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

IC Document Collections

IC ID	Document Title	Status
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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