Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (Renewal)

Forms and Documents

Document	Type	Status	Availability
2195ss07.docx	Supporting Statement A	Uploaded 2026-04-24	Available
2195.07 Attachment C- Respondent Burden-Costs.docx	Supplementary Document	Uploaded 2026-04-23	Available
2195.07 Attachment A- PSP User Guide.pdf	Supplementary Document	Uploaded 2026-04-23	Available
2195.07 Attachment B- Consultation Qs.docx	Supplementary Document	Uploaded 2026-04-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
25015	Research Involving Exposure of Human Subjects		Modified
187530	All Other Submitted Research with Human Subjects		Unchanged

ICR Details

OMB Control No: 2070-0169	ICR Reference No: 202604-2070-002
Status: Received in OIRA	Previous ICR Reference No: 202204-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2195.07
Title: Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/28/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2026
Responses	13	14
Time Burden (Hours)	6,237	8,276
Cost Burden (Dollars)	0	0

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Abstract: The EPA is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Based on this regulation EPA aims to assess the risks of exposure based on studies that may occasionally use humans. Specifically, the EPA regulations at 40 CFR 26 protect subjects of third-party human research (i.e., research that is not conducted or supported by the EPA) that may be submitted to EPA in support of pesticide product registration and/or labeling or conducted to provide data for generic exposure databases. In addition to other protections, the regulations require affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to the EPA upon the completion of, certain studies that involve human research participants. The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional exposure of human subjects, these individuals (respondents) are required to submit study protocols to the EPA and an IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to the EPA. As such, the purpose of this document is to estimate the third-party response burden from complying with the requirements in 40 CFR 26.

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Authorizing Statute(s): US Code: 7 USC 136 Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
   US Code: 21 USC 346a Name of Law: Federal Food, Drug and Cosmetic Act (FFDCA)
  

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:
	90 FR 34657	07/23/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 21810	04/23/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
All Other Submitted Research with Human Subjects
Research Involving Exposure of Human Subjects

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ICR Summary of Burden

	Total Request	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	13	14	0	0	-1	0
Annual Time Burden (Hours)	6,237	8,276	0	0	-2,039	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: There is a decrease of 2,039 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This change, which is discussed in more detail in the ICR, reflects the decrease in anticipated number of respondent responses per year from 4 to 3 for the next three years. This change is an adjustment.

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Annual Cost to Federal Government: $188,089

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

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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: 04/28/2026

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