View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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:
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
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
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.
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:
01/17/2025
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