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

Forms and Documents

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

IC Document Collections

IC ID	Collection	Type	Status	Form
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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