[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31053-31054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13112]


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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 (NIMH)

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: The National Institute of Mental Health 
Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control 
Number 0925-0697. National Institute of Mental Health, National 
Institutes of Health.
    Need and Use of Information Collection: Recruitment Milestone 
Reporting (RMR) allows NIMH staff to monitor more accurately the 
required recruitment of participants in NIMH-sponsored clinical trials 
and other 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. Studies that fail to meet their 
milestones may be requested to provide interim monthly reports. 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

[[Page 31054]]

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 2295.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
             Form                    Type of         Number of     Frequency of    per response     Annual hour
                                   respondent       respondents      response       (in hours)        burden
----------------------------------------------------------------------------------------------------------------
NIMH Recruitment Milestone      Principal                    900               3           45/60            2025
 Reporting.                      Investigators/
                                 Research
                                 Assistant.
NIMH Recruitment Milestone      Principal                     40               9           45/60             270
 Monthly Report.                 Investigators/
                                 Research
                                 Assistant.
----------------------------------------------------------------------------------------------------------------


    Dated: May 21, 2015.
Keisha L Shropshire,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2015-13112 Filed 5-29-15; 8:45 am]
 BILLING CODE 4140-01-P