[Federal Register Volume 90, Number 139 (Wednesday, July 23, 2025)]
[Notices]
[Pages 34657-34658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13819]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2021-0315; FRL-12695-01-OCSPP]
Agency Information Collection Activities; Proposed Renewal
Collection and Request for Comment; Submission of Protocols and Study
Reports for Environmental Research Involving Human Subjects
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces the availability of and solicits public comment on
the following Information Collection Request (ICR) that EPA is planning
to submit to the Office of Management and Budget (OMB): Submission of
Protocols and Study Reports for Environmental Research Involving Human
Subjects (EPA ICR No. 2195.07 and OMB Control No. 2070-0169). This ICR
represents a renewal of an existing ICR that is currently approved
through April 30, 2026. Before submitting the ICR to OMB for review and
approval under the PRA, EPA is soliciting comments on specific aspects
of the information collection that is summarized in this document. The
ICR and accompanying material are available in the docket for public
review and comment.
DATES: Comments must be received on or before September 22, 2025.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number Docket ID No. EPA-HQ-OPP-2021-0315, online at https://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Additional instructions on
commenting or visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Office of Program Support
(Mail Code 7602M), Office of Chemical Safety and Pollution Prevention,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 566-1205; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. What information is EPA particularly interested in?
Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to
be collected.
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.
II. What information collection activity or ICR does this action apply
to?
Title: Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects.
EPA ICR No.: 2195.07.
OMB Control No.: 2070-0169.
ICR Status: This ICR is currently approved through April 30, 2026.
Under the PRA, 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. The OMB control numbers
for EPA's regulations in title 40 of the Code of Federal Regulations
(CFR), after appearing in the Federal Register when approved, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers for certain EPA
regulations is consolidated in 40 CFR part 9.
Abstract: The U.S. Environmental Protection Agency (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
[[Page 34658]]
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, per 40 CFR 26.
Estimated number of potential respondents: 13.
Frequency of response: On occasion.
Total estimated average number of responses for each respondent: 1.
Total estimated burden: 6,237 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated costs: $742,361 (per year), includes $0 annualized
capital investment or maintenance and operational costs.
III. Are there changes in the estimates from the last approval?
There is a decrease of 2,159 hours in the total estimated
respondent burden compared with that identified in the ICR currently
approved by OMB. This decrease is a result of the anticipated number of
responses per year from four to three for the next three years. These
changes are an adjustment.
IV. What is the next step in the process for this ICR?
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.
Authority: 44 U.S.C. 3501 et seq.
Dated: July 18, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2025-13819 Filed 7-22-25; 8:45 am]
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