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
Multi-site Study Child School Record Abstraction Form	Form and Instruction	New	Available
Multi-site Study Medical Record Abstraction Form - Child	Form and Instruction	New	Available
Multi-site Study Medical Record Abstraction Form - Adult	Form and Instruction	New	Available
Child/Parent Neurobehavioral Test Battery	Form and Instruction	New	Available
Child/Parent Neurobehavioral Test Battery	Form and Instruction	New	Available
Multi-site Study Child Questionnaire – Short Form	Form and Instruction	New	Available
Multi-site Study Child Questionnaire – Long Form	Form and Instruction	New	Available
Multi-site Study Adult Questionnaire	Form and Instruction	New	Available
Blood Draw and Urine Collection Form	Form and Instruction	New	Available
Body and Blood Pressure Measures Form	Form and Instruction	New	Available
Medication List	Form and Instruction	New	Available
Update Contact Information Hardcopy Form	Form and Instruction	New	Available
Appointment Reminder Telephone Script	Form and Instruction	New	Available
Eligibility Screening Script	Form and Instruction	New	Available
Multi-site study protocol_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att22_PFASResultsReport_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att21_ClinicalTestResultsReport_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att20b_LetterRprtCriticalValue_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att20a_AdvncClinicalTestReportTrackingForm_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att20_AdvReportScriptClinicalTests_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
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_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att09_ApptTrackingForm_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att07c_StudyFactSheet_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att07b_InformedConsentPacket_Template_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att07a_ApptReminderCard_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att06_RecrTrackingForm_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att05_Multi-siteStudyRecrtmMaterials_20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
M_Att03_JustificationSampleSizeCalcs 20191212.docx	Supplementary Document	Uploaded 2019-12-20	Available
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
1 - SSB Multi Site Study 20191213.docx	Supporting Statement B	Uploaded 2019-12-20	Available
1 - SSA Multi Site Study 20191213 v2.docx	Supporting Statement A	Uploaded 2019-12-20	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
239069	Child School Record Abstraction	Form and Instruction	New	Multi-site Study Child School Record Abstraction Form
239068	Request for Child School Record Abstraction	Other-Letter of Request to School Administrator with Study Infor	New
239067	Medical Record Abstraction - Child	Form and Instruction	New	Multi-site Study Medical Record Abstraction Form - Child
239066	Medical Record Abstraction - Adult	Form and Instruction	New	Multi-site Study Medical Record Abstraction Form - Adult
239065	Request for Medical Record Abstraction	Other-Letter of Request to Provider with Study Information	New
239061	Child Neurobehavioral Test Battery	Form and Instruction	New	Child/Parent Neurobehavioral Test Battery
239060	Parent Neurobehavioral Test Battery	Form and Instruction	New	Child/Parent Neurobehavioral Test Battery
239059	Child Questionnaire - Short Form	Form and Instruction	New	Multi-site Study Child Questionnaire – Short Form
239058	Child Questionnaire - Long Form	Form and Instruction	New	Multi-site Study Child Questionnaire – Long Form
239057	Adult Questionnaire	Form and Instruction	New	Multi-site Study Adult Questionnaire
239056	Blood Draw and Urine Collection	Form and Instruction	New	Blood Draw and Urine Collection Form
239053	Body and Blood Pressure Measures	Form and Instruction	New	Body and Blood Pressure Measures Form
239052	Medication List	Form and Instruction	New	Medication List
239051	Update Contact Information	Form and Instruction	New	Update Contact Information Hardcopy Form
239050	Appointment Reminder	Form and Instruction	New	Appointment Reminder Telephone Script
239035	Eligibility Screening	Form and Instruction	New	Eligibility Screening Script

ICR Details

OMB Control No: 0923-0063	ICR Reference No: 201908-0923-002
Status: Historical Inactive	Previous ICR Reference No:
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: Withdrawn	Conclusion Date: 01/03/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/23/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	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: 16

table that charts list of burden

IC Title	Form No.	Form Name
Adult Questionnaire	n/a	Multi-site Study Adult Questionnaire
Appointment Reminder	n/a	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	n/a	Multi-site Study 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
Eligibility Screening	n/a	Eligibility Screening Script
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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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? 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: 12/23/2019

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