Process Evaluation of the NIH Roadmap Epigenomics Program (NIDA)

Forms and Documents

Document Name	Status
Form 1 Principal Investigators Form and Instruction	New
EP PI Survey-OMB SupportingStatement B_7 Feb 2011.doc Supporting Statement B	2011-05-18
EP PI Survey_Att B-3_Survey Reminder Email Notices.docx Supplementary Document	2011-05-18
EP PI Survey_Att B-2_Initial Contact Email for Survey Invitation to Participant.docx Supplementary Document	2011-05-18
EP PI Survey_Att_B-1_Introductory Email from NIH Program Staff_Attachment.docx Supplementary Document	2011-05-18
EP PI Survey_Att A-1_RFA Eval Language.docx Supplementary Document	2011-05-18
EP PI Survey - Attachment A4 IRB Approval Letter.pdf Supplementary Document	2011-05-18
EP PI Survey_Att a-2B EP PI Survey-Stokols et al.pdf Supplementary Document	2011-05-18
EP PI Survey_Att A-2A EP PI Survey-Masse 2008.pdf Supplementary Document	2011-05-18
EP PI Survey-OMB SupportingStatement A _7 Feb 11.doc Supporting Statement A	2011-05-18

IC Document Collections

IC ID	Document Title	Status
197893	Principal Investigators Form and Instruction	New

ICR Details

OMB Control No: 0925-0637	ICR Reference No: 201105-0925-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Process Evaluation of the NIH Roadmap Epigenomics Program (NIDA)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/24/2011
	Date Received in OIRA: 05/26/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	04/30/2012
Responses	53	0	0
Time Burden (Hours)	17	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Under this collection, Social & Scientific Systems, with funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), will conduct a survey of principal investigators as part of the process evaluation required by each of the relevant RFAs funded under the NIH Roadmap Epigenomics Program. The purpose of the process evaluation, a formative evaluation study which is descriptive in nature, is to examine the implementation and progress of the program, up to mid-course in the program. The evaluation findings will report the achievement from the implementation and process of a multiple-component research program, will contribute lessons for developing an innovative program that requires coordination and collaboration across multiple components, will identify the collaboration and synergies of a coordinated data processing and analysis center and four individual reference mapping centers providing validated epigenome reference maps, and describe evidence of global use of the data and research results.

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Authorizing Statute(s): US Code: 42 USC 285o Name of Law: Director of National Institutes of Health, Duties and authority
  

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:
	76 FR 13648	03/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 30178	05/24/2011
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
Principal Investigators	1	Principal Investigator (PI) Survey

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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	53	0	0	53	0	0
Annual Time Burden (Hours)	17	0	0	17	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: No

Burden Reduction Due to:

Short Statement: This is a new data collection activity.

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Annual Cost to Federal Government: $249,099

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 05/26/2011

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