The Natural History of Spina Bifida in Children Pilot Project

Forms and Documents

Document Name	Status
Form No number Child - Bracken Basic Concept Scale - School Readiness Composite Form	New
Form No number Child - Wide Range Assessment of Visual Motor Abilities Form	New
Form No number Child - NEPSY-II Form	New
Form No number Child - Peabody Picture Vocabulary Test Form	New
Form No number Child - Differential Abilities Scale Form	New
Form No number Parent - Children's Healthcare of Atlanta Patient History Questionnaire (in-depth evaluation) Form	New
Form No number Parent - Adaptive Behavior Assessment System (in-depth evaluation) Form	New
Form No number Parent - Behavior Assessment System for Children (in-depth evaluation) Form	New
Form No number Parent - Behavior Rating Inventory of Executive Function, Preschool Version Form	New
Form No number Parent - Pediatric Evaluation of Disability Inventory Form	New
Form No number Parent - McMaster Family Assessment Device Form	New
Form No number Parent - Survey Form	New
Supporting Statement Section B.doc Supporting Statement B	2008-08-26
Attachment O.doc Supplementary Document	2008-08-26
Attachment N.doc Supplementary Document	2008-08-26
Attachment M.doc Supplementary Document	2008-08-26
Attachment L.doc Supplementary Document	2008-08-26
Attachment K.doc Supplementary Document	2008-08-26
Attachment J.doc Supplementary Document	2008-08-26
Attachment I.doc Supplementary Document	2008-08-26
Attachment H.doc Supplementary Document	2008-08-26
Attachment G.doc Supplementary Document	2008-08-26
Attachment F.doc Supplementary Document	2008-08-26
Attachment E.doc Supplementary Document	2008-08-26
Attachment D.doc Supplementary Document	2008-08-26
Attachment B.doc Supplementary Document	2008-08-26
Attachment A.doc Supplementary Document	2008-08-26
Supporting Statement Section A_Aug_20_2008_revised.doc Supporting Statement A	2008-08-29

IC Document Collections

IC ID	Document Title	Status
186666	SB Clinic Coordinator Recruitment Effort Other-Burden Description	New
186665	Child - Bracken Basic Concept Scale - School Readiness Composite Form	New
186664	Child - Wide Range Assessment of Visual Motor Abilities Form	New
186663	Child - NEPSY-II Form	New
186662	Child - Peabody Picture Vocabulary Test Form	New
186661	Child - Differential Abilities Scale Form	New
186660	Parent - Children's Healthcare of Atlanta Patient History Questionnaire (in-depth evaluation) Form	New
186659	Parent - Adaptive Behavior Assessment System (in-depth evaluation) Form	New
186658	Parent - Behavior Assessment System for Children (in-depth evaluation) Form	New
186657	Parent - Behavior Rating Inventory of Executive Function, Preschool Version Form	New
186656	Parent - Pediatric Evaluation of Disability Inventory Form	New
186655	Parent - McMaster Family Assessment Device Form	New
186654	Parent - Survey Form	New

ICR Details

OMB Control No: 0920-0799	ICR Reference No: 200809-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: The Natural History of Spina Bifida in Children Pilot Project
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: 01/08/2009
	Date Received in OIRA: 09/18/2008
Terms of Clearance: Approval is based on changes agreed upon via email memo dated 01/05/09. For the full study, we will need a specific justification for each of the questions asked (i.e. the utility of the data collected).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2011	24 Months From Approved
Responses	246	0	0
Time Burden (Hours)	94	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Neural tube defects are still ranked as one of the most common potentially disabling conditions in the U.S. The long-term purpose of this Spina bifida (SB) project is to increase knowledge about the natural history of SB by prospectively studying children who were born with this potentially disabling condition.

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Authorizing Statute(s): PL: Pub.L. 108 - 154 317C Name of Law: Birth Defects and Developmental Disabilities Act of 2003
  

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:
	73 FR 6727	02/05/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 50820	08/28/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Parent - Children's Healthcare of Atlanta Patient History Questionnaire (in-depth evaluation)	No number	Children's Healthcare of Atlanta Patient History Questionnaire
Child - Differential Abilities Scale	No number	Differential Abilities Scale
Parent - Survey	No number	Parent Survey
Parent - McMaster Family Assessment Device	No number	McMaster Family Assessment Device
Parent - Pediatric Evaluation of Disability Inventory	No number	Pediatric Evaluation of Disability Inventory
Parent - Behavior Rating Inventory of Executive Function, Preschool Version	No number	Behavior Rating Preschool Version
Parent - Behavior Assessment System for Children (in-depth evaluation)	No number	Behavior Assessment System for Children
Parent - Adaptive Behavior Assessment System (in-depth evaluation)	No number	Adaptive Behavior Assessment System
Child - Peabody Picture Vocabulary Test	No number	Peabody Picture Vocabulary Test
Child - NEPSY-II	No number	NEPSY-II
Child - Wide Range Assessment of Visual Motor Abilities	No number	Wide Range Assessment of Visual
Child - Bracken Basic Concept Scale - School Readiness Composite	No number	Bracken Basic Concept Scale
SB Clinic Coordinator Recruitment Effort

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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	246	0	0	246	0	0
Annual Time Burden (Hours)	94	0	0	94	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: $168,187

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/18/2008

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