Information Collection Request

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

ICR 201012-0925-006 · OMB 0925-0593 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 8 Two-Tier (High): Birth Visit Interview Form and Instruction Modified Repair queued
Form 7 Two Tier (High): Pregnancy Visit 2 Interview Form and Instruction Modified Repair queued
Form 6 Two Tier (High): Pregnancy Visit 1 Interview Form and Instruction Modified Available
Form 3.1 Two Tier (High): Women's Informed Consent Form Form and Instruction Modified Repair queued
Form 5.1 Two Tier (High): Pregnancy Probability Group Follow Up Script Form and Instruction Modified Repair queued
Form 4 Two Tier (High): Pre-Pregnancy Interview Form and Instruction Modified Available
Form 2 Two Tier (High): Pregnancy Screening Form and Instruction Modified Available
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) Form and Instruction Modified Repair queued
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) Form and Instruction Modified Available
Form 5.2 Two Tier (Low): Pregnancy Probability Group Follow Up Script Form and Instruction Modified Repair queued
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) Form and Instruction Modified Repair queued
Form 3.2 Two Tier (Low): Low-Intensity Consent Script Form and Instruction Modified Available
Form 2.2 Two Tier (Low): Low-Intensity CATI Pregnancy Screener Form and Instruction Modified Repair queued
Form 8 Enhanced Household: Birth Visit Interview Form and Instruction Modified Available
Form 7 Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction Modified Repair queued
Form 6 Enhanced Household: Pregnancy Visit 1 Interview Form and Instruction Modified Available
Form 3.1 Enhanced Household: Women's Informed Consent Form Form and Instruction Modified Repair queued
Form 5.1 Enhanced Household: Pregnancy Probability Group Follow Up Script Form and Instruction Modified Repair queued
Form 4 Enhanced Household: Pre-pregnancy Interview Form and Instruction Modified Repair queued
Form 10 Enhanced Household: Neighbor Report Form Modified Available
Form 8 Provider-Based: Birth Visit Interview Form and Instruction Modified Repair queued
Form 7 Provider-Based: Pregnancy Visit 2 Interview Form and Instruction Modified Available
Form 6 Provider-Based: Pregnancy Visit 1 Interview Form and Instruction Modified Repair queued
Form 3.1 Provider-Based: Women's Informed Consent Form Form and Instruction Modified Available
Form 5.1 Provider-Based: Pregnancy Probability Group Follow Up Script Form and Instruction Modified Repair queued
Form 4 Provider-Based: Pre-Pregnancy Visit Form and Instruction Modified Repair queued
Form 2.3 Provider-Based: Pregnancy Screening Form and Instruction Modified Repair queued
Form 2 Enhanced Household: Pregnancy Screening Form and Instruction Modified Repair queued
Form 1 Enhanced Household: Household Enumeration Script Form and Instruction Modified Available
3. 6 month Infant Feeding SAQ 20101130.docx Supplementary Document Uploaded 2010-12-03 Repair queued
2. 6 Month Mother Interview - abbreviated - 20101119.docx Supplementary Document Uploaded 2010-12-03 Repair queued
1. 6 Month Visit Information Sheet 20101119.docx Supplementary Document Uploaded 2010-12-03 Repair queued
Cover Memorandum NCS 20101130 (2).docx Justification for No Material/Nonsubstantive Change Uploaded 2010-12-03 Available
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Repair queued
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Repair queued
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Repair queued
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Repair queued
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
0925-0593 201012-0925-006
Historical Active 201011-0925-001
HHS/NIH
Recruitment Strategy Substudy for the National Children's Study (NICHD)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/27/2010
Retrieve Notice of Action (NOA) 12/20/2010
Prior terms continue.
  Inventory as of this Action Requested Previously Approved
07/31/2013 07/31/2013 07/31/2013
390,068 0 390,068
128,042 0 128,042
0 0 0

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.

PL: Pub.L. 106 - 310 1004 Name of Law: Childrens Health Act of 2000
  
None

Not associated with rulemaking

Yes

30
IC Title Form No. Form Name
Enhanced Household: Neighbor Report 10 Form
Enhanced Household: Pre-pregnancy Interview 4 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 Screening 2 Survey
Two Tier (High): Pre-Pregnancy Interview 4 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
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
Provider-Based: Pregnancy Visit 2 Interview 7 Survey
Provider-Based: Birth Visit Interview 8 Survey
Enhanced Household: Household Enumeration Script 1 Survey
Enhanced Household: Pregnancy Screening 2 Survey
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: Women's Informed Consent Form 3.1 Consent
Provider-Based: Pregnancy Visit 1 Interview 6 Survey

  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
No
No

$110,000,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
12/20/2010