National Children's Study Formative Generic Clearance

Forms and Documents

Document Name	Status
Form 1 LOI2-QUEX-25-B, "National Children's Study Recruitment and Retention Network" Form and Instruction	New
Form 1 Assessment of Communication Messages and Materials Form	New
Form 1 Testing of automated self-response methods for collecting the reduced content version of NCS pregnancy status follow-up contacts Form and Instruction	New
Form 1 Best Practices Form and Instruction	New
Form 1 Community Informants/Participants UCI Form and Instruction	New
Form 1 Investigating small group information meetings as a community engagement strategy to encourage Latina/o and undocumented worker participation in the National Children's Study - Duplin County NC Form and Instruction	New
4 NCS Formative Studies - Supporting Statement - Part B - 2008-Jan.pdf Supporting Statement B	2008-02-07
Appendix A.1.pdf Supplementary Document	2008-02-11
NCS Formative Studies - Supporting Statement - Part A - 2008-Feb.pdf Supporting Statement A	2008-02-20

IC Document Collections

IC ID	Document Title	Status
197614	LOI2-QUEX-25-B, "National Children's Study Recruitment and Retention Network" Form and Instruction	New
192335	Assessment of Communication Messages and Materials Form	New
190084	Testing of automated self-response methods for collecting the reduced content version of NCS pregnancy status follow-up contacts Form and Instruction	New
189057	Best Practices Form and Instruction	New
187748	Community Informants/Participants UCI Form and Instruction	New
187554	Investigating small group information meetings as a community engagement strategy to encourage Latina/o and undocumented worker participation in the National Children's Study - Duplin County NC Form and Instruction	New

ICR Details

OMB Control No: 0925-0590	ICR Reference No: 200802-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: National Children's Study Formative Generic Clearance
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: 06/12/2008
	Date Received in OIRA: 02/20/2008
Terms of Clearance: We will try to review each request within one month, provided you give us a head up in advance of submission. Make sure that each application includes: 1) a description of the purpose of the formative research project, including how it relates to the larger study; 2) a description of the method and why it is appropriate; and 3) a discussion of criteria for evaluating the results of the project.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved
Responses	3,150	0	0
Time Burden (Hours)	5,825	0	0
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: PL: Pub.L. 106 - 310 1004 Name of Law: Children's Health Act of 2000

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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:
	72 FR 222	11/19/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 5856	01/31/2008
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Best Practices	1	survey
Community Informants/Participants UCI	1, 2	instrument ,   guide
Testing of automated self-response methods for collecting the reduced content version of NCS pregnancy status follow-up contacts	1, 2, 3, 4, 5, 6	survey ,   survey ,   survey ,   survey ,   survey ,   survey
Assessment of Communication Messages and Materials	1, 2, 3, 4	Focus Group Screener ,   Focus Group Guide ,   Interview Screener ,   Interview Guidelines
Investigating small group information meetings as a community engagement strategy to encourage Latina/o and undocumented worker participation in the National Children's Study - Duplin County NC	1, 1	survey ,   survey
LOI2-QUEX-25-B, "National Children's Study Recruitment and Retention Network"	1, 2	Screening Tool ,   Moderator's Guide

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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	3,150	0	3,150	0	0	0
Annual Time Burden (Hours)	5,825	0	5,825	0	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $500,000

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]? 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: 02/20/2008

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