Neuropsychosocial Measures Formative Research Methodology Studies for the National Childrens Study (NICHD)

Forms and Documents

Document Name	Status
2012 Neuropsychosocial Generic Clearance Request Part B 20120313.docx Supporting Statement B	2012-04-02
LOI2-QUEX-5 Exemplar Telephone Screener.docx Supplementary Document	2012-04-02
LOI2-QUEX-5 Exemplar Recruitment Flyer.docx Supplementary Document	2012-04-02
LOI2-QUEX-05 Exemplar Protocol Summary.docx Supplementary Document	2012-04-02
LOI2-QUEX-05 Exemplar IRB Approval Letters.pdf Supplementary Document	2012-04-02
LOI2-QUEX-5 Exemplar Consent.docx Supplementary Document	2012-04-02
LOI2-QUEX-5 Exemplar Assessment Description Bayley-3 Short Form.docx Supplementary Document	2012-04-02
Example Neuropsychosocial Generic Clearance Project.docx Supplementary Document	2012-04-02
2012 Neuropsychosocial Generic Clearance Request Part A 20120313.docx Supporting Statement A	2012-04-02

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0925-0661	ICR Reference No: 201205-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neuropsychosocial Measures Formative Research Methodology Studies for the National Childrens Study (NICHD)
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 without change	Conclusion Date: 06/15/2012
	Date Received in OIRA: 05/15/2012
Terms of Clearance: NIH must submit each project/IC to OMB for approval under the PRA prior to implementation. Submissions for each project (IC) must include all relevant information usually submitted as part of Supporting Statements Parts A and B, although an IRB protocol or contractor work plan, accompanied by a cover letter, may be submitted instead of Parts A and B, provided the substitute documents include all necessary information.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	36 Months From Approved
Responses	135,000	0	0
Time Burden (Hours)	162,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection involves the collection of neurodevelopmental and psychosocial measures gathered via physical examinations, designed experimental tasks, surveys, focus groups, and/or cognitive interviews to assess physical, emotional, and neurological development, psychosocial growth and adaptation, and behavioral changes in both children and adults. This Neuropsychosocial Generic Clearance will allow the NCS to develop best-practice protocols and by answering several questions surrounding child development.

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Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Children's Health 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:
	76 FR 24497	05/02/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 19022	03/29/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 0

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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	135,000	0	0	135,000	0	0
Annual Time Burden (Hours)	162,000	0	0	162,000	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 ICR.

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Annual Cost to Federal Government: $2,793,681

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 05/15/2012

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