NIMH Recruitment Milestone Reporting System

Forms and Documents

Document Name	Status
Form 1 NIMH Recruitment Milestone Reporting Form and Instruction	New
RMR Support_Stmt_A_REVISED_ 04242014 CLEAN.doc Supporting Statement A	2014-04-24

IC Document Collections

IC ID	Document Title	Status
210643	NIMH Recruitment Milestone Reporting Form and Instruction	New

ICR Details

OMB Control No: 0925-0697	ICR Reference No: 201403-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 20269
Title: NIMH Recruitment Milestone Reporting System
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/16/2014
	Date Received in OIRA: 03/11/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved
Responses	2,025	0	0
Time Burden (Hours)	2,531	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The mission of NIMH is to transform the understanding and treatment of mental illness through basic and clinical research, paving the way for prevention, recovery, and cure. In order for NIMH clinical research to meet it is objectives (including sufficient power to test hypotheses and generalizability to the appropriate target population) it is critical that studies meet their recruitment goals. NIMH developed the Recruitment Milestone Reporting (RMR) System to ensure NIMH investigators develop realistic recruitment targets and that these targets are met throughout the course of the clinical research. The RMR system monitors 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 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. 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. NIMH program staff will use the information collected by the Recruitment Milestone Reporting application to evaluate the feasibility of the recruitment targets and timeline, the appropriateness of the distribution of subjects to the research question, and the acceptability of actual recruitment progress.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 46994	08/02/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 10817	02/26/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
NIMH Recruitment Milestone Reporting	1, 2	NIMH RMR Homepage ,   NIMH RMR Screenshots

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,025	0	0	0	0	2,025
Annual Time Burden (Hours)	2,531	0	0	0	0	2,531
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $283,500

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/11/2014

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