data on 

grants and cooperative agreements; (7) 

assures that contractor performance is in 

accordance with contractual 

commitments; (8) provides leadership 

and guidance to CDC project officers 

and program officials; (9) provides 

leadership, direction, procurement 

options, and approaches in developing 

specifications/statements of work and 

contract awards; (10) participates with 

top program management in program 

planning, policy determination, 

evaluation, and directions concerning 

acquisition strategies and execution; 

(11) maintains branch’s official contract 

files; (12) maintains a close working 

relationship with CDC program office 

components in carrying out their 

missions; (13) establishes branch goals, 

objectives, and priorities, and assures 

their consistency and coordination with 

the overall objectives of PGO. 

Dated: August 10, 2005. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC). 

[FR Doc. 05–17073 Filed 8–26–05; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0331] 

Able Laboratories, Inc.; Withdrawal of 

Approval of Ten Abbreviated New Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of ten abbreviated new drug 

applications (ANDAs) held by Able 

Laboratories, Inc. (Able Labs), One Able 

Dr., Cranbury, NJ 08512. Able Labs has 

initiated a class II recall of the products 

covered by these ANDAs. The company 

has requested that the applications be 

withdrawn and has waived its 

opportunity for a hearing. 

DATES: Effective August 29, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

SUPPLEMENTARY INFORMATION: On May 

25, 2005, Able Labs notified the agency 

that, because of improper laboratory 

practices and noncompliance with 

standard operating procedures, Able 

Labs was initiating a voluntary, class II 

recall of the products covered by the 

ANDAs listed in the table of this 

document. The company voluntarily 

requested withdrawal of approval of the 

ANDAs under § 314.150(d) (21 CFR 

314.150(d)), and waived its opportunity 

for a hearing, provided under 

§ 314.150(a) and (b). The following 

ANDAs are affected by this action: 

ANDA No. Drug 

40–395 Diphenoxylate Hydrochloride (HCl) and Atropine Sulfate Tablets USP, 

2.5 milligrams (mg)/0.025 mg 

40–404 Methylphenidate HCl Tablets USP, 5 mg, 10 mg, and 20 mg 

40–407 Prochlorperazine Suppositories USP, 2.5 mg, 5 mg, and 25 mg 

40–452 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg 

40–459 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg 

71–780 Clorazepate Dipotassium Tablets USP, 3.75 mg 

71–781 Clorazepate Dipotassium Tablets USP, 7.5 mg 

71–782 Clorazepate Dipotassium Tablets USP, 15 mg 

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