Data Use Certification for the Adolescent Brain Cognitive Development Study (NIDA)

Forms and Documents

Document Name	Status
Form 2 Data Use Certification for Research on NIH Brain Development Cohorts Data from American Indian/Alaska Native Individuals (A-DUC) Form	New
Form 1 Data Use Certification for NIH Brain Development Cohorts Form and Instruction	New
Attachment 3 - Privacy Act Memo- signed.pdf Supplementary Document	2023-09-19
Supporting Statement A for ABCD Study DUC.docx Supporting Statement A	2023-09-19
NIDA Published 30-day Notice.pdf Supplementary Document	2023-09-19

IC Document Collections

IC ID	Document Title	Status
262235	Data Use Certification for Research on NIH Brain Development Cohorts Data from American Indian/Alaska Native Individuals (A-DUC) Form	New
262234	Data Use Certification for NIH Brain Development Cohorts Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202309-0925-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Data Use Certification for the Adolescent Brain Cognitive Development Study (NIDA)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/19/2023

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

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Abstract: These Data Use Certification (DUC) Agreements outline the terms of use for requesting access to data from the Adolescent Brain Cognitive DevelopmentSM (ABCD) Study. Data from the ABCD Study® 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.

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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:
	88 FR 25411	04/26/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 63968	09/18/2023
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
Data Use Certification for NIH Brain Development Cohorts	1	DUC for NIH Brain Development Cohorts
Data Use Certification for Research on NIH Brain Development Cohorts Data from American Indian/Alaska Native Individuals (A-DUC)	2	Data Use Certification for Research on NIH Brain Development Cohorts Data from American Indian/Alaska Native Individuals (A-DUC)

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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	0	0	2,000	0	0
Annual Time Burden (Hours)	2,000	0	0	2,000	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $7,051

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: 09/19/2023

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