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

Forms and Documents

Document Name	Status
Form 2 Renewal/project Close-out process Signing Official to Certify Request Form and Instruction	New
Form 2 Renewal/Project Close-out process Investigator Requesting Data Form and Instruction	New
Form 2 Requesting Access to Data Signing Official to Certify Request Form and Instruction	New
Form 2 Requesting Access to Data Investigator Requesting Data Form and Instruction	New
Form 1 Study Registration and Data Submission Institutional Official to Certify Submission Form and Instruction	New
Form 2 Data Access Request (DAR) Form and Instruction	Removed
Form 1 Study Registration and Data Submission Form and Instruction	Modified
30-day 2016-05910.pdf Supplementary Document	2016-03-16
Revised_GDS PRA Revision supporting statement A 2016 updated 6_30_2016.doc Supporting Statement A	2016-07-05
Attachment 2_Institutional CertificationTemplate.pdf Supplementary Document	2013-01-29

IC Document Collections

IC ID	Document Title	Status
220221	Renewal/project Close-out process Signing Official to Certify Request Form and Instruction	New
220220	Renewal/Project Close-out process Investigator Requesting Data Form and Instruction	New
220219	Requesting Access to Data Signing Official to Certify Request Form and Instruction	New
220218	Requesting Access to Data Investigator Requesting Data Form and Instruction	New
220217	Study Registration and Data Submission Institutional Official to Certify Submission Form and Instruction	New
205638	Data Access Request (DAR) Form and Instruction	Removed
205637	Study Registration and Data Submission Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0670	ICR Reference No: 201602-0925-015
Status: Historical Active	Previous ICR Reference No: 201301-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 18667
Title: NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)
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: 07/06/2016
	Date Received in OIRA: 03/16/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2019	36 Months From Approved	07/31/2016
Responses	5,364	0	1,366
Time Burden (Hours)	2,505	0	1,646
Cost Burden (Dollars)	0	0	0

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Abstract: Sharing of research data is an integral element of the mission of the National Institutes of Health (NIH), as it advances our understanding of factors that influence health and disease, while also providing opportunities to accelerate research through the power of combining large and information-rich datasets. To promote robust sharing of human and non-human genomic data from a wide range of large-scale genomic research, and to provide appropriate protections for research involving human data, the NIH issued the NIH Genomic Data Sharing Policy (GDS Policy). The GDS Policy, an extension of the 2008 NIH Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (the GWAS Policy), applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.

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Authorizing Statute(s): US Code: 42 USC 241 sect. 301 Name of Law: Public Health Service Act
  

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:
	80 FR 75120	12/01/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 14118	03/16/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Renewal/Project Close-out process Investigator Requesting Data	2	Attachment 2 Documentation of the dbGaP access system
Requesting Access to Data Investigator Requesting Data	2	Attachment 2 Documentation of the dbGaP access system
Requesting Access to Data Signing Official to Certify Request	2	Attachment 2 Documentation of the dbGaP access system
Renewal/project Close-out process Signing Official to Certify Request	2	Attachment 2 Documentation of the dbGaP access system
Study Registration and Data Submission	1	Attachment 1 Documentation of the dbGaP Registration system
Data Access Request (DAR)	2	Screen Shots of Online Forms form Data Access Request, Renewal, and Close-out
Study Registration and Data Submission Institutional Official to Certify Submission	1	Attachment 1 Documentation of the dbGaP registration system

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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	5,364	1,366	0	5,264	-1,266	0
Annual Time Burden (Hours)	2,505	1,646	0	2,442	-1,583	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: Revision

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Annual Cost to Federal Government: $5,100,000

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: 03/16/2016

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