[ATSDR] Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-site Cross-sectional Study

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Water Information Collection Form for Environmental Protection Agencies	Form and Instruction	Unchanged	Available
Drinking Water Information Collection (Environmental Protection Agencies)	Form and Instruction	Unchanged	Repair queued
Drinking Water Information Collection Form for Public Water Purveyors	Form and Instruction	Unchanged	Available
Drinking Water Information Collection (Public Water Purveyors)	Form and Instruction	Unchanged	Repair queued
Multi-site Study Child School Record Abstraction Form	Form and Instruction	Modified	Available
Child School Record Abstraction	Form and Instruction	Modified	Repair queued
Multi-site Study Medical Record Abstraction Form - Child	Form and Instruction	Modified	Available
Medical Record Abstraction - Child	Form and Instruction	Modified	Repair queued
Multi-site Study Medical Record Abstraction Form - Adult	Form and Instruction	Modified	Repair queued
Medical Record Abstraction - Adult	Form and Instruction	Modified	Repair queued
Child/Parent Neurobehavioral Test Battery	Form and Instruction	Modified	Available
Child Neurobehavioral Test Battery	Form and Instruction	Modified	Repair queued
Child/Parent Neurobehavioral Test Battery	Form and Instruction	Modified	Available
Parent Neurobehavioral Test Battery	Form and Instruction	Modified	Repair queued
Multi-site Study Child Questionnaire - Short Form	Form and Instruction	Modified	Available
Child Questionnaire - Short Form	Form and Instruction	Modified	Repair queued
Child questionnaire - long form	Form and Instruction	Modified	Available
Child Questionnaire - Long Form	Form and Instruction	Modified	Repair queued
Adult questionnaire	Form and Instruction	Modified	Available
Adult Questionnaire	Form and Instruction	Modified	Repair queued
Blood Draw and Urine Collection Form	Form and Instruction	Modified	Available
Blood Draw and Urine Collection	Form and Instruction	Modified	Repair queued
Body and Blood Pressure Measures Form	Form and Instruction	Modified	Available
Body and Blood Pressure Measures	Form and Instruction	Modified	Repair queued
Medication List	Form and Instruction	Modified	Available
Medication List	Form and Instruction	Modified	Repair queued
Update Contact Information Hardcopy Form	Form and Instruction	Modified	Available
Update Contact Information	Form and Instruction	Modified	Repair queued
Appointment reminder telephone script	Form and Instruction	Modified	Available
Appointment Reminder	Form and Instruction	Modified	Repair queued
Eligibility screener	Form and Instruction	Modified	Available
Eligibility Screening	Form and Instruction	Modified	Repair queued
0 - MSS protocol_Clean 2021-11-16.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att12_MnlPrcdres_2020-08-31.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att09_ApptTrckng_20201110.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att07b_InfrmdCnsnts_2021-05-18.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att07a_ApptCard_202011010.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att22a ATSDR PFAS Factsheet.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
1 - SSB MSS 2023.docx	Supporting Statement B	Uploaded 2023-05-11	Repair queued
1 - SSA MSS 20230426_final.docx	Supporting Statement A	Uploaded 2023-05-15	Repair queued
M_Att22_PFASChemReport_20211116.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att21_ClinicalTestResultsReport_20211116.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att20b_LetterRprtCriticalValue_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att20a_AdvncClinicalTestReportTrackingForm_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att20_AdvReportScriptClinicalTests_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att19_BodyBloodPressMsReport_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att18a_NBT - TimeEstAgeinYears_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att07c_StudyFactSheet_20191212_passback_CLEAN.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att06_RecrTrackingForm_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att05_Multi-siteStudyRecrtmMaterials_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att03_JustificationSampleSizeCalcs 20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att02_BiochemAnalPlanChildrenAdults 20211116.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
M_Att01_InvestigatorsKeyPersonnel_20191212.docx	Supplementary Document	Uploaded 2023-05-12	Repair queued
1 - AppndxG Data Sharing and Disclosure Review (Multi-site Study) 20190725.docx	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxF IRB Approval Memo.docx	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxE Privacy Impact Assessment 20230425signed.pdf	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxD Pease_Feasibility_Assessment_November-2017_508.pdf	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxC NOFO No. CDC-RFA-TS-19-002 rev 20190531.pdf	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxB 60D FRN.pdf	Supplementary Document	Uploaded 2023-05-11	Repair queued
1 - AppndxA Authorizing Legislation Multi-site Study.docx	Supplementary Document	Uploaded 2023-05-11	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
242013	Drinking Water Information Collection (Environmental Protection Agencies)	Form and Instruction	Unchanged	Water Information Collection Form for Environmental Protection Agencies
242013	Drinking Water Information Collection (Environmental Protection Agencies)	Form and Instruction	Unchanged
242012	Drinking Water Information Collection (Public Water Purveyors)	Form and Instruction	Unchanged	Drinking Water Information Collection Form for Public Water Purveyors
242012	Drinking Water Information Collection (Public Water Purveyors)	Form and Instruction	Unchanged
239069	Child School Record Abstraction	Form and Instruction	Modified	Multi-site Study Child School Record Abstraction Form
239069	Child School Record Abstraction	Form and Instruction	Modified
239068	Request for Child School Record Abstraction	Other-Letter of Request to School Administrator with Study Infor	Modified
239067	Medical Record Abstraction - Child	Form and Instruction	Modified	Multi-site Study Medical Record Abstraction Form - Child
239067	Medical Record Abstraction - Child	Form and Instruction	Modified
239066	Medical Record Abstraction - Adult	Form and Instruction	Modified	Multi-site Study Medical Record Abstraction Form - Adult
239066	Medical Record Abstraction - Adult	Form and Instruction	Modified
239065	Request for Medical Record Abstraction	Other-Letter of Request to Provider with Study Information	Modified
239061	Child Neurobehavioral Test Battery	Form and Instruction	Modified	Child/Parent Neurobehavioral Test Battery
239061	Child Neurobehavioral Test Battery	Form and Instruction	Modified
239060	Parent Neurobehavioral Test Battery	Form and Instruction	Modified	Child/Parent Neurobehavioral Test Battery
239060	Parent Neurobehavioral Test Battery	Form and Instruction	Modified
239059	Child Questionnaire - Short Form	Form and Instruction	Modified	Multi-site Study Child Questionnaire - Short Form
239059	Child Questionnaire - Short Form	Form and Instruction	Modified
239058	Child Questionnaire - Long Form	Form and Instruction	Modified	Child questionnaire - long form
239058	Child Questionnaire - Long Form	Form and Instruction	Modified
239057	Adult Questionnaire	Form and Instruction	Modified	Adult questionnaire
239057	Adult Questionnaire	Form and Instruction	Modified
239056	Blood Draw and Urine Collection	Form and Instruction	Modified	Blood Draw and Urine Collection Form
239056	Blood Draw and Urine Collection	Form and Instruction	Modified
239053	Body and Blood Pressure Measures	Form and Instruction	Modified	Body and Blood Pressure Measures Form
239053	Body and Blood Pressure Measures	Form and Instruction	Modified
239052	Medication List	Form and Instruction	Modified	Medication List
239052	Medication List	Form and Instruction	Modified
239051	Update Contact Information	Form and Instruction	Modified	Update Contact Information Hardcopy Form
239051	Update Contact Information	Form and Instruction	Modified
239050	Appointment Reminder	Form and Instruction	Modified	Appointment reminder telephone script
239050	Appointment Reminder	Form and Instruction	Modified
239035	Eligibility Screening	Form and Instruction	Modified	Eligibility screener
239035	Eligibility Screening	Form and Instruction	Modified

ICR Details

OMB Control No: 0923-0063	ICR Reference No: 202305-0923-001
Status: Historical Active	Previous ICR Reference No: 202010-0923-002
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0063
Title: [ATSDR] Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-site Cross-sectional Study
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: 07/06/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/16/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2026	36 Months From Approved	07/31/2023
Responses	35,121	0	35,121
Time Burden (Hours)	8,149	0	8,149
Cost Burden (Dollars)	233,544	0	233,544

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Abstract: The main goal of this cross-sectional multi-site PFAS study is to evaluate associations between measured and reconstructed historic serum levels of PFAS including PFOA, PFOS, and PFHxS, and selected health outcomes. ATSDR seeks to enroll at least 8,000 participants (6,000 adults and 2,000 children) from communities exposed to PFAS-contaminated drinking water over the first three years of the five-year cooperative agreement program. This revision request includes minor changes to the study protocol and reports.

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Authorizing Statute(s): PL: Pub.L. 115 - 32 315(a) Name of Law: John S. McCain National Defense Authorization Act for FY 2019
   PL: Pub.L. 115 - 91 316(a) Name of Law: 2018 National Defense Authorization Act
  

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
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 1584	01/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 30747	05/12/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

table that charts list of burden

IC Title	Form No.	Form Name
Adult Questionnaire	none	Adult questionnaire
Appointment Reminder	none	Appointment reminder telephone script
Blood Draw and Urine Collection	n/a	Blood Draw and Urine Collection Form
Body and Blood Pressure Measures	n/a	Body and Blood Pressure Measures Form
Child Neurobehavioral Test Battery	n/a	Child/Parent Neurobehavioral Test Battery
Child Questionnaire - Long Form	none	Child questionnaire - long form
Child Questionnaire - Short Form	n/a	Multi-site Study Child Questionnaire - Short Form
Child School Record Abstraction	n/a	Multi-site Study Child School Record Abstraction Form
Drinking Water Information Collection (Environmental Protection Agencies)	n/a	Water Information Collection Form for Environmental Protection Agencies
Drinking Water Information Collection (Public Water Purveyors)	n/a	Drinking Water Information Collection Form for Public Water Purveyors
Eligibility Screening	none	Eligibility screener
Medical Record Abstraction - Adult	n/a	Multi-site Study Medical Record Abstraction Form - Adult
Medical Record Abstraction - Child	n/a	Multi-site Study Medical Record Abstraction Form - Child
Medication List	n/a	Medication List
Parent Neurobehavioral Test Battery	n/a	Child/Parent Neurobehavioral Test Battery
Request for Child School Record Abstraction
Request for Medical Record Abstraction
Update Contact Information	n/a	Update Contact Information Hardcopy Form

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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	35,121	35,121	0	0	0	0
Annual Time Burden (Hours)	8,149	8,149	0	0	0	0
Annual Cost Burden (Dollars)	233,544	233,544	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: $15,285,872

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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? No

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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: 05/16/2023

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