Recruitment Strategy Substudy for the National Children's Study (NICHD)

Forms and Documents

Document Name	Status
Form 29.1 24-Month Maternal Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
Form 28.1 18-Month Maternal Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
Form 27.2 12-Month Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 26.1 9-Month Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
Form 25.1 6-Month Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 24.1 3-Month Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
Form 23.1 Low-Intensity Questionnaire (Child-focus) (TT-LI) Form and Instruction	Modified
Form 22.1 Infant Feeding Log (PB, EH, TT-HI) Form and Instruction	Modified
Form 21.1 Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Modified
Form 20.1 Birth Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 19.1 Father Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 18.1 Father Informed Consent Form (PB, EH, TT-HI) Form and Instruction	Modified
Form 17.1 Pregnancy Health Care Log (PB, EH, TT-HI) Form and Instruction	Modified
Form 16.1 Pregnancy Visit 2 Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 15.1 Pregnancy Visit 1 Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 14.1 Pregnant Women's Informed Consent Form (PB, EH, TT-HI) Form and Instruction	Modified
Form 13.1 Validation Script (PB, EH, TT-HI, TT-LI) Form and Instruction	Modified
Form 12.1 Low-Intensity Questionnaire (Non- and Pregnant) (TT-LI) Form and Instruction	Modified
Form 11.1 Pregnancy Probability Group Follow Up Script (PB, EH, TT-HI, TT-LI) Form and Instruction	Modified
Form 10.1 Biological and Environmental Sample Collection (PB, EH, TT-HI) Form and Instruction	Modified
Form 9.2 Pre-Pregnancy Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 8.1 Non-pregnant Women's Informed Consent (PB, EH, TT-HI) Form and Instruction	Modified
Form 7.1 Low-Intensity Consent Script (TT-LI) Form and Instruction	Modified
Form 6.1 Pregnancy Screener (TT-LI, TT-HI) Form and Instruction	Modified
Form 5.1 Low-Intensity Invitation to High-Intensity Script (TT-HI) Form and Instruction	Modified
Form 4.1 Household Enumeration Instrument (EH) Form and Instruction	Modified
Form 3.1 Healthcare Provider Questionnaire (PB) Form and Instruction	Modified
Form 2.1 Pregnancy Screener (PB, EH, TT-HI) Form and Instruction	Modified
Cover Memorandum 20110621.docx Justification for No Material/Nonsubstantive Change	2011-08-18
Consent Form 20110621 - LOI2-BIO-18.pdf Supplementary Document	2011-08-18
C.4.12 Exemplar IRB Protocol LOI2-QUEX-14.docx Supplementary Document	2011-08-18
C.4.11 IRB Approval Letters LOI2-QUEX-14.pdf Supplementary Document	2011-08-18
C.3.10 Exemplar IRB Protocol LOI3-PHYS-01.pdf Supplementary Document	2011-08-18
C.3.9 IRB Approval Letter LOI3-PHYS-01.pdf Supplementary Document	2011-08-18
C.2.7 Exemplar IRB Protocol LOI2-PHYS-02.pdf Supplementary Document	2011-08-18
C.2.6 IRB Approval Letters LOI3-PHYS-02.pdf Supplementary Document	2011-08-18
C.1.4 Exemplar IRB Protocol LOI2-BIO-18.pdf Supplementary Document	2011-08-18
C.1.3 IRB Approval Letters LOI2-BIO-18.pdf Supplementary Document	2011-08-18
READ ME - POSTING INSTRUCTIONS (OMB # 0925-0593 Expiration Date 7 31 2013).docx Supplementary Document	2011-07-01
TWQ Part Ins 20110621.doc Supplementary Document	2011-07-01
TWF Part Ins 20110621.doc Supplementary Document	2011-07-01
Food Portion Guide 20110621 - LOI2-QUEX-14.docx Supplementary Document	2011-07-01
Exemplar Consent Form 20110621 - LOI2-QUEX-14.doc Supplementary Document	2011-07-01
Exemplar Flyer 20110621 - LOI3-PHYS-01.docx Supplementary Document	2011-07-01
Informed Consent 20110621 - LOI3-PHYS-01.docx Supplementary Document	2011-07-01
Exemplar VIS 20110621 - LOI3-PHYS-01.docx Supplementary Document	2011-07-01
Birth Visit Information Sheet 20110621 - LOI2-BIO-18.docx Supplementary Document	2011-07-01
ASA24 Instructions 20110621 - LOI2-QUEX-14.doc Supplementary Document	2011-07-01
Consent Form 20110621 - LOI2-BIO-18.pdf Supplementary Document	2011-07-01
Flier 20110621 - LOI3-PHYS-02.pdf Supplementary Document	2011-07-01
Visit Information Sheet 20110621 - LOI3-PHYS-02.docx Supplementary Document	2011-07-01
VBD Part Ins 20110621.doc Supplementary Document	2011-07-01
Food Diary Instructions for Parent_MOM 20110621 - LOI2-QUEX-14.docx Supplementary Document	2011-07-01
Exemplar Consent 20110621 - LOI3-PHYS-02.pdf Supplementary Document	2011-07-01
Cover Memorandum 201106021.docx Justification for No Material/Nonsubstantive Change	2011-06-30
Note to File - Birth Visit - Umbilical Cord Blood Collection.docx Supplementary Document	2011-04-08
TWF Distrib 20110621.doc Supplementary Document	2011-07-01
VBD Distrib 20110621.doc Supplementary Document	2011-07-01
TWQ Distrib 20110621.doc Supplementary Document	2011-07-01
Note to File - Biological and Environmental Sample Collection.docx Supplementary Document	2011-04-08

IC Document Collections

IC ID	Document Title	Status
193580	Formative - Developmental Instruction	Modified
193579	24-Month Maternal Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
193578	18-Month Maternal Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
193577	12-Month Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
193576	9-Month Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
193575	6-Month Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
193574	3-Month Phone Call (PB, EH, TT-HI) Form and Instruction	Modified
193573	Low-Intensity Questionnaire (Child-focus) (TT-LI) Form and Instruction	Modified
193572	Infant Feeding Log (PB, EH, TT-HI) Form and Instruction	Modified
193571	Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Modified
193570	Birth Visit Interview (PB, EH, TT-HI) Form and Instruction	Modified
193569	Father Interview (PB, EH, TT-HI) Form and Instruction	Modified
193568	Father Informed Consent Form (PB, EH, TT-HI) Form and Instruction	Modified
193567	Pregnancy Health Care Log (PB, EH, TT-HI) Form and Instruction	Modified
193566	Pregnancy Visit 2 Interview (PB, EH, TT-HI) Form and Instruction	Modified
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI) Form and Instruction	Modified
193564	Pregnant Women's Informed Consent Form (PB, EH, TT-HI) Form and Instruction	Modified
193563	Validation Script (PB, EH, TT-HI, TT-LI) Form and Instruction	Modified
193562	Low-Intensity Questionnaire (Non- and Pregnant) (TT-LI) Form and Instruction	Modified
193561	Pregnancy Probability Group Follow Up Script (PB, EH, TT-HI, TT-LI) Form and Instruction	Modified
193560	Biological and Environmental Sample Collection (PB, EH, TT-HI) Form and Instruction	Modified
193559	Pre-Pregnancy Interview (PB, EH, TT-HI) Form and Instruction	Modified
193558	Non-pregnant Women's Informed Consent (PB, EH, TT-HI) Form and Instruction	Modified
193557	Low-Intensity Consent Script (TT-LI) Form and Instruction	Modified
193556	Pregnancy Screener (TT-LI, TT-HI) Form and Instruction	Modified
193555	Low-Intensity Invitation to High-Intensity Script (TT-HI) Form and Instruction	Modified
193554	Household Enumeration Instrument (EH) Form and Instruction	Modified
193553	Healthcare Provider Questionnaire (PB) Form and Instruction	Modified
184272	Pregnancy Screener (PB, EH, TT-HI) Form and Instruction	Modified
184271	Address Lookup Tool (PB) Instruction	Modified

ICR Details

OMB Control No: 0925-0593	ICR Reference No: 201107-0925-001
Status: Historical Active	Previous ICR Reference No: 201105-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Recruitment Strategy Substudy for the National Children's 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: 08/23/2011
	Date Received in OIRA: 07/05/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	07/31/2013	07/31/2013
Responses	455,206	0	455,206
Time Burden (Hours)	159,966	0	159,966
Cost Burden (Dollars)	0	0	0

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Abstract: The Initial Vanguard Study protocol was designed to enroll approximately 1,750 pregnant women through seven study locations after 12 months of data collection. Two of the locations began recruitment in January 2009 and the remaining 5 in April 2009. As of May 2010, however, approximately 900 pregnant women have been enrolled, leading to questions about the assumptions underlying the Initial Vanguard Study recruitment model. The seven Initial Vanguard sites use a household enumeration and screening strategy to identify eligible women for recruitment into the study. Although household enumeration is often considered a gold standard for maximizing coverage, in that all dwelling units are identified and enumerated, for the NCS Initial Vanguard Study this method has not yielded the target number of births in the time frame projected from initial models. Consequently, additional methodological research is needed to evaluate the feasibility, acceptability, and cost of alternate recruitment strategies for enrollment of pregnant women into the NCS. This research will be conducted through the NCS Recruitment Substudy. The Recruitment Substudy will assess three alternate recruitment strategies - (1) a provider-based recruitment strategy; (2) an enhanced version of a household enumeration strategy; and (3) a two-tier recruitment strategy involving high-intensity and low-intensity data collection efforts.

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Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Childrens 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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 30

IC Title	Form No.	Form Name
Pregnancy Screener (PB, EH, TT-HI)	2.3, 2.2, 2.1	Survey ,   Survey ,   Survey
Healthcare Provider Questionnaire (PB)	3.1	Survey
Father Interview (PB, EH, TT-HI)	19.1	Survey
Birth Visit Interview (PB, EH, TT-HI)	20.1	Survey
Low-Intensity Questionnaire (Birth focus) (TT-LI)	21.1	Survey
Infant Feeding Log (PB, EH, TT-HI)	22.1	Log
Low-Intensity Questionnaire (Child-focus) (TT-LI)	23.1	Survey
3-Month Phone Call (PB, EH, TT-HI)	24.1	Survey
6-Month Visit Interview (PB, EH, TT-HI)	25.1, 25.2	Survey ,   Survey
9-Month Phone Call (PB, EH, TT-HI)	26.1	Survey
12-Month Visit Interview (PB, EH, TT-HI)	27.2, 27.1	Survey ,   Survey
Non-pregnant Women's Informed Consent (PB, EH, TT-HI)	8.1	Consent
Pre-Pregnancy Interview (PB, EH, TT-HI)	9.1, 9.2	Survey ,   Survey
Biological and Environmental Sample Collection (PB, EH, TT-HI)	10.1	Survey
Pregnancy Visit 1 Interview (PB, EH, TT-HI)	15.1, 15.2	Survey ,   Survey
Pregnancy Visit 2 Interview (PB, EH, TT-HI)	16.1, 16.2	Survey ,   Survey
Pregnancy Health Care Log (PB, EH, TT-HI)	17.1	Log
Father Informed Consent Form (PB, EH, TT-HI)	18.1	Consent
Validation Script (PB, EH, TT-HI, TT-LI)	13.1	Survey
Pregnant Women's Informed Consent Form (PB, EH, TT-HI)	14.1	Consent
Pregnancy Probability Group Follow Up Script (PB, EH, TT-HI, TT-LI)	11.1, 11.2	Survey ,   Survey
Low-Intensity Questionnaire (Non- and Pregnant) (TT-LI)	12.1	Survey
Address Lookup Tool (PB)
18-Month Maternal Phone Call (PB, EH, TT-HI)	28.1, 28.2	Survey ,   Survey
24-Month Maternal Phone Call (PB, EH, TT-HI)	29.1, 29.2	Survey ,   Survey
Formative - Developmental
Household Enumeration Instrument (EH)	4.1	Survey
Low-Intensity Invitation to High-Intensity Script (TT-HI)	5.1	Survey
Pregnancy Screener (TT-LI, TT-HI)	6.1	Survey
Low-Intensity Consent Script (TT-LI)	7.1	Consent

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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	455,206	455,206	0	0	0	0
Annual Time Burden (Hours)	159,966	159,966	0	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:

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Annual Cost to Federal Government: $27,000,000

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: 07/05/2011

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