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

Forms and Documents

Document Name	Status
Form 2 Provisional Institutional Certification Institutional Official to Certify Form and Instruction	Unchanged
Form 2 Provisional Institutional Certification Investigator filling out Form and Instruction	Unchanged
Form 2 Institutional Certification Institutional Official to Certify Submission Form and Instruction	Unchanged
Form 1 Project Renewal or Project Close-out Official to Certify Request Form and Instruction	Unchanged
Form 1 Project Renewal or Project Close-out Requester Submitting Request Form and Instruction	Unchanged
Form 1 Requesting Access to Data Signing Official to Certify Request Form and Instruction	Unchanged
Form 1 Data Access Request Form and Instruction	Unchanged
Form 2 Institutional Certification Investigator filing out Form and Instruction	Unchanged
Form 1 Study Registration and Data Submission Form	Modified
RevOER-0925-0670-Change Request for Requesting Access to Data-Track Changes.pptx Supplementary Document	2025-01-16
OER-0925-0670-Change Request-January2025.docx Justification for No Material/Nonsubstantive Change	2025-01-16
rev final GDS PRA SSA Highlighted for 2022 response 03082023.docx Supporting Statement A	2023-03-09
Attachment 3 - 06_1 HHS Privacy Impact Assessment-NIH NLM dbGaP Database of Genotype an.pdf Supplementary Document	2022-11-18

IC Document Collections

IC ID	Document Title	Status
257010	Provisional Institutional Certification Institutional Official to Certify Form and Instruction	Unchanged
257009	Provisional Institutional Certification Investigator filling out Form and Instruction	Unchanged
257006	Institutional Certification Institutional Official to Certify Submission Form and Instruction	Unchanged
236992	Project Renewal or Project Close-out Official to Certify Request Form and Instruction	Unchanged
236991	Project Renewal or Project Close-out Requester Submitting Request Form and Instruction	Unchanged
236987	Requesting Access to Data Signing Official to Certify Request Form and Instruction	Unchanged
236986	Data Access Request Form and Instruction	Unchanged
236985	Institutional Certification Investigator filing out Form and Instruction	Unchanged
236984	Study Registration and Data Submission Form	Modified

ICR Details

OMB Control No: 0925-0670	ICR Reference No: 202501-0925-001
Status: Active	Previous ICR Reference No: 202211-0925-001
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/17/2025
	Date Received in OIRA: 01/17/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	03/31/2026	03/31/2026
Responses	159,350	0	159,350
Time Burden (Hours)	158,776	0	158,776
Cost Burden (Dollars)	0	0	0

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Abstract: This application is for a revision to an existing Office of Management and Budget (OMB) approved collection of information, 0925-0670, to continue supporting NIH’s goals for sharing genomic data and HHS's goals of enhancing data sharing. The online forms described in the rest of this document reduce the burden for investigators who submit data and for requesters who wish to access the data for secondary 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:
	87 FR 57705	09/21/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 73009	11/28/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Data Access Request	1	online dbGaP Data Access Request Forms
Institutional Certification Institutional Official to Certify Submission	2	Institutional Official to Certify Submission
Institutional Certification Investigator filing out	2	Institutional Certification Investigator filling out
Project Renewal or Project Close-out Official to Certify Request	1	Online dbGaP Data Access Request Forms
Project Renewal or Project Close-out Requester Submitting Request	1	Online dbGaP Data Access Request Forms
Provisional Institutional Certification Institutional Official to Certify	2	Provisional Institutional certification Institutional Official to Certify
Provisional Institutional Certification Investigator filling out	2	Provisional Institutional certification investigator filling out
Requesting Access to Data Signing Official to Certify Request	1	Online dbGaP Data Access Request Forms
Study Registration and Data Submission	1	Online Registration

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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	159,350	159,350	0	0	0	0
Annual Time Burden (Hours)	158,776	158,776	0	0	0	0
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: This application is for a revision to an existing Office of Management and Budget (OMB) approved collection of information. Some changes focus on reducing redundancy among data submissions and access requests and increasing awareness of the ethical responsibilities associated with the responsible use of genomic information.

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Annual Cost to Federal Government: $7,532,596

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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? No

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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: 01/17/2025

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