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

Forms and Documents

Document Name	Status
Form 1 Assessment of Executive Function for the National Children's Study Form and Instruction	Unchanged
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	Unchanged
Form 1.5 LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study Form and Instruction	Unchanged
B.12 LOI3-MHLTH-09 Saliva Collection and Transport Form.pdf Supplementary Document	2014-12-03
B.11 LOI3-MHLTH-09 IRB Approval Letter 08092014.pdf Supplementary Document	2014-12-03
B.10 LOI3-MHLTH-09 IRB Approval Letter 07222014.pdf Supplementary Document	2014-12-03
B.9 LOI3-MHLTH-09 Quality Assurance Interview.docx Supplementary Document	2014-12-03
B.6 LOI3-MHLTH-09 Consent Form Amended.docx Supplementary Document	2014-12-03
B.1 LOI3-MHLTH-09 IRB Protocol 07152014 Amended.docx Supplementary Document	2014-12-03
PMH Nonsubstantive Change Memorandum Request 12022014.docx Justification for No Material/Nonsubstantive Change	2014-12-03
NCS Cover Memorandum for 0925-0661 Change Request.doc Justification for No Material/Nonsubstantive Change	2012-06-22
2012 Neuropsychosocial Generic Clearance Request Part A 20120409.doc Supporting Statement A	2012-06-22

IC Document Collections

IC ID	Document Title	Status
212511	Assessment of Executive Function for the National Children's Study Form and Instruction	Unchanged
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	Unchanged
204488	LOI2 QUEX 8 Development and Validation of an Autism Case Confirmation Approach for Use in the National Children's Study Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0661	ICR Reference No: 201412-0925-001
Status: Historical Inactive	Previous ICR Reference No: 201206-0925-004
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: Improperly submitted and continue	Conclusion Date: 12/12/2014
	Date Received in OIRA: 12/03/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	06/30/2015	06/30/2015
Responses	11,500	0	11,500
Time Burden (Hours)	19,500	0	19,500
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 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	LOI2 QUEX-8 Parent Video-Guided Self Report (VGPR) ,   LOI2 QUEX-8 Screening Tool for Autism in Toddlers (STAT-NCS) ,   LOI2 QUEX-8 Exemplar Telephone Script ,   LO12 QUEX-8 Autism Diagnostic Screener (ADI-S)
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	1.1, 1.3, 1.5, 1.2, 1.4	Survey ,   Survey ,   Survey ,   Survey - Placeholder for Copyrighted Item ,   Survey
Assessment of Executive Function for the National Children's Study	6, 7, 8, 9, 10, 11, 12, 13, 12, 1, 2, 3, 4, 5	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

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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: No

Burden Reduction Due to:

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: 12/03/2014

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