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	Unchanged
Environmental Sampling Consent Form	Unchanged
Household Recruitment Script for Environmental Sampling Form and Instruction	Modified
Exposure Questionnaire for Biological Testing - Child Completed Form	Unchanged
Child Assent Form and Instruction	Unchanged
Exposure Questionnaire for Biological Testing - Parent Proxy Form	Unchanged
Parental Permission Form	Unchanged
Adult Exposure Assessment Questionnaire Form	Unchanged
Adult Consent Form	Unchanged
Household Eligibility Screener Form and Instruction	Modified
Community Event Evaluation Survey Form	Unchanged
Recruitment Memo_v5 20200624.docx Supplementary Document	2020-06-24
PrtApndxJ_PFAS EA Restart Plan_06242020_clean.docx Supplementary Document	2020-06-24
0923-0059 Change Request #4 Justification Crosswalk_06172020 final.docx Justification for No Material/Nonsubstantive Change	2020-06-17
PFAS Exposure Assessment Protocol_06032020_clean.docx Supplementary Document	2020-06-17
PrtApndxE_UrineCollctnInstrctns_20200205 clean.docx Supplementary Document	2020-02-13
PrtApndxD_ChainCustodyForms_20200205 clean.docx Supplementary Document	2020-02-13
PrtApndxI_Data MangmntPlan_06032020_clean.docx Supplementary Document	2020-06-17
PrtApndxH_SiteHlthSafety Plan_06032020_clean.docx Supplementary Document	2020-06-17
0923~0059 Change Request #3 Justification.docx Justification for No Material/Nonsubstantive Change	2020-02-13
PrtApndxG2_RsultsLttrEnviroSmpling 20200109 clean.docx Supplementary Document	2020-01-30
PrtApndxG1_RsultsLttrBiolgcSmplng 20200109 clean.docx Supplementary Document	2020-01-30
0923-0059 PFAS EA Factsheet - Understanding Your PFAS Test Results 20200109 clean.docx Supplementary Document	2020-01-30
0923-0059 PFAS - Overview Sci Guidance for Clinicians 20200109 clean.docx Supplementary Document	2020-01-30
0923-0059 Change Request Justification and crosswalk table_PFAS EA comm materials 20200109.docx Justification for No Material/Nonsubstantive Change	2020-01-30
0923-0059 Change Request Justification and crosswalk table PrtApndxB4 20190718.docx Justification for No Material/Nonsubstantive Change	2019-07-29
Site Selection Supplement_20190509.docx Supplementary Document	2019-06-27
PFAS EA SSB_20190501_clean.docx Supporting Statement B	2019-06-27
PFAS EA SSA_20190524 clean.docx Supporting Statement A	2019-06-27
PrtApndxG2_RsultsLttrEnviroSmpling 20181012.docx Supplementary Document	2019-06-27
PrtApndxG1_RsultsLttrBiolgcSmplng 20181012.docx Supplementary Document	2019-06-27
Att6 PFAS EA Research Determination 20180711.pdf Supplementary Document	2018-11-01
Att5 PIA_PFAS EA signed OCISO 20181001.pdf Supplementary Document	2018-11-01
Att4 ExmpleEIRprt for PFAS 20161128.pdf Supplementary Document	2019-06-27
Att3 PFAS Exposure Assessment Technical Tools (PEATT).pdf Supplementary Document	2019-06-27
Att2a Agency Responses to Public Comments 20181012.pdf Supplementary Document	2018-11-01
Att2 PFAS EA 60-day FRN 20180719.pdf Supplementary Document	2018-11-01
Att1 PFAS EA Authorizing Legislation 20181012.pdf Supplementary Document	2018-11-01

IC Document Collections

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

ICR Details

OMB Control No: 0923-0059	ICR Reference No: 202006-0923-001
Status: Active	Previous ICR Reference No: 202002-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0059-20HS
Title: Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/24/2020
	Date Received in OIRA: 06/18/2020
Terms of Clearance: Prior to initiating collection at any future sites, ATSDR will provide a detailed site selection supplement similar to the current site supplement but specific to additional study sites for review and approval. Provided that the methodology and data collection are consistent with the approved exposure assessment protocol, the new sites may be included in the package through a non-substantive change request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	06/30/2022	06/30/2022
Responses	8,551	0	8,551
Time Burden (Hours)	2,131	0	2,131
Cost Burden (Dollars)	33,029	0	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 request for non-material change will enable virtual meetings and telephone interviews instead of in-person contact. The changes are being made due to COVID-19 precautions and the need to practice social distancing.

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

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 34135	07/19/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 60867	11/27/2018
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
Environmental Sample Collection Form	none	Environmental sample collection form
EA Participants (All Ages) - Biological Testing Tracking	none	EA participants biological testing tracking
Household Eligibility Screener	n/a	Household Eligibility Screener
Community Event Evaluation Survey	none	Exposure assessment community event survey
Adult Consent	none	Adult consent
Child Assent	none	Child assent
Exposure Questionnaire for Biological Testing - Child Completed	none	Child exposure assessment
Adult Exposure Assessment Questionnaire	none	Adult-Child Exposure Assessment Questionnaire
Parental Permission	none	Parental permission
Exposure Questionnaire for Biological Testing - Parent Proxy	NA	Exposure Assessment Child
Household Recruitment Script for Environmental Sampling	n/a	Household Recruitment Script for Environmental Sampling
Environmental Sampling Consent	none	Consent for environmental sampling

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ICR Summary of Burden

	Total Approved	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	8,551	8,551	0	0	0	0
Annual Time Burden (Hours)	2,131	2,131	0	0	0	0
Annual Cost Burden (Dollars)	33,029	33,029	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $3,500,000

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? Yes

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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: 06/18/2020

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