NDAR Data Access Request (NIMH)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 2 Certification	Form and Instruction	Modified	Available
Form 2 Certification	Form and Instruction	Modified	Available
Form 2 NDA Data Use Certification (DUC)	Form and Instruction	Modified	Repair queued
Form 1 Submission Agreement	Form and Instruction	Modified	Available
Form 1 Submission Agreement	Form and Instruction	Modified	Available
Form 1 NDA Data Submission Agreement (DSA)	Form and Instruction	Modified	Repair queued
NIMH Data Archive Data Submission Agreement_6.17.25_tracked.docx	Supplementary Document	Uploaded 2025-07-23	Available
NIMH Data Archive Data Submission Agreement_tracked.docx	Supplementary Document	Uploaded 2025-07-21	Available
NIMH Data Archive Data Submission Agreement_tracked.docx	Supplementary Document	Uploaded 2025-07-21	Repair queued
NIMH Data Archive Data Use Certification_tracked.docx	Supplementary Document	Uploaded 2025-07-21	Available
NIMH Data Archive Data Use Certification_tracked.docx	Supplementary Document	Uploaded 2025-07-21	Repair queued
Non-Substantive Change Request Memo_NIMH NDA.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-07-21	Available
Non-Substantive Change Request Memo_NIMH NDA.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-07-21	Repair queued
0925-0667.SSA.REVISION.NIMH Data Archive_05.09.23.docx	Supporting Statement A	Uploaded 2023-05-18	Available
0925-0667.SSA.REVISION.NIMH Data Archive_05.09.23.docx	Supporting Statement A	Uploaded 2023-05-18	Missing upstream
A_Privacy Impact Assessment-NIH NIMH NDA.pdf	Supplementary Document	Uploaded 2023-05-18	Available
A_Privacy Impact Assessment-NIH NIMH NDA.pdf	Supplementary Document	Uploaded 2023-05-18	Repair queued
D_NDA Consult List.docx	Supplementary Document	Uploaded 2023-05-17	Available
D_NDA Consult List.docx	Supplementary Document	Uploaded 2023-05-17	Repair queued
30-day notice 0667.pdf	Supplementary Document	Uploaded 2023-05-17	Available
30-day notice 0667.pdf	Supplementary Document	Uploaded 2023-05-17	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
228276	NDA Data Use Certification (DUC)	Form and Instruction	Modified	Certification
228276	NDA Data Use Certification (DUC)	Form and Instruction	Modified	Certification
228276	NDA Data Use Certification (DUC)	Form and Instruction	Modified
228274	NDA Data Submission Agreement (DSA)	Form and Instruction	Modified	Submission Agreement
228274	NDA Data Submission Agreement (DSA)	Form and Instruction	Modified	Submission Agreement
228274	NDA Data Submission Agreement (DSA)	Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 202507-0925-003
Status: Active	Previous ICR Reference No: 202305-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 21290
Title: NDAR Data Access Request (NIMH)
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 with change	Conclusion Date: 07/28/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/21/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	06/30/2026	06/30/2026
Responses	1,250	0	1,250
Time Burden (Hours)	1,875	0	1,875
Cost Burden (Dollars)	0	0	0

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Abstract: The National Institute of Mental Health (NIMH) is requesting approval of this revision application for three years (36 months). This application aims to obtain approvals for the revised Data Submission Agreement (DSA) and Data Use Certification (DUC) information collection documents, which collect information about researchers submitting data and requesting access to shared data in the NIMH Data Archive (NDA). The NDA is an infrastructure for sharing human subjects research data and tools to further collaboration and scientific discovery. While the NDA is a single system, it is comprised of several research domains each with their own associated permission group. The information collected in the DSA and DUC is needed to provide appropriate permissions to either submit or access data, monitor the expiration of these permissions, track and report on permissions and requests, ensure that the terms of submission/access are followed, and provide appropriate attribution for data contributions, and communicate important information about the NDA.

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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 13835	03/06/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 31267	05/16/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
NDA Data Submission Agreement (DSA)	1, 1	Submission Agreement ,   Submission Agreement
NDA Data Use Certification (DUC)	2, 2	Certification ,   Certification

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ICR Summary of Burden

table that charts list 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	1,250	1,250	0	0	0	0
Annual Time Burden (Hours)	1,875	1,875	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: $29,830

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: 07/21/2025

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