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:
0925-0780
ICR Reference No:
202505-0925-003
Status:
Active
Previous ICR Reference No:
202309-0925-001
Agency/Subagency:
HHS/NIH
Agency Tracking No:
Title:
Data Use Certification for the NIH Brain Development Cohorts (NBDC), (NIDA)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/01/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
36 Months From Approved
10/31/2026
Responses
2,000
0
2,000
Time Burden (Hours)
2,000
0
2,000
Cost Burden (Dollars)
0
0
0
Abstract:
This document reflects a revision to a package (0925-0780) which was originally submitted for approval in September 2023. These Data Use Certification (DUC) Agreements outline the terms of use for requesting access to data from the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study and the Healthy Brain and Child Development (HBCD) Study, collectively known as the NIH Brain Development Cohorts (NBDC). Data from both studies will be maintained at an outside entity contracted by the National Institute on Drug Abuse. This submission is seeking approval for collecting limited information from researchers who wish to access these data for further research studies. While the data are intended to be leveraged by other researchers, it is essential that the integrity of the data is maintained by requiring that researchers and their institutions sign the DUC agreements. Since the time of the original package submission, we have simplified the process by including only the data use and progress report statements in the package for review, rather than the full data use certification forms, as the respondent burden is limited to completing the statements.
Authorizing Statute(s):
US Code:
42 USC 203
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:
89 FR 89019
11/12/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 21323
05/19/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
American Indian Alaska Native Data Use Statement and Progress Report
1
Form
General Data Use Statement and Progress Report
1
Form
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
2,000
2,000
0
0
0
0
Annual Time Burden (Hours)
2,000
2,000
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:
Annual Cost to Federal Government:
$10,056
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:
05/30/2025
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