OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202508-0925-001 · OMB 0925-0670 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 1 New System – Authorized Access Form New Repair queued
Form 1 New System – Authorized Access Form New Available
Form 1 New System – Authorized Access Form New Repair queued
Form 1 New System – Authorized Access Form New Available
Form 1 Legacy System – Authorized Access Form New Repair queued
Form 1 Legacy System – Authorized Access Form New Available
Form 1 Legacy System – Authorized Access Form New Repair queued
Form 1 Legacy System – Authorized Access Form New Available
Form 1 New System – Authorized Access Form New Repair queued
Form 1 New System – Authorized Access Form New Available
Form 1 New System – Authorized Access Form Modified Repair queued
Form 1 New System – Authorized Access Form Modified Available
Form 1 New System – Authorized Access Form Modified Repair queued
Form 1 New System – Authorized Access Form Modified Available
Form 1 Legacy System – Authorized Access Form Modified Repair queued
Form 1 Legacy System – Authorized Access Form Modified Available
Form 1 Data Submission Certification Form Modified Repair queued
Form 1 Data Submission Certification Form Modified Available
Form 1 Institutional Certification Form Modified Repair queued
Form 1 Institutional Certification Form Modified Available
Form 1 New System – Registration and Data Submission Form Modified Repair queued
Form 1 New System – Registration and Data Submission Form Modified Available
Form 1 Data Submission Certification Form Modified Repair queued
Form 1 Data Submission Certification Form Modified Available
Form 1 Institutional Certification Form Modified Repair queued
Form 1 Institutional Certification Form Modified Available
Form 2 Legacy System – Registration and Data Submission Form Modified Repair queued
Form 2 Legacy System – Registration and Data Submission Form Modified Available
Form 1 NIH Study Registration Information (SRI) Form Modified Repair queued
Form 1 NIH Study Registration Information (SRI) Form Modified Available
30day 0670.pdf Supplementary Document Uploaded 2026-03-16 Repair queued
30day 0670.pdf Supplementary Document Uploaded 2026-03-16 Available
Attachment 8 - NLM BBIS dbGaP PIA.pdf Supplementary Document Uploaded 2026-03-09 Repair queued
Attachment 8 - NLM BBIS dbGaP PIA.pdf Supplementary Document Uploaded 2026-03-09 Available
SSA 2026 OD dbGaP submission.docx Supporting Statement A Uploaded 2026-03-09 Repair queued
SSA 2026 OD dbGaP submission.docx Supporting Statement A Uploaded 2026-03-09 Available
IC Document Collections
IC IDCollectionTypeStatusForm
279282 Project Renewal or Project Close-out form (Institutional Signing Official) Form NewNew System – Authorized Access
279282 Project Renewal or Project Close-out form (Institutional Signing Official) Form NewNew System – Authorized Access
279282 Project Renewal or Project Close-out form (Institutional Signing Official) Form New
279281 Project Renewal or Project Close-out form (Principal Investigator) Form NewNew System – Authorized Access
279281 Project Renewal or Project Close-out form (Principal Investigator) Form NewNew System – Authorized Access
279281 Project Renewal or Project Close-out form (Principal Investigator) Form New
279280 Renewal or Close-out (Institutional Signing Official) Form NewLegacy System – Authorized Access
279280 Renewal or Close-out (Institutional Signing Official) Form NewLegacy System – Authorized Access
279280 Renewal or Close-out (Institutional Signing Official) Form New
279279 Renewal or Close-out (Principal Investigator) Form NewLegacy System – Authorized Access
279279 Renewal or Close-out (Principal Investigator) Form NewLegacy System – Authorized Access
279279 Renewal or Close-out (Principal Investigator) Form New
279278 dbGaP Authorized Access System (Institutional Signing Official) (New Authorized Access System) Form NewNew System – Authorized Access
279278 dbGaP Authorized Access System (Institutional Signing Official) (New Authorized Access System) Form NewNew System – Authorized Access
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 ModifiedNew System – Authorized Access
257010 dbGaP Authorized Access System (Principal Investigator) (New Authorized Access System) Form ModifiedNew System – Authorized Access
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 ModifiedNew System – Authorized Access
257009 dbGaP Authorized Access System (Institutional Signing Official) (Legacy Authorized Access System) Form ModifiedNew System – Authorized Access
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 ModifiedLegacy System – Authorized Access
257006 dbGaP Authorized Access System (Principal Investigator) (Legacy Authorized Access System) Form ModifiedLegacy System – Authorized Access
257006 dbGaP Authorized Access System (Principal Investigator) (Legacy Authorized Access System) Form Modified
236992 Data Submission Certification (New System) Form ModifiedData Submission Certification
236992 Data Submission Certification (New System) Form ModifiedData Submission Certification
236992 Data Submission Certification (New System) Form Modified
236991 Institutional Certification (New System) Form ModifiedInstitutional Certification
236991 Institutional Certification (New System) Form ModifiedInstitutional Certification
236991 Institutional Certification (New System) Form Modified
236987 Study Registration Information Form (Online) and Data Submission Form ModifiedNew System – Registration and Data Submission
236987 Study Registration Information Form (Online) and Data Submission Form ModifiedNew System – Registration and Data Submission
236987 Study Registration Information Form (Online) and Data Submission Form Modified
236986 Data Submission Certification (Legacy System) Form ModifiedData Submission Certification
236986 Data Submission Certification (Legacy System) Form ModifiedData Submission Certification
236986 Data Submission Certification (Legacy System) Form Modified
236985 Institutional Certification (Legacy System) Form ModifiedInstitutional Certification
236985 Institutional Certification (Legacy System) Form ModifiedInstitutional Certification
236985 Institutional Certification (Legacy System) Form Modified
236984 Study Registration and Data Submission Form ModifiedLegacy System – Registration and Data Submission
236984 Study Registration and Data Submission Form ModifiedLegacy System – Registration and Data Submission
236984 Study Registration and Data Submission Form ModifiedNIH Study Registration Information (SRI)
236984 Study Registration and Data Submission Form ModifiedNIH Study Registration Information (SRI)
236984 Study Registration and Data Submission Form Modified
ICR Details
0925-0670 202508-0925-001
Active 202501-0925-001
HHS/NIH 18667
NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)
Revision of a currently approved collection   No
Regular
Approved without change 05/07/2026
Retrieve Notice of Action (NOA) 03/17/2026
  Inventory as of this Action Requested Previously Approved
05/31/2029 36 Months From Approved 05/31/2026
20,232 0 159,350
9,784 0 158,776
0 0 0
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.
US Code: 42 USC 241 sect. 301 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  90 FR 30073 07/08/2025
91 FR 12201 03/12/2026
No
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 1, 2 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
  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 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
Yes
Miscellaneous Actions
Yes
Changing Forms
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.
$7,532,596
No
    Yes
    Yes
No
No
No
No
Mikia Currie 3014350941
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/17/2026