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

Forms and Documents

Document Name	Status
Form 84.2 Two-Tier (Low): Low-Intensity Questionnaire (Child-focus) Form and Instruction	New
Form 83.1 Two-Tier (Low): Validation Script Form and Instruction	New
Form 80.1 Two-Tier (High): 24-Month Maternal Phone Call Form and Instruction	New
Form 79.1 Two-Tier (High): 18-Month Maternal Phone Call Form and Instruction	New
Form 78.1 Two-Tier (High): 12-Month Visit Interview Form and Instruction	New
Form 77.1 Two-Tier (High): 9-Month Phone Call Form and Instruction	New
Form 76.1 Two-Tier (High): 6-Month Visit Interview Form and Instruction	New
Form 75.1 Two-Tier (High): 3-Month Phone Call Form and Instruction	New
Form 74.1 Two-Tier (High): Infant/Child Health Care Log Form and Instruction	New
Form 73.1 Two-Tier (High): Father Interview Form and Instruction	New
Form 72.1 Two-Tier (High): Father Informed Consent Form Form and Instruction	New
Form 71.1 Two-Tier (High): Pregnancy Health Care Log Form and Instruction	New
Form 70.1 Two-Tier (High): Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
Form 68,1 Two-Tier (High): Pregnant Women's Informed Consent Form Form and Instruction	New
Form 67.1 Two-Tier (High): Validation Script Form and Instruction	New
Form 66.1 Two-Tier (High): Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
Form 65.1 Two-Tier (High): Non-pregnant Women's Informed Consent Form and Instruction	New
Form 64.1 Two-Tier (High): Invitation from Low- to High-Intensity Script Form and Instruction	New
Form 63.1 Enhanced Household: 24-Month Maternal Phone Call Form and Instruction	New
Form 62.2 Enhanced Household: 18-Month Maternal Phone Call Form and Instruction	New
Form 61.1 Enhanced Household: 12-Month Visit Interview Form and Instruction	New
Form 60.1 Enhanced Household: 9-Month Phone Call Form and Instruction	New
Form 59.1 Enhanced Household: 6-Month Visit Interview Form and Instruction	New
Form 58.1 Enhanced Household: 3-Month Phone Call Form and Instruction	New
Form 57.1 Enhanced Household: Infant/Child Health Care Log Form and Instruction	New
Form 56.1 Enhanced Household: Father Interview Form and Instruction	New
Form 55.1 Enhanced Household: Father Informed Consent Form Form and Instruction	New
Form 54.1 Enhanced Household: Pregnancy Health Care Log Form and Instruction	New
Form 53.1 Enhanced Household: Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
Form 52.1 Enhanced Household: Pregnancy Visit 1 Blood and Urine Collection Form and Instruction	New
Form 51.1 Enhanced Household: Pregnant Women's Informed Consent Form Form and Instruction	New
Form 50.1 Enhanced Household: Validation Script Form and Instruction	New
Form 49.1 Enhanced Household: Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
Form 48.1 Enhanced Household: Non-pregnant Women's Informed Consent Form and Instruction	New
Form 47.1 Provider-Based: 24-Month Maternal Phone Call Form and Instruction	New
Form 46.1 Provider-Based: 18-Month Maternal Phone Call Form and Instruction	New
Form 45.2 Provider-Based: 12-Month Visit Interview Form and Instruction	New
Form 44.1 Provider-Based: 9-Month Phone Call Form and Instruction	New
Form 43.1 Provider-Based: 6-Month Visit Interview Form and Instruction	New
Form 42.1 Provider-Based: 3-Month Phone Call Form and Instruction	New
Form 41.1 Provider-Based: Infant/Child Health Care Log Form and Instruction	New
Form 40.1 Provider-Based: Father Interview Form and Instruction	New
Form 39.1 Provider-Based: Father Informed Consent Form Form and Instruction	New
Form 38.1 Provider-Based: Pregnancy Health Care Log Form and Instruction	New
Form 37.1 Provider-Based: Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
Form 36.1 Provider-Based: Pregnancy Visit 1 Blood and Urine Collection Form and Instruction	New
Form 51.1 Provider-Based: Pregnant Women's Informed Consent Form Form and Instruction	New
Form 34.1 Provider-Based: Validation Script Form and Instruction	New
Form 33.1 Provider-Based: Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
Form 32.1 Provider-Based: Non-pregnant Women's Informed Consent Form and Instruction	New
Form 31.1 Provider-Based: Healthcare Provider Questionnaire Form and Instruction	New
Form 30.1 Two-Tier (High): Birth Visit Interview Form and Instruction	Modified
Form 29.1 Two-Tier (High): Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 3.1 Two Tier (High): Women's Informed Consent Form Form and Instruction	Removed
Form 26.1 Two-Tier (High): Pregnancy Probability Group Script Form and Instruction	Modified
Form 25.1 Two-Tier (High): Pre-Pregnancy Interview Form and Instruction	Modified
Form 24.1 Two-Tier (High): Pregnancy Screener Form and Instruction	Modified
Form 23.1 Two-Tier (Low): Low-Intensity Questionnaire (Birth-focus) Form and Instruction	Modified
Form 22.2 Two-Tier (Low): Low-Intensity Questionnaire (Pregnant) Form and Instruction	Modified
Form 21.1 Two-Tier (Low): Pregnancy Probability Group Script Form and Instruction	Modified
Form 20.1 Two-Tier (Low): Low-Intensity Questionnaire (Non-Pregnant) Form and Instruction	Modified
Form 19.1 Two-Tier (Low): Low-Intensity Consent Script Form and Instruction	Modified
Form 18.1 Two-Tier (Low): Pregnancy Screener (TT-LI, TT-HI) Form and Instruction	Modified
Form 16.1 Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 3.1 Enhanced Household: Women's Informed Consent Form Form and Instruction	Removed
Form 13.1 Enhanced Household: Pregnancy Probability Group Script Form and Instruction	Modified
Form 12.1 Enhanced Household: Pre-Pregnancy Interview Form and Instruction	Modified
Form 10 Enhanced Household: Neighbor Report Form	Removed
Form 10.1 Provider-Based: Birth Visit Interview Form and Instruction	Modified
Form 9.1 Provider-Based: Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 3.1 Provider-Based: Women's Informed Consent Form Form and Instruction	Removed
Form 6.1 Provider-Based: Pregnancy Probability Group Script Form and Instruction	Modified
Form 5.1 Provider-Based: Pre-Pregnancy Interview Form and Instruction	Modified
Form 4.1 Provider-Based: Pregnancy Screener Form and Instruction	Modified
Form 2.1 Enhanced Household: Pregnancy Screener Form and Instruction	Modified
Form 1.1 Enhanced Household: Household Enumeration Script Form and Instruction	Modified
Supporting Statement Part B 20110211.docx Supporting Statement B	2011-02-11
Itemized Burden Estimate.docx Supplementary Document	2011-02-23
List of Instruments for Phase 1 and 2, NCS Vanguard (Pilot) Study.xlsx Supplementary Document	2011-02-23
12-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
6-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Fathers Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document	2010-06-07
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document	2010-06-07
12-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
6-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Fathers Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
12-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
6-Month Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Fathers Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Cord blood Collection Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Birth Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 2 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 1 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pre-Pregnancy Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Cord blood Collection Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Birth Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 2 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 1 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pre-Pregnancy Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Birth Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Cord blood Collection Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 2 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pregnancy Visit 1 Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Pre-Pregnancy Visit Information Sheet 20110211.docx Supplementary Document	2011-02-11
Supporting Statement Part A 20110211.docx Supporting Statement A	2011-02-23

IC Document Collections

IC ID	Document Title	Status
196549	Two-Tier (Low): Low-Intensity Questionnaire (Child-focus) Form and Instruction	New
196548	Two-Tier (Low): Validation Script Form and Instruction	New
196547	Two-Tier (High): 24-Month Maternal Phone Call Form and Instruction	New
196546	Two-Tier (High): 18-Month Maternal Phone Call Form and Instruction	New
196545	Two-Tier (High): 12-Month Visit Interview Form and Instruction	New
196544	Two-Tier (High): 9-Month Phone Call Form and Instruction	New
196543	Two-Tier (High): 6-Month Visit Interview Form and Instruction	New
196542	Two-Tier (High): 3-Month Phone Call Form and Instruction	New
196541	Two-Tier (High): Infant/Child Health Care Log Form and Instruction	New
196540	Two-Tier (High): Father Interview Form and Instruction	New
196539	Two-Tier (High): Father Informed Consent Form Form and Instruction	New
196538	Two-Tier (High): Pregnancy Health Care Log Form and Instruction	New
196537	Two-Tier (High): Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
196536	Two-Tier (High): Pregnancy Visit 1 Blood and Urine Collection Instruction	New
196535	Two-Tier (High): Pregnant Women's Informed Consent Form Form and Instruction	New
196534	Two-Tier (High): Validation Script Form and Instruction	New
196533	Two-Tier (High): Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
196532	Two-Tier (High): Non-pregnant Women's Informed Consent Form and Instruction	New
196531	Two-Tier (High): Invitation from Low- to High-Intensity Script Form and Instruction	New
196530	Enhanced Household: 24-Month Maternal Phone Call Form and Instruction	New
196529	Enhanced Household: 18-Month Maternal Phone Call Form and Instruction	New
196528	Enhanced Household: 12-Month Visit Interview Form and Instruction	New
196527	Enhanced Household: 9-Month Phone Call Form and Instruction	New
196526	Enhanced Household: 6-Month Visit Interview Form and Instruction	New
196525	Enhanced Household: 3-Month Phone Call Form and Instruction	New
196524	Enhanced Household: Infant/Child Health Care Log Form and Instruction	New
196523	Enhanced Household: Father Interview Form and Instruction	New
196522	Enhanced Household: Father Informed Consent Form Form and Instruction	New
196521	Enhanced Household: Pregnancy Health Care Log Form and Instruction	New
196520	Enhanced Household: Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
196519	Enhanced Household: Pregnancy Visit 1 Blood and Urine Collection Form and Instruction	New
196518	Enhanced Household: Pregnant Women's Informed Consent Form Form and Instruction	New
196517	Enhanced Household: Validation Script Form and Instruction	New
196516	Enhanced Household: Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
196515	Enhanced Household: Non-pregnant Women's Informed Consent Form and Instruction	New
196514	Provider-Based: 24-Month Maternal Phone Call Form and Instruction	New
196513	Provider-Based: 18-Month Maternal Phone Call Form and Instruction	New
196512	Provider-Based: 12-Month Visit Interview Form and Instruction	New
196511	Provider-Based: 9-Month Phone Call Form and Instruction	New
196510	Provider-Based: 6-Month Visit Interview Form and Instruction	New
196509	Provider-Based: 3-Month Phone Call Form and Instruction	New
196508	Provider-Based: Infant/Child Health Care Log Form and Instruction	New
196507	Provider-Based: Father Interview Form and Instruction	New
196506	Provider-Based: Father Informed Consent Form Form and Instruction	New
196505	Provider-Based: Pregnancy Health Care Log Form and Instruction	New
196504	Provider-Based: Pregnancy Visit 2 Blood and Urine Collection Form and Instruction	New
196503	Provider-Based: Pregnancy Visit 1 Blood and Urine Collection Form and Instruction	New
196502	Provider-Based: Pregnant Women's Informed Consent Form Form and Instruction	New
196501	Provider-Based: Validation Script Form and Instruction	New
196500	Provider-Based: Pre-Pregnancy Blood and Urine Collection Form and Instruction	New
196499	Provider-Based: Non-pregnant Women's Informed Consent Form and Instruction	New
196498	Provider-Based: Healthcare Provider Questionnaire Form and Instruction	New
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 Instruction	Modified
193577	Two Tier (High): Women's Informed Consent Form Form and Instruction	Removed
193576	Two-Tier (High): Pregnancy Probability Group Script Form and Instruction	Modified
193575	Two-Tier (High): Pre-Pregnancy Interview Form and Instruction	Modified
193574	Two-Tier (High): Pregnancy Screener Form and Instruction	Modified
193573	Two-Tier (Low): Low-Intensity Questionnaire (Birth-focus) Form and Instruction	Modified
193572	Two-Tier (Low): Low-Intensity Questionnaire (Pregnant) Form and Instruction	Modified
193571	Two-Tier (Low): Pregnancy Probability Group Script Form and Instruction	Modified
193570	Two-Tier (Low): Low-Intensity Questionnaire (Non-Pregnant) Form and Instruction	Modified
193569	Two-Tier (Low): Low-Intensity Consent Script Form and Instruction	Modified
193568	Two-Tier (Low): Pregnancy Screener (TT-LI, TT-HI) Form and Instruction	Modified
193567	Enhanced Household: Birth Visit Interview Instruction	Modified
193566	Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction	Modified
193565	Enhanced Household: Pregnancy Visit 1 Interview Instruction	Modified
193564	Enhanced Household: Women's Informed Consent Form Form and Instruction	Removed
193563	Enhanced Household: Pregnancy Probability Group Script Form and Instruction	Modified
193562	Enhanced Household: Pre-Pregnancy Interview Form and Instruction	Modified
193561	Enhanced Household: Neighbor Report Form	Removed
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 Instruction	Modified
193557	Provider-Based: Women's Informed Consent Form Form and Instruction	Removed
193556	Provider-Based: Pregnancy Probability Group Script Form and Instruction	Modified
193555	Provider-Based: Pre-Pregnancy Interview Form and Instruction	Modified
193554	Provider-Based: Pregnancy Screener Form and Instruction	Modified
193553	Provider-Based: Address Lookup Tool Instruction	Modified
184272	Enhanced Household: Pregnancy Screener Form and Instruction	Modified
184271	Enhanced Household: Household Enumeration Script Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0593	ICR Reference No: 201103-0925-001
Status: Historical Inactive	Previous ICR Reference No: 201102-0925-002
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: Withdrawn and continue	Conclusion Date: 04/04/2011
	Date Received in OIRA: 03/03/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	36 Months From Approved	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. Additionally, retention and selected study visit assessments will be evaluated to inform study logistics and measures to be used in the Main Study.

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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 69680	11/15/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6478	02/04/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 78

IC Title	Form No.	Form Name
Two-Tier (Low): Validation Script	83.1	Survey
Two-Tier (Low): Low-Intensity Questionnaire (Child-focus)	84.2, 84.1	Consent ,   Survey
Two-Tier (High): Father Interview	73.1	Survey
Two-Tier (High): Infant/Child Health Care Log	74.1	Log
Two-Tier (High): 3-Month Phone Call	75.1	Survey
Two-Tier (High): 6-Month Visit Interview	76.1, 76.2	Survey ,   Survey
Two-Tier (High): 9-Month Phone Call	77.1	Survey
Two-Tier (High): 12-Month Visit Interview	78.1, 78.2	Survey ,   Survey
Two-Tier (High): 18-Month Maternal Phone Call	79.1, 79.2	Survey ,   Survey
Two-Tier (High): 24-Month Maternal Phone Call	80.1, 80.2	Survey ,   Survey
Enhanced Household: Pregnancy Visit 1 Blood and Urine Collection	52.1, 52.2	Survey ,   Survey
Enhanced Household: Pregnancy Visit 2 Blood and Urine Collection	53.1, 53.2	Survey ,   Survey
Enhanced Household: Pregnancy Health Care Log	54.1	Log
Enhanced Household: Father Informed Consent Form	55.1	Consent
Enhanced Household: Father Interview	56.1	Survey
Enhanced Household: Infant/Child Health Care Log	57.1	Log
Enhanced Household: 3-Month Phone Call	58.1	Survey
Two-Tier (High): Pregnant Women's Informed Consent Form	68,1	Consent
Two-Tier (High): Pregnancy Visit 1 Blood and Urine Collection	69.2, 69.1	Survey ,   Survey
Two-Tier (High): Pregnancy Visit 2 Blood and Urine Collection	70.2, 70.1	Survey ,   Survey
Provider-Based: Women's Informed Consent Form	3.1	Consent
Enhanced Household: Neighbor Report	10	Form
Two Tier (High): Women's Informed Consent Form	3.1	Consent
Enhanced Household: Household Enumeration Script	1.1	Survey
Enhanced Household: Pregnancy Screener	2.1	Survey
Provider-Based: Address Lookup Tool
Provider-Based: Pregnancy Screener	4.1	Survey
Provider-Based: Pre-Pregnancy Interview	5.1	Survey
Provider-Based: Pregnancy Probability Group Script	6.1, 6.2	Survey ,   Survey
Provider-Based: Pregnancy Visit 1 Interview	8.1	Survey
Provider-Based: Pregnancy Visit 2 Interview	9.1	Survey
Provider-Based: Birth Visit Interview	10.1	Survey
Enhanced Household: Pre-Pregnancy Interview	12.1	Survey
Enhanced Household: Pregnancy Probability Group Script	13.1, 13.2	Survey ,   Survey
Enhanced Household: Pregnancy Visit 1 Interview	15.1	Survey
Enhanced Household: Women's Informed Consent Form	3.1	Consent
Enhanced Household: Pregnancy Visit 2 Interview	16.1	Survey
Enhanced Household: Birth Visit Interview	17.1	Survey
Two-Tier (Low): Pregnancy Screener (TT-LI, TT-HI)	18.1	Survey
Two-Tier (Low): Low-Intensity Consent Script	19.1, 19.2	Consent ,   Consent
Two-Tier (Low): Low-Intensity Questionnaire (Non-Pregnant)	20.1, 20.2	Survey ,   Consent
Two-Tier (Low): Pregnancy Probability Group Script	21.1, 21.2	Survey ,   Survey
Two-Tier (Low): Low-Intensity Questionnaire (Pregnant)	22.2, 22.1	Consent ,   Survey
Two-Tier (Low): Low-Intensity Questionnaire (Birth-focus)	23.1, 23.2	Survey ,   Consent
Two-Tier (High): Birth Visit Interview	30.1	Survey
Provider-Based: Healthcare Provider Questionnaire	31.1	Survey
Provider-Based: Non-pregnant Women's Informed Consent	32.1	Consent
Provider-Based: Pre-Pregnancy Blood and Urine Collection	33.1, 33.2	Survey ,   Survey
Provider-Based: Validation Script	34.1	Survey
Provider-Based: Pregnant Women's Informed Consent Form	51.1	Consent
Provider-Based: 12-Month Visit Interview	45.1, 45.2	Survey ,   Survey
Provider-Based: 18-Month Maternal Phone Call	46.1, 46.2	Survey ,   Survey
Provider-Based: 24-Month Maternal Phone Call	47.1, 47.2	Survey ,   Survey
Provider-Based: 3-Month Phone Call	42.1	Survey
Provider-Based: 6-Month Visit Interview	43.1, 43.2	Survey ,   Survey
Provider-Based: 9-Month Phone Call	44.1	Survey
Enhanced Household: Validation Script	50.1	Survey
Enhanced Household: Pregnant Women's Informed Consent Form	51.1	Consent
Enhanced Household: Non-pregnant Women's Informed Consent	48.1	Consent
Enhanced Household: Pre-Pregnancy Blood and Urine Collection	49.1, 49.2	Survey ,   Survey
Two-Tier (High): Pre-Pregnancy Interview	25.1	Survey
Two-Tier (High): Pregnancy Probability Group Script	26.1, 26.2	Survey ,   Survey
Two-Tier (High): Pregnancy Visit 1 Interview	28.1	Survey
Two-Tier (High): Pregnancy Visit 2 Interview	29.1	Survey
Two-Tier (High): Pregnancy Screener	24.1	Survey
Provider-Based: Pregnancy Visit 1 Blood and Urine Collection	36.1, 36.2	Survey ,   Survey
Provider-Based: Pregnancy Visit 2 Blood and Urine Collection	37.1, 37.2	Survey ,   Survey
Provider-Based: Pregnancy Health Care Log	38.1	Log
Provider-Based: Father Informed Consent Form	39.1	Consent
Provider-Based: Father Interview	40.1	Survey
Provider-Based: Infant/Child Health Care Log	41.1	Log
Enhanced Household: 6-Month Visit Interview	59.1, 59.2	Survey ,   Survey
Enhanced Household: 9-Month Phone Call	60.1	Survey
Enhanced Household: 12-Month Visit Interview	61.1, 61.2	Survey ,   Survey
Enhanced Household: 18-Month Maternal Phone Call	62.2, 62.1	Survey ,   Survey
Enhanced Household: 24-Month Maternal Phone Call	63.1, 63.2	Survey ,   Survey
Two-Tier (High): Invitation from Low- to High-Intensity Script	64.1	Survey
Two-Tier (High): Non-pregnant Women's Informed Consent	65.1	Consent
Two-Tier (High): Pre-Pregnancy Blood and Urine Collection	66.1, 49.2	Survey ,   Survey
Two-Tier (High): Validation Script	67.1	Survey
Two-Tier (High): Pregnancy Health Care Log	71.1	Log
Two-Tier (High): Father Informed Consent Form	72.1	Consent

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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: This request for revision proposes the addition of a Recruitment Substudy to the Initial Vanguard Study to better inform the design and implementation of the Main Study. Additionally, we request that eligibility of women in the Initial Vanguard Study be extended to include women who resided in the geographically-eligible locations at recruitment, but who subsequently moved residence outside of a geographically-eligible location prior to the sample child's birth. We estimate that this extension of the eligibility criteria pertains to very few women, but it would be advantageous to the study by maintaining good will with participants and supporting analysis on instrument functionality. Since the Initial Vanguard Study is not designed to yield national rates, expanding inclusion criteria in this small way would not impair the ability of the study to meet its objectives.

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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: 03/03/2011

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