Submission for OMB Review; 30-Day Comment Request; NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH), 60478-60479 [2014-23938]
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60478
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
knowledge of product analyses used by
tobacco product manufacturers to
ensure product consistency.
Dated: September 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
II. Description of Site Tours Program
[FR Doc. 2014–23844 Filed 10–6–14; 8:45 am]
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:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
BILLING CODE 4164–01–P
In the Laboratory Site Tours Program,
small groups of CTP staff plan to
observe the operations of laboratories
that perform testing and analyses of
tobacco products and tobacco smoke
relative to analytical chemistry,
microbiology, toxicology, biomarkers of
exposure or risk, and analytical method
development. Please note that the
Laboratory Site Tours Program is not
intended to include official FDA
inspections of facilities to determine
compliance with the FD&C Act or for
the purposes of developing Tobacco
Product Manufacturing Practice
regulations; rather, the program is meant
to educate CTP staff and improve their
understanding of laboratory testing and
analyses used by the tobacco industry.
III. Site Selection
CTP plans to select a wide variety of
laboratories that include academic,
private, and those affiliated with
tobacco manufacturers. All travel
expenses associated with the site tours
will be the responsibility of CTP. Final
site selections will be based on the
availability of CTP funds and resources
for the relevant fiscal year, as well as the
following factors, if applicable: (1)
Compliance status of the requesting
facility and affiliated firm, (2) whether
the requesting facility is in arrears for
user fees, and (3) whether the requesting
facility or affiliated firm has a
significant request or marketing
application or submission pending with
FDA.
IV. Requests for Participation
Identify requests for participation
with the docket number found in
brackets in the heading of this
document. Received requests are
available for public examination in the
Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; NIMH Database of
Cognitive Training and Remediation
Studies (DCTRS) (NIMH)
Proposed Collection
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the 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 April 15, 2014,
pages 21250–21252 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 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
SUMMARY:
NIMH Database of Cognitive Training
and Remediation Studies (DCTRS)—
New—National Institute of Mental
Health (NIMH), National Institute of
Health (NIH).
Need and Use of Information
Collection: The NIMH Database of
Cognitive Training and Remediation
Studies (DCTRS) is an integrated
database that includes study- and
subject-level data from studies of
cognitive remediation (CR) in
schizophrenia. DCTRS will allow NIMH
staff and interested investigators to
examine the ways in which various
patient characteristics, intervention
approaches and features, and treatment
combinations affect responses to
remediation. The DCTRS Study
Information Form and Data Submission
Agreement are necessary for the
‘‘Submitter’’ to request permission to
submit study data to the NIMH DCTRS
for general research purposes. The
primary use of this information is to
collect submitter information and study
information for inclusion in the NIMH
DCTRS database. The DCTRS data
submission agreement includes two
forms: (1) The data submission form that
includes the terms, agreement,
submitter information and certifications,
and (2) the study information form
which collects de-identified data for
each study.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
60.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Type of
respondent
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
Data Submission Agreement ............
Principal Investigators/Physicians ....
12
1
5
60
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60479
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
Dated: September 29, 2014.
Keisha Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014–23938 Filed 10–6–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NIMH Data Repositories Data
Submission Request; NIMH Data
Repositories Data Access and Use
Certification
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
SUMMARY:
Mental Health (NIMH) Data Repositories
are a group of Federal data repositories
based on an informatics platform for
human-subjects research domains
related to mental health, initially
established as the National Database for
Autism Research (NDAR) to support
autism-related research. In 2013, NIMH
received approval from OMB for use of
the NIMH Data Access Request and Use
Certification (DUC) Form to meet the
unique data access needs of all existing
NIMH data repositories, which at the
time consisted of NDAR, Pediatric MRI
(PedsMRI), and the NIMH Clinical
Research Datasets (NCRD)—OMB#
0925–0667 (Expiration: 09/30/2016).
Now in 2014, two new databases have
been added and integrated into the
NDAR infrastructure, NDCT and
RDoCdb. At this time, NIMH is seeking
OMB approval to add an all-purpose
NIMH Data Repositories Data
Submission Request Form and to add a
revised all-purpose NIMH Data
Repositories Data Access and Use
Certification Form. As the data
repositories have matured, and with the
introduction of the new databases—
namely NDCT and RDoCdb—the
information being collected for data
submission has become more complex,
rendering an OMB-approved submission
form a new necessity.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
221.
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: 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:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: NIMH Data
Repositories (NDR) Data Submission
Request, the NIMH Data Repositories
Data Access and Use Certification,
0925–0667 Revision; National Institute
of Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The National Institutes of
ESTIMATED ANNUALIZED BURDEN HOURS
A. Estimates annual burden hours
Number of
respondents
Form
NIMH Data Repositories Data Submission Request Form .............................
NIMH Data Repositories Data Access and Use Certification Form ................
Dated: September 29, 2014.
Keisha L Shropshire,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2014–23959 Filed 10–6–14; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
40
100
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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Frequency of
response
1
1
Average time
per response
(in hours)
95/60
95/60
Annual burden
hour
63
158
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Fellowships:
Synthetic and Biological Chemistry.
Date: November 4–5, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\07OCN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60478-60479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23938]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; NIMH Database
of Cognitive Training and Remediation Studies (DCTRS) (NIMH)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the 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 April 15, 2014, pages 21250-21252 and allowed 60-days 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 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: 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: nimhprapubliccomments@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Proposed Collection
NIMH Database of Cognitive Training and Remediation Studies
(DCTRS)--New--National Institute of Mental Health (NIMH), National
Institute of Health (NIH).
Need and Use of Information Collection: The NIMH Database of
Cognitive Training and Remediation Studies (DCTRS) is an integrated
database that includes study- and subject-level data from studies of
cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH
staff and interested investigators to examine the ways in which various
patient characteristics, intervention approaches and features, and
treatment combinations affect responses to remediation. The DCTRS Study
Information Form and Data Submission Agreement are necessary for the
``Submitter'' to request permission to submit study data to the NIMH
DCTRS for general research purposes. The primary use of this
information is to collect submitter information and study information
for inclusion in the NIMH DCTRS database. The DCTRS data submission
agreement includes two forms: (1) The data submission form that
includes the terms, agreement, submitter information and
certifications, and (2) the study information form which collects de-
identified data for each study.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 60.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time
Form Type of respondent Number of Frequency of per response Annual hour
respondents response (in hours) burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submission Agreement....................... Principal Investigators/Physicians 12 1 5 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 60479]]
Dated: September 29, 2014.
Keisha Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014-23938 Filed 10-6-14; 8:45 am]
BILLING CODE 4140-01-P
