[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