Notice2022-14937
PB&ACSS JV, LLC.; Transfer of Data (June 2022)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 13, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be transferred to PB&ACSS JV, LLC. and its subcontractors and consultants, CDM Smith, Summitec LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, in accordance with the CBI regulations. PB&ACSS JV, LLC. and its subcontractors and consultants have been awarded a contract to perform work for OPP, and access to this information will enable PB&ACSS JV, LLC. and its subcontractors and consultants to fulfill the obligations of the contract.
Full Text
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<title>Federal Register, Volume 87 Issue 133 (Wednesday, July 13, 2022)</title>
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[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41713-41714]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14937]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2022-0164; FRL-9998-01-OCSPP]
PB&ACSS JV, LLC.; Transfer of Data (June 2022)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to PB&ACSS JV, LLC. and its
subcontractors and consultants, CDM Smith, Summitec LLC, ICF, Gibb
Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, in accordance with
the CBI regulations. PB&ACSS JV, LLC. and its subcontractors and
consultants have been awarded a contract to perform work for OPP, and
access to this information will enable PB&ACSS JV, LLC. and its
subcontractors and consultants to fulfill the obligations of the
contract.
DATES: Data transfer and access to information will occur by July 18,
2022.
FOR FURTHER INFORMATION CONTACT: William Northern, Information
Technology and Resources Management Division (7601T), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number: (703) 305-6478;
email address: <a href="/cdn-cgi/l/email-protection#9df3f2efe9f5f8eff3b3eaf4f1f1f4fcf0ddf8edfcb3faf2eb"><span class="__cf_email__" data-cfemail="4c22233e3824293e22623b252020252d210c293c2d622b233a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA- EPA-HQ-OPP-2022-0164, is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Additional information about the docket, along
with instructions for visiting the docket in-person, is available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Contractor Requirements
Under Contract No. 68HERC22D0017, PB&ACSS JV, LLC. and its
subcontractors and consultants, CDM Smith, Summitec, LLC, ICF, Gibb
Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, will perform
critical reviews of EPA designated studies submitted by the registrants
and/or from the open literature, and these reviews will be provided to
the task order Contract Officer's Representative (COR) in DER or other
similar study evaluation report form or system, as applicable. A
template of the DER format provided to the contractor shall be followed
in the preparation of Data Evaluation Records (DER)s. See DER Templates
for Test Guidelines <a href="https://www.epa.gov/pesticide-registration/study-profile-templates">https://www.epa.gov/pesticide-registration/study-profile-templates</a>. Specific guidance for completing each section is
provided in the DER templates. Each review will encompass all items in
the study that contribute to the overall knowledge of the pesticide,
and will include the following:
1. An evaluation of the accuracy, credibility and scientific
validity of that study;
2. Its suitability for meeting specific data requirements.
3. Any necessary graphic displays of data, and/or summary tables
illustrating results of the study.
4. Sound scientific rationale for the conclusions reached on
specific studies.
5. Clarity in data presentation and adherence to the template and
overall guidance.
An evaluation for each study will include the following:
<bullet> Study identifying information.
<bullet> An in-depth examination of the materials and methods
employed.
<bullet> An in-depth examination of the reported results.
<bullet> An in-depth discussion of the reviewer's scientific
assessment of the study.
<bullet> A description of the reviewer's assessment which
summarizes the overall conclusions and significance of the study.
<bullet> Establishment of a no observable adverse effects levels
(NOAEL) and lowest observable adverse effects levels (LOAEL) based on
significant toxicological effects, if applicable.
<bullet> Characterize Good Laboratory Practice (GLP) compliance in
study protocols, reviews, and for data evaluations.
<bullet> Discussion of data's relevancy for supporting public
health claims in review of efficacy data.
OPP has determined that access by PB&ACSS JV, LLC. and its
subcontractors and consultants, CDM Smith, Summitec, LLC, ICF, Gibb
Epidemiology, Jerrold Ward, DVM, and WinTech, LLC, to information on
all pesticide chemicals is necessary for the performance of this
contract.
Some of this information may be entitled to confidential treatment.
The information has been submitted to EPA under FIFRA sections 3, 4, 6,
and 7 and under FFDCA sections 408 and 409.
In accordance with the requirements of 40 CFR 2.307(h)(2), the
contract with PB&ACSS JV, LLC. and its subcontractors and consultants,
CDM Smith, Summitec, LLC, ICF, Gibb Epidemiology, Jerrold Ward, DVM,
and WinTech, LLC, prohibits use of the information for any purpose not
specified in the contract; prohibits disclosure of the information to a
third party without prior written approval from the Agency; and
requires that each official and employee of the contractor sign an
agreement to protect the information from unauthorized release and to
handle it in accordance with the FIFRA Information Security Manual. In
addition, to the contractor and its subcontractors and consultants are
required to submit for EPA approval a security plan under which any CBI
will be secured and protected against unauthorized release or
compromise. No information will be provided to the contractor and its
subcontractors and consultants until the requirements in this document
have been fully satisfied. Records of information provided to the
contractor and its subcontractors and consultants will be maintained by
EPA Project Officers for this contract. All information supplied to to
the contractor and its subcontractors and consultants by EPA for use in
connection with this contract will be returned to EPA when to the
contractor
[[Page 41714]]
and its subcontractors and consultants have completed their work.
Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.
Dated: July 5, 2022.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2022-14937 Filed 7-12-22; 8:45 am]
BILLING CODE 6560-50-P
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