Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025% and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 35038-35039 [2013-13782]
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35038
Federal Register / Vol. 78, No. 112 / Tuesday, June 11, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Evaluation of the Head Start
Designation Renewal System.
OMB No.: New Collection.
Description: In the fall of 2011, the
Administration for Children and
Families (ACF) within the US
Department of Health and Human
Services (HHS) significantly expanded
its accountability provisions with the
implementation of the Head Start
Designation Renewal System (DRS). The
DRS is designed to identify which Head
Start and Early Head Start grantees are
providing high quality, comprehensive
services to the children and families in
their communities. Where they are not,
grantees are denied automatic renewal
of their grant and must apply for
continuing funding through an open
competition process. Determinations are
based on seven conditions designed to
measure service quality, program
operational quality, and fiscal and
internal integrity.
The ACF is proposing to conduct an
evaluation of the DRS. The purpose of
the evaluation is to understand if the
DRS is working as intended, as a valid,
reliable, and transparent method for
identifying high-quality programs that
can receive continuing five-year grants
without competition and as a system
that encourages overall program quality
improvement. It also seeks to
understand how the system is working,
the circumstances in which it works
more or less well, and the contextual,
demographic, and program factors and
program actions associated with how
well the system is working. The study
will employ a mixed-methods design
that integrates and layers administrative
and secondary data sources,
observational measures, and interviews
to develop a rich knowledge base about
what the DRS accomplishes and how it
does so.
Respondents: Head Start program
directors; other program managers
including grantee agency directors,
center directors, and education services
coordinators; Head Start teachers; and
members of Head Start governing bodies
and local policy councils.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Quality Measures Follow Up Interview: Teachers .............
Quality Measures Follow Up Interview: Center Directors
Quality Measures Follow Up Interview: Program Directors
DRS Telephone Interview: Program Directors ..................
DRS In-Depth Interview: Agency Directors .......................
DRS In-Depth Interview: Program Directors .....................
DRS In-Depth Interview: Policy Council/Governing Body
DRS In-Depth Program Managers ....................................
Competition In-Depth Interview: Agency and Program Directors .............................................................................
Competition In-Depth Interview: Policy Council/Governing
Body ...............................................................................
Competition In-Depth Interview: Program Managers ........
Competition Data Capture Sheet .......................................
Estimated Total Annual Burden Hours .......................
In compliance with the requirements
of Section 3506(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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address:
OPREinfocollection@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
VerDate Mar<15>2010
15:13 Jun 10, 2013
Jkt 229001
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Annual
burden hours
830
350
70
35
15
15
75
45
1
1
1
1
1
1
1
1
0.4
1.5
1.1
1.25
1
1.5
1.5
1.5
332
525
77
44
15
23
113
68
166
263
39
22
8
12
57
34
18
1
1.25
23
12
45
27
500
........................
1
1
1
........................
1.5
1.5
0.15
..........................
68
41
75
........................
34
21
38
706
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)
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Steven M. Hanmer,
Reports Clearance Officer.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that CORDRAN (flurandrenolide)
Ointment USP, 0.025% and 0.05%,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
[FR Doc. 2013–13716 Filed 6–10–13; 8:45 am]
BILLING CODE 4184–22–P
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Food and Drug Administration
[Docket No. FDA–2013–P–0113]
Determination That CORDRAN
(Flurandrenolide) Ointment USP,
0.025% and 0.05%, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\11JNN1.SGM
Notice.
11JNN1
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 112 / Tuesday, June 11, 2013 / Notices
flurandrenolide ointment, 0.025% and
0.05%, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Christine Kirk, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–2465.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products 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 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).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CORDRAN (flurandrenolide)
Ointment USP, 0.025% and 0.05%, are
the subject of NDA 012806, held by
Aqua Pharmaceuticals, and initially
approved on October 18, 1965.
CORDRAN Ointment is a topical
corticosteroid indicated for the relief of
the inflammatory and pruritic
manifestations of corticosteroidresponsive dermatoses.
VerDate Mar<15>2010
15:13 Jun 10, 2013
Jkt 229001
CORDRAN (flurandrenolide)
Ointment USP, 0.025% and 0.05%, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
IGI Labs, Inc., submitted a citizen
petition dated January 15, 2013 (Docket
No. FDA–2013–P–0113), under 21 CFR
10.30, requesting that the Agency
determine whether CORDRAN
(flurandrenolide) Ointment USP, 0.05%,
was voluntarily withdrawn or withheld
from sale for reasons of safety or
effectiveness. Although the citizen
petition did not address the 0.025%
strength, that strength has also been
discontinued. On our own initiative, we
have also determined whether that
strength was withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CORDRAN
(flurandrenolide) Ointment USP,
0.025% and 0.05%, were not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
CORDRAN (flurandrenolide) Ointment
USP, 0.025% and 0.05%, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CORDRAN (flurandrenolide) Ointment
USP, 0.025% and 0.05%, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CORDRAN
(flurandrenolide) Ointment USP,
0.025% and 0.05%, 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 CORDRAN (flurandrenolide)
Ointment USP, 0.025% or 0.05%, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
PO 00000
Frm 00066
Fmt 4703
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35039
Dated: June 6, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–13782 Filed 6–10–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Stem Cell Therapeutic Outcomes
Database (OMB No. 0915–0310)—
Revision.
Abstract: The Stem Cell Therapeutic
and Research Act of 2005, Public Law
(Pub. L.) 109–129, as amended by the
Stem Cell Therapeutic and Research
Reauthorization Act of 2010, Public Law
111–264 (the Act), provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. HRSA’s
Healthcare Systems Bureau has
established the Stem Cell Therapeutic
Outcomes Database. Operation of this
database necessitates certain record
keeping and reporting requirements in
E:\FR\FM\11JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35038-35039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0113]
Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025%
and 0.05%, Were 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
CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for
[[Page 35039]]
flurandrenolide ointment, 0.025% and 0.05%, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-2465.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products 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 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, are the
subject of NDA 012806, held by Aqua Pharmaceuticals, and initially
approved on October 18, 1965. CORDRAN Ointment is a topical
corticosteroid indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, are
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
IGI Labs, Inc., submitted a citizen petition dated January 15, 2013
(Docket No. FDA-2013-P-0113), under 21 CFR 10.30, requesting that the
Agency determine whether CORDRAN (flurandrenolide) Ointment USP, 0.05%,
was voluntarily withdrawn or withheld from sale for reasons of safety
or effectiveness. Although the citizen petition did not address the
0.025% strength, that strength has also been discontinued. On our own
initiative, we have also determined whether that strength was withdrawn
for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that CORDRAN (flurandrenolide) Ointment USP, 0.025%
and 0.05%, were not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that CORDRAN (flurandrenolide) Ointment USP, 0.025% and 0.05%, were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of CORDRAN
(flurandrenolide) Ointment USP, 0.025% and 0.05%, from sale. We have
also independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that these products were withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list CORDRAN
(flurandrenolide) Ointment USP, 0.025% and 0.05%, 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 CORDRAN (flurandrenolide) Ointment
USP, 0.025% or 0.05%, may be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for these drug products should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: June 6, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-13782 Filed 6-10-13; 8:45 am]
BILLING CODE 4160-01-P
