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	Type	Status	Availability
Medical Record Abstraction - Child	Form	New	Repair queued
Medical Record Abstraction - Adult	Form	New	Repair queued
Child School Record Abstraction	Form	New	Repair queued
Child Questionnaire - Short Form	Form	New	Available
Child Questionnaire - Long Form	Form	New	Repair queued
Adult Questionnaire	Form	New	Available
Blood Draw and Urine Collection Form	Form and Instruction	New	Repair queued
Body and Blood Pressure Measures Form	Form	New	Repair queued
Medication List	Form and Instruction	New	Repair queued
Update Contact Information Hardcopy Form	Form and Instruction	New	Available
Appointment Reminder Telephone Script	Form and Instruction	New	Repair queued
Wave Three Eligibility Screening Script	Form and Instruction	New	Available
Wave Two Eligibility Screening Script	Form and Instruction	New	Available
Wave One Elligibility Screening Script	Form and Instruction	New	Repair queued
SSA Pease Study 20181217 clean.docx	Supporting Statement A	Uploaded 2019-01-10	Available
P_Att06_WaveOne_NHDHHSInvitationLttrsStudyRollout_20181218 clean.docx	Supplementary Document	Uploaded 2018-12-20	Available
Pease Study Protocol 20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att24a_ATSDRPFASFactsheet.pdf	Supplementary Document	Uploaded 2018-12-20	Available
P_Att24_PFASChemReport_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att23_ClinicalTestResultsReport_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att22b_LetterRprtCriticalValue_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att22a_AdvncClinicalTestReportTrackingForm_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att22_AdvReportScriptClinicalTests_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att21_BodyBloodPressMsReport_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att20a_NBT - TimeEstAgeinYears 20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att19_LetterProviderRecAbstrctn_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att14 PeaseManualofProcedures_rev110918x.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att11_ApptTrackingForm_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att09c_StudyFactSheet_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att09b_InformedConsentPacket_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att09a_ApptReminderCard_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att08_RecrTrackingForm_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att07_WavesTwoThreeRecruitmentMaterials_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att05_PeaseStudyCommnctnPlan_20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att04_JustificationSampleSizeCalcs 20190802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att03_BiochemAnalPlanChildrenAdults 20181109_clean.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
P_Att02_PFASLevelsPease_vs_ExtrnlPopn 20180802.docx	Supplementary Document	Uploaded 2018-12-20	Available
P_Att01_InvestigatorsKeyPersonnel updated 20180802.docx	Supplementary Document	Uploaded 2018-12-20	Repair queued
AppndxE IRB Approval Memo.pdf	Supplementary Document	Uploaded 2018-12-20	Available
AppndxC_Pease_Feasibility_Assessment_November-2017_508.pdf	Supplementary Document	Uploaded 2018-12-20	Available
AppndxD PrivacyImpactAssessment - Pease POC.pdf	Supplementary Document	Uploaded 2018-12-20	Available
AppndxB1 ATSDR-2018-0008 SmmryPblcCmmntsAgncyRspnses_20181212.pdf	Supplementary Document	Uploaded 2018-12-20	Available
AppndxB Pease 60-day FRN.pdf	Supplementary Document	Uploaded 2018-12-20	Available
AppndxA Pease_Study_ Authorizing Legislation 20180802.pdf	Supplementary Document	Uploaded 2018-12-20	Available
SSB Pease Study 20181211.docx	Supporting Statement B	Uploaded 2018-12-20	Available

IC Document Collections

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

ICR Details

OMB Control No: 0923-0061	ICR Reference No: 201812-0923-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-18AUZ
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 08/14/2019
	Date Received in OIRA: 02/13/2019
Terms of Clearance:

	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 study goals are to: 1) evaluate the study procedures and methods to identify issues that need to be addressed. ATSDR will examine the association between PFAS compounds and 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. ATSDR will investigate if PFAS is related to differences in sex hormones and sexual maturation, vaccine response, and neurobehavioral outcomes in children. In adults, additional outcomes of interest include cardiovascular disease, osteoarthritis, osteoporosis, endometriosis, and autoimmune disease.

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

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: 16

IC Title	Form No.	Form Name
Wave One Elligibility Screening Script	none	Wave 1 Eligibility Screening Script
Wave Two Eligibility Screening Script	none	Wave Two Eligibility Screening Script
Wave Three Eligibility Screening Script	none	Wave Three Eligibility Screening Script
Appointment Reminder Telephone Script	none	Appointment Reminder Script
Body and Blood Pressure Measures Form	none	Body and Blood Pressure Measures
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
Child Neurobehavioral Test Battery
Child School Record Abstraction	none	Child School Record Abstraction
Medical Record Abstraction - Child	none	Medical Record Abstraction - Child
Medical Record Abstraction - Adult	none	Medical Record Abstraction - Adult
Update Contact Information Hardcopy Form	none	Update Contact Information Form
Medication List	none	Medication List

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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 ICR.

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Annual Cost to Federal Government: $1,629,467

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: 02/13/2019

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