NIMH Recruitment Milestone Reporting System

Forms and Documents

Document Name	Status
Form 2 Monthly NIMH Recruitment Milestone Reporting (RMR) Form and Instruction	New
Form 1 Tri-yearly NIMH Recruitment Milestone Reporting Form and Instruction	New
Form 1 NIMH Recruitment Milestone Reporting Form and Instruction	Removed
30dayFRN.2015-25941.pdf Supplementary Document	2015-10-14
RMR Revision Support_Stmt_A Mar2016_Final_OMB_NIMH.docx Supporting Statement A	2016-03-18

IC Document Collections

IC ID	Document Title	Status
218558	Monthly NIMH Recruitment Milestone Reporting (RMR) Form and Instruction	New
218557	Tri-yearly NIMH Recruitment Milestone Reporting Form and Instruction	New
210643	NIMH Recruitment Milestone Reporting Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0697	ICR Reference No: 201510-0925-002
Status: Historical Active	Previous ICR Reference No: 201403-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 20269
Title: NIMH Recruitment Milestone Reporting System
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/24/2016
	Date Received in OIRA: 10/14/2015
Terms of Clearance: Approved consistent with the understanding that NIMH program staff may waive the requirement for monthly reporting at their discretion (e.g. for smaller studies subject to more variability in the percent target achieved), and that NIMH will maintain communication and guidance for program investigators regarding applicability of the reporting requirements and milestone achievement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	05/31/2017
Responses	3,060	0	2,025
Time Burden (Hours)	2,295	0	2,531
Cost Burden (Dollars)	0	0	0

---

Abstract: The RMR System allows NIMH staff to monitor more effectively the 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. 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

---

Authorizing Statute(s): US Code: 42 USC sections 232,281 and 285 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 31053	06/01/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 61439	10/13/2015
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
NIMH Recruitment Milestone Reporting	1, 2	NIMH RMR Homepage ,   NIMH RMR Screenshots
Tri-yearly NIMH Recruitment Milestone Reporting	1	RMR Revision Screenshots
Monthly NIMH Recruitment Milestone Reporting (RMR)	2	RMR Revision Screenshots

---

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	3,060	2,025	0	1,035	0	0
Annual Time Burden (Hours)	2,295	2,531	0	-236	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision of a currently approved submission.

---

Annual Cost to Federal Government: $21,332

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

---

Common Form ICR:  No

---

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: 10/14/2015

---