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

Forms and Documents

Document	Type	Status	Availability
Form 1 Assessment of Executive Function for the National Children's Study	Form and Instruction	New	Repair queued
Form 1.1 LOI2-QUEX-5 Bayley-3 Short Form for the National Children's Study AND LOI3-MHLTH-09 A Methodological Study to Assess Mental Disorders for NCS Birth Parents	Form and Instruction	New	Repair queued
Form 1.4 LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study	Form and Instruction	New	Available
NCS Cover Memorandum for 0925-0661 Change Request.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2012-06-22	Repair queued
2012 Neuropsychosocial Generic Clearance Request Part A 20120409.doc	Supporting Statement A	Uploaded 2012-06-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
212511	Assessment of Executive Function for the National Children's Study	Form and Instruction	New
208126	LOI2-QUEX-5 Bayley-3 Short Form for the National Children's Study AND LOI3-MHLTH-09 A Methodological Study to Assess Mental Disorders for NCS Birth Parents	Form and Instruction	New
204488	LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study	Form and Instruction	New

ICR Details

OMB Control No: 0925-0661	ICR Reference No: 201206-0925-004
Status: Historical Active	Previous ICR Reference No: 201205-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Neuropsychosocial Measures Formative Research Methodology Studies for the National Childrens Study (NICHD)
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: 06/26/2012
	Date Received in OIRA: 06/26/2012
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	06/30/2015	06/30/2015
Responses	11,500	0	135,000
Time Burden (Hours)	19,500	0	162,000
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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
LOI2-QUEX-5 Bayley-3 Short Form for the National Children's Study AND LOI3-MHLTH-09 A Methodological Study to Assess Mental Disorders for NCS Birth Parents	1.2, 1.4, 1.1, 1.3, 1.5	Survey ,   Survey ,   Survey ,   Survey - Placeholder for Copyrighted Item ,   Survey
Assessment of Executive Function for the National Children's Study	1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 12	Recruitment Screening Interview ,   Family Demographic Questionnaire ,   CBQ-VSF+EF ,   Ages and Stages Social Emotional Questionnaire ,   Strengths and Difficulties Questionnaire ,   Q-ABC ,   Touch Screen Tutorial ,   Dimensional Change Card Sort Test ,   Flanker Inhibitory Control and Attention Test ,   Picture Vocabulary Test ,   Picture Sequence Memory Test ,   Peg Tapping ,   WPPSI-IV Block Design ,   Woodcock-Johnson III Tests of Achievement
LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study	1.5, 1.6, 1.2, 1.4	LO12 QUEX-8 Autism Diagnostic Screener (ADI-S) ,   LOI2 QUEX-8 Exemplar Telephone Script ,   LOI2 QUEX-8 Parent Video-Guided Self Report (VGPR) ,   LOI2 QUEX-8 Screening Tool for Autism in Toddlers (STAT-NCS)

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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	11,500	135,000	0	-123,500	0	0
Annual Time Burden (Hours)	19,500	162,000	0	-142,500	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: A change request is being submitted to correct the burden hours and place the revised supporting statement in the docket.

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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: 06/26/2012

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