80 FR 61439 - Submission for OMB Review; 30-Day Comment Request: National Institute of Mental Health (NIMH) Recruitment Milestone Reporting System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 197 (October 13, 2015)

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), 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 June 1, 2015, page 31053, and allowed 60-days for public comment. Four (4) public comments were received. Comments include concerns about the clarity of the announcement, the utility of the information collected, and the frequency of tri-annual and monthly reporting. NIMH carefully considered all comments received and has changed the language in the supporting statement to confirm that reporting of recruitment milestones in the RMR applies to participants in all extramural NIMH- sponsored clinical trials, regardless of size, as well as other clinical research studies that plan to enroll 150 or more human subjects in a single study. Investigators who fail to meet their milestones may be requested to submit interim monthly reports. NIMH has determined tri-annual reporting to be the minimum necessary to provide effective recruitment monitoring. When studies fall significantly behind their recruitment goals, monthly reporting is necessary in order to ensure the study can be completed within the proposed budget and timeframe. Based on current study performance, NIMH expects less than 5% of respondents will require monthly reporting. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health, 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.

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61439-61440]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25941]


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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 (NIMH) Recruitment Milestone Reporting 
System

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Mental Health (NIMH), 
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 June 1, 
2015, page 31053, and allowed 60-days for public comment. Four (4) 
public comments were received. Comments include concerns about the 
clarity of the announcement, the utility of the information collected, 
and the frequency of tri-annual and monthly reporting. NIMH carefully 
considered all comments received and has changed the language in the 
supporting statement to confirm that reporting of recruitment 
milestones in the RMR applies to participants in all extramural NIMH-
sponsored clinical trials, regardless of size, as well as other 
clinical research studies that plan to enroll 150 or more human 
subjects in a single study. Investigators who fail to meet their 
milestones may be requested to submit interim monthly reports. NIMH has 
determined tri-annual reporting to be the minimum necessary to provide 
effective recruitment monitoring. When studies fall significantly 
behind their recruitment goals, monthly reporting is necessary in order 
to ensure the study can be completed within the proposed budget and 
timeframe. Based on current study performance, NIMH expects less than 
5% of respondents will require monthly reporting. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institute of Mental Health, 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: 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.

Proposed Collection

    National Institute of Mental Health (NIMH) Recruitment Milestone 
Reporting System (OMB control number 0925-0697)--REVISION--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 effectively the

[[Page 61440]]

recruitment of participants in all NIMH-sponsored clinical trials, 
regardless of size, 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 recruitment goals are met within the expected 
timeframe. 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. Investigators who fail to meet their milestones may be 
requested to submit interim monthly reports. The primary use of this 
information is to ensure that realistic recruitment milestones are 
established from the onset of a project, and that these milestones 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, potentially increasing efficiency in the funding process and 
expediting the availability of treatments for mental illness.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,295.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Tri-yearly NIMH Recruitment     NIMH Principal               900               3           45/60           2,025
 Milestone Reporting (RMR).      Investigators.
Monthly NIMH Recruitment        NIMH Principal                40               9           45/60             270
 Milestone Reporting (RMR).      Investigators.
                                                 ---------------------------------------------------------------
    Total.....................  ................             940           3,060           45/60           2,295
----------------------------------------------------------------------------------------------------------------


    Dated: October 6, 2015.
Melba Rojas,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2015-25941 Filed 10-9-15; 8:45 am]
 BILLING CODE 4140-01-P