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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:
2070-0060
ICR Reference No:
202005-2070-003
Status:
Historical Active
Previous ICR Reference No:
201909-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
0277.20
Title:
Application for New and Amended Pesticide Registration (Renewal)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/23/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/29/2020
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2024
36 Months From Approved
03/31/2021
Responses
8,228
0
8,203
Time Burden (Hours)
1,562,517
0
1,524,893
Cost Burden (Dollars)
0
0
0
Abstract:
This is a renewal of an existing information collection request (ICR) designed to provide the Environmental Protection Agency (EPA) with the necessary information to evaluate an application for the registration of a pesticide product, as required under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (see Attachment A). FIFRA provides EPA with the authority to regulate the distribution, sale and use of pesticides in the United States and ensure that pesticides will not pose unreasonable adverse effects to human health and the environment. Pesticides that meet this test receive a license or "registration."
Authorizing Statute(s):
PL:
Pub.L. 80 - 104 3
Name of Law: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Citations for New Statutory Requirements:
None
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:
85 FR 6944
02/06/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 60992
09/29/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient
EPA Form 8570-34, EPA Form 8570-37, EPA Form 8570-35, EPA Form 8570-36, EPA Form 8570-27
Formulator's Exemption Statement
,
Certification with Respect to Citation of Data
,
Self-Certification Statement for the Physical/Chemical Properties
,
Data Matrix
,
Summary of the Physical/Chemical Properties
"Type B" application for registration of a new or amended product that contains a currently registered active ingredient
EPA Form 8570-1, EPA Form 8570-4, EPA Form 8570-27, EPA Form 8570-36, EPA Form 8570-34
Application for Pesticide, Registration, Amendment, Other
,
Confidential Statement of Formula
,
Formulator's Exemption Statement
,
Certification with Respect to Citation of Data
,
Summary of the Physical/Chemical Properties
"Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements
EPA Form 8570-1, EPA Form 8570-4, EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-37
Application for Pesticide, Registration, Amendment, Other
,
Confidential Statement of Formula
,
Formulator's Exemption Statement
,
Certification with Respect to Citation of Data
,
Self-Certification Statement for the Physical/Chemical Properties
Data Generation (for New AIs & New Products)
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
8,228
8,203
0
211
-186
0
Annual Time Burden (Hours)
1,562,517
1,524,893
0
40,689
-3,065
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The activities in this ICR increase net respondent burden by 37,624 hours annually over the levels approved in the currently approved collection. While burden per response levels remain unchanged, the number of responses expected in certain categories has shifted as a result of using an updated data set (Section 3 registration actions annually, on average, during the years 2015-2017) to predict future registration application levels. Additionally, in this iteration of the ICR, the Agency calculates the expected annual application burden of three proposed programs that are anticipated to come online in the next three years. The average annual number of Section 3 registration actions dropped during the years 2015-2017 from 7,478 to 7,292. As a result, baseline registration levels, exclusive of the new programs, were reset at an annual averages of 205 “Type A” activities, 7,082 “Type B” activities, and 5 “Type C” activities. EPA estimates that the addition of several new fee-for-service PRIA categories will increase the annual number of Type B actions by 40. The Agency does not anticipate any paperwork burden from data generation for new products or for new active ingredients resulting from these new PRIA categories. The Antimicrobial Performance Evaluation Program (APEP) may impact up to 99 products annually, with an application burden for the registrant of each product. The Agency expects this burden to be similar to a Type B action. Furthermore, there may be a data generation burden for these products annually under this program. EPA conservatively estimates the paperwork burden for data generation under APEP may look similar to the burden for an Antimicrobial new product and has included this burden in the calculations for the Data Generation IC in this ICR. The Agency anticipates that the “Interim Process for Evaluating Potential Synergistic Effects of Pesticides During the Registration Process” will not cause a change in the number of product registrations, but will impose an additional Type A burden on registrants equivalent to about 8 active ingredients annually. The Agency does not anticipate a paperwork burden from data generation for new active ingredients or new products for the draft GTA guidance.
Annual Cost to Federal Government:
$33,929,979
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
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:
09/29/2020
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