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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0925-0593
ICR Reference No:
201102-0925-002
Status:
Historical Active
Previous ICR Reference No:
201101-0925-004
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:
02/04/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/03/2011
Terms of Clearance:
Prior terms continue.
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
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
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
30
IC Title
Form No.
Form Name
Enhanced Household: Birth Visit Interview
8
Survey
Enhanced Household: Household Enumeration Script
1
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: Pregnancy Screening
2
Survey
Enhanced Household: Pregnancy Visit 1 Interview
6
Survey
Enhanced Household: Pregnancy Visit 2 Interview
7
Survey
Enhanced Household: Women's Informed Consent Form
3.1
Consent
Provider-Based: Address Look-Up
Provider-Based: Birth Visit Interview
8
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 Screening
2.3
Survey
Provider-Based: Pregnancy Visit 1 Interview
6
Survey
Provider-Based: Pregnancy Visit 2 Interview
7
Survey
Provider-Based: Women's Informed Consent Form
3.1
Consent
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): Pregnancy Screening
2
Survey
Two Tier (High): Pregnancy Visit 1 Interview
6
Survey
Two Tier (High): Pregnancy Visit 2 Interview
7
Survey
Two Tier (High): Women's Informed Consent Form
3.1
Consent
Two Tier (Low): Low-Intensity CATI Pregnancy Screener
2.2
Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women)
9
Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities)
9
Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities)
9
Survey
Two Tier (Low): Low-Intensity Consent Script
3.2, 3.3
Consent
,
Consent
Two Tier (Low): Pregnancy Probability Group Follow Up Script
5.2, 5.1
Survey
,
Survey
Two-Tier (High): Birth Visit Interview
8
Survey
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:
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
Agency Contact:
Mikia Currie 3014350941
Common Form ICR:
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:
(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:
02/03/2011