NDAR Data Access Request (NIMH)

Forms and Documents

Document Name	Status
Form 2 NDA Data Use Certification (DUC) Form and Instruction	Unchanged
Form 1 NDA Data Submission Agreement (DSA) Form and Instruction	Modified
Attachment A_Revised tracked changes copy of NDA Data Submission Agreement.docx Supplementary Document	2021-10-20
NDA Non-Substantive Change Request Memo_0925-0667_October 2021.docx Justification for No Material/Nonsubstantive Change	2021-10-20
A_NDA Data Use Certification_Tracked Changes (1).docx Supplementary Document	2021-02-24
NDA Non-Substantive Change Request Memo_0925-0667_February2021.docx Justification for No Material/Nonsubstantive Change	2021-02-24
pub 30-day FRN2020-22932.pdf Supplementary Document	2020-10-19
D_NDA Consult List_09082020.docx Supplementary Document	2020-10-07
A_Privacy Impact Assessment-NIH NIMH NDA_09182020.pdf Supplementary Document	2020-10-07
0925-0667.SSA.REVISION.NIMH Data Archive_10052020.docx Supporting Statement A	2021-01-12
NDA Data Use Certification_0925-0667_August 2019_TrackedChanges.docx Supplementary Document	2019-08-15
NDA Data Submission Agreement_0925-0667_August 2019_TrackedChanges (1).docx Supplementary Document	2019-08-15
NDA Non-Substantive Change Request Memo_0925-0667_August 2019v2.docx Justification for No Material/Nonsubstantive Change	2019-08-15

IC Document Collections

IC ID	Document Title	Status
228276	NDA Data Use Certification (DUC) Form and Instruction	Unchanged
228274	NDA Data Submission Agreement (DSA) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 202110-0925-002
Status: Received in OIRA	Previous ICR Reference No: 202102-0925-011
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	Date Submitted to OIRA: 10/21/2021

	Requested	Previously Approved
Expiration Date	01/31/2024	01/31/2024
Responses	1,250	1,250
Time Burden (Hours)	1,875	1,875
Cost Burden (Dollars)	0	0

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Abstract: The National Institute of Mental Health (NIMH) is requesting approval of 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.

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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:
	85 FR 36869	06/18/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 65855	10/16/2020
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
NDA Data Submission Agreement (DSA)	1	NDA Data Submission Agreement
NDA Data Use Certification (DUC)	2, 2	NDA Data Use Certification ,   B NDA Data Use Certification revised clean 022421

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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	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: To provide a segmentation of the research domains supported, we added a hyperlink leading to the current list of permission groups and their data access requirements on the DUC. Because the NDA requires one DUC for each request for access to a permission group, the DUC now includes fillable fields for the description, data use limitations, IRB approval, and institutional sponsorship for the chosen permission group. Additionally, the Data Use Terms and Conditions on the DUC have been updated. Specifically: new details have been added to the section titled “No Distribution of Data”; the section titled “Annual Update/Research Use Reporting” has been deleted; the section “Data Access for Research” has been deleted; and a new section, “Deletion of Data” has been added. Some sections have also been reordered or renamed, but the content of these sections has not been changed. Another change to the DUC concerns applications for renewal of an expiring DUC. The DUC section titled “4. Renewal Applicants Only” has been reordered and renamed to “2. Progress Updates (For Renewal Requests Only).” A new fillable field titled “Progress Report Statement” has been added to this section for renewal requestors to describe progress on research they have conducted using data from the NDA. Another overarching change relates to the requirements for accessing data. In the past all data access requests have required sponsorship by an Institution with an active FWA, which includes the signature of an institutional signing official. New research domains have been incorporated into the NDA that do not carry this level of requirement. A newly added Individual sponsorship does not require an active FWA or institutional business official signature but does still require the requestor to agree to the terms of data access. In both cases, new groups from which data are requested have been added to the DUC. The DSA has added the collection of additional grant related information that is targeted toward researchers not funded by the NIH who are requesting permission to submit data. Because the funding information is not accessible by NDA staff, the information is requested on the form.

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Annual Cost to Federal Government: $28,950

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: 10/21/2021

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