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

Forms and Documents

Document Name	Status
Form 26.1 30-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 25.1 Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 20.1 Physical Measures - Child Blood Pressure (12-,24-Month) (PB, EH, TT-HI) Form and Instruction	Modified
Form 19.1 Physical Measures - Child Anthropometry (6-,12-,24-Month) (PB, EH, TT-HI) Form and Instruction	Modified
Form 16.2 Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI) Form and Instruction	Modified
Form 6.1 Tracing Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 5.1 Participant Verification (PB, EH, TT-HI, TT-HI, PBS) Form and Instruction	Modified
Form 3.1 Nonrespondent Questionnaire (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 2.3 Provider-Based Sampling Frame Questionnaire (PBS) Form and Instruction	Modified
Form 1.1 Provider-Based Sampling Eligibility Screener (PBS) Form and Instruction	Modified
Form 24.3 24-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 23.1 18-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 22.1 12-Month Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 21.1 9-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 18.1 6-Month Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 24.1 3-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 15.1 Infant Feeding Log (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 14.1 Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Modified
Form 13.1 Birth Visit Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 12.1 Father Interview (PB, EH, TT-HI) Form and Instruction	Modified
Form 11.1 Pregnancy Health Care Log (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 9.2 Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 8.3 Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Form 4.1 Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
Form 7.1 Low-Intensity Questionnaire (Found Pregnant) (TT-LI) Form and Instruction	Modified
Form 10.3 Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS) Form and Instruction	Modified
Cover_Memorandum_NCS_Request_for_Nonsubstantive_Change.docx Justification for No Material/Nonsubstantive Change	2013-03-08
List of Instruments.docx Supplementary Document	2013-03-08
Consent Documents.pdf Supplementary Document	2013-03-08
12 MO Child Saliva Instructions 20120413.docx Supplementary Document	2012-04-16
6, 12 MO Child Urine Collection Instructions 20120413.docx Supplementary Document	2012-04-16
1, 3 MO Breast Milk Collection Instructions 20120413.docx Supplementary Document	2012-04-16
Attach A17. PFQ Refusal Letter for Providers_final.docx Supplementary Document	2013-03-09
Provider Based Sampling Provider List Revision Letter.doc Supplementary Document	2012-04-16
Provider Based Sampling Brochure.docx Supplementary Document	2012-04-16
Provider Based Sampling Advance Letter to Office Manager.docx Supplementary Document	2012-04-16
Exemplar Letter to Accompany Questionnaire.doc Supplementary Document	2012-04-16
Advance Letter to Providers.docx Supplementary Document	2012-04-16
Attach B1. LOI2-QUEX-14-Phase 2 OIRA Template.docx Supplementary Document	2012-11-01
Attach B14. LOI2-QUEX-14 Manual of Procedures.pdf Supplementary Document	2012-10-19
Attach B17. Vanguard Pilot Study Biospecimen Collection Chart.docx Supplementary Document	2012-10-19
Attach B15. LOI2-QUEX-14 Exemplar Recruitment Flyer.docx Supplementary Document	2012-10-19
Attach B13. LOI2-QUEX-14 IRB Approval Letters.pdf Supplementary Document	2012-10-19
Attach B2. LOI2-QUEX-14 Exemplar Consent Form.doc Supplementary Document	2012-10-19
Note to File - 24 Month -- Administration of Ages and Stages 3 Questionnaire.docx Supplementary Document	2012-04-16
Note to File - 18 Month -- Administration of Ages and Stages 3 Questionnaire.docx Supplementary Document	2012-04-16
Birth Visit VIS No Sample Collection 20120413.docx Supplementary Document	2012-04-13
Birth VIS With Samples 20120413.docx Supplementary Document	2012-04-13
Note to File - Birth Visit - Umbilical Cord Blood Collection.docx Supplementary Document	2011-04-08
Father Visit Information Sheet 20120413.docx Supplementary Document	2012-04-13
Pregnancy Visit 2 Visit Information Sheet.docx Supplementary Document	2012-04-13
Attach A10. PLSND Telephone Reminder Call Script.docx Supplementary Document	2012-10-19
Attach A9. PLSND Mail Reminder Call Script.docx Supplementary Document	2012-10-19
Attach A8. PLSND Telephone Medical Records and Death Cert Release.docx Supplementary Document	2012-10-19
Attach A7. PLSND Telephone Medical Records Release Forms Letter.docx Supplementary Document	2012-10-19
Attach A6. PLSND Follow-Up SAQ and Release Forms Letter.docx Supplementary Document	2012-10-19
Attach A5. PLSND Item NR Rates.docx Supplementary Document	2012-10-19
Attach A4. PLSND Death Certificate Release Form.docx Supplementary Document	2012-10-19
Attach A3. PLSND Medical Records Release Form.docx Supplementary Document	2012-10-19
Pregnancy Visit 1 Visit Information Sheet.docx Supplementary Document	2012-04-13
Vacuum Bag Participant Instructions 20110211.doc Supplementary Document	2012-04-17
Urine Collection Instructions 20110211.doc Supplementary Document	2012-04-17
Pre-Visit Instructions for Blood and Urine Collection 20110211.doc Supplementary Document	2012-04-16
Pre-Visit Information for Non Fasting Venous Blood Adult Urine Vacuum Collection 20110211.doc Supplementary Document	2012-04-16
Pre-visit Information for Fasting Blood Urine Vacuum Collection 20110211.doc Supplementary Document	2012-04-16
Note to File - Biological and Environmental Sample Collection (Prenatal).docx Supplementary Document	2012-04-13
VBD Sample Distribution Script 20120413.docx Supplementary Document	2012-04-13
TWQ Sample Distribution Script 20120413.docx Supplementary Document	2012-04-13
TWF Sample Distribution Script 20120413.docx Supplementary Document	2012-04-13

IC Document Collections

IC ID	Document Title	Status
202215	30-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
202214	Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
202213	Physical Measures - Child Blood Pressure (12-,24-Month) (PB, EH, TT-HI) Form and Instruction	Modified
202212	Physical Measures - Child Anthropometry (6-,12-,24-Month) (PB, EH, TT-HI) Form and Instruction	Modified
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI) Form and Instruction	Modified
202210	Tracing Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
202209	Participant Verification (PB, EH, TT-HI, TT-HI, PBS) Form and Instruction	Modified
202208	Nonrespondent Questionnaire (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
202207	Provider-Based Sampling Frame Questionnaire (PBS) Form and Instruction	Modified
202206	Provider-Based Sampling Eligibility Screener (PBS) Form and Instruction	Modified
193580	Formative - Developmental Other-Research	Modified
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
193577	12-Month Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193576	9-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
193575	6-Month Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193574	3-Month Interview (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
193572	Infant Feeding Log (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193571	Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Modified
193570	Birth Visit Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193569	Father Interview (PB, EH, TT-HI) Form and Instruction	Modified
193567	Pregnancy Health Care Log (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193566	Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS) Form and Instruction	Modified
193563	Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS) Form and Instruction	Modified
193562	Low-Intensity Questionnaire (Found Pregnant) (TT-LI) Form and Instruction	Modified
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0593	ICR Reference No: 201211-0925-001
Status: Historical Active	Previous ICR Reference No: 201205-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Provider-Based Sampling Feasibility Study for the Vanguard (Pilot) Study and Data Collection Updates 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 with change	Conclusion Date: 03/09/2013
	Date Received in OIRA: 11/06/2012
Terms of Clearance: 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
Expiration Date	08/31/2014	08/31/2014	08/31/2014
Responses	55,748	0	55,748
Time Burden (Hours)	22,791	0	22,791
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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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	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

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:

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Annual Cost to Federal Government: $71,904,774

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: 11/06/2012

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