[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