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 EPAs
burden estimates, OMB 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.
Inventory as of this Action
Requested
Previously Approved
10/31/2012
36 Months From Approved
1,287
0
0
161,415
0
0
0
0
0
This new ICR covers the information
collection activities associated with Tier 1 screening of 67
chemicals identified under the Endocrine Disruptor Screening
Program (EDSP). The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires
endocrine screening of all pesticide chemicals.
US Code:
21
USC 346a(p) Name of Law: section 408(p) of the Federal Food,
Drug, and Cosmetic Act (FFDCA)
US Code: 21 USC 346a(p) Name of Law: section
408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
This ICR represents the initial
implementation of a statutory mandate that imposes paperwork
burdens on chemical companies.
$1,137,236
No
No
Uncollected
Uncollected
No
Uncollected
Angela Hofmann
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:
(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.
Form 6300-05-C Data Submitters
2249.01_Amendment-F2_Optional-Qs-2009-09-18.pdf
Data Submitters