NDAR Data Access Request

Forms and Documents

Document Name	Status
Form 2 NIMH DUC - GRDR Form and Instruction	New
0925-0667 Change Request Memo 1 6 2014.doc Justification for No Material/Nonsubstantive Change	2014-01-06

IC Document Collections

IC ID	Document Title	Status
209964	NIMH DUC - GRDR Form and Instruction	New
204810	Principal Investigators/Research Assistants Instruction	Modified

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 201401-0925-001
Status: Historical Active	Previous ICR Reference No: 201308-0925-003
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: 01/10/2014
	Date Received in OIRA: 01/09/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	09/30/2016	09/30/2016
Responses	1,040	0	40
Time Burden (Hours)	1,646	0	63
Cost Burden (Dollars)	0	0	0

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Abstract: Several National Institutes of Health (NIH) data repositories require applicants to complete a data access request form, generally consisting of an abbreviated Standard Form 424 and a data use certification. The use of this previously OMB-approved information collection form was an expedient measure to jumpstart the use of these databases. The National Institute of Mental Health (NIMH) recently received OMB-approval for use of the National Database for Autism Research (NDAR) Data Use Certification Form (Title: NDAR Data Access Request; OMB Control Number: 0925-0667; Expiration Date: 01/31/2016). NIMH is interested in renaming this form the "NIMH Data Access Request and Use Certification (DUC) Form" and using it to meet the unique data access needs of all NIMH data repositories. There are currently three data repositories/sets positioned to use the NIMH DUC form: NDAR, the NIH Pediatric MRI Data Repository (PedsMRI), and the NIMH Clinical Research Datasets (NCRD).

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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

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
Principal Investigators/Research Assistants	1, 1, 1	NDAR Data Access Request (DUC) Form ,   NIMH DUC (NDAR and PedsMRI) ,   NIMH DUC (NCRD)
NIMH DUC - GRDR	2	NIMH DUC - GRDR

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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	1,040	40	0	1,000	0	0
Annual Time Burden (Hours)	1,646	63	0	1,583	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Additional users of the form added.

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Annual Cost to Federal Government: $8,450

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: 01/09/2014

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