Approved consistent with CDCâs characterization of the study as exploratory, and will not be sufficient by itself to directly answer the publicâs 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 publicâs 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
08/31/2018
08/31/2018
08/31/2018
225
0
225
173
0
173
2,362
0
2,362
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. ATSDR and EPA will be recruiting participants in-person versus over the phone. Therefore, the Non-Substantive Change Request aims to remove the âcallerâ-specific language from the eligibility screening questionnaire. Additionally, in order to increase efficiency, we would like to remove questions 5-8 on the eligibility screening questionnaire. These questions are redundant to those on the exposure characterization questionnaire.
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:
(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;
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.
Youth Exposure Measurement
Change Request_OMB Control Number 0923-0058 20170828 clean.docx
Att8 US EPA Human Research Review Approval.pdf
Youth Exposure Measurement