NDAR Data Access Request

Forms and Documents

Document Name	Status
Form 2 NIMH Data Repositories Submission Request Form and Instruction	New
Form 1 NIMH Data Repositories Access DUC Form and Instruction	New
Form 2 NIMH DUC - GRDR Form and Instruction	Removed
NIMH_DR_support_stmt_a.doc Supporting Statement A	2014-12-17

IC Document Collections

IC ID	Document Title	Status
214311	NIMH Data Repositories Submission Request Form and Instruction	New
214310	NIMH Data Repositories Access DUC Form and Instruction	New
209964	NIMH DUC - GRDR Form and Instruction	Removed
204810	Principal Investigators/Research Assistants Instruction	Removed

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 201412-0925-003
Status: Historical Active	Previous ICR Reference No: 201401-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 21290
Title: NDAR Data Access Request
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/18/2015
	Date Received in OIRA: 01/05/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	09/30/2016
Responses	140	0	1,040
Time Burden (Hours)	221	0	1,646
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:
	79 FR 60479	10/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 77014	12/23/2014
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
NIMH DUC - GRDR	2	NIMH DUC - GRDR
NIMH Data Repositories Access DUC	1	NIMH Data Repositories AccessDUC
NIMH Data Repositories Submission Request	2	NIMH Data Repositories Submission Request
Principal Investigators/Research Assistants	1, 1, 1	NDAR Data Access Request (DUC) Form ,   NIMH DUC (NDAR and PedsMRI) ,   NIMH DUC (NCRD)

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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	140	1,040	0	-900	0	0
Annual Time Burden (Hours)	221	1,646	0	-1,425	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb

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Annual Cost to Federal Government: $23,763

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 01/05/2015

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