Submission for OMB Review; Comment Request, 37784 [07-3351]
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37784
Federal Register / Vol. 72, No. 132 / Wednesday, July 11, 2007 / Notices
are invited to participate in the Effective
Healthcare Program by making
suggestions for research and providing
comment on key questions and draft
reviews. In addition, a listserv has been
established and those interested may
join to be notified when items of interest
become available for review or public
comment. Opportunities for
involvement in the Effective Health Care
Program are described at https://
www.EffectiveHealthCare.ahrq.gov.
Dated: July 3, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07–3360 Filed 7–10–07; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ANA Consultant and Evaluator
Qualifications Form.
OMB No.: 0970–0265.
Description: The ANA Consultant and
Evaluator Qualifications Form is used to
collect information from prospective
proposal reviewers in compliance with
42 U.S.C. 2291d–1. The form will allow
the Commissioner of ANA to select
qualified people to review grant
applications for Social and Economic
Development Strategies (SEDS), Native
Language Preservation and
Maintenance, Environmental Regulatory
Enhancement, and Environmental
Mitigation. The panel review process is
a legislative mandate in the ANA grant
funding process.
Respondents: Native Americans,
Native Alaskans, Native Hawaiians and
other Pacific Islanders.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden hours per
response
Total burden
hours
ANA Consultant and Evaluator Qualifications Form .......................................
300
1
1
300
jlentini on PROD1PC65 with NOTICES
Estimated Total Annual Burden
Hours: 300.
Additional Information:
Copies of the proposed collection may
be obtained 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. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 5, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–3351 Filed 7–10–07; 8:45 am]
BILLING CODE 4184–01–M
VerDate Aug<31>2005
17:56 Jul 10, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0218]
Determination That ARISTOCORT
FORTE Injectable Suspension
(Triamcinolone Diacetate), 40
Milligrams per Milliliter, 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) has determined
that ARISTOCORT FORTE Injectable
Suspension (triamcinolone diacetate),
40 milligrams (mg) per milliliter (mL),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for triamcinolone
diacetate suspension, 40 mg/mL.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
under an ANDA procedure. ANDA
sponsors 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 typically a version of the drug
that was previously approved. Sponsors
of ANDAs 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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 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.
E:\FR\FM\11JYN1.SGM
11JYN1
Agencies
[Federal Register Volume 72, Number 132 (Wednesday, July 11, 2007)]
[Notices]
[Page 37784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: ANA Consultant and Evaluator Qualifications Form.
OMB No.: 0970-0265.
Description: The ANA Consultant and Evaluator Qualifications Form
is used to collect information from prospective proposal reviewers in
compliance with 42 U.S.C. 2291d-1. The form will allow the Commissioner
of ANA to select qualified people to review grant applications for
Social and Economic Development Strategies (SEDS), Native Language
Preservation and Maintenance, Environmental Regulatory Enhancement, and
Environmental Mitigation. The panel review process is a legislative
mandate in the ANA grant funding process.
Respondents: Native Americans, Native Alaskans, Native Hawaiians
and other Pacific Islanders.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ANA Consultant and Evaluator Qualifications 300 1 1 300
Form.......................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 300.
Additional Information:
Copies of the proposed collection may be obtained 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. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974,
Attn: Desk Officer for the Administration for Children and Families.
Dated: July 5, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07-3351 Filed 7-10-07; 8:45 am]
BILLING CODE 4184-01-M