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

Forms and Documents

Document Name	Status
Drinking Water Information Collection (Environmental Protection Agencies) Form and Instruction	New
Drinking Water Information Collection (Public Water Purveyors) Form and Instruction	New
Child School Record Abstraction Form and Instruction	Unchanged
Medical Record Abstraction - Child Form and Instruction	Unchanged
Medical Record Abstraction - Adult Form and Instruction	Unchanged
Child Neurobehavioral Test Battery Form and Instruction	Unchanged
Parent Neurobehavioral Test Battery Form and Instruction	Unchanged
Child Questionnaire - Short Form Form and Instruction	Modified
Blood Draw and Urine Collection Form and Instruction	Unchanged
Body and Blood Pressure Measures Form and Instruction	Unchanged
Medication List Form and Instruction	Unchanged
Update Contact Information Form and Instruction	Unchanged
Appointment Reminder Form and Instruction	Unchanged
Eligibility Screening Form and Instruction	Unchanged
M_Att22a ATSDR PFAS Factsheet.docx Supplementary Document	2020-05-28
1 - SSB Multi Site Study _REVISED042420_CLEAN.docx Supporting Statement B	2020-05-28
1 - SSA Multi Site Study_REVISED042420_CLEAN.docx Supporting Statement A	2020-05-28
Multi-site study protocol_REV042420_Clean.docx Supplementary Document	2020-05-28
M_Att22_PFASResultsReport_20191212.docx Supplementary Document	2019-12-20
M_Att21_ClinicalTestResultsReport_20191212.docx Supplementary Document	2019-12-20
M_Att20b_LetterRprtCriticalValue_20191212.docx Supplementary Document	2019-12-20
M_Att20a_AdvncClinicalTestReportTrackingForm_20191212.docx Supplementary Document	2019-12-20
M_Att20_AdvReportScriptClinicalTests_20191212.docx Supplementary Document	2019-12-20
M_Att19_BodyBloodPressMsReport_20191212.docx Supplementary Document	2019-12-20
M_Att18a_NBT - TimeEstAgeinYears_20191212.docx Supplementary Document	2019-12-20
M_Att12_ManualofProcedures_Clean.docx Supplementary Document	2020-05-28
M_Att09_ApptTrackingForm_20191212.docx Supplementary Document	2019-12-20
M_Att07c_StudyFactSheet_20191212_passback_CLEAN.docx Supplementary Document	2020-05-28
M_Att07b_InformedConsentPacket_Template_20191212.docx Supplementary Document	2019-12-20
M_Att07a_ApptReminderCard_20191212.docx Supplementary Document	2019-12-20
M_Att06_RecrTrackingForm_20191212.docx Supplementary Document	2019-12-20
M_Att05_Multi-siteStudyRecrtmMaterials_20191212.docx Supplementary Document	2019-12-20
M_Att03_JustificationSampleSizeCalcs 20191212.docx Supplementary Document	2019-12-20
M_Att02_BiochemAnalPlanChildrenAdults 20191212.docx Supplementary Document	2019-12-20
M_Att01_InvestigatorsKeyPersonnel_20191212.docx Supplementary Document	2019-12-20
1 - AppndxG_Data Sharing_19ACF_20190725.docx Supplementary Document	2019-12-20
1 - AppndxF IRB Apprvl Mmo 20191211.pdf Supplementary Document	2019-12-20
1 - AppndxE Priv Imp Assmt 20190729.pdf Supplementary Document	2019-12-20
1 - AppndxD Pease_Feasibility_Nov-2017_508.pdf Supplementary Document	2019-12-20
1 - AppndxC NOFO No. CDC-RFA-TS-19-002 rev 20190531.pdf Supplementary Document	2019-12-20
1 - AppndxB 60-day FRN 20190423.pdf Supplementary Document	2019-12-20
1 - AppndxA_Authorizing Legislation.pdf Supplementary Document	2019-12-20

IC Document Collections

IC ID	Document Title	Status
242013	Drinking Water Information Collection (Environmental Protection Agencies) Form and Instruction	New
242012	Drinking Water Information Collection (Public Water Purveyors) Form and Instruction	New
239069	Child School Record Abstraction Form and Instruction	Unchanged
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	Unchanged
239066	Medical Record Abstraction - Adult Form and Instruction	Unchanged
239065	Request for Medical Record Abstraction Other-Letter of Request to Provider with Study Information	Unchanged
239061	Child Neurobehavioral Test Battery Form and Instruction	Unchanged
239060	Parent Neurobehavioral Test Battery Form and Instruction	Unchanged
239059	Child Questionnaire - Short Form Form and Instruction	Modified
239058	Child Questionnaire - Long Form	Modified
239057	Adult Questionnaire	Modified
239056	Blood Draw and Urine Collection Form and Instruction	Unchanged
239053	Body and Blood Pressure Measures Form and Instruction	Unchanged
239052	Medication List Form and Instruction	Unchanged
239051	Update Contact Information Form and Instruction	Unchanged
239050	Appointment Reminder Form and Instruction	Unchanged
239035	Eligibility Screening Form and Instruction	Unchanged

ICR Details

OMB Control No: 0923-0063	ICR Reference No: 202001-0923-002
Status: Historical Active	Previous ICR Reference No: 201908-0923-002
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-19ACF
Title: Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-site Cross-sectional Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/28/2020
	Date Received in OIRA: 01/07/2020
Terms of Clearance: We appreciate ATSDR’s agreement to collect whole blood samples in pre-screened vials suitable for trace and heavy metals analyses, and to upload revisions to the package reflecting this agreement through a non-substantive change request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved
Responses	35,121	0	0
Time Burden (Hours)	8,149	0	0
Cost Burden (Dollars)	233,544	0	0

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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.

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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:
	84 FR 16857	04/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 70544	12/23/2019
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Eligibility Screening	n/a	Eligibility Screening Script
Blood Draw and Urine Collection	n/a	Blood Draw and Urine Collection 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
Appointment Reminder	n/a	Appointment Reminder Telephone Script
Update Contact Information	n/a	Update Contact Information Hardcopy Form
Body and Blood Pressure Measures	n/a	Body and Blood Pressure Measures Form
Adult Questionnaire	n/a
Parent Neurobehavioral Test Battery	n/a	Child/Parent Neurobehavioral Test Battery
Drinking Water Information Collection (Environmental Protection Agencies)	n/a	Water Information Collection Form for Environmental Protection Agencies
Child Neurobehavioral Test Battery	n/a	Child/Parent Neurobehavioral Test Battery
Request for Medical Record Abstraction
Medical Record Abstraction - Child	n/a	Multi-site Study Medical Record Abstraction Form - Child
Medication List	n/a	Medication List
Child Questionnaire - Long Form	n/a
Medical Record Abstraction - Adult	n/a	Multi-site Study Medical Record Abstraction Form - Adult
Request for Child School Record Abstraction
Drinking Water Information Collection (Public Water Purveyors)	n/a	Drinking Water Information Collection Form for Public Water Purveyors

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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	35,121	0	0	35,121	0	0
Annual Time Burden (Hours)	8,149	0	0	8,149	0	0
Annual Cost Burden (Dollars)	233,544	0	0	233,544	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $7,379,582

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: 01/07/2020

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