Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)

Forms and Documents

Document Name	Status
Medical Record Abstraction - Child Form	Unchanged
Medical Record Abstraction - Adult Form	Unchanged
Child School Record Abstraction Form	Unchanged
Child Questionnaire - Short Form Form	Unchanged
Child Questionnaire - Long Form Form	Unchanged
Adult Questionnaire Form	Unchanged
Blood Draw and Urine Collection Form Form	Unchanged
Body and Blood Pressure Measures Form Form	Unchanged
Medication List Form	Unchanged
Update Contact Information Hardcopy Form Form	Unchanged
Appointment Reminder Telephone Script Form and Instruction	Unchanged
Wave Three Eligibility Screening Script Form and Instruction	Unchanged
Wave Two Eligibility Screening Script Form and Instruction	Unchanged
Wave One Elligibility Screening Script Form and Instruction	Unchanged
P_Att09b_InformedConsentPacket_20190823 clean.docx Supplementary Document	2019-09-05
Pease Study Protocol 20190823 clean.docx Supplementary Document	2019-09-05
1 - AppndxE IRB Apprvl Memos 20190903.pdf Supplementary Document	2019-09-05
0923-0061 Change Request Justification 20190903.docx Justification for No Material/Nonsubstantive Change	2019-09-05
0 - SSB Pease Study 20190813 clean.docx Supporting Statement B	2019-08-16
0 - SSA Pease Study 20190815.docx Supporting Statement A	2019-08-16
0 - Pease Study Protocol 20190813 clean.docx Supplementary Document	2019-08-15
P_Att24a_ATSDRPFASFactsheet.pdf Supplementary Document	2019-08-15
P_Att24_PFASResultsReport 20190813 clean.docx Supplementary Document	2019-08-15
P_Att23_ClinicalTestResultsReport_20180802.docx Supplementary Document	2019-08-15
P_Att22b_LetterRprtCriticalValue_20180802.docx Supplementary Document	2019-08-15
P_Att22a_AdvncClinicalTestReportTrackingForm_20180802.docx Supplementary Document	2019-08-15
P_Att22_AdvReportScriptClinicalTests_20180802.docx Supplementary Document	2019-08-15
P_Att21_BodyBloodPressMsReport_20180802.docx Supplementary Document	2019-08-15
P_Att14 PeaseManualofProcedures_rev110918x.docx Supplementary Document	2019-08-15
P_Att11_ApptTrackingForm_20180802.docx Supplementary Document	2019-08-15
P_Att09c_StudyFactSheet_20180802.docx Supplementary Document	2019-08-15
P_Att09b_InformedConsentPacket_20190813 clean.docx Supplementary Document	2019-08-15
P_Att09a_ApptReminderCard_20180802.docx Supplementary Document	2019-08-15
P_Att08_RecrTrackingForm_20180802.docx Supplementary Document	2019-08-15
P_Att07_WavesTwoThreeRecruitmentMaterials_20180802.docx Supplementary Document	2019-08-15
P_Att06_WaveOne_NHDHHSInvitationLttrsStudyRollout_20181218 clean.docx Supplementary Document	2019-08-15
P_Att05_PeaseStudyCommnctnPlan_20190813 clean.docx Supplementary Document	2019-08-15
P_Att04_JustificationSampleSizeCalcs 20180802.docx Supplementary Document	2019-08-15
P_Att03_BiochemAnalPlanChildrenAdults 20181109_clean.docx Supplementary Document	2019-08-15
P_Att02_PFASLevelsPease_vs_ExtrnlPopn 20180802.docx Supplementary Document	2019-08-15
P_Att01_InvestigatorsKeyPersonnel updated 20180802.docx Supplementary Document	2019-08-15
AppndxF_Data Sharing and Disclosure Review 20190813.docx Supplementary Document	2019-08-15
AppndxE IRB Approval Memo 20180912.pdf Supplementary Document	2019-08-15
AppndxD PrivacyImpactAssessment 20181210.pdf Supplementary Document	2019-08-15
AppndxC_Pease_Feasibility_Assessment_November-2017_508.pdf Supplementary Document	2019-08-15
AppndxB1 ATSDR-2018-0008 SmmryCmntsRspnses 20190813.pdf Supplementary Document	2019-08-15
AppndxB Pease 60-day FRN.pdf Supplementary Document	2018-12-20
AppndxA Pease_Study_ Authorizing Legislation 20180802.pdf Supplementary Document	2018-12-20

IC Document Collections

IC ID	Document Title	Status
237378	Request for Medical Record Abstraction Instruction	Unchanged
237377	Request for Child School Record Abstraction Instruction	Unchanged
234702	Medical Record Abstraction - Child Form	Unchanged
234701	Medical Record Abstraction - Adult Form	Unchanged
234700	Child School Record Abstraction Form	Unchanged
234699	Child Neurobehavioral Test Battery Instruction	Unchanged
234698	Parent Neurobehavioral Test Battery Instruction	Unchanged
234697	Child Questionnaire - Short Form Form	Unchanged
234696	Child Questionnaire - Long Form Form	Unchanged
234695	Adult Questionnaire Form	Unchanged
234694	Blood Draw and Urine Collection Form Form	Unchanged
234693	Body and Blood Pressure Measures Form Form	Unchanged
234692	Medication List Form	Unchanged
234691	Update Contact Information Hardcopy Form Form	Unchanged
234690	Appointment Reminder Telephone Script Form and Instruction	Unchanged
234689	Wave Three Eligibility Screening Script Form and Instruction	Unchanged
234688	Wave Two Eligibility Screening Script Form and Instruction	Unchanged
234687	Wave One Elligibility Screening Script Form and Instruction	Unchanged

ICR Details

OMB Control No: 0923-0061	ICR Reference No: 201909-0923-001
Status: Historical Active	Previous ICR Reference No: 201908-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0061
Title: Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study)
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 without change	Conclusion Date: 09/10/2019
	Date Received in OIRA: 09/05/2019
Terms of Clearance: Previous terms continue: Consistent with the Supporting Statement, the statistical power and sampling frame of this proof of concept study limits ATSDR’s ability to detect moderate differences (between exposed and nonexposed individuals) in many of health conditions queried in this collection. Approval for the collection of information about conditions for which there is not adequate statistical power is provided specifically for the purposes of evaluating the study procedures, methods, and hypotheses for a future multi-site study. Approval is provided contingent upon a commitment to investigate other contributing environmental factors when associations or trends are observed between PFAS exposure and health conditions. Approval is also provided contingent upon a commitment to work with the National Center for Health Statistics on disclosure review procedures and include a member of NCHS’s disclosure review board for NHANES on the PEAS disclosure review board.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	08/31/2022	08/31/2022
Responses	5,852	0	5,852
Time Burden (Hours)	1,454	0	1,454
Cost Burden (Dollars)	42,227	0	42,227

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Abstract: The Pease Study will serve as a proof-of-concept model for a multi-site study of PFAS health effects. The existence of a large body of state and local environmental monitoring and population blood testing data makes the Pease community in Portsmouth, NH particularly suitable as ATSDR’s initial PFAS research study site. The main goals of the research study are to: 1) evaluate the study procedures and methods to identify any changes to the design or protocol that need to be made before embarking on a multi-site study; and 2) examine associations between a limited number of health outcomes for which statistical power is adequate and measured and historically reconstructed serum levels of PFAS (e.g., lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults). Request for change to retain leftover blood with participant consent.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: PHSA
   PL: Pub.L. 115 - 141 8006 Name of Law: Consolidated Appropriations Act
   US Code: 42 USC 9604 Name of Law: CERCLA
  

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:
	83 FR 43685	08/27/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 3449	02/12/2019
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
Child Neurobehavioral Test Battery
Child School Record Abstraction	none	Child School Record Abstraction
Medical Record Abstraction - Child	none	Medical Record Abstraction - Child
Appointment Reminder Telephone Script	none	Appointment Reminder Telephone Script
Update Contact Information Hardcopy Form	none	Update Contact Hardcopy Form
Medication List	none	Medication List
Body and Blood Pressure Measures Form	none	Body and Blood Pressure Measures
Wave One Elligibility Screening Script	none	Wave One Eligibility Screening Script
Wave Two Eligibility Screening Script	none	Wave Two Eligibility Script
Wave Three Eligibility Screening Script	none	Wave Three Eligibility Script
Blood Draw and Urine Collection Form	none	Blood Draw and Urine Collection
Adult Questionnaire	none	Adult Questionnaire
Child Questionnaire - Long Form	none	Child Questionnaire - Long Form
Child Questionnaire - Short Form	none	Child Questionnaire - Short Form
Parent Neurobehavioral Test Battery
Medical Record Abstraction - Adult	none	Medical Record Abstraction -Adult
Request for Child School Record Abstraction
Request for Medical Record Abstraction

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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	5,852	5,852	0	0	0	0
Annual Time Burden (Hours)	1,454	1,454	0	0	0	0
Annual Cost Burden (Dollars)	42,227	42,227	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: This is a resubmission of a new ICR.

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Annual Cost to Federal Government: $1,912,122

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: 09/05/2019

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