Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 10805-10806 [2010-4925]
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10805
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
Dated: February 26, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–4885 Filed 3–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Support Enforcement
Program Expenditure Report (Form
OCSE–396A) and the Child Support
Enforcement Program Collection Report
(Form OCSE–34A).
OMB No.: 0970–0181.
Description: State and Tribal agencies
administering the Child Support
Enforcement Program under Title IV–D
of the Social Security Act are required
to provide information each fiscal
quarter to the Office of Child Support
Enforcement (OCSE) concerning
administrative expenditures and the
receipt and disposition of child support
payments from non-custodial parents.
State title IV–D agencies report quarterly
expenditures and collections using
Forms OCSE–396A and OCSE–34A,
respectively. Tribal title IV–D agencies
report quarterly expenditures using
Form SF–269, as prescribed in program
regulations, and formerly reported
quarterly collections using only a
modified version of Form OCSE–34A.
The information collected on these
reporting forms is used to compute
quarterly grant awards to States and
Tribes, the annual incentive payments
to States and provides valuable
information on program finances. This
information is also included in a
published annual statistical and
financial report, available to the general
public.
Under Public Law 111–5, the
‘‘American Recovery and Reinvestment
Act of 2009’’ (ARRA), enacted in
February 2009, the availability of
Federal funding to State administered
child support enforcement programs
was substantially increased with a
change in methodology of calculating
these funds. We propose to formally
incorporate this necessary revision into
the quarterly expenditure report and to
update the existing quarterly collection
report to enable the same version of that
form to be used by both State and Tribal
IV–D agencies. We also propose to
review other data entry elements and
the accompanying instructions in both
data collection forms to assure that the
financial information requested from
States and Tribes remains relevant and
will assure that OCSE collects the
information needed in the most efficient
format feasible.
Respondents: State agencies
(including the District of Columbia,
Puerto Rico, Guam and the Virgin
Islands) administering the Child
Support Enforcement Program. Tribal
agencies with approved plans to
administer the Child Support
Enforcement Program.
ANNUAL BURDEN ESTIMATES
Number of respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
54
100
4
4
8
8
sroberts on DSKD5P82C1PROD with NOTICES
OCSE–396A ....................................................................................................
OCSE–34A ......................................................................................................
Estimated Total Annual Burden
Hours: 4,928.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 3, 2010.
Robert Sargis,
Reports Clearance Officer.
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–P–0435 and FDA–
2008–P–0554]
Determination That DOVONEX
(Calcipotriene) Ointment, 0.005%, Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that DOVONEX
(calcipotriene) Ointment, 0.005%, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for calcipotriene
Ointment, 0.005%, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
BILLING CODE 4184–01–P
Frm 00052
1,728
3,200
HHS.
[FR Doc. 2010–4895 Filed 3–8–10; 8:45 am]
PO 00000
Total burden
hours
Sfmt 4703
E:\FR\FM\09MRN1.SGM
09MRN1
sroberts on DSKD5P82C1PROD with NOTICES
10806
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
Ave., Bldg. 51, rm. 6358, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
DOVONEX (calcipotriene) Ointment,
0.005%, is the subject of NDA 20–273,
held by LEO Pharmaceutical Products
Ltd. (LEO) and initially approved on
December 29, 1993. DOVONEX is
indicated for the treatment of plaque
psoriasis in adults. In its annual report
dated February 28, 2008, LEO notified
FDA that DOVONEX (calcipotriene)
Ointment, 0.005%, had been
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated July
25, 2008 (Docket No. FDA–2008–P–
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
0435), under 21 CFR 10.30, requesting
that the agency determine whether
DOVONEX (calcipotriene) Ointment,
0.005%, was withdrawn from sale for
reasons of safety or effectiveness. A
second citizen petition was submitted
by Mya Thomae Consulting, Inc., dated
October 13, 2008 (Docket No. FDA–
2008–P–0554), requesting that the
agency determine whether DOVONEX
(calcipotriene) Ointment, 0.005%, was
withdrawn from sale for reasons of
safety or effectiveness.
FDA has reviewed its records and,
under § 314.161, has determined that
DOVONEX (calcipotriene) Ointment,
0.005%, was not withdrawn from sale
for reasons of safety or effectiveness.
The petitioners identified no data or
other information suggesting that
DOVONEX (calcipotriene) Ointment,
0.005%, was withdrawn for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list DOVONEX
(calcipotriene) Ointment, 0.005%, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to DOVONEX (calcipotriene) Ointment,
0.005%, may be approved by the agency
if all other legal and regulatory
requirements for the approval of ANDAs
are met. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the agency
will advise ANDA applicants to submit
such labeling.
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–4925 Filed 3–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0108]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00053
Fmt 4703
Sfmt 4703
SUMMARY: The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the agency
by May 10, 2010 Federal Register].
FOR FURTHER INFORMATION CONTACT: Beth
Duvall-Miller, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466,
Silver Spring, MD 20993–0002, 301–
796–0700, e-mail:
elizabeth.duvallmiller@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) First hand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10805-10806]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4925]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-P-0435 and FDA-2008-P-0554]
Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was
Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire
[[Page 10806]]
Ave., Bldg. 51, rm. 6358, Silver Spring, MD 20993-0002, 301-796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162). Under Sec. 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must determine whether a listed drug was
withdrawn from sale for reasons of safety or effectiveness before an
ANDA that refers to that listed drug may be approved. FDA may not
approve an ANDA that does not refer to a listed drug.
DOVONEX (calcipotriene) Ointment, 0.005%, is the subject of NDA 20-
273, held by LEO Pharmaceutical Products Ltd. (LEO) and initially
approved on December 29, 1993. DOVONEX is indicated for the treatment
of plaque psoriasis in adults. In its annual report dated February 28,
2008, LEO notified FDA that DOVONEX (calcipotriene) Ointment, 0.005%,
had been discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc., submitted a citizen petition
dated July 25, 2008 (Docket No. FDA-2008-P-0435), under 21 CFR 10.30,
requesting that the agency determine whether DOVONEX (calcipotriene)
Ointment, 0.005%, was withdrawn from sale for reasons of safety or
effectiveness. A second citizen petition was submitted by Mya Thomae
Consulting, Inc., dated October 13, 2008 (Docket No. FDA-2008-P-0554),
requesting that the agency determine whether DOVONEX (calcipotriene)
Ointment, 0.005%, was withdrawn from sale for reasons of safety or
effectiveness.
FDA has reviewed its records and, under Sec. 314.161, has
determined that DOVONEX (calcipotriene) Ointment, 0.005%, was not
withdrawn from sale for reasons of safety or effectiveness. The
petitioners identified no data or other information suggesting that
DOVONEX (calcipotriene) Ointment, 0.005%, was withdrawn for reasons of
safety or effectiveness. FDA has independently evaluated relevant
literature and data for possible postmarketing adverse events and has
found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DOVONEX (calcipotriene)
Ointment, 0.005%, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to DOVONEX (calcipotriene) Ointment, 0.005%, may be approved by
the agency if all other legal and regulatory requirements for the
approval of ANDAs are met. If FDA determines that labeling for this
drug product should be revised to meet current standards, the agency
will advise ANDA applicants to submit such labeling.
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4925 Filed 3-8-10; 8:45 am]
BILLING CODE 4160-01-S
