[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60478-60479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23938]


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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, [email protected] 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: [email protected]. 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
 
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                                                                                                                          Average time
                      Form                                Type of  respondent            Number of       Frequency of     per response     Annual hour
                                                                                        respondents        response        (in hours)         burden
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Data Submission Agreement.......................  Principal Investigators/Physicians              12                1                5               60
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[[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