NDAR Data Access Request

Forms and Documents

Document	Type	Status	Availability
Form 2 NDA Data Use Certification (DUC)	Form and Instruction	Modified	Repair queued
Form 1 NDA Data Submission Agreement (DSA)	Form and Instruction	Modified	Repair queued
NDA Data Use Certification_0925-0667_August 2019_TrackedChanges.docx	Supplementary Document	Uploaded 2019-08-15	Repair queued
NDA Data Submission Agreement_0925-0667_August 2019_TrackedChanges (1).docx	Supplementary Document	Uploaded 2019-08-15	Repair queued
NDA Non-Substantive Change Request Memo_0925-0667_August 2019v2.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2019-08-15	Repair queued
30dayFRN 2017-21267.pdf	Supplementary Document	Uploaded 2017-10-04	Repair queued
NDAR PIA.docx	Supplementary Document	Uploaded 2017-09-13	Repair queued
NIMH Data Archive.0925-0667.SSA.Revision3_FINALv5.docx	Supporting Statement A	Uploaded 2017-09-13	Available

IC Document Collections

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

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 201908-0925-004
Status: Active	Previous ICR Reference No: 201709-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 21290
Title: NDAR Data Access Request
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 without change	Conclusion Date: 09/16/2019
	Date Received in OIRA: 08/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	11/30/2020	11/30/2020
Responses	1,000	0	1,000
Time Burden (Hours)	1,500	0	1,500
Cost Burden (Dollars)	0	0	0

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Abstract: In 2013, NIMH received approval from OMB for use of the NIMH Data Access Request and Use Certification (DUC) Form to meet the unique data access needs of all existing NIMH data repositories, which at the time consisted of NDAR, PedsMRI, and the NIMH Clinical Research Datasets (NCRD)-OMB# 0925-0667 (Expiration: 09/30/2016). Now in 2014, two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb. At this time, NIMH is seeking OMB approval to revise, the all-purpose NIMH Data Repositories Data Access & Use Certification form, as well as add a new all-purpose NIMH Data Repositories Data Submission form. As the data repositories have matured, and with the introduction of the new databases-namely NDCT and RDoCdb-the information being collected for data submission has become more complex,

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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:
	82 FR 32005	07/11/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 46253	10/04/2017
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 Use Certification (DUC)	2	NDA Data Use Certification
NDA Data Submission Agreement (DSA)	1	NDA Data Submission Agreement

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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	1,000	1,000	0	0	0	0
Annual Time Burden (Hours)	1,500	1,500	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: $27,108

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? Uncollected

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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: 08/16/2019

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