ICR Documents

Supporting Statement A Document Date Uploaded 0 - SSA Pease Study 20190815.docx 08/16/2019 Supporting Statement B Document Date Uploaded 0 - SSB Pease Study 20190813 clean.docx 08/16/2019 Supplementary Documents Title Document Document Type Date Uploaded Authorizing Legislation AppndxA Pease_Study_ Authorizing Legislation 20180802.pdf Supplementary Document 12/20/2018 60 day FRN AppndxB Pease 60-day FRN.pdf Supplementary Document 12/20/2018 Summary of Public Comments AppndxB1 ATSDR-2018-0008 SmmryCmntsRspnses 20190813.pdf Supplementary Document 08/15/2019 Feasibility Assessment AppndxC_Pease_Feasibility_Assessment_November-2017_508.pdf Supplementary Document 08/15/2019 PIA AppndxD PrivacyImpactAssessment 20181210.pdf Supplementary Document 08/15/2019 IRB Approval AppndxE IRB Approval Memo 20180912.pdf Supplementary Document 08/15/2019 Data Sharing and Disclosure Review AppndxF_Data Sharing and Disclosure Review 20190813.docx Supplementary Document 08/15/2019 Investigators and Key Personnel P_Att01_InvestigatorsKeyPersonnel updated 20180802.docx Supplementary Document 08/15/2019 PFAS Levels P_Att02_PFASLevelsPease_vs_ExtrnlPopn 20180802.docx Supplementary Document 08/15/2019 Biochemical Analysis Plan P_Att03_BiochemAnalPlanChildrenAdults 20181109_clean.docx Supplementary Document 08/15/2019 Sample Size Justification P_Att04_JustificationSampleSizeCalcs 20180802.docx Supplementary Document 08/15/2019 Communication Plan P_Att05_PeaseStudyCommnctnPlan_20190813 clean.docx Supplementary Document 08/15/2019 Invitation Letters - Wave 1 P_Att06_WaveOne_NHDHHSInvitationLttrsStudyRollout_20200729_clean.docx Supplementary Document 08/12/2020 Recruitment Materials - Waves 2-3 P_Att07_WavesTwoThreeRecruitmentMaterials_20180802.docx Supplementary Document 08/15/2019 Recruitment Tracking Form P_Att08_RecrTrackingForm_20180802.docx Supplementary Document 08/15/2019 Appointment Reminder Card P_Att09a_ApptReminderCard_20200729_clean.docx Supplementary Document 08/12/2020 Informed Consent Packet P_Att09b_InformedConsentPacket_20200729_clean.docx Supplementary Document 08/12/2020 Study Fact Sheet P_Att09c_StudyFactSheet_20200729_clean.docx Supplementary Document 08/12/2020 Appointment Tracking Form P_Att11_ApptTrackingForm_20200729_clean.docx Supplementary Document 08/12/2020 Manual of Procedures P_Att14 PeaseManualofProcedures_08032020_clean.docx Supplementary Document 08/12/2020 Body and Blood Pressure Measurement Report P_Att21_BodyBloodPressMsReport_20180802.docx Supplementary Document 08/15/2019 Reporting Script for Clinical Tests P_Att22_AdvReportScriptClinicalTests_20180802.docx Supplementary Document 08/15/2019 Clinical Test Report Tracking Form P_Att22a_AdvncClinicalTestReportTrackingForm_20180802.docx Supplementary Document 08/15/2019 Letter Report of Critical Values P_Att22b_LetterRprtCriticalValue_20180802.docx Supplementary Document 08/15/2019 Clinical Test Results Report P_Att23_ClinicalTestResultsReport_20180802.docx Supplementary Document 08/15/2019 PFAS Results Report P_Att24_PFASResultsReport 20190813 clean.docx Supplementary Document 08/15/2019 PFAS Fact Sheet P_Att24a_ATSDRPFASFactsheet.pdf Supplementary Document 08/15/2019 Study Protocol Pease Study Protocol_20200729_clean.docx Supplementary Document 08/12/2020 IRB Approval Memos 1 - AppndxE IRB Apprvl Memos 20190903.pdf Supplementary Document 09/05/2019 Study Protocol 9-5-19 Pease Study Protocol 20190823 clean.docx Supplementary Document 09/05/2019 Consent Packet 9-5-19 P_Att09b_InformedConsentPacket_20190823 clean.docx Supplementary Document 09/05/2019 Request for change 9-5-19 0923-0061 Change Request Justification 20190903.docx Justification for No Material/Nonsubstantive Change 09/05/2019 Change Request Justification 20200807 Pease 0923-0061 Chng Reqst Justfctn X-Walk Table.docx Justification for No Material/Nonsubstantive Change 08/12/2020 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received