OMB control number

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

OMB 0923-0061 · HHS/TSDR.

OMB 0923-0061

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. This change request reflects modifications to the currently approved information collection request (ICR) and incorporates the need to practice social distancing to the extent possible, such as changing from in-person contact to virtual meetings and telephone interviews. Where necessary, ATSDR has modified its scripts and forms to let the public know of the COVID-19 precautions that the agency is implementing.

The latest form for Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study) expires 2022-08-31 and is listed under ICR 202008-0923-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Medical Record Abstraction - ChildForm
Medical Record Abstraction - AdultForm
Child School Record AbstractionForm
Child Questionnaire - Short FormForm
Child Questionnaire - Long FormForm
Adult QuestionnaireForm
Blood Draw and Urine Collection FormForm
Body and Blood Pressure Measures FormForm
Medication ListForm
Update Contact Information Hardcopy FormForm
Form 0923-0061 Appointment Reminder Telephone ScriptForm and Instruction
Form 0923-0061 Wave Three Eligibility Screening ScriptForm and Instruction
Form 0923-0061 Wave Two Eligibility Screening ScriptForm and Instruction
Form 0923-0061 Wave One Elligibility Screening ScriptForm and Instruction
0923-0061 Change Request 3 Justification 20210928.docx Justification for No Material/Nonsubstantive Change
20200807 Pease 0923-0061 Chng Reqst Justfctn X-Walk Table.docx Justification for No Material/Nonsubstantive Change
AppndxE IRB Approval Memo 20210907.docx Supplementary Document
0923-0061 Change Request Justification 20190903.docx Justification for No Material/Nonsubstantive Change
0 - SSB Pease Study 20190813 clean.docxSupporting Statement B
0 - SSA Pease Study 20190815.docxSupporting Statement A
Pease Study Protocol_20201222 clean 20210826.docx Supplementary Document
P_Att24a_ATSDRPFASFactsheet.pdf Supplementary Document
P_Att24_PFASChemReport_20190711_clean 20210826.docx Supplementary Document
P_Att23_ClinicalTestResultsReport_20180802.docx Supplementary Document
P_Att22b_LetterRprtCriticalValue_20180802.docx Supplementary Document
P_Att22a_AdvncClinicalTestReportTrackingForm_20180802.docx Supplementary Document
P_Att22_AdvReportScriptClinicalTests_20180802.docx Supplementary Document
P_Att21_BodyBloodPressMsReport_20180802.docx Supplementary Document
P_Att14 PeaseManualofProcedures_08032020_clean.docx Supplementary Document
P_Att11_ApptTrackingForm_20200729_clean.docx Supplementary Document
P_Att09c_StudyFactSheet_20200729_clean.docx Supplementary Document
P_Att09b_InformedConsentPacket_20200729_clean.docx Supplementary Document
P_Att09a_ApptReminderCard_20200729_clean.docx Supplementary Document
P_Att08_RecrTrackingForm_20180802.docx Supplementary Document
P_Att07_WavesTwoThreeRecruitmentMaterials_20180802.docx Supplementary Document
P_Att06_WaveOne_NHDHHSInvitationLttrsStudyRollout_20200729_clean.docx Supplementary Document
P_Att05_PeaseStudyCommnctnPlan_20190813 clean.docx Supplementary Document
P_Att04_JustificationSampleSizeCalcs 20180802.docx Supplementary Document
P_Att03_BiochemAnalPlanChildrenAdults 20180802 clean 20210826.docx Supplementary Document
P_Att02_PFASLevelsPease_vs_ExtrnlPopn 20180802.docx Supplementary Document
P_Att01_InvestigatorsKeyPersonnel updated 20180802.docx Supplementary Document
AppndxF_Data Sharing and Disclosure Review 20190813.docx Supplementary Document
AppndxD PrivacyImpactAssessment 20181210.pdf Supplementary Document
AppndxC_Pease_Feasibility_Assessment_November-2017_508.pdf Supplementary Document
AppndxB1 ATSDR-2018-0008 SmmryCmntsRspnses 20190813.pdf Supplementary Document
AppndxB Pease 60-day FRN.pdf Supplementary Document
AppndxA Pease_Study_ Authorizing Legislation 20180802.pdf Supplementary Document
Request for Medical Record Abstraction Instruction
Request for Child School Record Abstraction Instruction
Medical Record Abstraction - Child Form
Medical Record Abstraction - Adult Form
Child School Record Abstraction Form
Child Neurobehavioral Test Battery Instruction
Parent Neurobehavioral Test Battery Instruction
Child Questionnaire - Short Form Form
Child Questionnaire - Long Form Form
Adult Questionnaire Form
Blood Draw and Urine Collection Form Form
Body and Blood Pressure Measures Form Form
Medication List Form
Update Contact Information Hardcopy Form Form
Appointment Reminder Telephone Script Form and Instruction
Wave Three Eligibility Screening Script Form and Instruction
Wave Two Eligibility Screening Script Form and Instruction
Wave One Elligibility Screening Script Form and Instruction

All Historical Document Collections

OMB Details

Wave One Elligibility Screening Script

Federal Enterprise Architecture: Health - Public Health Monitoring

Information collection instruments
FormNameElectronic accessType
Form 0923-0061Wave One Eligibility Screening ScriptFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.