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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
279282	Project Renewal or Project Close-out form (Institutional Signing Official) Form	New
279281	Project Renewal or Project Close-out form (Principal Investigator) Form	New
279280	Renewal or Close-out (Institutional Signing Official) Form	New
279279	Renewal or Close-out (Principal Investigator) Form	New
279278	dbGaP Authorized Access System (Institutional Signing Official) (New Authorized Access System) Form	New
257010	dbGaP Authorized Access System (Principal Investigator) (New Authorized Access System) Form	Modified
257009	dbGaP Authorized Access System (Institutional Signing Official) (Legacy Authorized Access System) Form	Modified
257006	dbGaP Authorized Access System (Principal Investigator) (Legacy Authorized Access System) Form	Modified
236992	Data Submission Certification (New System) Form	Modified
236991	Institutional Certification (New System) Form	Modified
236987	Study Registration Information Form (Online) and Data Submission Form	Modified
236986	Data Submission Certification (Legacy System) Form	Modified
236985	Institutional Certification (Legacy System) Form	Modified
236984	Study Registration and Data Submission Form	Modified

ICR Details

OMB Control No: 0925-0670	ICR Reference No: 202508-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202501-0925-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/17/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	20,232	159,350
Time Burden (Hours)	9,784	158,776
Cost Burden (Dollars)	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 the National Institute of Health’s (NIH’s) goals for sharing of controlled-access genomic and associated data and HHS goals of enhancing data sharing. The updates to online forms and web interfaces described in this document support enhanced data security procedures, the modernization of the dbGaP Authorized Access System, and the streamlining of the registration/submission system.

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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:
	90 FR 30073	07/08/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 12201	03/12/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Data Submission Certification (Legacy System)	1	Data Submission Certification
Data Submission Certification (New System)	1	Data Submission Certification
Institutional Certification (Legacy System)	1	Institutional Certification
Institutional Certification (New System)	1	Institutional Certification
Project Renewal or Project Close-out form (Institutional Signing Official)	1	New System – Authorized Access
Project Renewal or Project Close-out form (Principal Investigator)	1	New System – Authorized Access
Renewal or Close-out (Institutional Signing Official)	1	Legacy System – Authorized Access
Renewal or Close-out (Principal Investigator)	1	Legacy System – Authorized Access
Study Registration Information Form (Online) and Data Submission	1	New System – Registration and Data Submission
Study Registration and Data Submission	2, 1	NIH Study Registration Information (SRI) ,   Legacy System – Registration and Data Submission
dbGaP Authorized Access System (Institutional Signing Official) (Legacy Authorized Access System)	1	New System – Authorized Access
dbGaP Authorized Access System (Institutional Signing Official) (New Authorized Access System)	1	New System – Authorized Access
dbGaP Authorized Access System (Principal Investigator) (Legacy Authorized Access System)	1	Legacy System – Authorized Access
dbGaP Authorized Access System (Principal Investigator) (New Authorized Access System)	1	New System – Authorized Access

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ICR Summary of Burden

	Total Request	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	20,232	159,350	0	-139,118	0	0
Annual Time Burden (Hours)	9,784	158,776	0	-148,992	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: Changing Forms

Short Statement: Since the last OMB approval, NIH has made several necessary changes to the forms and web interfaces required for registering and submitting data and requesting data access to be compliant with national security directives, security and operational standards for NIH CADRs, and customer service improvements for Principal Investigators (PIs) and Institutional Signing Officials submitting a DAR application.

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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: 03/17/2026

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