NDAR Data Access Request

Forms and Documents

Document Name	Status
Form 1 Principal Investigators/Research Assistants Form and Instruction	New
NDAR PIA.docx Supplementary Document	2012-12-10
NDAR_DATA_ACCESS_support_stmt_a_FINAL[2].doc Supporting Statement A	2012-12-10

IC Document Collections

IC ID	Document Title	Status
204810	Principal Investigators/Research Assistants Form and Instruction	New

ICR Details

OMB Control No: 0925-0667	ICR Reference No: 201211-0925-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: NDAR Data Access Request
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/03/2013
	Date Received in OIRA: 11/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2016	36 Months From Approved
Responses	40	0	0
Time Burden (Hours)	63	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Institutes of Health (NIH) created the National Database for Autism Research (NDAR, http://ndar.nih.gov), an informatics system and central data repository, housed at the NIH Center for Information Technology, to support and accelerate research in the prevention, cause, diagnosis, and treatment of autism spectrum disorder (ASD). NDAR collects a wide range of data types, including phenotypic, clinical, and genomic, as well as medical images, derived from individuals who participate in ASD research, regardless of the source of funding.

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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:
	77 FR 37683	06/22/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 66622	11/06/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Principal Investigators/Research Assistants	1	NDAR Data User Certification

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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	40	0	0	40	0	0
Annual Time Burden (Hours)	63	0	0	63	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: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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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: 11/09/2012

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