Application for New and Amended Pesticide Registration (Renewal)

Forms and Documents

Document	Type	Status	Availability
Form EPA Form 8570-27 "Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form	Modified	Available
Form EPA Form 8570-1 "Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements	Form and Instruction	Modified	Repair queued
Form EPA Form 8570-1 "Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Modified	Repair queued
0277.17_Attachment N-Pesticide Submission Portal (PSP); Instructions, Screenshots and Related Guidance.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment L-Registrant Communication with EPA (Bayer CropScience LP).pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment I-2 - Form Instructions and Relevant Information_Guidance for Completing the CSPS.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment I-1 - Proposed New Joint Confidential Statement of Product Specifications.pdf	Supplementary Document	Uploaded 2016-07-01	Repair queued
0277.17_Attachment M-Public Comments & EPA Responses.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment K-Display Related to OMB Control # 2070-0060.pdf	Supplementary Document	Uploaded 2016-07-01	Repair queued
0277.17_Attachment J-Labor Wage Formulas - Sec 3 ICR.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment H-Consultations Contacts, Questionnaire, and Responses.pdf	Supplementary Document	Uploaded 2016-07-01	Repair queued
0277.17_Attachment G-40 CFR 158-Data Requirements for Pesticide Registration.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment F-40 CFR 156-Labeling Requirements for Pesticides and Devices.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment E-40 CFR 152-Pesticide Registration and Classification Procedures.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277 17_Attachment D-PR Notice 97-3 Guidelines for Expedited Review of Conventional Pesticides under the Reduced-Risk Initiative and for Bio-Pestici.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277 17_Attachment B-Statute-Registration Service Fees.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277.17_Attachment A-Statute-Registration.pdf	Supplementary Document	Uploaded 2016-07-01	Available
0277ss17.docx	Supporting Statement A	Uploaded 2016-07-01	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
24913	"Type A" application for registration of a new active ingredient or a new use for a currently registered active ingredient	Form	Modified
222287	Data Generation (for New AIs & New Products)		New
187236	"Type C" application for registration of new conventional active ingredients or uses that may qualify as "reduced risk" chemicals and/or OP replacements	Form and Instruction	Modified
187235	"Type B" application for registration of a new or amended product that contains a currently registered active ingredient	Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0060	ICR Reference No: 201606-2070-001
Status: Historical Active	Previous ICR Reference No: 201205-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0277.17
Title: Application for New and Amended Pesticide Registration (Renewal)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/15/2017
	Date Received in OIRA: 07/11/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved
Responses	8,203	0	0
Time Burden (Hours)	1,524,893	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This data collection program is designed to provide EPA with necessary data to evaluate an application for 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). Under FIFRA, EPA must evaluate pesticides thoroughly before they can be marketed and used in the United States, to ensure that they will not pose unreasonable adverse effects to human health and the environment. Pesticides that meet this test are granted a license or "registration" which permits their distribution, sale and use according to requirements set by EPA to protect human health and the environment.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 34153	06/15/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 43197	07/01/2016
Did the Agency receive public comments on this ICR? No

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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 8570-1, EPA Form 8570-4, EPA Form 8570-27, EPA Form 8570-34, EPA Form 8570-37, EPA Form 8570-35, EPA Form 8570-36	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 ,   Application for Pesticide, Registration, Amendment, Other ,   Confidential Statement of Formula
"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 8570-34, EPA Form 8570-36, EPA Form 8570-35, 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 ,   Summary of the Physical/Chemical Properties ,   Data Matrix ,   Self-Certification Statement for 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, EPA Form 8570-36, EPA Form 8570-35	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 ,   Summary of the Physical/Chemical Properties ,   Data Matrix
Data Generation (for New AIs & New Products)

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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	8,203	0	0	0	67	8,136
Annual Time Burden (Hours)	1,524,893	0	0	0	1,356,689	168,204
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: There is a net increase of 1,356,689 hours in the total estimated respondent burden compared with the ICR previously approved by OMB. The increase is the result of EPA’s updating of the methodology used to estimate the paperwork burden that involves the addition of previously unaccounted for burden for study data generation; while a decrease of approximately 23,000 hours reflects EPA's receipt of fewer applications. These changes are an adjustment.

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Annual Cost to Federal Government: $35,843,792

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? Uncollected

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Common Form ICR:  No

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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: 07/11/2016

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