Provider-Based Sampling Feasibility Study for the Vanguard (Pilot) Study and Data Collection Updates for the National Children's Study (NICHD)

ICR 201211-0925-001

OMB: 0925-0593

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2013-03-08
Supplementary Document
2013-03-08
Supplementary Document
2013-03-08
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2013-03-09
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-11-01
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-13
Supplementary Document
2012-04-13
Supplementary Document
2011-04-08
Supplementary Document
2012-04-13
Supplementary Document
2012-04-13
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-10-19
Supplementary Document
2012-04-13
Supplementary Document
2012-04-17
Supplementary Document
2012-04-17
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-16
Supplementary Document
2012-04-13
Supplementary Document
2012-04-13
Supplementary Document
2012-04-13
Supplementary Document
2012-04-13
IC Document Collections
IC ID
Document
Title
Status
202215 Modified
202214 Modified
202213 Modified
202212 Modified
202211 Modified
202210 Modified
202209 Modified
202208 Modified
202207 Modified
202206 Modified
193580 Modified
193579 Modified
193578 Modified
193577 Modified
193576 Modified
193575 Modified
193574 Modified
193572 Modified
193571 Modified
193570 Modified
193569 Modified
193567 Modified
193566 Modified
193565 Modified
193563 Modified
193562 Modified
193560 Modified
ICR Details
0925-0593 201211-0925-001
Historical Active 201205-0925-002
HHS/NIH
Provider-Based Sampling Feasibility Study for the Vanguard (Pilot) Study and Data Collection Updates for the National Children's Study (NICHD)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 03/09/2013
Retrieve Notice of Action (NOA) 11/06/2012
Prior terms continue. Approved consistent with the follow two terms: 1) In advance of adding biological and environmental sampling for the participants in the provider-based sampling arm of the Vanguard study, NIH will consult with the IRB amount whether the time between written consent for biosampling and the actual implementation of this activity warrents written re-consent. 2) NIH agrees to brief OMB/OIRA on the results of this test, particularly the measures in Table A.16 in advance of finalizing the design for the main study of the NCS.
  Inventory as of this Action Requested Previously Approved
08/31/2014 08/31/2014 08/31/2014
55,748 0 55,748
22,791 0 22,791
0 0 0

The National Children's Study is an integrated system of activities that includes a Vanguard (Pilot) Study for operations and methods development, and an NCS Main Study to collect data on exposure and response. The Vanguard (Pilot) Study, which includes the Initial Vanguard Study, the Alternate Recruitment Substudy (Phases 1 and 2), and the Provider-Based Sampling Feasibility Study (proposed in this information collection request), is currently underway. The Main Study is expected to follow within the next year. This request for revision includes (1) the addition of a Provider-Based Sampling Feasibility Study, and (2) supplemental measures for the Alternate Recruitment Substudy involving revised study visit assessments, physical measurements, and additional biospecimen collections. These information collections, revisions of instruments, physical measure implementation, and biospecimen collections will evaluate the feasibility, acceptability, and cost of study design elements to inform the Main Study.

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

Not associated with rulemaking

Yes

27
IC Title Form No. Form Name
Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS) 10.3, 10.4, 10.2, 10.5, 10.6 Survey ,   Survey ,   Survey ,   Survey ,   Survey
Infant Feeding Log (PB, EH, TT-HI, PBS) 15.1 Log
Low-Intensity Questionnaire (Found Pregnant) (TT-LI) 7.1 Survey
Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS) 4.1 Survey
Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI) 16.2, 16.1, 16.5, 16.3, 16.4 Survey ,   Survey ,   Survey ,   Survey ,   Survey
Physical Measures - Child Anthropometry (6-,12-,24-Month) (PB, EH, TT-HI) 19.1 Survey
Physical Measures - Child Blood Pressure (12-,24-Month) (PB, EH, TT-HI) 20.1 Survey
Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS) 25.1 Survey
30-Month Interview (PB, EH, TT-HI, TT-LI, PBS) 26.3, 26.1, 26.4, 26.2 Survey ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey
3-Month Interview (PB, EH, TT-HI, TT-LI, PBS) 24.1 Survey
6-Month Interview (PB, EH, TT-HI, PBS) 18.1, 18.2 Survey ,   Survey
9-Month Interview (PB, EH, TT-HI, TT-LI, PBS) 21.1 Survey
12-Month Interview (PB, EH, TT-HI, PBS) 22.1, 22.2, 22.3 Survey ,   Survey ,   Survey - Placeholder for Copyrighted Material
18-Month Interview (PB, EH, TT-HI, TT-LI, PBS) 23.1, 23.4, 23.2, 23.3, 23.5, 23.6 Survey ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material
24-Month Interview (PB, EH, TT-HI, TT-LI, PBS) 24.1, 24.2, 24.3, 24.4, 24.5 Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey ,   Survey
Formative - Developmental none, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.8, 17.9, 17.10, 17.11, 17.7 Attach B25. Participant Verification Birth Cohort ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Provider-Based Sampling Eligibility Screener (PBS) 1.1 Survey
Provider-Based Sampling Frame Questionnaire (PBS) 2.3, 2.1, 2.2, 2.4 Survey ,   Survey ,   Survey ,   Survey
Nonrespondent Questionnaire (PB, EH, TT-HI, TT-LI, PBS) 3.1 Survey
Participant Verification (PB, EH, TT-HI, TT-HI, PBS) 5.1 Survey
Tracing Interview (PB, EH, TT-HI, TT-LI, PBS) 6.1 Survey
Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS) 8.3, 8.4, 8.1, 8.2 Survey ,   Survey ,   Survey ,   Survey
Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS) 9.2, 9.1 Survey ,   Survey
Pregnancy Health Care Log (PB, EH, TT-HI, PBS) 11.1 Log
Father Interview (PB, EH, TT-HI) 12.1 Survey
Birth Visit Interview (PB, EH, TT-HI, PBS) 13.1 Survey
Low-Intensity Questionnaire (Birth focus) (TT-LI) 14.1 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 55,748 55,748 0 0 0 0
Annual Time Burden (Hours) 22,791 22,791 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$71,904,774
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.
11/06/2012


© 2024 OMB.report | Privacy Policy