Data Use Certification for the NIH Brain Development Cohorts (NBDC), (NIDA)

Forms and Documents

Document Name	Status
Form 1 American Indian Alaska Native Data Use Statement and Progress Report Form	Modified
Form 1 General Data Use Statement and Progress Report Form	Modified
Supporting Statement A for NBDC DUC REVISION-_OMB Control Number 0925-0780.docx Supporting Statement A	2025-05-29
Attachment 3 - Privacy Act Memo- signed.pdf Supplementary Document	2025-05-29
30day NIDA.pdf Supplementary Document	2025-05-29

IC Document Collections

IC ID	Document Title	Status
262235	American Indian Alaska Native Data Use Statement and Progress Report Form	Modified
262234	General Data Use Statement and Progress Report Form	Modified

ICR Details

OMB Control No: 0925-0780	ICR Reference No: 202505-0925-003
Status: Received in OIRA	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	Date Submitted to OIRA: 05/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	2,000	2,000
Time Burden (Hours)	2,000	2,000
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 203 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:
	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

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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

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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	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:

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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

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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: 05/30/2025

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