Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0176
ICR Reference No:
200904-2070-001
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
2249.01
Title:
Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)
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:
10/02/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/15/2009
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 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
Expiration Date
10/31/2012
36 Months From Approved
Responses
1,287
0
0
Time Burden (Hours)
161,415
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 346a(p)
Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
Citations for New Statutory Requirements:
US Code: 21 USC 346a(p) Name of Law: section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
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:
72 FR 70839
12/13/2007
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 17477
04/15/2009
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Data Submitters
6300-05-C, 6300-05
Initial Response Form for Individual Order Recipients
,
Initial Response Form for Consortium/ Task Force
Optional Questionnaire
6300-05-Q
Optional Questionnaire Level of Effort for Recipients of Tier 1 Screening Orders
Recordkeeping
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
1,287
0
903
384
0
0
Annual Time Burden (Hours)
161,415
0
161,172
243
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This ICR represents the initial implementation of a statutory mandate that imposes paperwork burdens on chemical companies.
Annual Cost to Federal Government:
$1,137,236
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Angela Hofmann
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:
04/15/2009
An official website of the United States government
The .gov means it's official.
The site is secure.
