Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)

Forms and Documents

Document Name	Status
EA Participants (All Ages) - Biological Testing Tracking Form	Modified
Environmental Sample Collection Form Form	Modified
Environmental Sampling Consent Form	Modified
Household Recruitment Script for Environmental Sampling Form and Instruction	Modified
Exposure Questionnaire for Biological Testing - Child Completed Form	Modified
Child Assent Form and Instruction	Modified
Exposure Questionnaire for Biological Testing - Parent Proxy Form	Modified
Parental Permission Form	Modified
Adult Exposure Assessment Questionnaire Form	Modified
Adult Consent Form	Modified
Household Eligibility Screener Form and Instruction	Modified
Community Event Evaluation Survey Form	Modified
PrtApndxK_Crosswalk table for Protocol Modifications.xlsx Supplementary Document	2022-06-10
PrtApndxJ_PFAS EA Restart Plan_v8.docx Supplementary Document	2022-06-10
PrtApndxC1_SampleCollectionLog_20191108.docx Supplementary Document	2022-06-10
PrtApndxB1_PrivacyActStatement_20191108.docx Supplementary Document	2022-06-10
PrtApndxA2_HHRecruitmentLetter_20220609.docx Supplementary Document	2022-06-10
PFAS Exposure Assessment Protocol Revision clean.docx Supplementary Document	2022-06-10
PrtApndxE_UrineCollctnInstrctns_20191108.docx Supplementary Document	2022-06-10
PrtApndxD_ChainCustodyForms_20191108.docx Supplementary Document	2022-06-10
PrtApndxI_Data MangmntPlan_revision clean.docx Supplementary Document	2022-06-10
PrtApndxH_SiteHlthSafety Plan_06_02_2020.docx Supplementary Document	2022-06-10
1 - PFAS EA SSB_2022_6_1_22.docx Supporting Statement B	2022-06-10
1 - PFAS EA SSA_2022_6_1_22.docx Supporting Statement A	2022-06-10
PrtApndxG2_RsultsLttrEnviroSmpling 20200109.docx Supplementary Document	2022-06-10
PrtApndxG1_RsultsLttrBiolgcSmplng 20200109.docx Supplementary Document	2022-06-10
Att6 STARS Determination.pdf Supplementary Document	2022-06-10
Att5 PIA_PFAS EA signed OCISO 20220509.pdf Supplementary Document	2022-06-10
Att4 PFAS EA Example report-508.pdf Supplementary Document	2022-06-10
Att3 PFAS EA Technical Tools (PEATT).pdf Supplementary Document	2022-06-10
Att2 0923-0059 PFAS EA 60D FRN.pdf Supplementary Document	2022-06-10
Att1 AuthLegsl PFAS EA.docx Supplementary Document	2022-06-10

IC Document Collections

IC ID	Document Title	Status
236722	EA Participants (All Ages) - Biological Testing Tracking Form	Modified
233861	Environmental Sample Collection Form Form	Modified
233860	Environmental Sampling Consent Form	Modified
233859	Household Recruitment Script for Environmental Sampling Form and Instruction	Modified
233858	Exposure Questionnaire for Biological Testing - Child Completed Form	Modified
233857	Child Assent Form and Instruction	Modified
233855	Exposure Questionnaire for Biological Testing - Parent Proxy Form	Modified
233853	Parental Permission Form	Modified
233852	Adult Exposure Assessment Questionnaire Form	Modified
233851	Adult Consent Form	Modified
233850	Household Eligibility Screener Form and Instruction	Modified
233849	Community Event Evaluation Survey Form	Modified

ICR Details

OMB Control No: 0923-0059	ICR Reference No: 202206-0923-001
Status: Received in OIRA	Previous ICR Reference No: 202006-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0059
Title: Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/17/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2022
Responses	8,735	8,551
Time Burden (Hours)	1,535	2,131
Cost Burden (Dollars)	31,381	33,029

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Abstract: This information collection addresses the requirements for completing exposure assessments (EAs) for PFAS authorized in Section 8006 of the Consolidated Appropriations Act, 2018. ATSDR/NCEH will use statistical methods to recruit respondents at a minimum of eight current or former domestic military installations known to have PFAS contamination in water sources. ATSDR will collect biological and environmental samples to evaluate exposure. This is a revision request and involves minor protocol changes and burden changes.

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Authorizing Statute(s): US Code: 42 USC 9604 Name of Law: CERCLA
   PL: Pub.L. 115 - 141 8006 Name of Law: Consolidated Appropriations Act
   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:
	86 FR 63390	11/16/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 36502	06/16/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Adult Consent	none	Adult consent
Adult Exposure Assessment Questionnaire	none	Adult-Child Exposure Assessment Questionnaire
Child Assent	none	Child assent
Community Event Evaluation Survey	none	Exposure assessment community event survey
EA Participants (All Ages) - Biological Testing Tracking	none	EA participants biological testing tracking
Environmental Sample Collection Form	none	Environmental sample collection form
Environmental Sampling Consent	none	Consent for environmental sampling
Exposure Questionnaire for Biological Testing - Child Completed	none	Child exposure assessment
Exposure Questionnaire for Biological Testing - Parent Proxy	NA	Exposure Assessment Child
Household Eligibility Screener	n/a	Household Eligibility Screener
Household Recruitment Script for Environmental Sampling	n/a	Household Recruitment Script for Environmental Sampling
Parental Permission	none	Parental permission

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ICR Summary of Burden

	Total Request	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	8,735	8,551	0	184	0	0
Annual Time Burden (Hours)	1,535	2,131	0	-596	0	0
Annual Cost Burden (Dollars)	31,381	33,029	0	-1,648	0	0

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Number of respondents were adjusted for the ICs.

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Annual Cost to Federal Government: $2,100,000

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? No

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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: 06/17/2022

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