Supplemental Measurements for Exploratory Research regarding Exposure during Activities Conducted on Synthetic Turf Fields with Tire Crumb Rubber Infill

Forms and Documents

Document Name	Status
Form 0923-19GW Exposure Measurement Form Form and Instruction	New
Form 0923-19GW Youth an Child Questionnaire Form and Instruction	New
Form 0923-19GW Adult and Adolescent Questionnaire Form and Instruction	New
Form 0920-19GW Eligibility Screening Form Form and Instruction	New
Att6_6881 Amendment #5 IRB approval.docx Supplementary Document	2019-04-23
Att5_Protocol 6881_Amendment 5_3.5.19_Clean.docx Supplementary Document	2019-04-23
Att4_Privacy Impact Assessment_ST3 signed OCISO.pdf Supplementary Document	2019-04-23
Att3h2_ExpMsrtmtFormNoticePost.docx Supplementary Document	2019-04-23
Att3h1_ExpMsrtmtFormNotice.docx Supplementary Document	2019-04-23
Att3d_ConsentAssentForms.docx Supplementary Document	2019-04-23
Att3b_FacilityOwnerFactSheet.docx Supplementary Document	2019-04-23
Att3a_FieldUserFactSheet.docx Supplementary Document	2019-04-23
Att2a_PublicCommentandAgencyResponse.pdf Supplementary Document	2019-04-23
Att2 60-day FRN.pdf Supplementary Document	2019-04-23
Att1 AuthLegsl.docx Supplementary Document	2019-04-23
1 - SSB_Synthetic Turf 3_3.18.19 response to OMB comments_8.19 Final edits 9_3_Clean.docx Supporting Statement B	2019-10-15
1 - SSA_Synthetic Turf 3_3.18.19 response to OMB comments_8.19 Final edits 9_3_Clean.docx Supporting Statement A	2019-10-15

IC Document Collections

IC ID	Document Title	Status
235811	Exposure Measurement Form Form and Instruction	New
235810	Youth an Child Questionnaire Form and Instruction	New
235809	Adult and Adolescent Questionnaire Form and Instruction	New
235808	Eligibility Screening Form Form and Instruction	New

ICR Details

OMB Control No: 0923-0062	ICR Reference No: 201904-0923-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No: 0923-19GW
Title: Supplemental Measurements for Exploratory Research regarding Exposure during Activities Conducted on Synthetic Turf Fields with Tire 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 with change	Conclusion Date: 10/16/2019
	Date Received in OIRA: 04/29/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time the agency will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	24 Months From Approved
Responses	620	0	0
Time Burden (Hours)	184	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The research protocol, Collections Related to Synthetic Turf Fields with Crumb Rubber Infill, has been conducted previously under two information collection requests (ICRs): Activity 1 under OMB Control No. 0923-0054 (expiration date 01/31/2017) and Activities 2 and 3 under OMB Control No. 0923-0058 (expiration date 08/13/2018), which were limited to collections from August to October, 2017. Activities 2 and 3 aim to evaluate and characterize the human exposure potential to constituents in crumb rubber infill among a convenience sample of 60 field users (Activity 2) and to collect biological specimens (blood and urine) from 45 participants (Activity 3). Due to the limited enrollment and collection period, the target Activity 2 and Activity 3 samples sizes were not met in 2017. The current request seeks to conduct supplemental measurements to expand the exploratory analysis conducted under OMB 0923-0058. The current request allows for further investigation of patterns observed in the preliminary data from the 2017 pilot-scale exposure measurements of individuals playing on synthetic turf fields with crumb rubber infill and collecting data from a small number of individuals who are playing on grass fields.

---

Authorizing Statute(s): US Code: 42 USC 9604(i)(1)(E), (7), (9) Name of Law: Superfund Amendments and Reauthorization Act of 1986
   US Code: 42 USC 103 Name of Law: Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA)
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 66265	12/26/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 16856	04/23/2019
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Eligibility Screening Form	0920-19GW	Eligibility Screener
Adult and Adolescent Questionnaire	0923-19GW	Adult/Ado Field Questionnaire
Youth an Child Questionnaire	0923-19GW	Youth/Child Field Questionnaire
Exposure Measurement Form	0923-19GW	Exposure Measurement Form

---

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	620	0	0	620	0	0
Annual Time Burden (Hours)	184	0	0	184	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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 Collection

---

Annual Cost to Federal Government: $400,000

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.     No

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.     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

---

Common Form ICR:  No

---

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: 04/29/2019

---