82_FR_44798 82 FR 44614 - FIFRA Scientific Advisory Panel; Notice of Public Meeting for the Clarification of Charge Questions on PBPK

82 FR 44614 - FIFRA Scientific Advisory Panel; Notice of Public Meeting for the Clarification of Charge Questions on PBPK

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 184 (September 25, 2017)

Page Range44614-44615
FR Document2017-20430

There will be a three-hour meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to review and consider the scope and clarity of the draft charge questions for the October 24-27, 2017 SAP Meeting on physiologically-based pharmacokinetic (PBPK) modeling to address pharmacokinetic differences between and within species.

Federal Register, Volume 82 Issue 184 (Monday, September 25, 2017) 
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44614-44615]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20430]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0180; FRL-9967-59]


FIFRA Scientific Advisory Panel; Notice of Public Meeting for the 
Clarification of Charge Questions on PBPK

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a three-hour meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
review and consider the scope and clarity of the draft charge questions 
for the October 24-27, 2017 SAP Meeting on physiologically-based 
pharmacokinetic (PBPK) modeling to address pharmacokinetic differences 
between and within species.

DATES: The meeting will be held on October 2, 2017, from approximately 
2 p.m. to 5 p.m. (EST). This is an open public meeting that will be 
conducted via webcast using Adobe Connect and telephone. Registration 
is required to attend this meeting. Please visit: http://www.epa.gov/sap to register.
    Comments. Written comments on the scope and clarity of the draft 
charge questions should be submitted by noon on September 27, 2017. 
FIFRA SAP may not be able to fully consider written comments submitted 
after noon on September 27, 2017. Requests to make oral comments at the 
meeting should be submitted on or before noon on September 27, 2017 by 
registering at http://www.epa.gov/sap. For additional instructions, see 
Unit I.C. of the SUPPLEMENTARY INFORMATION or contact the Designated 
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT.
    Webcast. This meeting will be webcast only. Please refer to the 
FIFRA SAP Web site at http://www.epa.gov/sap for information on how to 
access the webcast.
    Special accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT at least 10 days prior to the meeting to allow EPA time to 
process your request.

ADDRESSES: Meeting: This meeting will be webcast only. Please refer to 
the following Web site to register and for information on how to access 
the webcast: http://www.epa.gov/sap.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2017-0180, by one of the following methods:
     Federal eRulemaking Portal: 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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    Requests for special accommodations. Submit requests for special 
accommodations to the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:  Dr. Marquea D. King, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 
telephone number: 202-564-3626; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. If your comments contain any information that 
you consider to be CBI or otherwise protected, please contact the DFO 
listed under FOR FURTHER INFORMATION CONTACT to obtain special 
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. How may I participate in this meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2017-0180 in the subject line 
on the first page of your request.
    1. Written comments. Written comments should be submitted, using 
the instructions in ADDRESSES and Unit I.B., on or before noon on 
September 27, 2017, to provide FIFRA SAP the time necessary to consider 
and review the written comments. FIFRA SAP may not be able to fully 
consider written comments submitted after noon on September 27, 2017.
    2. Oral comments. Registration is required to attend this meeting. 
Please visit: http://www.epag.gov/sap to register. Each individual or 
group wishing to make brief oral comments to FIFRA SAP may submit their 
request by registering on or before noon September 27, 2017. Oral 
comments before FIFRA SAP are limited to approximately 5 minutes due to 
the time constraints of this webcast.

II. Background

A. Purpose of FIFRA SAP Virtual Meeting on PBPK Charge Questions

    FIFRA SAP serves as the primary scientific peer review mechanism of 
EPA's Office of Chemical Safety and

[[Page 44615]]

Pollution Prevention (OCSPP) and is structured to provide scientific 
advice, information and recommendations to the EPA Administrator on 
pesticides and pesticide-related issues as to the impact of regulatory 
actions on health and the environment. FIFRA SAP is a Federal advisory 
committee established in 1975 pursuant to FIFRA and operates in 
accordance with requirements of the Federal Advisory Committee Act (5 
U.S.C. Appendix). FIFRA SAP is composed of a permanent panel consisting 
of seven members who are appointed by the EPA Administrator from 
nominees provided by the National Institutes of Health and the National 
Science Foundation. The FIFRA SAP is assisted in their reviews by ad 
hoc participation from the Science Review Board (SRB). As a scientific 
peer review mechanism, FIFRA SAP provides comments, evaluations, and 
recommendations to improve the effectiveness and quality of analyses 
made by Agency scientists. The FIFRA SAP strives to reach consensus 
however, is not required to reach consensus in its recommendations to 
the Agency.

B. Public Meeting

    During the meeting scheduled for October 2, 2017, the FIFRA SAP 
will review and consider the Charge Questions for the Panel's October 
24-27, 2017 Meeting on Physiologically Based Pharmacokinetic (PBPK) 
Modeling. The SAP will receive a short background briefing including 
the EPA's history and current position on the use of PBPK modeling. In 
addition, the panel members will have the opportunity to comment on the 
scope and clarity of the draft charge questions. Subsequent to this 
meeting, final charge questions will be provided for the FIFRA SAP's 
deliberation on the white papers and supplemental information during 
the in-person meeting to be held on October 24-27, 2017.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background documents, charge questions to the FIFRA SAP, and 
the meeting agenda will be available before or on September 13, 2017. 
In addition, the Agency may provide additional background documents as 
additional materials become available. You may obtain electronic copies 
of most meeting documents, including FIFRA SAP composition (i.e., 
members and ad hoc members for this meeting) and the meeting agenda, at 
http://www.regulations.gov and the FIFRA SAP Web site at http://www.epa.gov/sap.
    FIFRA SAP will prepare meeting minutes approximately 90 calendar 
days after the meeting. The meeting minutes will be posted on the FIFRA 
SAP Web site: http://www.epa.gov/sap and may be accessed in the docket 
at http://www.regulations.gov.

    Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

    Dated: September 11, 2017.
Inza Graves,
Acting, Director, Office of Science Coordination and Policy.
[FR Doc. 2017-20430 Filed 9-22-17; 8:45 am]
 BILLING CODE 6560-50-P

44614 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices Proposed Agreement may be obtained September 27, 2017 by registering at I. General Information from Andrew S. Goldman (3RC41), http://www.epa.gov/sap. For additional A. Does this action apply to me? Senior Assistant Regional Counsel, U.S. instructions, see Unit I.C. of the Environmental Protection Agency, 1650 SUPPLEMENTARY INFORMATION or contact This action is directed to the public Arch Street, Philadelphia, PA 19103. the Designated Federal Official (DFO) in general. This action may, however, be Comments should reference the ‘‘New listed under FOR FURTHER INFORMATION of interest to persons who are or may be Jersey Fireworks Superfund Site, CONTACT. required to conduct testing of chemical Proposed Settlement Agreement’’ and substances under the Federal Food, Webcast. This meeting will be ‘‘EPA CERCLA Docket No. CERC–03– Drug, and Cosmetic Act (FFDCA) and webcast only. Please refer to the FIFRA 2017–0138CR,’’ and should be FIFRA. Since other entities may also be SAP Web site at http://www.epa.gov/sap forwarded to Andrew S. Goldman at the interested, the Agency has not for information on how to access the above address. attempted to describe all the specific webcast. FOR FURTHER INFORMATION CONTACT: entities that may be affected by this Special accommodations. For action. Andrew S. Goldman (3RC41), U.S. information on access or services for Environmental Protection Agency, 1650 individuals with disabilities, and to B. What should I consider as I prepare Arch Street, Philadelphia, PA 19103, request accommodation of a disability, my comments for EPA? Phone: (215) 814–2487; please contact the DFO listed under FOR 1. Submitting CBI. Do not submit CBI Goldman.andrew@epa.gov. FURTHER INFORMATION CONTACT at least information to EPA through Dated: August 31, 2017. 10 days prior to the meeting to allow regulations.gov or email. If your Karen Melvin, EPA time to process your request. comments contain any information that Director, Hazardous Site Cleanup Division, ADDRESSES: Meeting: This meeting will you consider to be CBI or otherwise U.S. Environmental Protection Agency, be webcast only. Please refer to the protected, please contact the DFO listed Region III. following Web site to register and for under FOR FURTHER INFORMATION [FR Doc. 2017–20313 Filed 9–22–17; 8:45 am] CONTACT to obtain special instructions information on how to access the BILLING CODE 6560–50–P webcast: http://www.epa.gov/sap. before submitting your comments. 2. Tips for preparing your comments. Comments. Submit your comments, When preparing and submitting your ENVIRONMENTAL PROTECTION identified by docket identification (ID) comments, see the commenting tips at AGENCY number EPA–HQ–OPP–2017–0180, by http://www.epa.gov/dockets/ one of the following methods: comments.html. [EPA–HQ–OPP–2017–0180; FRL–9967–59] • Federal eRulemaking Portal: http:// C. How may I participate in this FIFRA Scientific Advisory Panel; www.regulations.gov. Follow the online meeting? Notice of Public Meeting for the instructions for submitting comments. Do not submit electronically any You may participate in this meeting Clarification of Charge Questions on by following the instructions in this PBPK information you consider to be Confidential Business Information (CBI) unit. To ensure proper receipt by EPA, AGENCY: Environmental Protection or other information whose disclosure is it is imperative that you identify docket Agency (EPA). restricted by statute. ID number EPA–HQ–OPP–2017–0180 in ACTION: Notice. • Mail: OPP Docket, Environmental the subject line on the first page of your Protection Agency Docket Center (EPA/ request. SUMMARY: There will be a three-hour 1. Written comments. Written DC), (28221T), 1200 Pennsylvania Ave. meeting of the Federal Insecticide, comments should be submitted, using NW., Washington, DC 20460–0001. Fungicide, and Rodenticide Act the instructions in ADDRESSES and Unit Scientific Advisory Panel (FIFRA SAP) • Hand Delivery: To make special I.B., on or before noon on September 27, to review and consider the scope and arrangements for hand delivery or 2017, to provide FIFRA SAP the time clarity of the draft charge questions for delivery of boxed information, please necessary to consider and review the the October 24–27, 2017 SAP Meeting follow the instructions at http:// written comments. FIFRA SAP may not on physiologically-based www.epa.gov/dockets/contacts.html. be able to fully consider written pharmacokinetic (PBPK) modeling to Additional instructions on commenting comments submitted after noon on address pharmacokinetic differences or visiting the docket, along with more September 27, 2017. between and within species. information about dockets generally, is 2. Oral comments. Registration is DATES: The meeting will be held on available at http://www.epa.gov/ required to attend this meeting. Please October 2, 2017, from approximately 2 dockets. visit: http://www.epag.gov/sap to p.m. to 5 p.m. (EST). This is an open Requests for special accommodations. register. Each individual or group public meeting that will be conducted Submit requests for special wishing to make brief oral comments to via webcast using Adobe Connect and accommodations to the DFO listed FIFRA SAP may submit their request by telephone. Registration is required to under FOR FURTHER INFORMATION registering on or before noon September attend this meeting. Please visit: http:// CONTACT. 27, 2017. Oral comments before FIFRA www.epa.gov/sap to register. SAP are limited to approximately 5 FOR FURTHER INFORMATION CONTACT: minutes due to the time constraints of asabaliauskas on DSKBBXCHB2PROD with NOTICES Comments. Written comments on the scope and clarity of the draft charge Dr. Marquea D. King, DFO, Office of this webcast. questions should be submitted by noon Science Coordination and Policy (7201M), Environmental Protection II. Background on September 27, 2017. FIFRA SAP may not be able to fully consider written Agency, 1200 Pennsylvania Ave. NW., A. Purpose of FIFRA SAP Virtual comments submitted after noon on Washington, DC 20460–0001; telephone Meeting on PBPK Charge Questions September 27, 2017. Requests to make number: 202–564–3626; email address: FIFRA SAP serves as the primary oral comments at the meeting should be king.marquea@epa.gov. scientific peer review mechanism of submitted on or before noon on SUPPLEMENTARY INFORMATION: EPA’s Office of Chemical Safety and VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1

Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44615 Pollution Prevention (OCSPP) and is FIFRA SAP will prepare meeting to states and tribes as they apply for and structured to provide scientific advice, minutes approximately 90 calendar days carry out these grants. information and recommendations to after the meeting. The meeting minutes DATES: This action is applicable as of the EPA Administrator on pesticides will be posted on the FIFRA SAP Web October 15, 2017. EPA expects to make and pesticide-related issues as to the site: http://www.epa.gov/sap and may non-competitive grant awards to states impact of regulatory actions on health be accessed in the docket at http:// and tribes which apply during fiscal and the environment. FIFRA SAP is a www.regulations.gov. year 2018. Federal advisory committee established Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. ADDRESSES: Mailing addresses for EPA in 1975 pursuant to FIFRA and operates 301 et seq. Regional Offices and EPA Headquarters in accordance with requirements of the can be found at www.epa.gov/ Dated: September 11, 2017. Federal Advisory Committee Act (5 brownfields and at the end of this U.S.C. Appendix). FIFRA SAP is Inza Graves, Acting, Director, Office of Science Notice. Funding requests may be composed of a permanent panel Coordination and Policy. submitted electronically to the EPA consisting of seven members who are [FR Doc. 2017–20430 Filed 9–22–17; 8:45 am] Regional Offices. appointed by the EPA Administrator from nominees provided by the National BILLING CODE 6560–50–P FOR FURTHER INFORMATION CONTACT: Institutes of Health and the National EPA’s Office of Land and Emergency Science Foundation. The FIFRA SAP is Management, Office of Brownfields and assisted in their reviews by ad hoc ENVIRONMENTAL PROTECTION Land Revitalization, (202) 566–2745 or participation from the Science Review AGENCY the applicable EPA Regional Office Board (SRB). As a scientific peer review listed at the end this Notice. mechanism, FIFRA SAP provides [FRL–9967–74–OLEM] SUPPLEMENTARY INFORMATION: comments, evaluations, and I. General Information recommendations to improve the Comprehensive Environmental effectiveness and quality of analyses Response, Compensation and Liability Section 128(a) of the Comprehensive made by Agency scientists. The FIFRA Act (CERCLA) or Superfund, Section Environmental Response, SAP strives to reach consensus 128(a); Notice of Grant Funding Compensation, and Liability Act however, is not required to reach Guidance for State and Tribal (CERCLA), as amended, authorizes a consensus in its recommendations to Response Programs for FY2018 noncompetitive $50 million grant the Agency. program to establish and enhance state 1 AGENCY: Environmental Protection and tribal 2 response programs. CERCLA B. Public Meeting Agency (EPA). section 128(a) response program grants During the meeting scheduled for ACTION: Notice. are funded with categorical 3 State and October 2, 2017, the FIFRA SAP will Tribal Assistance Grant (STAG) review and consider the Charge SUMMARY: The Environmental Protection appropriations. Section 128(a) Questions for the Panel’s October 24–27, Agency (EPA) will accept requests, from cooperative agreements are awarded and 2017 Meeting on Physiologically Based October 15, 2017 through December 15, administered by the EPA regional Pharmacokinetic (PBPK) Modeling. The 2017, for grants to establish and offices. Generally, these response SAP will receive a short background enhance State and Tribal Response programs address the assessment, briefing including the EPA’s history and Programs. This notice provides cleanup, and redevelopment of current position on the use of PBPK guidance on eligibility for funding, use brownfields sites and other sites with modeling. In addition, the panel of funding, grant mechanisms and actual or perceived contamination. This members will have the opportunity to process for awarding funding, the document provides guidance that will comment on the scope and clarity of the allocation system for distribution of enable states and tribes to apply for and draft charge questions. Subsequent to funding, and terms and reporting under use Fiscal Year 2018 section 128(a) this meeting, final charge questions will these grants. EPA has consulted with funds.4 be provided for the FIFRA SAP’s state and tribal officials in developing The Catalogue of Federal Domestic deliberation on the white papers and this guidance. Assistance entry for the section 128(a) supplemental information during the in- The primary goal of this funding is to State and Tribal Response Program person meeting to be held on October ensure that state and tribal response cooperative agreements is 66.817. This 24–27, 2017. programs include, or are taking grant program is eligible to be included reasonable steps to include, certain in state and tribal Performance C. FIFRA SAP Documents and Meeting elements of a response program and Minutes Partnership Grants under 40 CFR part establishing a public record. Another 35 Subparts A and B, with the exception EPA’s background documents, charge goal is to provide funding for other of funds used to capitalize a revolving questions to the FIFRA SAP, and the activities that increase the number of loan fund for brownfield remediation meeting agenda will be available before response actions conducted or overseen or on September 13, 2017. In addition, by a state or tribal response program. 1 The term ‘‘state’’ is defined in this document as the Agency may provide additional This funding is not intended to supplant defined in CERCLA section 101(27). background documents as additional current state or tribal funding for their 2 The term ‘‘Indian tribe’’ is defined in this document as it is defined in CERCLA section asabaliauskas on DSKBBXCHB2PROD with NOTICES materials become available. You may response programs. Instead, it is to 101(36). Intertribal consortia, as defined in the obtain electronic copies of most meeting supplement their funding to increase Federal Register Notice at 67 FR 67181, November documents, including FIFRA SAP their response capacity. 4, 2002, are also eligible for funding under CERCLA composition (i.e., members and ad hoc For fiscal year 2018, EPA will section 128(a). members for this meeting) and the consider funding requests up to a 3 Categorical grants are issued by the U.S. meeting agenda, at http:// maximum of $1.0 million per state or Congress to fund state and local governments for narrowly defined purposes. www.regulations.gov and the FIFRA tribe. Subject to the availability of 4 The Agency may waive any provision of this SAP Web site at http://www.epa.gov/ funds, EPA regional personnel will be guidance that is not required by statute, regulation, sap. available to provide technical assistance Executive Order or overriding Agency policies. 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Document Created: 2018-10-24 14:44:37
Document Modified: 2018-10-24 14:44:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on October 2, 2017, from approximately 2 p.m. to 5 p.m. (EST). This is an open public meeting that will be conducted via webcast using Adobe Connect and telephone. Registration is required to attend this meeting. Please visit: http://www.epa.gov/ sap to register.
ContactDr. Marquea D. King, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
FR Citation82 FR 44614 
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