NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes

Forms and Documents

Document Name	Status
Form 2 Data Access Request (DAR) Form and Instruction	New
Form 2 Study Registration and Data Submission Form and Instruction	New
Attachment 2_Institutional CertificationTemplate.pdf Supplementary Document	2013-01-29
GWAS PRA Supporting Statement A 1-14-13.docx Supporting Statement A	2013-01-29

IC Document Collections

IC ID	Document Title	Status
205638	Data Access Request (DAR) Form and Instruction	New
205637	Study Registration and Data Submission Form and Instruction	New

ICR Details

OMB Control No: 0925-0670	ICR Reference No: 201301-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 18667
Title: NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes
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: 03/20/2013
	Date Received in OIRA: 01/31/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved
Responses	1,366	0	0
Time Burden (Hours)	1,646	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The sharing of research data supports the mission of the National Institutes of Health (NIH) and is essential to facilitate the translation of research results into knowledge, products, practices, and procedures that improve human health. By enabling secondary research questions to be addressed, data sharing also maximizes research investments. In 2008, NIH implemented the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) to enable the full value of GWAS data to be realized. GWAS data are maintained in a central data repository, the database of Genotypes and Phenotypes (dbGaP), which is administered by the National Center for Biotechnology Information (NCBI), part of the National Library of Medicine at NIH.

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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:
	77 FR 61008	10/05/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 6119	01/29/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Study Registration and Data Submission	2	Online Form for Study Registration
Data Access Request (DAR)	2	Screen Shots of Online Forms form Data Access Request, Renewal, and Close-out

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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	1,366	0	0	1,366	0	0
Annual Time Burden (Hours)	1,646	0	0	1,646	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: NIH has been collecting study information and data from submitters and processing data access requests since 2008 under the OMB-approved SF424 R&R form (OMB Number 4040-0001, expiration date February 28, 2013). NIH is seeking approval to modify the manner of collecting the study registration information, study data, and access information in order to ease the burden for submitters and requesters.

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Annual Cost to Federal Government: $9,250,000

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: 01/31/2013

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