Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Forms and Documents

Document Name	Status
Activity 2 - Exposure Measurement Form (Youth/Child Facility Users Form and Instruction	Unchanged
Activity 2 - Phlebotomist Safety Exclusion Questions Form (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
Activity 2 - Youth and Child Questionnaire - (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
Activity 2 - Eligibility Screening Script (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
Activity 2 - Phlebotomist Safety Exclusion Questions Form - (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
Activity 2 - Exposure Measurement Form - (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
Activity 2 - Adult and Adolescent Questionnaire (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
Activity 2 - Eligibility Screening Script (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
Activity 1 - Field Sampling Collection Form Form and Instruction	Unchanged
Activity 1 - Owner Manager Questionnaire Form and Instruction	Unchanged
Activity 1 - Eligibility Screening Form Form and Instruction	Unchanged
Activity 1 - Facility Sampling Collection Form Form and Instruction	Unchanged
Activity 1 - Invitation Telephone Script Form and Instruction	Unchanged
Att7 Synthetic Turf Research Protocol_20160801_Clean.docx Supplementary Document	2016-08-12
Change Request Justification - 0923-0054 Synthetic Turf 20160811.docx Justification for No Material/Nonsubstantive Change	2016-08-12
Att5c Activity 2 ConsentAssentPermissionForms_Clean 8.1.16.docx Supplementary Document	2016-08-02
Att5a Field User Fact Sheet_20160801_Clean.docx Supplementary Document	2016-08-02
Att4g SynTurfFldFacilSmpleCollctnAgrmntForm_20160801_Clean.docx Supplementary Document	2016-08-02
Att4e Synthetic Turf Field Facility Fact Sheet_20160801_Clean.docx Supplementary Document	2016-08-02
Att4c TireRecyclngFacil Sample Collctn Agrmnt Form_20160801_Clean.docx Supplementary Document	2016-08-02
Att4a Tire Recycling Plant Fact Sheet_20160801_Clean.docx Supplementary Document	2016-08-02
Att8 CDC IRB Approval 20160729.pdf Supplementary Document	2016-08-02
Change Request Justification - 0923-0054 Synthetic Turf.docx Justification for No Material/Nonsubstantive Change	2016-08-02
Att5c Activity 2 ConsentAssentPermissionForms_20160716 clean.docx Supplementary Document	2016-07-21
Att5a Field User Fact Sheet_20160716 clean.docx Supplementary Document	2016-07-21
Att4g SynTurfFldFacilSmpleCollctnAgrmntForm_20160716 clean.docx Supplementary Document	2016-07-21
Att4e Synthetic Turf Field Facility Fact Sheet_20160716 clean.docx Supplementary Document	2016-07-21
Att4c TireRecyclngFacil Sample Collctn Agrmnt Form_20160718 clean.docx Supplementary Document	2016-07-21
Att4a Tire Recycling Plant Fact Sheet_20160716 clean.docx Supplementary Document	2016-07-21
SSB _Synthetic Turf_20160716 clean.docx Supporting Statement B	2016-07-21
SSA _Synthetic Turf_20160720 clean.docx Supporting Statement A	2016-07-21
Att9 US EPA Human Research Review Approval.pdf Supplementary Document	2016-07-13
Att8 CDC IRB Approval.docx Supplementary Document	2016-07-13
Att7 Research Protocol.docx Supplementary Document	2016-07-13
Att3 ExtrnlPeerReviewCmmnts and AgencyRspnses.docx Supplementary Document	2016-07-13
Att2a Responses to Public Comments.docx Supplementary Document	2016-07-13
Att2a Category 8 - Previous Studies and Literature Review Comments.pdf Supplementary Document	2016-07-13
Att2a Category 7 - Epidemiological study comments.pdf Supplementary Document	2016-07-13
Att2a Category 6 - Methodology Comments.pdf Supplementary Document	2016-07-13
Att2a Category 5 - Detailed Requests.pdf Supplementary Document	2016-07-13
Att2a Category 4 - Banning moratorium and precautionary principle comments.pdf Supplementary Document	2016-07-13
Att2a Category 3 - Beyond the Scope Comments.pdf Supplementary Document	2016-07-13
Att2a Category 2 - Children and Childrens Health Comments.pdf Supplementary Document	2016-07-13
Att2a Category 1 - General Comments.pdf Supplementary Document	2016-07-13
ATSDR 30-Day FRN_Synthetic Turf.docx Supplementary Document	2016-07-12
Att2 60d FRN SynthcTrf Crumb Rubber 20160218.pdf Supplementary Document	2016-07-12
Att1 AuthLegsl.docx Supplementary Document	2016-07-12
20160711 OMBEmerRqustMemo Synthetic Turf 7.11.16_Signed.pdf Supplementary Document	2016-07-12

IC Document Collections

IC ID	Document Title	Status
222469	Activity 2 - Exposure Measurement Form (Youth/Child Facility Users Form and Instruction	Unchanged
222468	Activity 2 - Phlebotomist Safety Exclusion Questions Form (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
222467	Activity 2 - Youth and Child Questionnaire - (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
222466	Activity 2 - Eligibility Screening Script (Parents/Guardians of Youth/Child Facility Users) Form and Instruction	Unchanged
222465	Activity 2 - Phlebotomist Safety Exclusion Questions Form - (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
222464	Activity 2 - Exposure Measurement Form - (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
222463	Activity 2 - Adult and Adolescent Questionnaire (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
222460	Activity 2 - Eligibility Screening Script (Adult/Adolescent Facility Users) Form and Instruction	Unchanged
222459	Activity 1 - Field Sampling Collection Form Form and Instruction	Unchanged
222458	Activity 1 - Owner Manager Questionnaire Form and Instruction	Unchanged
222457	Activity 1 - Eligibility Screening Form Form and Instruction	Unchanged
222456	Activity 1 - Facility Sampling Collection Form Form and Instruction	Unchanged
222455	Activity 1 - Invitation Telephone Script Form and Instruction	Unchanged

ICR Details

OMB Control No: 0923-0054	ICR Reference No: 201608-0923-002
Status: Historical Active	Previous ICR Reference No: 201608-0923-001
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-0054-16AWQ
Title: Collections Related to Synthetic Turf Fields with Crumb Rubber Infill
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 07/22/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/15/2016
	Date Received in OIRA: 08/12/2016
Terms of Clearance: Previous terms apply: 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. 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. The biological specimens collected during this study will be archived until suitable methods and funding are available.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	01/31/2017	01/31/2017
Responses	379	0	379
Time Burden (Hours)	333	0	333
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this information collection is research to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to contaminants in crumb rubber infill made with recycled tires. ATSDR, along with US EPA, will implement a research protocol with two main research activities to collect this data. The data will be used to inform public health policy decisions and to guide future research activities.

Emergency Justfication: In November 2015, the White House Council on Environmental Quality, requested that the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry (CDC/ATSDR) and the United States Environmental Protection Agency (US EPA), in collaboration with the Consumer Product Safety Commission (CPSC), develop a Federal Research Action Plan to address the issues surrounding synthetic turf with crumb rubber infill. On February 12, 2016, US EPA, ATSDR, and the CPSC, released the Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds. As part of the action plan, ATSDR and US EPA are co-sponsoring this research study this titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. This is a new information collection request (ICR). Given the highly constrained timeline in the action plan, ATSDR is requesting Paperwork Reduction Act (PRA) clearance for 6 months (180 days), in accordance with 5 CFR 1320, Controlling Paperwork Burdens on the Public, Section 1320.13 Emergency Processing. By the end of November 2016, the agencies anticipate releasing a draft status report that describes the preliminary findings and conclusions of the research through that point in time.

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Authorizing Statute(s): US Code: 42 USC 9604 Name of Law: Superfund Amendments and Reauthorization Act of 1986 (SARA)
  

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:
	81 FR 8201	02/17/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Activity 2 - Youth and Child Questionnaire - (Parents/Guardians of Youth/Child Facility Users)	NA	Activity 2 - Youth and Child Questionnaire (Parents/Guardians of Youth/Child Facility Users)
Activity 2 - Phlebotomist Safety Exclusion Questions Form (Parents/Guardians of Youth/Child Facility Users)	NA	Activity 2 - Phlebotomist Safety Exclusion Questions
Activity 2 - Adult and Adolescent Questionnaire (Adult/Adolescent Facility Users)	NA	Activity 2 - Adult and Adolescent Questionnaire (Adult/Adolescent Facility Users)
Activity 2 - Phlebotomist Safety Exclusion Questions Form - (Adult/Adolescent Facility Users)	NA	Activity 2 - Phlebotomist Safety Exclusion Questions
Activity 2 - Eligibility Screening Script (Parents/Guardians of Youth/Child Facility Users)	NA	Activity 2 - Eligibility Screening Script (Parents/Guardians of Youth/Child Facility Users)
Activity 1 - Invitation Telephone Script	NA	Activity 1 - Tire Recycling Plant Telephone Script
Activity 1 - Facility Sampling Collection Form	NA	Activity 1 - Tire Recycling Plant Sample Collection Form
Activity 1 - Eligibility Screening Form	NA	Activity 1 - Synthetic Turf Field Facility Eligibility Screening Script
Activity 1 - Owner Manager Questionnaire	NA	Synthetic Turf Field Facility Owner/Manager Questionnaire
Activity 1 - Field Sampling Collection Form	NA	Activity 1 - Synthetic Turf Field Facility Sampling Collection Form
Activity 2 - Eligibility Screening Script (Adult/Adolescent Facility Users)	NA	Activity 2 - Eligibility Screening Script (Adult/Adolescent Facility Users)
Activity 2 - Exposure Measurement Form (Youth/Child Facility Users	NA	Activity 2 - Exposure Measurement Form
Activity 2 - Exposure Measurement Form - (Adult/Adolescent Facility Users)	NA	Activity 2 - Exposure Measurement 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	379	379	0	0	0	0
Annual Time Burden (Hours)	333	333	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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: $2,880,000

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: 08/12/2016

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