Notice2022-08707
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)
Primary source
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Published
April 25, 2022
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 2195.06, 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.
Full Text
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<title>Federal Register, Volume 87 Issue 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24297-24298]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08707]
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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.
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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 2195.06, 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 <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
[[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
<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, 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: <a href="/cdn-cgi/l/email-protection#0f7c667a216c6e7d606376614f6a7f6e21686079"><span class="__cf_email__" data-cfemail="22514b570c4143504d4e5b4c624752430c454d54">[email protected]</span></a>.
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
<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="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
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