Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)

Forms and Documents

Document Name	Status
EA Participants (All Ages) - Biological Testing Tracking Form	Unchanged
Environmental Sample Collection Form Form	Unchanged
Environmental Sampling Consent Form	Unchanged
Household Recruitment Script for Environmental Sampling Form	Unchanged
Exposure Questionnaire for Biological Testing - Child Completed Form	Unchanged
Child Assent Form and Instruction	Modified
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	Unchanged
Community Event Evaluation Survey Form	Unchanged
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 Exposure Assessment Protocol_20190604_clean.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
PrtApndxE_UrineCollctnInstrctns 20181012.docx Supplementary Document	2019-06-27
PrtApndxD_ChainCustodyForms 20181012.docx Supplementary Document	2019-06-27
PrtApndxI_DataMangmntPlan 20181012.docx Supplementary Document	2019-06-27
PrtApndxH_SiteHlthSafetyPlan 20181024.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	Unchanged
233861	Environmental Sample Collection Form Form	Unchanged
233860	Environmental Sampling Consent Form	Unchanged
233859	Household Recruitment Script for Environmental Sampling Form	Unchanged
233858	Exposure Questionnaire for Biological Testing - Child Completed Form	Unchanged
233857	Child Assent Form and Instruction	Modified
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	Unchanged
233849	Community Event Evaluation Survey Form	Unchanged

ICR Details

OMB Control No: 0923-0059	ICR Reference No: 201907-0923-001
Status: Historical Active	Previous ICR Reference No: 201811-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0059-19BMN
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 without change	Conclusion Date: 08/06/2019
	Date Received in OIRA: 07/29/2019
Terms of Clearance: We appreciate CDC/ATSDR's agreement to the following 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. ATSDR will issue no individual results reports until completion of the interagency scientific review and OMB approves the content and uses of the relevant communication materials.

	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.

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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 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
Adult Exposure Assessment Questionnaire	NA	Adult Exposure Assessment
Household Eligibility Screener	NA	Household Eligibility Screener
Community Event Evaluation Survey	NA	PFAS Exposure Assessment Community Event Evaluation
Adult Consent	NA	Adult Consent
Parental Permission	NA	Parental Permission Form
Exposure Questionnaire for Biological Testing - Parent Proxy	NA	Exposure Assessment Child
Child Assent	none	Assent for Minors
Exposure Questionnaire for Biological Testing - Child Completed	NA	Exposure Assessment Child
Household Recruitment Script for Environmental Sampling	NA	Household Recruitment Script for Environmental Sampling
Environmental Sampling Consent	NA	Consent for Environmental Sampling
EA Participants (All Ages) - Biological Testing Tracking	NA	FAS EA Biological Testing Tracking Form
Environmental Sample Collection Form	NA	Environmental Sampling Collection Form

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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? 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: 07/29/2019

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