Document ID: EPA-HQ-OPP-2021-0315-0013
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: 2022-04-25T04:00Z

[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24297-24298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08707]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0315; FRL-9790-01-OMS]

Information Collection Request Submitted to OMB 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.

-----------------------------------------------------------------------

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 2195.06, 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, 2022. Public comments 
were previously requested via the Federal Register on September 1, 
2021, during a 60-day comment period. This notice allows for an 
additional 30 days for public comments. A fuller description of the ICR 
is given below, including its estimated burden and cost to the public. 
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.

DATES: Additional comments may be submitted on or before May 25, 2022.

ADDRESSES: Submit your comments to EPA, referencing Docket ID Number 
EPA-HQ-OPP-2021-0315, online using www.regulations.gov (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

[[Page 24298]]

(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 
www.reginfo.gov/public/do/PRAMain. 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, 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; telephone number: (202) 
566-1205; email address: [email protected].

SUPPLEMENTARY INFORMATION: 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 
www.regulations.gov 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 https://www.epa.gov/dockets.
    Abstract: 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'' research (i.e., 
research that is not conducted or sponsored by 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.
    Form Numbers: None.
    Respondents/affected entities: Any entities that submits to EPA 
under FIFRA and/or FFDCA protocols and study reports for environmental 
research involving human subjects.
    Respondent's obligation to respond: Mandatory under 40 CFR part 26.
    Estimated number of respondents: 10 (total).
    Frequency of response: On occasion.
    Total estimated burden: 8,276 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $859,215 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    Changes in the Estimates: There is an estimated decrease of 1,966 
hours in the total estimated respondent burden compared with the ICR 
currently approved by OMB. This decrease is a result of the anticipated 
number of responses per year for the next three years based on comments 
received from stakeholders. This change is an adjustment.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-08707 Filed 4-22-22; 8:45 am]
BILLING CODE 6560-50-P