1139.18 Study Plan ECAs

Request for Approval under the “Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement” (OMB Control Number: 2070-0033)

TITLE OF INFORMATION COLLECTION:

Study Plan, Enforceable Consent Agreements (ECAs)

DESCRIPTION OF INFORMATION COLLECTION:

For more information about this Information Collection, including description of respondents, need for this collection, and more details of respondent activities, please refer to the Supporting Statement for this generic Information Collection Request (ICR). After the voluntary initial contact has occurred, respondents must then provide a study plan to EPA. The study plan includes documents detailing the different types of tests, health effects, and endpoints covered in each chemical report. One study plan for each chemical is required at the beginning of the testing period. CBI substantiation to support confidentiality claims for relevant data elements throughout the testing period must be provided in conjunction with the study plan transmittal. The CBI substantiations, address chemID and other data elements.

TOTAL ANNUAL BURDEN:

Activity	Adjusted Unit Burden (hours)	Number of Respondents (Sponsors)1	Number of Responses (Chemicals Tested within an Action)	Overlap Factor	Total Burden (hours)	Total Labor Cost	Total Non-Labor Cost	Total Cost
Study Plan	12.987	3.50	3.50	2.80	127.273	$9,713.47	$0.00	$9,713.47
CBI Substantiation	1.215	3.50	3.50	2.80	11.907	$923.36	$0.00	$923.36
Total, Reporting	14.202	3.50	3.50	2.80	139.180	$10,636.83	$0.00	$10,636.83
Total, Recordkeeping	0.000	0.00	0.00	2.80	0.000	$0.00	$0.00	$0.00
Total, Study Plan, ECAs	14.202	3.50	3.50	2.80	139.180	$10,636.83	$0.00	$10,636.83
Footnotes: 1 Assumes one sponsor per chemical.

TOTAL 3-YEAR BURDEN: 417.54 hours.

2