NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION

Environmental Protection Agency

Office of Prevention, Pesticides and Toxic Substances

FOR CERTIFYING OFFICIAL: Linda Travers

FOR CLEARANCE OFFICER: Rick Westlund

In accordance with the Paperwork Reduction Act, OMB has taken action on your request received

04/15/2009

ACTION REQUESTED: New collection (Request for a new OMB Control Number)

TYPE OF REVIEW REQUESTED: Regular

ICR REFERENCE NUMBER: 200904-2070-001

AGENCY ICR TRACKING NUMBER: 2249.01

TITLE: Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)

LIST OF INFORMATION COLLECTIONS: See next page

OMB ACTION: Approved with change

OMB CONTROL NUMBER: 2070-0176

The agency is required to display the OMB Control Number and inform respondents of its legal significance in 

accordance with 5 CFR 1320.5(b).

EXPIRATION DATE: 10/31/2012 DISCONTINUE DATE:

BURDEN: RESPONSES HOURS COSTS

Previous 0 0 0

New 1,287 161,415 0

Difference

 Change due to New Statute 903 161,172 0
NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION

 Change due to Agency Adjustment 0 0 0

 Change Due to Potential Violation of the PRA 0 0 0

TERMS OF CLEARANCE: This information collection is approved for the 67 chemicals published by EPA at 

74 Fed. Reg. 17579 (April 15, 2009).

OMB appreciates the continuing dialog with respect to the practical utility of the Tier I battery of EDSP assays 

and the role that the results from these first 67 chemicals will play in ensuring practical utility for subsequent 

groups of chemicals. Nonetheless, under the principles of the PRA, EPA should promote and encourage test 

order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of 

the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the greatest extent 

possible.

For this reason, and to further validate EPA’s burden estimates, O MB requests that EPA provide a report 

re-estimating the burden of this information collection based on responses to the Tier I test orders, including 

the use of cost-sharing and data compensation, the submission and acceptance of existing data and OSRI,

and description of any instances in which submission of OSRI was deemed insufficient to satisfy the testing 

order. OMB requests this report prior to or at the time of submission of revision of this information collection 

to cover additional chemicals.

In addition, in order to ensure that EPA has maximized the practical utility of the Tier I assays as the program 

moves forward, EPA should ensure sufficient opportunity prior to submission of any revision to this collection 

for public comment and peer review of the EPA tools to be developed to guide agency decisions on whether a 

chemical must proceed to Tier II, including the Weight of the Evidence Approach and Standard Evaluation

Procedures.

OMB Authorizing Official: Kevin F. Neyland

 Deputy Administrator,

 Office Of Information And Regulatory Affairs
List of ICs

IC Title Form No. Form Name CFR Citation

Recordkeeping 40 CFR 169.2(k)

Optional Questionnaire 

Level of Effort for 

Recipients of Tier 1 

Screening Orders

Optional Questionnaire 6300-05-Q

Initial Response Form for 

Consortium/ Task Force, 

Initial Response Form for 

Individual Order

Recipients

Data Submitters 6300-05-C, 6300-05