[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10816-10817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; National 
Institute of Mental Health Recruitment and Milestone Reporting System

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 August 2, 2013, page 46994 and allowed 60-days for public 
comment. One public comment was received regarding human subjects 
research recruitment and retention and the perception of coercion. The 
recruitment and enrollment procedures proposed by a NIMH-funded 
clinical trial are reviewed and approved by an IRB of record, which has 
agreed to review human subject research projects in accordance with 45 
CFR Part 46 and its Federal-wide Assurance. The IRB of record ensures 
that the possibility of coercion or undue influence is minimized, that 
an investigator seeks consent only under circumstances that provide the 
prospective subject/representative sufficient opportunity to consider 
whether or not to participate. To address these concerns, we plan to 
add a statement about human subject protections to the policy and add a 
link to the human subjects training on the policy Web page. 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,

[[Page 10817]]

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

    National Institute of Mental Health Recruitment Milestone Reporting 
System-Existing collection in use without OMB control number--National 
Institute of Mental Health (NIMH), National Institute of Health (NIH).
    Need and Use of Information Collection: The Recruitment Milestone 
Reporting (RMR) System 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 2,531.

                                                            Estimated Annualized Burden Hours
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                                                                                                                         Average burden
                      Form                                Type of respondent             Number of       Frequency of     per response     Total annual
                                                                                        respondents        response        (in hours)      burden hours
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NIMH Recruitment Milestone Reporting............  Principal Investigators/Research               675                3            75/60            2,531
                                                   Assistant.
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    Dated: February 18, 2014.
Keisha Shropshire,
Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014-04194 Filed 2-25-14; 8:45 am]
BILLING CODE 4140-01-P