Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 35039-35040 [2013-13790]
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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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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.
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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
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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
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35040
Federal Register / Vol. 78, No. 112 / Tuesday, June 11, 2013 / Notices
order to perform the functions related to
hematopoietic stem cell transplantation
under contract to the U.S. Department of
Health and Human Services (HHS). The
Act requires the Secretary to contract for
the establishment and maintenance of
information related to patients who
have received stem cell therapeutic
products and to do so using a
standardized, electronic format. Data is
collected from transplant centers by the
Center for International Blood and
Marrow Transplant Research and is
used for ongoing analysis of transplant
outcomes. HRSA uses the information
in order to carry out its statutory
responsibilities. Information is needed
to monitor the clinical status of
transplantation and to provide the
Secretary of HHS with an annual report
of transplant center-specific survival
data. The increase in burden, as
reflected in this revised submission
request, is due to an increase in the
annual number of transplants and
increasing survivorship after
transplantation.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Responses
per
respondent
Total
responses
Hours per
response
Baseline Pre-TED (Transplant Essential Data) ...................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-Day Post-TED ...............................................................
6-Month Post-TED ...............................................................
12-Month Post-TED .............................................................
Annual Post-TED .................................................................
200
38
7,600
200
200
200
200
200
29
38
31
27
104
5,800
7,600
6,200
5,400
20,800
1
0.85
1
1
1
5,800
6,460
6,200
5,400
20,800
Total ..............................................................................
200
........................
53,400
........................
52,260
Dated: June 5, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–13790 Filed 6–10–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Submission for OMB Review; 30-day
Comment Request; Web-Based Media
Literacy Parent Training for Substance
Use Prevention in Rural Locations
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse, National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 27, 2013,
pages 18612–18613 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute on Drug Abuse
(NIDA), National Institutes of Health,
may not conduct or sponsor, and the
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respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Augie Diana, Health
Scientist Administrator, Prevention
Research Branch, Division of
Epidemiology, Services, and Prevention
Research, NIDA, NIH, 6001 Executive
Boulevard, Room 5163, Bethesda, MD
20892, or call non-toll-free number (301)
443–1942 or Email your request,
including your address to:
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1
Total burden
hours
7,600
dianaa@nida.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Web-based
Media Literacy Parent Training for
Substance Use Prevention in Rural
Locations, 0925-New, National Institute
on Drug Abuse (NIDA), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This study will develop a
web-based media literacy substance use
prevention intervention for use with
parents and their elementary school
children (approximately ages 7–12), and
will evaluate the program in a
randomized controlled trial to establish
program efficacy in six rural
communities in North Carolina and
Texas. The primary objectives of the
study are to assess the efficacy of a
media literacy education program that is
specifically designed to overcome
barriers to prevention efforts in rural
communities, and to provide the
scientific basis for establishing the
program, Media Detective Family, as an
evidence-based substance use
prevention curriculum. The findings
will provide valuable information
concerning: (1) The appropriateness of
using technology for substance use
prevention programming (i.e., internet,
Smartphone, or tablet-based
applications) to reach rural families
with elementary school-aged children;
E:\FR\FM\11JNN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35039-35040]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13790]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
[[Page 35040]]
order to perform the functions related to hematopoietic stem cell
transplantation under contract to the U.S. Department of Health and
Human Services (HHS). The Act requires the Secretary to contract for
the establishment and maintenance of information related to patients
who have received stem cell therapeutic products and to do so using a
standardized, electronic format. Data is collected from transplant
centers by the Center for International Blood and Marrow Transplant
Research and is used for ongoing analysis of transplant outcomes. HRSA
uses the information in order to carry out its statutory
responsibilities. Information is needed to monitor the clinical status
of transplantation and to provide the Secretary of HHS with an annual
report of transplant center-specific survival data. The increase in
burden, as reflected in this revised submission request, is due to an
increase in the annual number of transplants and increasing
survivorship after transplantation.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form name respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-TED (Transplant 200 38 7,600 1 7,600
Essential Data).................
Product Form (includes Infusion, 200 29 5,800 1 5,800
HLA, and Infectious Disease
Marker inserts).................
100-Day Post-TED................. 200 38 7,600 0.85 6,460
6-Month Post-TED................. 200 31 6,200 1 6,200
12-Month Post-TED................ 200 27 5,400 1 5,400
Annual Post-TED.................. 200 104 20,800 1 20,800
------------------------------------------------------------------------------
Total........................ 200 .............. 53,400 ............. 52,260
----------------------------------------------------------------------------------------------------------------
Dated: June 5, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-13790 Filed 6-10-13; 8:45 am]
BILLING CODE 4165-15-P
