83_FR_14702 83 FR 14636 - Human Studies Review Board; Notification of Public Meetings

83 FR 14636 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 66 (April 5, 2018)

Page Range14636-14637
FR Document2018-06990

The Environmental Protection Agency (EPA), Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

Federal Register, Volume 83 Issue 66 (Thursday, April 5, 2018)
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14636-14637]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06990]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9976-38-ORD]


Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA), Office of the 
Science Advisor announces two separate public meetings of the Human 
Studies Review Board (HSRB) to advise the Agency on the ethical and 
scientific review of research involving human subjects.

DATES: A virtual public meeting will be held on Tuesday, April 24, 
2018, Wednesday, April 25, 2018, and Thursday, April 26, 2018 from 1:00 
p.m. to approximately 5:30 p.m. Eastern Time on all dates. A separate, 
subsequent teleconference meeting is planned for Thursday, June 14, 
2018, from 2:00 p.m. to approximately 3:30 p.m. Eastern Time for the 
HSRB to finalize its Final Report of the April 24-26, 2018 meeting and 
review other possible topics.

ADDRESSES: All of these meetings will be conducted entirely by 
telephone and on the internet using Adobe Connect. For detailed access 
information visit the HSRB website: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact the HSRB Designated Federal 
Official (DFO), Thomas O'Farrell on telephone number (202) 564-8451; 
fax number: (202) 564-2070; email address: [email protected]; or 
mailing address: Environmental Protection Agency, Office of the Science 
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC 
20460.

SUPPLEMENTARY INFORMATION: 
    Meeting access: These meetings will be open to the public. The full 
Agenda and meeting materials will be available at the HSRB website: 
http://www2.epa.gov/osa/human-studies-review-board . For questions on 
document availability, or if you do not have access to the internet, 
consult with the DFO, Thomas O'Farrell, listed under FOR FURTHER 
INFORMATION, CONTACT.
    Special accommodations. For information on access or services for 
individuals with disabilities, or 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 give EPA 
as much time as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in 
these meetings by following the instructions in this section.
    1. Oral comments. To pre-register to make oral comments, please 
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER 
INFORMATION, CONTACT. Requests to present oral comments during either 
meeting will be accepted up to Noon Eastern Time on Tuesday, April 17, 
2018, for the April 24-26, 2018 meeting and up to Noon Eastern Time on 
Thursday, June 7, 2018 for the June 14, 2018 meeting. To the extent 
that time permits, interested persons who have not pre-registered may 
be permitted by the HSRB Chair to present oral comments during either 
meeting at the designated time on the agenda. Oral comments before the 
HSRB are generally limited to five minutes per individual or 
organization. If additional time is available, further public comments 
may be possible.
    2. Written comments. Submit your written comments prior to the 
meetings. For the Board to have the best opportunity to review and 
consider your comments as it deliberates, you should submit your 
comments by Noon Eastern Time on Tuesday, April 17, 2018, for the April 
24-26, 2018 meeting and up to Noon Eastern Time on Thursday, June 7, 
2018 for the June 14, 2018 meeting. If you submit comments after these 
dates, those comments will be provided to the HSRB members, but you 
should recognize that the HSRB members may not have adequate time to 
consider your comments prior to their discussion. You should submit 
your comments to the DFO, Thomas O'Farrell listed under FOR FURTHER 
INFORMATION, CONTACT. There is no limit on the length of written 
comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act 5 U.S.C. App.2 Sec.  9. The 
HSRB provides advice, information, and recommendations on issues 
related to scientific and ethical aspects of third-party human subjects 
research that are submitted to the Office of Pesticide Programs (OPP) 
to be used for regulatory purposes.
    Topic for discussion. On April 24-26, 2018, EPA's Human Studies 
Review Board will consider four topics: (1) A protocol for laboratory-
based testing of a tick repellent containing Oil of Lemon Eucalyptus, 
submitted by ARCTEC (Arthropod Control Product Centre) and by sponsored 
by Citrefine International, (2) a published article titled ``Assessing 
key safety concerns of a Wolbachia-based strategy to control dengue 
transmission by Aedes mosquitoes'', authored by Jean Popovici, Luciano 
A Moriera, Anne Poinsignon, Inaki Iturbe-Ormaetxe, Darlene McNaughton, 
and Scott O'Neill, (3) a completed study submitted by the Antimicrobial 
Exposure Assessment Task Force: ``Determination of Removal Efficiency 
of 1,2-Benzisothiazol-3(2H)-one (BIT) from Hand Surfaces Using an 
Isopropyl Alcohol/Water Wipe and Wash Procedure'', and (4) a completed 
study submitted by the Antimicrobial Exposure Assessment Task Force: 
``A Study for Measurement of Potential Dermal and Inhalation Exposure 
During Application of a Latex Paint Containing an Antimicrobial 
Pesticide Product Using a Brush and Roller for Indoor Surface 
Painting''.
    The Agenda and meeting materials for these topics will be available 
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On June 14, 2018, the HSRB will review and finalize their draft 
Final Report from the April 24-26, 2018 meeting, in addition to other 
topics that may come before the Board. The HSRB may also discuss 
planning for future HSRB meetings. The agenda and the draft report will 
be available prior to the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings, 
summarizing the matters discussed and recommendations made by the HSRB, 
will be released within 90 calendar days of the meeting. These minutes 
will be available at http://www2.epa.gov/osa/

[[Page 14637]]

human-studies-review-board. In addition, information regarding the 
HSRB's Final Report, will be found at http://www2.epa.gov/osa/human-studies-review-board or from Thomas O'Farrell listed under FOR FURTHER 
INFORMATION, CONTACT.

    Dated: March 26, 2018.
Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2018-06990 Filed 4-4-18; 8:45 am]
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                                             14636                          Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices

                                             circulation in the state. A notice will                 address: Environmental Protection                     listed under FOR FURTHER INFORMATION,
                                             also be sent to both the person(s)                      Agency, Office of the Science Advisor,                CONTACT.  There is no limit on the length
                                             requesting the hearing and the state. The               Mail code 8105R, 1200 Pennsylvania                    of written comments for consideration
                                             hearing notice will include a statement                 Avenue NW, Washington, DC 20460.                      by the HSRB.
                                             of purpose of the hearing, information                  SUPPLEMENTARY INFORMATION:                            Background
                                             regarding time and location for the                        Meeting access: These meetings will
                                             hearing, and the address and telephone                  be open to the public. The full Agenda                   The HSRB is a Federal advisory
                                             number where interested persons may                     and meeting materials will be available               committee operating in accordance with
                                             obtain further information. The RA will                 at the HSRB website: http://                          the Federal Advisory Committee Act 5
                                             issue an order affirming or rescinding                  www2.epa.gov/osa/human-studies-                       U.S.C. App.2 § 9. The HSRB provides
                                             the determination upon review of the                    review-board . For questions on                       advice, information, and
                                             hearing record.                                         document availability, or if you do not               recommendations on issues related to
                                                Please bring this notice to the                      have access to the internet, consult with             scientific and ethical aspects of third-
                                             attention of any persons known by you                   the DFO, Thomas O’Farrell, listed under               party human subjects research that are
                                             to have an interest in this                             FOR FURTHER INFORMATION, CONTACT.                     submitted to the Office of Pesticide
                                             determination.                                             Special accommodations. For                        Programs (OPP) to be used for regulatory
                                                                                                     information on access or services for                 purposes.
                                               Dated: March 8, 2018.                                                                                          Topic for discussion. On April 24–26,
                                                                                                     individuals with disabilities, or to
                                             Douglas H. Benevento,                                                                                         2018, EPA’s Human Studies Review
                                                                                                     request accommodation of a disability,
                                             Regional Administrator, Region 8.                                                                             Board will consider four topics: (1) A
                                                                                                     please contact the DFO listed under FOR
                                             [FR Doc. 2018–06758 Filed 4–4–18; 8:45 am]              FURTHER INFORMATION, CONTACT at least                 protocol for laboratory-based testing of a
                                             BILLING CODE 6560–50–P                                  10 days prior to the meeting to give EPA              tick repellent containing Oil of Lemon
                                                                                                     as much time as possible to process                   Eucalyptus, submitted by ARCTEC
                                                                                                     your request.                                         (Arthropod Control Product Centre) and
                                             ENVIRONMENTAL PROTECTION                                                                                      by sponsored by Citrefine International,
                                             AGENCY                                     How may I participate in this meeting?                             (2) a published article titled ‘‘Assessing
                                             [FRL–9976–38–ORD]                            The HSRB encourages the public’s                                 key safety concerns of a Wolbachia-
                                                                                        input. You may participate in these                                based strategy to control dengue
                                             Human Studies Review Board;                meetings by following the instructions                             transmission by Aedes mosquitoes’’,
                                             Notification of Public Meetings            in this section.                                                   authored by Jean Popovici, Luciano A
                                                                                          1. Oral comments. To pre-register to                             Moriera, Anne Poinsignon, Inaki Iturbe-
                                             AGENCY: Environmental Protection           make oral comments, please contact the                             Ormaetxe, Darlene McNaughton, and
                                             Agency (EPA).                              DFO, Thomas O’Farrell, listed under                                Scott O’Neill, (3) a completed study
                                             ACTION: Notice.                            FOR FURTHER INFORMATION, CONTACT.                                  submitted by the Antimicrobial
                                             SUMMARY: The Environmental Protection
                                                                                        Requests to present oral comments                                  Exposure Assessment Task Force:
                                             Agency (EPA), Office of the Science        during either meeting will be accepted                             ‘‘Determination of Removal Efficiency of
                                             Advisor announces two separate public      up to Noon Eastern Time on Tuesday,                                1,2-Benzisothiazol-3(2H)-one (BIT) from
                                                                                        April 17, 2018, for the April 24–26,                               Hand Surfaces Using an Isopropyl
                                             meetings of the Human Studies Review
                                                                                        2018 meeting and up to Noon Eastern                                Alcohol/Water Wipe and Wash
                                             Board (HSRB) to advise the Agency on
                                                                                        Time on Thursday, June 7, 2018 for the                             Procedure’’, and (4) a completed study
                                             the ethical and scientific review of
                                                                                        June 14, 2018 meeting. To the extent                               submitted by the Antimicrobial
                                             research involving human subjects.
                                                                                        that time permits, interested persons                              Exposure Assessment Task Force: ‘‘A
                                             DATES: A virtual public meeting will be    who have not pre-registered may be                                 Study for Measurement of Potential
                                             held on Tuesday, April 24, 2018,           permitted by the HSRB Chair to present                             Dermal and Inhalation Exposure During
                                             Wednesday, April 25, 2018, and             oral comments during either meeting at                             Application of a Latex Paint Containing
                                             Thursday, April 26, 2018 from 1:00 p.m. the designated time on the agenda. Oral
                                                                                                                                                           an Antimicrobial Pesticide Product
                                             to approximately 5:30 p.m. Eastern         comments before the HSRB are                                       Using a Brush and Roller for Indoor
                                             Time on all dates. A separate,             generally limited to five minutes per                              Surface Painting’’.
                                             subsequent teleconference meeting is       individual or organization. If additional                             The Agenda and meeting materials for
                                             planned for Thursday, June 14, 2018,       time is available, further public                                  these topics will be available in advance
                                             from 2:00 p.m. to approximately 3:30       comments may be possible.                                          of the meeting at http://www2.epa.gov/
                                             p.m. Eastern Time for the HSRB to            2. Written comments. Submit your                                 osa/human-studies-review-board.
                                             finalize its Final Report of the April 24– written comments prior to the meetings.                               On June 14, 2018, the HSRB will
                                             26, 2018 meeting and review other          For the Board to have the best                                     review and finalize their draft Final
                                             possible topics.                           opportunity to review and consider your                            Report from the April 24–26, 2018
                                             ADDRESSES: All of these meetings will be comments as it deliberates, you should                               meeting, in addition to other topics that
                                             conducted entirely by telephone and on submit your comments by Noon Eastern                                   may come before the Board. The HSRB
                                             the internet using Adobe Connect. For      Time on Tuesday, April 17, 2018, for                               may also discuss planning for future
                                             detailed access information visit the      the April 24–26, 2018 meeting and up                               HSRB meetings. The agenda and the
                                             HSRB website: http://www2.epa.gov/         to Noon Eastern Time on Thursday,                                  draft report will be available prior to the
                                             osa/human-studies-review-board.            June 7, 2018 for the June 14, 2018                                 meeting at http://www2.epa.gov/osa/
                                             FOR FURTHER INFORMATION CONTACT: Any meeting. If you submit comments after                                    human-studies-review-board.
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                                             member of the public who wishes to         these dates, those comments will be                                   Meeting minutes and final reports.
                                             receive further information should         provided to the HSRB members, but you                              Minutes of these meetings, summarizing
                                             contact the HSRB Designated Federal        should recognize that the HSRB                                     the matters discussed and
                                             Official (DFO), Thomas O’Farrell on        members may not have adequate time to                              recommendations made by the HSRB,
                                             telephone number (202) 564–8451; fax       consider your comments prior to their                              will be released within 90 calendar days
                                             number: (202) 564–2070; email address: discussion. You should submit your                                     of the meeting. These minutes will be
                                             ofarrell.thomas@epa.gov; or mailing        comments to the DFO, Thomas O’Farrell                              available at http://www2.epa.gov/osa/


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                                                                            Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices                                         14637

                                             human-studies-review-board. In                          Resources stating that the 2017 and                   ACTION: Notice of proposed settlement;
                                             addition, information regarding the                     2018 MVEBs contained in the                           request for public comments.
                                             HSRB’s Final Report, will be found at                   Attainment Demonstration for the 2008
                                             http://www2.epa.gov/osa/human-                          Ozone Standard for Sheboygan County                   SUMMARY:  In accordance with section
                                             studies-review-board or from Thomas                     are adequate for transportation                     122(i) of the Comprehensive
                                             O’Farrell listed under FOR FURTHER                      conformity purposes. Receipt of these               Environmental Response Compensation,
                                             INFORMATION, CONTACT.                                   MVEBs was announced on EPA’s                        and Liability Act, as amended
                                                                                                     transportation conformity website, and              (‘‘CERCLA’’), notice is hereby given of a
                                               Dated: March 26, 2018.                                                                                    proposed administrative Settlement
                                                                                                     no comments were submitted. The
                                             Jennifer Orme-Zavaleta,                                                                                     Agreement for recovery of Past
                                                                                                     finding is available at EPA’s conformity
                                             EPA Science Advisor.                                    website: https://www.epa.gov/state-and-             Response Costs, as defined in the
                                             [FR Doc. 2018–06990 Filed 4–4–18; 8:45 am]              local-transportation/adequacy-review-               Settlement Agreement, under CERCLA
                                             BILLING CODE 6560–50–P                                  state-implementation-plan-sip-                      section 122(h) of CERCLA, concerning
                                                                                                     submissions-conformity.                             the New Hampshire Dioxane Site,
                                                                                                        The 2017 and 2018 MVEBs, in tons                 located in Atkinson and Hampstead,
                                             ENVIRONMENTAL PROTECTION                                per day (tpd), for VOCs and NOX for the             New Hampshire with Gould Electronics
                                             AGENCY                                                  Sheboygan County, Wisconsin area are                Inc. The settlement requires Gould
                                             [EPA–R05–OAR–2017–0579; FRL–9976–12–                    as follows:                                         Electronics Inc. to pay $1,900,000, plus
                                             Region 5]                                                                                                   interest on that amount calculated from
                                                                                                        Sheboygan County                 NO  X   VOCs    March 28, 2016 through the date of
                                             Adequacy Status of the Sheboygan                                                            (tpd)   (tpd)   payment, to the Hazardous Substance
                                             County, Wisconsin Area for the                                                                              Superfund.
                                                                                                     2017 ..............................    1.62    3.29
                                             Submitted 2008 Ozone Standard                           2018 ..............................    1.49    2.96 DATES: Comments must be submitted by
                                             Attainment Demonstration for                                                                                May 7, 2018.
                                             Transportation Conformity Purposes                         Transportation conformity is required ADDRESSES: Comments should be
                                             AGENCY: Environmental Protection                        by section 176(c) of the Clean Air Act.             addressed to John Hultgren,
                                             Agency (EPA).                                           EPA’s conformity rule requires that                 Enforcement Counsel, U.S.
                                             ACTION: Notice of finding of adequacy.
                                                                                                     transportation plans, programs, and                 Environmental Protection Agency, 5
                                                                                                     projects conform to state air quality               Post Office Square, Suite 100 (OES04–
                                             SUMMARY:    In this notice, the EPA is                  implementation plans and establishes                2), Boston, MA 02109–3912 and should
                                             notifying the public that we find the                   the criteria and procedures for                     refer to: In re: New Hampshire Dioxane
                                             motor vehicle emissions budgets                         determining whether or not they do                  Site, EPA Region 1 CERCLA Docket No.
                                             (MVEBs) for volatile organic compounds                  conform. Conformity to a State                      01–2018–0013.
                                             (VOCs) and oxides of nitrogen (NOX) in                  Implementation Plan (SIP) means that                FOR FURTHER INFORMATION CONTACT: A
                                             the Sheboygan County, Wisconsin 2008                    transportation activities will not                  copy of the proposed Settlement
                                             Ozone Standard nonattainment area                       produce new air quality violations,                 Agreement may be obtained from John
                                             adequate for use in transportation                      worsen existing violations, or delay                Hultgren, Enforcement Counsel, U.S.
                                             conformity determinations. On                           timely attainment of the national                   Environmental Protection Agency, 5
                                             September 25, 2017, Wisconsin                           ambient air quality standards.                      Post Office Square, Suite 100 (OES04–
                                             submitted a 2008 Ozone Standard                            The criteria by which we determine               2), Boston, MA 02109–3912; (617) 918–
                                             Attainment Demonstration for                            whether a SIP’s MVEBs are adequate for 1761; hultgren.john@epa.gov.
                                             Sheboygan County, which included the                    transportation conformity purposes are
                                                                                                                                                         SUPPLEMENTARY INFORMATION: For 30
                                             MVEBs for 2017 and 2018. As a result                    outlined in 40 CFR 93.118(e)(4). Please
                                             of our finding, this area must use these                note that an adequacy review is separate days following the date of publication of
                                             MVEBs from the submitted Attainment                     from EPA’s completeness review, and is this notice, the Agency will receive
                                                                                                     also a separate action from EPA’s                   written comments relating to the
                                             Demonstration for future transportation                                                                     settlement. The United States will
                                             conformity determinations.                              evaluation of and decision whether to
                                                                                                     approve a proposed SIP revision.                    consider all comments received and
                                             DATES: This finding is applicable April                                                                     may modify or withdraw its consent to
                                             20, 2018.                                                  Authority: 42 U.S.C. 7401–7671 q.                the settlement if comments received
                                             FOR FURTHER INFORMATION CONTACT:                           Dated: March 20, 2018.                           disclose facts or considerations which
                                             Michael Leslie, Environmental                           Edward H. Chu,                                      indicate that the settlement is
                                             Engineer, Control Strategies Section                    Acting Regional Administrator, Region 5.            inappropriate, improper, or inadequate.
                                             (AR–18J), Air Programs Branch, Air and                  [FR Doc. 2018–06793 Filed 4–4–18; 8:45 am]          The Agency’s response to any comments
                                             Radiation Division, United States                       BILLING CODE 6560–50–P
                                                                                                                                                         received will be available for public
                                             Environmental Protection Agency,                                                                            inspection at 5 Post Office Square,
                                             Region 5, 77 West Jackson Boulevard,                                                                        Boston, MA 02109–3912.
                                             Chicago, Illinois 60604, (312) 353–6680,                ENVIRONMENTAL PROTECTION                               The proposed Settlement Agreement
                                             leslie.michael@epa.gov.                                 AGENCY                                              includes a covenant from EPA not to sue
                                             SUPPLEMENTARY INFORMATION:                                                                                  or take administrative action against
                                                                                                     [9976–15—Region 1]                                  Gould Electronics Inc. pursuant to
                                             Throughout this document, whenever
                                             ‘‘we’’, ‘‘us’’ or ‘‘our’’ is used, we mean              Proposed CERCLA Administrative                      section 107(a) of CERCLA, 42 U.S.C.
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                                             EPA.                                                    Cost Recovery Settlement; Gould                     9607(a), to recover Past Response Costs,
                                                                                                     Electronics Inc., New Hampshire                     and protection for Gould Electronics,
                                             Background                                                                                                  Inc. from contribution actions or claims
                                                                                                     Dioxane Site, Atkinson/Hampstead,
                                                This notice is an announcement of a                  New Hampshire                                       as provided by sections 113(f)(2) and
                                             finding that we have already made. On                                                                       122(h)(4) of CERCLA, 42 U.S.C. Section
                                             January 17, 2018, EPA sent a letter to                  AGENCY: Environmental Protection                    9613(f)(2) and 9622(h)(4). The
                                             the Wisconsin Department of Natural                     Agency (EPA).                                       settlement has been approved by the


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Document Created: 2018-11-01 09:13:36
Document Modified: 2018-11-01 09:13:36
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.
DatesA virtual public meeting will be held on Tuesday, April 24, 2018, Wednesday, April 25, 2018, and Thursday, April 26, 2018 from 1:00 p.m. to approximately 5:30 p.m. Eastern Time on all dates. A separate, subsequent teleconference meeting is planned for Thursday, June 14, 2018, from 2:00 p.m. to approximately 3:30 p.m. Eastern Time for the HSRB to finalize its Final Report of the April 24-26, 2018 meeting and review other possible topics.
ContactAny member of the public who wishes to receive further information should contact the HSRB Designated Federal Official (DFO), Thomas O'Farrell on telephone number (202) 564-8451;
FR Citation83 FR 14636 

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