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

Forms and Documents

Document Name	Status
Form 8 Two-Tier (High): Birth Visit Interview Form and Instruction	Modified
Form 7 Two Tier (High): Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 6 Two Tier (High): Pregnancy Visit 1 Interview Form and Instruction	Modified
Form 3.1 Two Tier (High): Women's Informed Consent Form Form and Instruction	Modified
Form 5.1 Two Tier (High): Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
Form 4 Two Tier (High): Pre-Pregnancy Interview Form and Instruction	Modified
Form 2 Two Tier (High): Pregnancy Screening Form and Instruction	Modified
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) Form and Instruction	Modified
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) Form and Instruction	Modified
Form 5.1 Two Tier (Low): Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) Form and Instruction	Modified
Form 3.2 Two Tier (Low): Low-Intensity Consent Script Form and Instruction	Modified
Form 2.2 Two Tier (Low): Low-Intensity CATI Pregnancy Screener Form and Instruction	Modified
Form 8 Enhanced Household: Birth Visit Interview Form and Instruction	Modified
Form 7 Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 6 Enhanced Household: Pregnancy Visit 1 Interview Form and Instruction	Modified
Form 3.1 Enhanced Household: Women's Informed Consent Form Form and Instruction	Modified
Form 5.1 Enhanced Household: Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
Form 4 Enhanced Household: Pre-pregnancy Interview Form and Instruction	Modified
Form 10 Enhanced Household: Neighbor Report Form	Modified
Form 8 Provider-Based: Birth Visit Interview Form and Instruction	Modified
Form 7 Provider-Based: Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 6 Provider-Based: Pregnancy Visit 1 Interview Form and Instruction	Modified
Form 3.1 Provider-Based: Women's Informed Consent Form Form and Instruction	Modified
Form 5.1 Provider-Based: Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
Form 4 Provider-Based: Pre-Pregnancy Visit Form and Instruction	Modified
Form 2.3 Provider-Based: Pregnancy Screening Form and Instruction	Modified
Form 2 Enhanced Household: Pregnancy Screening Form and Instruction	Modified
Form 1 Enhanced Household: Household Enumeration Script Form and Instruction	Modified
Memorandum Requesting Nonsubstantive Change 201001001.docx Justification for No Material/Nonsubstantive Change	2010-10-15
Birth Visit July Launch VIS 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document	2010-06-07
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document	2010-06-15
Birth Visit July Launch VIS 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document	2010-06-07
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document	2010-06-15
Birth Visit July Launch VIS 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document	2010-06-07
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document	2010-06-07
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document	2010-06-15

IC Document Collections

IC ID	Document Title	Status
193580	Two-Tier (High): Birth Visit Interview Form and Instruction	Modified
193579	Two Tier (High): Pregnancy Visit 2 Interview Form and Instruction	Modified
193578	Two Tier (High): Pregnancy Visit 1 Interview Form and Instruction	Modified
193577	Two Tier (High): Women's Informed Consent Form Form and Instruction	Modified
193576	Two Tier (High): Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
193575	Two Tier (High): Pre-Pregnancy Interview Form and Instruction	Modified
193574	Two Tier (High): Pregnancy Screening Form and Instruction	Modified
193573	Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) Form and Instruction	Modified
193572	Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) Form and Instruction	Modified
193571	Two Tier (Low): Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
193570	Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) Form and Instruction	Modified
193569	Two Tier (Low): Low-Intensity Consent Script Form and Instruction	Modified
193568	Two Tier (Low): Low-Intensity CATI Pregnancy Screener Form and Instruction	Modified
193567	Enhanced Household: Birth Visit Interview Form and Instruction	Modified
193566	Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction	Modified
193565	Enhanced Household: Pregnancy Visit 1 Interview Form and Instruction	Modified
193564	Enhanced Household: Women's Informed Consent Form Form and Instruction	Modified
193563	Enhanced Household: Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
193562	Enhanced Household: Pre-pregnancy Interview Form and Instruction	Modified
193561	Enhanced Household: Neighbor Report Form	Modified
193560	Provider-Based: Birth Visit Interview Form and Instruction	Modified
193559	Provider-Based: Pregnancy Visit 2 Interview Form and Instruction	Modified
193558	Provider-Based: Pregnancy Visit 1 Interview Form and Instruction	Modified
193557	Provider-Based: Women's Informed Consent Form Form and Instruction	Modified
193556	Provider-Based: Pregnancy Probability Group Follow Up Script Form and Instruction	Modified
193555	Provider-Based: Pre-Pregnancy Visit Form and Instruction	Modified
193554	Provider-Based: Pregnancy Screening Form and Instruction	Modified
193553	Provider-Based: Address Look-Up Instruction	Modified
184272	Enhanced Household: Pregnancy Screening Form and Instruction	Modified
184271	Enhanced Household: Household Enumeration Script Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0593	ICR Reference No: 201010-0925-002
Status: Historical Active	Previous ICR Reference No: 201007-0925-001
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: 10/15/2010
	Date Received in OIRA: 10/15/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	07/31/2013	07/31/2013
Responses	390,068	0	390,068
Time Burden (Hours)	128,042	0	128,042
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
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 14165	03/24/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 35042	06/21/2010
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
Two Tier (High): Pregnancy Screening	2	Survey
Two Tier (High): Pre-Pregnancy Interview	4	Survey
Enhanced Household: Household Enumeration Script	1	Survey
Enhanced Household: Pregnancy Screening	2	Survey
Provider-Based: Women's Informed Consent Form	3.1	Consent
Provider-Based: Address Look-Up
Provider-Based: Pregnancy Screening	2.3	Survey
Provider-Based: Pre-Pregnancy Visit	4	Survey
Provider-Based: Pregnancy Probability Group Follow Up Script	5.1, 5.2	Survey ,   Survey
Provider-Based: Pregnancy Visit 1 Interview	6	Survey
Provider-Based: Pregnancy Visit 2 Interview	7	Survey
Provider-Based: Birth Visit Interview	8	Survey
Enhanced Household: Neighbor Report	10	Form
Enhanced Household: Pre-pregnancy Interview	4	Survey
Enhanced Household: Pregnancy Probability Group Follow Up Script	5.1, 5.2	Survey ,   Survey
Enhanced Household: Women's Informed Consent Form	3.1	Consent
Enhanced Household: Pregnancy Visit 1 Interview	6	Survey
Enhanced Household: Pregnancy Visit 2 Interview	7	Survey
Enhanced Household: Birth Visit Interview	8	Survey
Two Tier (Low): Low-Intensity CATI Pregnancy Screener	2.2	Survey
Two Tier (Low): Low-Intensity Consent Script	3.2, 3.3	Consent ,   Consent
Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women)	9	Survey
Two Tier (Low): Pregnancy Probability Group Follow Up Script	5.2, 5.1	Survey ,   Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities)	9	Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities)	9	Survey
Two Tier (High): Pregnancy Probability Group Follow Up Script	5.1, 5.2	Survey ,   Survey
Two Tier (High): Women's Informed Consent Form	3.1	Consent
Two Tier (High): Pregnancy Visit 1 Interview	6	Survey
Two Tier (High): Pregnancy Visit 2 Interview	7	Survey
Two-Tier (High): Birth Visit Interview	8	Survey

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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	390,068	390,068	0	0	0	0
Annual Time Burden (Hours)	128,042	128,042	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: $110,000,000

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: 10/15/2010

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