Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill

Forms and Documents

Document Name	Status
Youth Exposure Measurement Form	New
Phlebotomist Safety Exclusion Questions Form	New
Parent/Guardians of Youth Field Users Questionnaire Form	New
Eligibility Screening - Parents/Guardians of Youth Field Users Form and Instruction	New
Phlebotomist Safety Exclusion Questions Form	New
Exposure Measurement - Adult and Adolescent Field Users Form	New
Adult and Adolescent Questionnaire Form	New
Eligibility Screening - Adult/Adolescent Field Users Form and Instruction	New
Att8 US EPA Human Research Review Approval.pdf Supplementary Document	2017-05-10
Att7 CDC IRB Approval.docx Supplementary Document	2017-05-10
Att6 Synthetic Turf Research Protocol_Final.docx Supplementary Document	2017-05-10
Att5 PIA_4.21.17.pdf Supplementary Document	2017-05-10
Att4c Activity 2 ConsentAssentPermissionForms_Final.docx Supplementary Document	2017-05-10
Att4a Field User Fact Sheet_Final.docx Supplementary Document	2017-05-10
Att3 ExtrnlPeerReviewCmmnts and AgencyRspnses.docx Supplementary Document	2017-05-10
Att2a Public Comments and Agency Responses.pdf Supplementary Document	2017-05-10
Att2 60-day FRN.pdf Supplementary Document	2017-05-10
Att1 AuthLegsl.docx Supplementary Document	2017-05-10
3 - 20170427 SSB _Synthetic Turf_EC.docx Supporting Statement B	2017-05-10
3 - 20170509 SSA _Synthetic Turf_EC.docx Supporting Statement A	2017-05-10

IC Document Collections

IC ID	Document Title	Status
226781	Youth Exposure Measurement Form	New
226780	Phlebotomist Safety Exclusion Questions Form	New
226779	Parent/Guardians of Youth Field Users Questionnaire Form	New
226778	Eligibility Screening - Parents/Guardians of Youth Field Users Form and Instruction	New
226777	Phlebotomist Safety Exclusion Questions Form	New
226776	Exposure Measurement - Adult and Adolescent Field Users Form	New
226775	Adult and Adolescent Questionnaire Form	New
226774	Eligibility Screening - Adult/Adolescent Field Users Form and Instruction	New

ICR Details

OMB Control No: 0923-0058	ICR Reference No: 201705-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-17OB
Title: Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill
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: Approved without change	Conclusion Date: 08/01/2017
	Date Received in OIRA: 06/12/2017
Terms of Clearance: Approved consistent with CDC’s characterization of the study as exploratory, and will not be sufficient by itself to directly answer the public’s questions about safety. The limitations include low sample size and a sample that may not be nationally representative due to the convenience sampling methods employed. Specifically, CDC explains that, while the sample design will not allow for generalization of results to the universe of tire crumb rubber infill and synthetic turf fields in the United States, the research will provide valuable information to better understand and identify the important potential chemical and microbiological exposures, and the tire crumb rubber constituents, exposures, and human activity factors. This investigative pilot study is intended to set the stage for designing and implementing future human exposure studies, if feasible. CDC will communicate to the public and other stakeholders that the study activities are not designed to and will not be sufficient by themselves to directly answer the public’s question about safety but will contribute to the more extensive research portfolio necessary to achieve that goal in the longer term.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	12 Months From Approved
Responses	225	0	0
Time Burden (Hours)	173	0	0
Cost Burden (Dollars)	2,362	0	0

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Abstract: This project is research to evaluate exposure potential to contaminants in crumb rubber infill made with recycled tires. ATSDR, with EPA, will implement a research protocol to collect data to be used to inform public health policy decisions and guide future research activities.

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Authorizing Statute(s): US Code: 42 USC 9604 Name of Law: CERCLA
  

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:
	82 FR 10357	02/10/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 26928	06/12/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Eligibility Screening - Parents/Guardians of Youth Field Users	none	Eligibility Screening Script
Parent/Guardians of Youth Field Users Questionnaire	none	Parents/Guardians of Youth Field User Questionnaire
Phlebotomist Safety Exclusion Questions	none	Phlebotomist Safety Exclusion Questions
Youth Exposure Measurement	none	Youth Exposure Measurement
Eligibility Screening - Adult/Adolescent Field Users	none	Field User Eligibility Screening Script
Adult and Adolescent Questionnaire	none	Adult/Adolescent Questionnaire
Exposure Measurement - Adult and Adolescent Field Users	none	Exposure Measurement
Phlebotomist Safety Exclusion Questions	none	Phlebotomist Safety Exclusion Questions

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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	225	0	0	225	0	0
Annual Time Burden (Hours)	173	0	0	173	0	0
Annual Cost Burden (Dollars)	2,362	0	0	2,362	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR. Burden hours are off by one due to rounding.

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Annual Cost to Federal Government: $2,119,660

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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: 06/12/2017

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