Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications, 51075-51076 [05-17151]
Download as PDF
<![CDATA[
Federal Register / Vol. 70, No. 166 / Monday, August 29, 2005 / Notices
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
51075
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.
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:
SUPPLEMENTARY INFORMATION:
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
VerDate Aug<18>2005
15:17 Aug 26, 2005
Jkt 205001
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
E:\FR\FM\29AUN1.SGM
29AUN1
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]
[Pages 51075-51076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17151]
-----------------------------------------------------------------------
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 Sec. 314.150(d) (21 CFR
314.150(d)), and waived its opportunity for a hearing, provided under
Sec. 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
------------------------------------------------------------------------
[[Page 51076]]
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
