Document ID: EPA-HQ-OPP-2021-0315-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects
Posted Date: 2021-09-01T04:00Z

[Federal Register Volume 86, Number 167 (Wednesday, September 1, 2021)]
[Notices]
[Pages 49022-49023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18836]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0315; FRL-8735-01-OCSPP]

Agency Information Collection Activities; Proposed Renewal of an 
Existing 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 
an Information Collection Request (ICR) that EPA is planning to submit 
to the Office of Management and Budget (OMB). The ICR, entitled: 
``Submission of Protocols and Study Reports for Environmental Research 
Involving Human Subjects'' and identified by EPA ICR No. 2195.06 and 
OMB Control No. 2070-0169, represents the renewal of an existing ICR 
that is scheduled to expire on April 30, 2022. Before submitting the 
ICR to OMB for review and approval under the PRA, EPA is soliciting 
comments on specific aspects of the proposed 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 November 1, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2021-0315, using http://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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Mission Support Division 
(7101M), Office of Program Support, Office of Chemical Safety and 
Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 34-0159; email address: siu.carolyn@epa.gov.

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.
    ICR number: EPA ICR No. 2195.06.
    OMB control number: OMB Control No. 2070-0169.
    ICR status: This ICR is currently scheduled to expire on April 30, 
2022. 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 listed in 40 CFR 
part 9,

[[Page 49023]]

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). The EPA regulations at 40 CFR 
part 26 protect subjects of ``third-party'' human research (i.e., 
research that is not conducted or supported by the EPA). 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 a cognizant local 
Human Subjects 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. This renewal ICR estimates the third-party response burden 
from complying with the requirements in 40 CFR part 26.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 
10,242 hours per response. Burden is defined in 5 CFR 1320.3(b).
    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:
    Respondents/Affected Entities: Entities potentially affected by 
this ICR are any entities that submits protocols and study reports for 
environmental research involving human subjects under FIFRA and/or 
FFDCA.
    Respondent's obligation to respond: Mandatory under 40 CFR part 26.
    Estimated total number of potential respondents: 5 annually for 
research involving intentional exposure of human subjects and 5 
annually for all other submitted research with human subjects.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 10,242 hours.
    Estimated total annual costs: $ 1,051,0896. This includes an 
estimated burden cost of $ 0 for capital investment or maintenance and 
operational costs.

III. Are there changes in the estimates from the last approval?

    The estimated respondent burden remains 10,242 hours, which is the 
same as that approved by OMB for the existing ICR. The anticipated 
number of responses per year is based on the submissions to the Agency 
in the recent past and recognition that some of the studies underway 
will be submitted prior to the start of the renewal period. The annual 
burden per activity is estimated to be 1,446 hours per response for 
research involving intentional exposure of human subjects, and 12 hours 
per response for all other research with human subjects.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal 
agencies and departments and that is based on the submission 
instructions established by OMB in 1995, replacing the alternate format 
developed by EPA and OMB prior to 1995. The Agency does not expect this 
change in format to result in substantive changes to the information 
collection activities or related estimated burden and costs.

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.

Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-18836 Filed 8-31-21; 8:45 am]
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