[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46994-46995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: National Institute 
of Mental Health Recruitment and Milestone Reporting System

Summary:
    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 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: 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.
    Comment Due Date: Comments received within 60 days of the date of 
this publication will receive fullest consideration.
    Proposed Collection: National Institute of Mental Health 
Recruitment Milestone Reporting System. 0925-New. National Institute of 
Mental Health (NIMH), National Institute of Health (NIH).
    Need and Use of Information Collection: Recruitment Milestone 
Reporting (RMR) allows NIMH staff to monitor more accurately the 
recruitment of participants in NIMH-sponsored clinical research studies 
that plan to enroll 150 or more human subjects in a single study. 
Clinical studies can have difficulty recruiting, and accurate and 
timely reporting is the best way to ensure proper use of the grant 
funds. Investigators develop a recruitment plan that includes tri-
yearly milestones for recruitment of the total study population, and 
for recruitment of racial and ethnic minority participants. Once 
recruitment is scheduled to begin, investigators report actual progress 
on recruitment milestones three times per year, by April 1, August 1, 
and December 1. The primary use of this information is to ensure that 
realistic recruitment targets are established from the onset of a 
project, and that these targets are met throughout the course of the 
research. By ensuring timely recruitment into clinical research 
studies, NIMH can reduce the need to extend timelines or supplement 
funds in order to complete the research project, and potentially 
increase efficiency in our funding process.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 1519.

[[Page 46995]]



                                                            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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NIMH Recruitment Milestone Reporting............  Principal Investigators/ Research              675                3            75/60             1519
                                                   Assistant.
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    Dated: July 19, 2013.
Sue Murrin,
Executive Officer, NIMH, NIH.
[FR Doc. 2013-18600 Filed 8-1-13; 8:45 am]
BILLING CODE 4140-01-P