Notice2026-07939
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (Renewal)
Primary source
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Published
April 23, 2026
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects (EPA ICR Number 2195.07, OMB Control Number 2070-0169), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through April 30, 2026. Public comments were previously requested via the Federal Register on July 23, 2025 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Full Text
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<title>Federal Register, Volume 91 Issue 78 (Thursday, April 23, 2026)</title>
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[Federal Register Volume 91, Number 78 (Thursday, April 23, 2026)]
[Notices]
[Pages 21810-21811]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07939]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2021-0315; FRL-13347-01-OMS]
Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (Renewal)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Submission of Protocols and Study
Reports for Environmental Research Involving Human Subjects (EPA ICR
Number 2195.07, OMB Control Number 2070-0169), to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through April 30, 2026. Public comments
were previously requested via the Federal Register on July 23, 2025
during a 60-day comment period. This notice allows for an additional 30
days for public comments.
[[Page 21811]]
DATES: Comments may be submitted on or before May 26, 2026.
ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPP-2021-0315, to EPA online using <a href="http://www.regulations.gov">www.regulations.gov</a> (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460.
EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
<a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Office of Mission
Critical Operations (Mail Code 7602M), Office of Chemical Safety and
Pollution Prevention, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-
1205; email address: <a href="/cdn-cgi/l/email-protection#d4a7bda1fab7b5a6bbb8adba94b1a4b5fab3bba2"><span class="__cf_email__" data-cfemail="02716b772c6163706d6e7b6c426772632c656d74">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through April 30, 2026. An agency may not
conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
Public comments were previously requested via the Federal Register
on July 23, 2025, during a 60-day comment period (90 FR 34657). This
notice allows for an additional 30 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting are available in the public docket for this ICR. The docket
can be viewed online at <a href="http://www.regulations.gov">www.regulations.gov</a> or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
<a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
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.
The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here.
Form number(s): None.
Respondents/affected entities: Entities potentially affected by
this ICR include those that submit to EPA under FIFRA and/or FFDCA
protocols and study reports for environmental research involving human
subjects. North American Industrial Classification System (NAICS) codes
identified in question 12 of the ICR.
Respondent's obligation to respond: Mandatory. 40 CFR 26.
Estimated number of respondents: 13 (total).
Frequency of response: On occasion.
Total estimated burden: 6,237 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated costs: $742,361 (per year), which includes $0
annualized capital or operation & maintenance costs.
Changes in the Estimates: 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.
Courtney Kerwin,
Deputy Director, Data & Enterprise Programs Division.
[FR Doc. 2026-07939 Filed 4-22-26; 8:45 am]
BILLING CODE 6560-50-P
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