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OMB Control No: 0925-0593	ICR Reference No: 201007-0925-001
Status: Historical Active	Previous ICR Reference No: 200803-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Recruitment Strategy Substudy for the National Children's Study (NICHD)
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: 07/23/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/02/2010
Terms of Clearance: Previous terms of clearance remain in effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	36 Months From Approved	09/30/2011
Responses	390,068	0	64,598
Time Burden (Hours)	128,042	0	13,797
Cost Burden (Dollars)	0	0	0

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.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	390,068	64,598	325,470
Annual Time Burden (Hours)	128,042	13,797	114,245
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The NCS Initial Vanguard Study, which consists of 7 Study locations, utilized the Household Enumeration and Screening Strategy, but did not yield the target number of births in the time frame projected from initial models. As a result, 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. Each recruitment approach would occur in 10 study locations, for a total of 30 study locations implementing alternate recruitment strategies. Recruitment strategies will be assessed and compared on the basis of feasibility (including success in recruiting and retaining sufficient numbers of participants), acceptability (including the extent of selection bias in recruitment, effect on respondent burden, and impact on study infrastructure), and cost. Ultimately, these comparisons will inform the recruitment approach or approaches to be taken for the NCS Main Study. Each recruitment strategy will be provided with approximately equally resources, and will be associated with a specific communications theme appropriate for its mode of participant enrollment.

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]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Mikia Currie 3014350941

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