Submission for OMB Review; 30-day Comment Request: National Institute of Mental Health Data Access Request and Use Certification, 48177-48178 [2013-19072]
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Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices
Dated: August 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19051 Filed 8–6–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0883]
Purdue Pharma L.P.; Withdrawal of
Approval of a New Drug Application for
Oxycontin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for OXYCONTIN (oxycodone
hydrochloride) Extended-Release
Tablets, held by Purdue Pharma L.P.
(Purdue), One Stamford Forum,
Stamford, CT 06901–3431. Purdue has
voluntarily requested that approval of
this application (NDA 20–553) be
withdrawn and has waived its
opportunity for a hearing.
DATES: Effective August 7, 2013.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
SUPPLEMENTARY INFORMATION: FDA
approved NDA 20–553 for OXYCONTIN
(oxycodone hydrochloride) ExtendedRelease Tablets, 10 milligrams (mg), 15
mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg,
and 160 mg, (original OxyContin), on
December 12, 1995. A reformulated
version of these products, OXYCONTIN
(oxycodone hydrochloride) ExtendedRelease Tablets, 10 mg, 15 mg, 20 mg,
30 mg, 40 mg, 60 mg, and 80 mg
(reformulated OxyContin), is the subject
of NDA 22–272, also held by Purdue
and initially approved on April 5, 2010.
Reformulated OxyContin was developed
with physicochemical properties that
are intended to make the tablet more
difficult to manipulate for purposes of
abuse or misuse. Both original and
reformulated OxyContin are opioid
agonist products. Original OxyContin
was indicated for the management of
moderate to severe pain when a
continuous, around-the-clock opioid
analgesic is needed for an extended
period of time.
In correspondence dated August 10,
2010, Purdue notified FDA that it had
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SUMMARY:
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17:03 Aug 06, 2013
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ceased shipment of original OxyContin,
and FDA subsequently moved original
OxyContin to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In a letter to FDA dated March 19,
2013, Purdue requested that FDA
withdraw approval of NDA 20–553 for
original OxyContin, noting that the
original formulation of OxyContin was
subject to abuse and misuse, and that it
was ‘‘not possible to develop labeling or
REMS provisions that would create a
positive risk/benefit ratio for the
original formulation of OxyContin.’’ In
that letter, Purdue waived its right to a
hearing.
On April 18, 2013, FDA published
notice of its determination that original
OxyContin, NDA 20–553, was
withdrawn from sale for reasons of
safety or effectiveness (78 FR 23273).
The notice concluded that ‘‘[o]riginal
OxyContin . . . poses an increased
potential for abuse by certain routes of
administration, when compared to
reformulated OxyContin. Based on the
totality of the data and information
available to the Agency at this time,
FDA concludes that the benefits of
original OxyContin no longer outweigh
its risks.’’
Under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(e)), and under
authority delegated by the
Commissioner to the Director, Center for
Drug Evaluation and Research, approval
of NDA 20–553, and all amendments
and supplements thereto, is withdrawn
(see DATES). Distribution of this product
in interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
Dated: July 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–18694 Filed 8–6–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: National Institute
of Mental Health Data Access Request
and Use Certification
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Mental Health (NIMH), the
National Institutes of Health, has
submitted to the Office of Management
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
48177
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
May 28, 2013, Volume 78, Number 102,
Pages 31947–31948 and allowed 60days for public comment. No comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Mental Health (NIMH),
National Institutes of Health, may not
conduct or sponsor, and the 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.
DATES: Comment 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, or request more
information on the proposed project,
contact: Keisha Shropshire, NIMH
Project Clearance Liaison, Science
Policy and Evaluation Branch, OSPPC,
NIMH, NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667,
Rockville Pike, Bethesda, MD 20892, or
call 301–443–4335 or email your
request, including your address to:
kshropsh@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: The National
Institute of Mental Health Data Access
Request and Use Certification
(previously National Database for
Autism Research Data Access Request),
0925–0667, Revision, Expiration Date:
01/31/2016; National Institute of Mental
Health (NIMH), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NIMH recently received
OMB approval for use of the National
Database for Autism Research (NDAR)
Data Use Certification (DUC) Form.
NIMH is interested in renaming this
form the ‘‘NIMH Data Access Request
and Use Certification (DUC) Form’’ and
using it to meet the unique data access
E:\FR\FM\07AUN1.SGM
07AUN1
48178
Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices
needs of all NIMH data repositories. The
NIMH DUC form is necessary for
‘‘Recipient’’ Principal Investigators and
their organization or corporations with
approved assurance from the DHHS
Office of Human Research Protections to
access data or images from NIMH
repositories and datasets for research
purposes. The primary use of this
(PedsMRI), and the NIMH Clinical
Research Datasets (NCRD).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
380.
information is to document, track,
monitor, and evaluate the use of the
NIMH repositories/datasets, as well as
to notify interested recipients of
updates, corrections or other changes to
the database. There are currently three
data repositories/sets positioned to use
the NIMH DUC form: NDAR, the NIH
Pediatric MRI Data Repository
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Type of respondent
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
NIMH Data Access Request and
Use Certification.
Principal Investigators/Research Assistant.
240
1
95/60
380
Dated: July 25, 2013.
Sue Murrin,
Executive Officer, NIMH, NIH.
[FR Doc. 2013–19072 Filed 8–6–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request: Autism Spectrum
Disorder Research Portfolio Analysis
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Mental Health (NIMH), the
National Institutes of Health, 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
May 24, 2013, Volume 78, Number 101,
Pages 31568–31569 and allowed 60days for public comment. One public
comment was received; in this
comment, a request was made for access
to any data that is collected on autism
projects that are funded. This comment
was considered, but it did not result in
alteration to the data collection or data
management process because steps are
already in place to make the data
publicly accessible via an online Web
SUMMARY:
Tool on the IACC Web site. No
comments that specifically addressed
cost and hour burden were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
The National Institute of Mental Health
(NIMH), National Institutes of Health,
may not conduct or sponsor, and the
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.
Comment 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, or request more
information on the proposed project,
contact: The Office of Autism Research
Coordination, NIMH, NIH, Neuroscience
Center, 6001 Executive Blvd., MSC
9663, Room 6184, Bethesda, MD 20892
or Email your request, including your
address to:
iaccpublicinquiries@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Autism
Spectrum Disorder (ASD) Research
Portfolio Analysis, 0925—NEWNational Institute of Mental Health
(NIMH), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of the ASD
portfolio analysis is to collect research
funding data from U.S. and
international ASD research funders, to
assist the Interagency Autism
Coordinating Committee (IACC) in
fulfilling the requirements of the
Combating Autism Act, and to inform
the committee and interested
stakeholders of the funding landscape
and current directions for ASD research.
Specifically, these analyses will
examine the extent to which current
funding and research topics align with
the IACC Strategic Plan for ASD
Research. The findings will help guide
future funding priorities by outlining
current gaps and opportunities in ASD
research as well as serving to highlight
annual activities and research progress.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
419.
mstockstill on DSK4VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
(funders)
Number of
respondents
U.S. Federal .....................................................................................................
U.S. Private ......................................................................................................
International Government ................................................................................
International Private .........................................................................................
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Number of
response per
respondent
26
12
4
4
E:\FR\FM\07AUN1.SGM
36
54
14
9
07AUN1
Average time
per response
(in hours )
15/60
15/60
15/60
15/60
Total burden
hours
234
162
14
9
]]>Agencies
[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48177-48178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day Comment Request: National
Institute of Mental Health Data Access Request and Use Certification
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute of Mental Health (NIMH),
the National Institutes of Health, 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 May 28,
2013, Volume 78, Number 102, Pages 31947-31948 and allowed 60-days for
public comment. No comments were received. The purpose of this notice
is to allow an additional 30 days for public comment. The National
Institute of Mental Health (NIMH), National Institutes of Health, may
not conduct or sponsor, and the 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.
DATES: Comment 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, or request more information on the
proposed project, contact: Keisha Shropshire, NIMH Project Clearance
Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH,
Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville
Pike, Bethesda, MD 20892, or call 301-443-4335 or email your request,
including your address to: kshropsh@mail.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: The National Institute of Mental Health Data
Access Request and Use Certification (previously National Database for
Autism Research Data Access Request), 0925-0667, Revision, Expiration
Date: 01/31/2016; National Institute of Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information Collection: NIMH recently received OMB
approval for use of the National Database for Autism Research (NDAR)
Data Use Certification (DUC) Form. NIMH is interested in renaming this
form the ``NIMH Data Access Request and Use Certification (DUC) Form''
and using it to meet the unique data access
[[Page 48178]]
needs of all NIMH data repositories. The NIMH DUC form is necessary for
``Recipient'' Principal Investigators and their organization or
corporations with approved assurance from the DHHS Office of Human
Research Protections to access data or images from NIMH repositories
and datasets for research purposes. The primary use of this information
is to document, track, monitor, and evaluate the use of the NIMH
repositories/datasets, as well as to notify interested recipients of
updates, corrections or other changes to the database. There are
currently three data repositories/sets positioned to use the NIMH DUC
form: NDAR, the NIH Pediatric MRI Data Repository (PedsMRI), and the
NIMH Clinical Research Datasets (NCRD).
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 380.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time
Form Type of respondent Number of Frequency of per response Annual hour
respondents response (in hours) burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIMH Data Access Request and Use Certification.. Principal Investigators/Research 240 1 95/60 380
Assistant.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: July 25, 2013.
Sue Murrin,
Executive Officer, NIMH, NIH.
[FR Doc. 2013-19072 Filed 8-6-13; 8:45 am]
BILLING CODE 4140-01-P
