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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 26.2 Survey	Form and Instruction	Modified	Available
Form 26.4 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 26.3 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Repair queued
Form 26.1 Survey	Form and Instruction	Modified	Available
Form 25.1 Survey	Form and Instruction	Modified	Available
Form 20.1 Survey	Form and Instruction	Modified	Available
Form 19.1 Survey	Form and Instruction	Modified	Available
Form 16.4 Survey	Form and Instruction	Modified	Available
Form 16.3 Survey	Form and Instruction	Modified	Available
Form 16.5 Survey	Form and Instruction	Modified	Available
Form 16.1 Survey	Form and Instruction	Modified	Available
Form 16.2 Survey	Form and Instruction	Modified	Available
Form 6.1 Survey	Form and Instruction	Modified	Available
Form 5.1 Survey	Form and Instruction	Modified	Available
Form 3.1 Survey	Form and Instruction	Modified	Available
Form 2.4 Survey	Form and Instruction	Modified	Available
Form 2.2 Survey	Form and Instruction	Modified	Available
Form 2.1 Survey	Form and Instruction	Modified	Available
Form 2.3 Survey	Form and Instruction	Modified	Available
Form 1.1 Survey	Form and Instruction	Modified	Available
Attach B25. Participant Verification Birth Cohort	Form and Instruction	Modified	Available
Form 17.7 Survey	Form and Instruction	Modified	Available
Form 17.11 Survey	Form and Instruction	Modified	Available
Form 17.10 Survey	Form and Instruction	Modified	Available
Form 17.9 Survey	Form and Instruction	Modified	Available
Form 17.8 Survey	Form and Instruction	Modified	Available
Form 17.6 Survey	Form and Instruction	Modified	Available
Form 17.5 Survey	Form and Instruction	Modified	Available
Form 17.4 Survey	Form and Instruction	Modified	Available
Form 17.3 Survey	Form and Instruction	Modified	Available
Form 17.2 Survey	Form and Instruction	Modified	Available
Form 17.1 Survey	Form and Instruction	Modified	Available
Form 24.5 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 24.4 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 24.2 Survey	Form and Instruction	Modified	Available
Form 24.1 Survey	Form and Instruction	Modified	Available
Form 24.3 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.6 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.5 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.3 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.2 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.4 Survey - Placeholder for copyrighted material	Form and Instruction	Modified	Available
Form 23.1 Survey	Form and Instruction	Modified	Available
Form 22.3 Survey - Placeholder for Copyrighted Material	Form and Instruction	Modified	Available
Form 22.2 Survey	Form and Instruction	Modified	Available
Form 22.1 Survey	Form and Instruction	Modified	Available
Form 21.1 Survey	Form and Instruction	Modified	Available
Form 18.2 Survey	Form and Instruction	Modified	Available
Form 18.1 Survey	Form and Instruction	Modified	Available
Form 24.1 Survey	Form and Instruction	Modified	Available
Form 15.1 Log	Form and Instruction	Modified	Available
Form 14.1 Survey	Form and Instruction	Modified	Available
Form 13.1 Survey	Form and Instruction	Modified	Available
Form 12.1 Survey	Form and Instruction	Modified	Available
Form 11.1 Log	Form and Instruction	Modified	Available
Form 9.1 Survey	Form and Instruction	Modified	Available
Form 9.2 Survey	Form and Instruction	Modified	Available
Form 8.2 Survey	Form and Instruction	Modified	Available
Form 8.1 Survey	Form and Instruction	Modified	Available
Form 8.4 Survey	Form and Instruction	Modified	Available
Form 8.3 Survey	Form and Instruction	Modified	Available
Form 4.1 Survey	Form and Instruction	Modified	Available
Form 7.1 Survey	Form and Instruction	Modified	Available
Form 10.6 Survey	Form and Instruction	Modified	Available
Form 10.5 Survey	Form and Instruction	Modified	Available
Form 10.2 Survey	Form and Instruction	Modified	Available
Form 10.4 Survey	Form and Instruction	Modified	Available
Form 10.3 Survey	Form and Instruction	Modified	Available
Cover_Memorandum_NCS_Request_for_Nonsubstantive_Change.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2013-03-08	Available
List of Instruments.docx	Supplementary Document	Uploaded 2013-03-08	Available
Consent Documents.pdf	Supplementary Document	Uploaded 2013-03-08	Available
12 MO Child Saliva Instructions 20120413.docx	Supplementary Document	Uploaded 2012-04-16	Available
6, 12 MO Child Urine Collection Instructions 20120413.docx	Supplementary Document	Uploaded 2012-04-16	Available
1, 3 MO Breast Milk Collection Instructions 20120413.docx	Supplementary Document	Uploaded 2012-04-16	Available
Attach A17. PFQ Refusal Letter for Providers_final.docx	Supplementary Document	Uploaded 2013-03-09	Available
Provider Based Sampling Provider List Revision Letter.doc	Supplementary Document	Uploaded 2012-04-16	Available
Provider Based Sampling Brochure.docx	Supplementary Document	Uploaded 2012-04-16	Available
Provider Based Sampling Advance Letter to Office Manager.docx	Supplementary Document	Uploaded 2012-04-16	Available
Exemplar Letter to Accompany Questionnaire.doc	Supplementary Document	Uploaded 2012-04-16	Available
Advance Letter to Providers.docx	Supplementary Document	Uploaded 2012-04-16	Available
Attach B1. LOI2-QUEX-14-Phase 2 OIRA Template.docx	Supplementary Document	Uploaded 2012-11-01	Available
Attach B14. LOI2-QUEX-14 Manual of Procedures.pdf	Supplementary Document	Uploaded 2012-10-19	Available
Attach B17. Vanguard Pilot Study Biospecimen Collection Chart.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach B15. LOI2-QUEX-14 Exemplar Recruitment Flyer.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach B13. LOI2-QUEX-14 IRB Approval Letters.pdf	Supplementary Document	Uploaded 2012-10-19	Available
Attach B2. LOI2-QUEX-14 Exemplar Consent Form.doc	Supplementary Document	Uploaded 2012-10-19	Available
Note to File - 24 Month -- Administration of Ages and Stages 3 Questionnaire.docx	Supplementary Document	Uploaded 2012-04-16	Available
Note to File - 18 Month -- Administration of Ages and Stages 3 Questionnaire.docx	Supplementary Document	Uploaded 2012-04-16	Available
Birth Visit VIS No Sample Collection 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available
Birth VIS With Samples 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available
Note to File - Birth Visit - Umbilical Cord Blood Collection.docx	Supplementary Document	Uploaded 2011-04-08	Available
Father Visit Information Sheet 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available
Pregnancy Visit 2 Visit Information Sheet.docx	Supplementary Document	Uploaded 2012-04-13	Available
Attach A10. PLSND Telephone Reminder Call Script.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A9. PLSND Mail Reminder Call Script.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A8. PLSND Telephone Medical Records and Death Cert Release.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A7. PLSND Telephone Medical Records Release Forms Letter.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A6. PLSND Follow-Up SAQ and Release Forms Letter.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A5. PLSND Item NR Rates.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A4. PLSND Death Certificate Release Form.docx	Supplementary Document	Uploaded 2012-10-19	Available
Attach A3. PLSND Medical Records Release Form.docx	Supplementary Document	Uploaded 2012-10-19	Available
Pregnancy Visit 1 Visit Information Sheet.docx	Supplementary Document	Uploaded 2012-04-13	Available
Vacuum Bag Participant Instructions 20110211.doc	Supplementary Document	Uploaded 2012-04-17	Available
Urine Collection Instructions 20110211.doc	Supplementary Document	Uploaded 2012-04-17	Available
Pre-Visit Instructions for Blood and Urine Collection 20110211.doc	Supplementary Document	Uploaded 2012-04-16	Available
Pre-Visit Information for Non Fasting Venous Blood Adult Urine Vacuum Collection 20110211.doc	Supplementary Document	Uploaded 2012-04-16	Available
Pre-visit Information for Fasting Blood Urine Vacuum Collection 20110211.doc	Supplementary Document	Uploaded 2012-04-16	Available
Note to File - Biological and Environmental Sample Collection (Prenatal).docx	Supplementary Document	Uploaded 2012-04-13	Available
VBD Sample Distribution Script 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available
TWQ Sample Distribution Script 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available
TWF Sample Distribution Script 20120413.docx	Supplementary Document	Uploaded 2012-04-13	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
202215	30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
202215	30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
202215	30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
202215	30-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
202214	Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
202213	Physical Measures - Child Blood Pressure (12-,24-Month) (PB, EH, TT-HI)	Form and Instruction	Modified	Survey
202212	Physical Measures - Child Anthropometry (6-,12-,24-Month) (PB, EH, TT-HI)	Form and Instruction	Modified	Survey
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	Form and Instruction	Modified	Survey
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	Form and Instruction	Modified	Survey
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	Form and Instruction	Modified	Survey
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	Form and Instruction	Modified	Survey
202211	Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	Form and Instruction	Modified	Survey
202210	Tracing Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
202209	Participant Verification (PB, EH, TT-HI, TT-HI, PBS)	Form and Instruction	Modified	Survey
202208	Nonrespondent Questionnaire (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
202207	Provider-Based Sampling Frame Questionnaire (PBS)	Form and Instruction	Modified	Survey
202207	Provider-Based Sampling Frame Questionnaire (PBS)	Form and Instruction	Modified	Survey
202207	Provider-Based Sampling Frame Questionnaire (PBS)	Form and Instruction	Modified	Survey
202207	Provider-Based Sampling Frame Questionnaire (PBS)	Form and Instruction	Modified	Survey
202206	Provider-Based Sampling Eligibility Screener (PBS)	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Attach B25. Participant Verification Birth Cohort
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Form and Instruction	Modified	Survey
193580	Formative - Developmental	Instruction	Modified
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193579	24-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey - Placeholder for copyrighted material
193578	18-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193577	12-Month Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey - Placeholder for Copyrighted Material
193577	12-Month Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193577	12-Month Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193576	9-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193575	6-Month Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193575	6-Month Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193574	3-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193572	Infant Feeding Log (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Log
193571	Low-Intensity Questionnaire (Birth focus) (TT-LI)	Form and Instruction	Modified	Survey
193570	Birth Visit Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193569	Father Interview (PB, EH, TT-HI)	Form and Instruction	Modified	Survey
193567	Pregnancy Health Care Log (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Log
193566	Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193566	Pregnancy Visit 2 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193565	Pregnancy Visit 1 Interview (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193563	Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS)	Form and Instruction	Modified	Survey
193562	Low-Intensity Questionnaire (Found Pregnant) (TT-LI)	Form and Instruction	Modified	Survey
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey
193560	Biological and Environmental Sample Collection (Prenatal) (PB, EH, TT-HI, PBS)	Form and Instruction	Modified	Survey

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
Retrieve Notice of Action (NOA)	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.

table that charts list comparision

	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

table that charts list of burden

IC Title	Form No.	Form Name
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 ,   Survey ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material ,   Survey - Placeholder for copyrighted material
3-Month Interview (PB, EH, TT-HI, TT-LI, PBS)	24.1	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
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
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
Biospecimen Sample Collection - Mother / Baby (PB, EH, TT-LI)	16.2, 16.1, 16.5, 16.3, 16.4	Survey ,   Survey ,   Survey ,   Survey ,   Survey
Birth Visit Interview (PB, EH, TT-HI, PBS)	13.1	Survey
Core Questionnaire (PB, EH, TT-HI, TT-LI, PBS)	25.1	Survey
Father Interview (PB, EH, TT-HI)	12.1	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	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Attach B25. Participant Verification Birth Cohort
Infant Feeding Log (PB, EH, TT-HI, PBS)	15.1	Log
Low-Intensity Questionnaire (Birth focus) (TT-LI)	14.1	Survey
Low-Intensity Questionnaire (Found Pregnant) (TT-LI)	7.1	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
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
Pregnancy Health Care Log (PB, EH, TT-HI, PBS)	11.1	Log
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
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
Tracing Interview (PB, EH, TT-HI, TT-LI, PBS)	6.1	Survey
Validation Interview - up to 30 months (PB, EH, TT-HI, TT-LI, PBS)	4.1	Survey

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ICR Summary of Burden

table that charts list 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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