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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:
201104-0925-002
Status:
Historical Active
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:
Approved without change
Conclusion Date:
04/13/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/08/2011
Terms of Clearance:
NCS may submit formative research directly related to the approved protocol as a nonsubstantive change. Each formative research proposal requires a ‘mini supporting statement’ that clearly identifies the aspect of the approved protocol that is being tested, the need for such testing, the study design, the protocol, and the IRB approval.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2013
36 Months From Approved
07/31/2013
Responses
440,665
0
390,068
Time Burden (Hours)
159,966
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
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
Number of Information Collection (IC) in this ICR:
30
IC Title
Form No.
Form Name
12-Month Visit Interview (PB, EH, TT-HI)
27.2, 27.1
Survey
,
Survey
18-Month Maternal Phone Call (PB, EH, TT-HI)
28.1, 28.2
Survey
,
Survey
24-Month Maternal Phone Call (PB, EH, TT-HI)
29.1, 29.2
Survey
,
Survey
3-Month Phone Call (PB, EH, TT-HI)
24.1
Survey
6-Month Visit Interview (PB, EH, TT-HI)
25.1, 25.2
Survey
,
Survey
9-Month Phone Call (PB, EH, TT-HI)
26.1
Survey
Address Lookup Tool (PB)
Biological and Environmental Sample Collection (PB, EH, TT-HI)
10.1
Survey
Birth Visit Interview (PB, EH, TT-HI)
20.1
Survey
Father Informed Consent Form (PB, EH, TT-HI)
18.1
Consent
Father Interview (PB, EH, TT-HI)
19.1
Survey
Formative - Developmental
Healthcare Provider Questionnaire (PB)
3.1
Survey
Household Enumeration Instrument (EH)
4.1
Survey
Infant Feeding Log (PB, EH, TT-HI)
22.1
Log
Low-Intensity Consent Script (TT-LI)
7.1
Consent
Low-Intensity Invitation to High-Intensity Script (TT-HI)
5.1
Survey
Low-Intensity Questionnaire (Birth focus) (TT-LI)
21.1
Survey
Low-Intensity Questionnaire (Child-focus) (TT-LI)
23.1
Survey
Low-Intensity Questionnaire (Non- and Pregnant) (TT-LI)
12.1
Survey
Non-pregnant Women's Informed Consent (PB, EH, TT-HI)
8.1
Consent
Pre-Pregnancy Interview (PB, EH, TT-HI)
9.1, 9.2
Survey
,
Survey
Pregnancy Health Care Log (PB, EH, TT-HI)
17.1
Log
Pregnancy Probability Group Follow Up Script (PB, EH, TT-HI, TT-LI)
11.1, 11.2
Survey
,
Survey
Pregnancy Screener (PB, EH, TT-HI)
2.1, 2.2, 2.3
Survey
,
Survey
,
Survey
Pregnancy Screener (TT-LI, TT-HI)
6.1
Survey
Pregnancy Visit 1 Interview (PB, EH, TT-HI)
15.1, 15.2
Survey
,
Survey
Pregnancy Visit 2 Interview (PB, EH, TT-HI)
16.1, 16.2
Survey
,
Survey
Pregnant Women's Informed Consent Form (PB, EH, TT-HI)
14.1
Consent
Validation Script (PB, EH, TT-HI, TT-LI)
13.1
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
440,665
390,068
0
50,597
0
0
Annual Time Burden (Hours)
159,966
128,042
0
31,924
0
0
Annual Cost Burden (Dollars)
0
0
0
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:
A second, fundamental research goal of the Recruitment Substudy is characterization of recruitment strategies associated with participant retention over time. Toward this objective, we propose to continue data collection among the 37 Vanguard Study locations up to and including the visit planned to take place when the sample children have reached 24 months of age. This would align the study visits approved for the initial 7 Vanguard Study locations (which extend past the birth visit to include a 3-, 6-, 9-, 18-, and 24-month visit) with the study visits approved for the 30 additional Vanguard Study locations (which were initially approved up to and including the birth visit). A third, central research goal of the Recruitment Substudy is to systematically identify study visit measures whose feasibility (scientific robustness), acceptability (burden to participants and study infrastructure), and cost are ideally suited for use in the NCS Main Study. We propose reintroduction of a limited set of study visit assessment measures to all 37 of the Vanguard Study locations engaged in data collection. Extensive measures, including biospecimens, were previously approved for use in the initial 7 Vanguard Study locations. The Phase 2 protocol would re-incorporate a father interview; maternal blood and urine collection; cord blood collection; home tap water and dust collection; a pregnancy health care log; and an infant and child health care log. In addition to supporting further testing of refined items, including these measures in the Recruitment Substudy would result in a data collection scope more closely mirroring the anticipated scope of the Main Study, thereby allowing better gauge of data collection scope and resources and the relationship with retention and study logistics over time. Another research goal of the Recruitment Substudy is to examine the feasibility, acceptability and cost of a series of formative research protocols within a subset of Vanguard Study participants and their peers with the aim of informing the NCS Main Study.
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
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:
04/08/2011