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View ICR - Agency Submission
COMMENT
Time Remaining
Days
HR
Min
Sec
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
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.
Authorizing Statute(s):
US Code:
42 USC 241 sect. 301
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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.
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
Agency Contact:
Mikia Currie 3014350941
Common Form ICR:
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:
(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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