National Children's Study Formative Generic Clearance

Forms and Documents

Document Name	Status
Form 1.1 Methods to Enhance Child Assent Practices (for Parents and Children) Form	New
2011 Generic Clearance (0925-0590) Renewal Request Part B REVISED 20110830.docx Supporting Statement B	2011-08-30
Example Approved Generic Clearance 0925-0590.docx Supplementary Document	2011-06-29
Generic Clearance (0925-0590) Renewal Request Part A 20110531.docx Supporting Statement A	2011-06-29

IC Document Collections

IC ID	Document Title	Status
201420	Methods to Enhance Child Assent Practices (for Parents and Children) Form	New

ICR Details

OMB Control No: 0925-0590	ICR Reference No: 201107-0925-005
Status: Historical Active	Previous ICR Reference No: 200802-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: National Children's Study Formative Generic Clearance
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/01/2011
	Date Received in OIRA: 07/30/2011
Terms of Clearance: This generic clearance is approved for 3 years under the following conditions: (1) For individual "sub-studies" NIH shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template mutually agreed upon by OMB and NIH (including a statement of need, intended use of information, study design, description of respondents, data collection procedures, justification for any proposed incentive, and estimated burden); (b) the IRB protocol and approval; (c) recruitment materials and participant screeners, (d) instruments/moderator guides, and (e) consent forms. (2) NIH may submit up to three independent sub-studies in a single submission to OMB. (3) OMB will respond to NIH within 45 days, which allows 15 days per sub-study. (4) NIH will brief OMB on the schedule of upcoming sub-studies on a quarterly basis.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	36 Months From Approved	08/31/2011
Responses	63,000	0	3,150
Time Burden (Hours)	90,000	0	5,825
Cost Burden (Dollars)	0	0	0

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Abstract: The National Children's Study is a multi-center longitudinal study that will enroll a nationally representative sample of approximately 100,000 children born in the U.S. This is a request for programmatic clearance of formative research to help develop instruments, materials, and procedures for the NCS. These activities will be conducted to improve the efficiency of data collection and to decrease participant burden throughout the course of the Study.

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Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Children's Health Act of 2000
  

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 23603	04/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 41508	07/14/2011
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Methods to Enhance Child Assent Practices (for Parents and Children)	1.1	Contact Information Form

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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	63,000	3,150	0	0	59,850	0
Annual Time Burden (Hours)	90,000	5,825	0	0	84,175	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $300,000

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: 07/29/2011

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