81_FR_14917 81 FR 14864 - Alternative Approaches for Acute Inhalation Toxicity To Address Global Regulatory and Non-Regulatory Data Requirements; Notice of Webinars; Registration Information

81 FR 14864 - Alternative Approaches for Acute Inhalation Toxicity To Address Global Regulatory and Non-Regulatory Data Requirements; Notice of Webinars; Registration Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range14864-14865
FR Document2016-06201

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the webinar series, ``Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-Regulatory Data Requirements.'' Webinar speakers will discuss the state of the science of alternative approaches for identifying acute systemic toxicants due to inhalation exposure, and identify knowledge and data gaps that need to be addressed prior to implementation of those approaches.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14864-14865]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Alternative Approaches for Acute Inhalation Toxicity To Address 
Global Regulatory and Non-Regulatory Data Requirements; Notice of 
Webinars; Registration Information

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) announces 
the webinar series, ``Alternative Approaches for Acute Inhalation 
Toxicity to Address Global Regulatory and Non-Regulatory Data 
Requirements.'' Webinar speakers will discuss the state of the science 
of alternative approaches for identifying acute systemic toxicants due 
to inhalation exposure, and identify knowledge and data gaps that need 
to be addressed prior to implementation of those approaches.

DATES: 
    First Webinar: March 29, 2016, from 11 a.m. to 12 p.m. Eastern 
Daylight Time (EDT).
    Subsequent Webinars: Five subsequent webinars will be presented 
monthly through August 2016; dates of the webinars will posted on the 
Web page.
    Registration for Webinars: Registration for each webinar will be 
open during the webinar.

ADDRESSES: Web page: The preliminary agenda, registration, and other 
meeting materials are at http://ntp.niehs.nih.gov/go/inhalation-2016.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION:
    Background: Acute systemic toxicity tests are designed to identify 
chemicals that could cause illness or death immediately or shortly 
after a single exposure. This webinar series will explore and discuss 
alternative approaches that could replace, reduce, or refine the use of 
animals for identifying chemicals that may cause acute systemic 
toxicity when inhaled.
    During the webinar series, participants will (1) define when and 
how acute systemic toxicity data are used for assessing inhalation 
toxicity hazard potential for both regulatory and non-regulatory 
testing; (2) review existing alternative approaches for identifying 
chemicals likely to cause acute systemic toxicity via inhalation, which 
could include mechanism-based models (i.e., in vitro and in silico 
approaches); and (3) identify mechanisms of acute toxicity that may 
constitute key events in adverse outcome pathways for acute inhalation 
toxicity.
    The webinar series steering committee is comprised of members from 
government and nongovernment stakeholder organizations including 
NICEATM, People for the Ethical Treatment of Animals, International 
Science Consortium Ltd., The Dow Chemical Company, European Union 
Reference Laboratory for Alternatives to Animal Testing, Simulations 
Plus, Inc., Netherlands Organisation for Applied Scientific Research, 
and U.S. Environmental Protection Agency.
    List of Webinar Topics and Other Information: A link to 
registration and additional information about the webinar series are 
available at http://ntp.niehs.nih.gov/go/inhalation-2016. Dates and 
topics for each webinar will be posted on this page as they are 
finalized.
    Meeting and Registration: The webinars are open to the public, free 
of charge, with attendance limited only by available webcast capacity. 
Individuals who plan to attend the first webinar should register at 
http://ntp.niehs.nih.gov/go/inhalation-2016 by March 29, 2016. 
Subsequent webinars will be convened monthly; registration for any 
webinar will automatically register the viewer for all subsequent 
webinars. Interested individuals are encouraged to visit http://ntp.niehs.nih.gov/go/inhalation-2016 for future webinar dates and 
topics and to stay abreast of the most current information about the 
webinar series.

[[Page 14865]]

    Individuals with disabilities who need accommodation to participate 
in this event should contact Dr. Elizabeth Maull at telephone: (919) 
316-4668 or email: [email protected]. TTY users should contact the 
Federal TTY Relay Service at (800) 877-8339. Requests should be made at 
least five business days in advance of the event.
    Background Information on NICEATM: NICEATM conducts data analyses, 
workshops, independent validation studies, and other activities to 
assess new, revised, and alternative test methods and strategies. 
NICEATM also provides support for the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) provides authority for 
ICCVAM and NICEATM in the development of alternative test methods. 
Information about NICEATM and ICCVAM is found at http://ntp.niehs.nih.gov/go/niceatm and http://ntp.niehs.nih.gov/go/iccvam, 
respectively.

    Dated: March 15, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-06201 Filed 3-17-16; 8:45 am]
BILLING CODE 4140-01-P



                                                    14864                           Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices

                                                      The meetings will be closed to the                      Place: Courtyard by Marriott Chevy Chase,           FOR FURTHER INFORMATION CONTACT:      Dr.
                                                    public in accordance with the                           5520 Wisconsin Avenue, Chevy Chase, MD                Warren Casey, Director, NICEATM;
                                                    provisions set forth in sections                        20815.                                                email: warren.casey@nih.gov; telephone:
                                                                                                              Contact Person: Shamala K. Srinivas,
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Ph.D., Associate Director, Office of Referral,
                                                                                                                                                                  (919) 316–4729.
                                                    as amended. The grant applications and                  Review, and Program Coordination, Division            SUPPLEMENTARY INFORMATION:
                                                    the discussions could disclose                          of Extramural Activities, National Cancer                Background: Acute systemic toxicity
                                                    confidential trade secrets or commercial                Institute, NIH, 9609 Medical Center Drive,            tests are designed to identify chemicals
                                                    property such as patentable material,                   Room 7W530, Rockville, MD 20850, 240–                 that could cause illness or death
                                                    and personal information concerning                     276–6442, ss537t@nih.gov.                             immediately or shortly after a single
                                                    individuals associated with the grant                   (Catalogue of Federal Domestic Assistance             exposure. This webinar series will
                                                    applications, the disclosure of which                   Program Nos. 93.392, Cancer Construction;             explore and discuss alternative
                                                    would constitute a clearly unwarranted                  93.393, Cancer Cause and Prevention                   approaches that could replace, reduce,
                                                                                                            Research; 93.394, Cancer Detection and
                                                    invasion of personal privacy.                                                                                 or refine the use of animals for
                                                                                                            Diagnosis Research; 93.395, Cancer
                                                      Name of Committee: National Cancer                    Treatment Research; 93.396, Cancer Biology            identifying chemicals that may cause
                                                    Institute Special Emphasis Panel; Population            Research; 93.397, Cancer Centers Support;             acute systemic toxicity when inhaled.
                                                    Science (U01).                                          93.398, Cancer Research Manpower; 93.399,                During the webinar series,
                                                      Date: April 5, 2016.                                  Cancer Control, National Institutes of Health,        participants will (1) define when and
                                                      Time: 8:00 a.m. to 4:30 p.m.                          HHS)                                                  how acute systemic toxicity data are
                                                      Agenda: To review and evaluate grant                    Dated: March 15, 2016.                              used for assessing inhalation toxicity
                                                    applications.
                                                                                                            Melanie J. Gray,                                      hazard potential for both regulatory and
                                                      Place: National Cancer Institute Shady                                                                      non-regulatory testing; (2) review
                                                    Grove, 9609 Medical Center Drive, Rockville,            Program Analyst, Office of Federal Advisory
                                                                                                            Committee Policy.                                     existing alternative approaches for
                                                    MD 20850 (Telephone Conference Call).                                                                         identifying chemicals likely to cause
                                                      Contact Person: Robert Bird, Ph.D.,                   [FR Doc. 2016–06194 Filed 3–17–16; 8:45 am]
                                                                                                                                                                  acute systemic toxicity via inhalation,
                                                    Scientific Review Officer, Resources and                BILLING CODE 4140–01–P
                                                                                                                                                                  which could include mechanism-based
                                                    Training Review Branch, Division of
                                                    Extramural Activities, National Cancer                                                                        models (i.e., in vitro and in silico
                                                    Institute, 9609 Medical Center Drive, Room              DEPARTMENT OF HEALTH AND                              approaches); and (3) identify
                                                    7W110, Bethesda, MD 20892–9750, 240–276–                HUMAN SERVICES                                        mechanisms of acute toxicity that may
                                                    6344, birdr@mail.nih.gov.                                                                                     constitute key events in adverse
                                                      Name of Committee: National Cancer                    National Institutes of Health                         outcome pathways for acute inhalation
                                                    Institute Special Emphasis Panel;                                                                             toxicity.
                                                    Fundamental Mechanisms of Affective and                 Alternative Approaches for Acute                         The webinar series steering committee
                                                    Decisional Processes in Cancer Control (U01).           Inhalation Toxicity To Address Global                 is comprised of members from
                                                      Date: April 6, 2016.                                  Regulatory and Non-Regulatory Data                    government and nongovernment
                                                      Time: 8:00 a.m. to 5:00 p.m.                          Requirements; Notice of Webinars;                     stakeholder organizations including
                                                      Agenda: To review and evaluate grant                  Registration Information                              NICEATM, People for the Ethical
                                                    applications.                                                                                                 Treatment of Animals, International
                                                      Place: National Cancer Institute Shady                SUMMARY:   The National Toxicology                    Science Consortium Ltd., The Dow
                                                    Grove, 9609 Medical Center Drive, Rockville,            Program (NTP) Interagency Center for                  Chemical Company, European Union
                                                    MD 20850 (Telephone Conference Call).                   the Evaluation of Alternative
                                                      Contact Person: Robert Bird, Ph.D.,                                                                         Reference Laboratory for Alternatives to
                                                                                                            Toxicological Methods (NICEATM)                       Animal Testing, Simulations Plus, Inc.,
                                                    Scientific Review Officer, Resources and
                                                                                                            announces the webinar series,                         Netherlands Organisation for Applied
                                                    Training Review Branch, Division of
                                                    Extramural Activities, National Cancer                  ‘‘Alternative Approaches for Acute                    Scientific Research, and U.S.
                                                    Institute, 9609 Medical Center Drive, Room              Inhalation Toxicity to Address Global                 Environmental Protection Agency.
                                                    7W110, Bethesda, MD 20892–9750, 240–276–                Regulatory and Non-Regulatory Data                       List of Webinar Topics and Other
                                                    6344, birdr@mail.nih.gov.                               Requirements.’’ Webinar speakers will                 Information: A link to registration and
                                                      Name of Committee: National Cancer                    discuss the state of the science of                   additional information about the
                                                    Institute Special Emphasis Panel; Oncology              alternative approaches for identifying                webinar series are available at http://
                                                    Co-Clinical Imaging Methods and Precision               acute systemic toxicants due to                       ntp.niehs.nih.gov/go/inhalation-2016.
                                                    Medicine.                                               inhalation exposure, and identify                     Dates and topics for each webinar will
                                                      Date: April 8, 2016.                                  knowledge and data gaps that need to be               be posted on this page as they are
                                                      Time: 1:00 p.m. to 5:00 p.m.                          addressed prior to implementation of                  finalized.
                                                      Agenda: To review and evaluate grant
                                                                                                            those approaches.                                        Meeting and Registration: The
                                                    applications and/or proposals.
                                                      Place: National Cancer Institute Shady                DATES:                                                webinars are open to the public, free of
                                                    Grove, 9609 Medical Center Drive, Room                     First Webinar: March 29, 2016, from                charge, with attendance limited only by
                                                    7W514, Rockville, MD 20850 (Telephone                   11 a.m. to 12 p.m. Eastern Daylight                   available webcast capacity. Individuals
                                                    Conference Call).                                       Time (EDT).                                           who plan to attend the first webinar
                                                      Contact Person: Peter J. Wirth, Ph.D.,                   Subsequent Webinars: Five                          should register at http://
                                                    Scientific Review Officer, Division of                  subsequent webinars will be presented                 ntp.niehs.nih.gov/go/inhalation-2016 by
                                                    Extramural Activities, National Cancer                  monthly through August 2016; dates of                 March 29, 2016. Subsequent webinars
                                                    Institute, NIH, 9609 Medical Center Drive,              the webinars will posted on the Web                   will be convened monthly; registration
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    7W514, Rockville, MD 20850, 240–276–6434                page.                                                 for any webinar will automatically
                                                    pw2q@nih.gov.                                              Registration for Webinars:                         register the viewer for all subsequent
                                                      Name of Committee: National Cancer                    Registration for each webinar will be                 webinars. Interested individuals are
                                                    Institute Special Emphasis Panel;                       open during the webinar.
                                                    Subcommittee A—Cancer Centers.                                                                                encouraged to visit http://
                                                      Date: May 5, 2016.                                    ADDRESSES: Web page: The preliminary                  ntp.niehs.nih.gov/go/inhalation-2016
                                                      Time: 8:00 a.m. to 4:00 p.m.                          agenda, registration, and other meeting               for future webinar dates and topics and
                                                      Agenda: To review and evaluate grant                  materials are at http://ntp.niehs.nih.gov/            to stay abreast of the most current
                                                    applications.                                           go/inhalation-2016.                                   information about the webinar series.


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                                                                                    Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices                                          14865

                                                       Individuals with disabilities who                       Submission of Oral Public Statements:              stay abreast of the most current meeting
                                                    need accommodation to participate in                    Deadline is May 13, 2016.                             information.
                                                    this event should contact Dr. Elizabeth                 ADDRESSES:                                              Meeting and Registration: This
                                                    Maull at telephone: (919) 316–4668 or                     Meeting Location: William H. Natcher                meeting is open to the public with time
                                                    email: maull@niehs.nih.gov. TTY users                   Conference Center, National Institutes of             scheduled for oral public statements
                                                    should contact the Federal TTY Relay                    Health, Bethesda, MD 20892.                           and for questions following ICCVAM’s
                                                    Service at (800) 877–8339. Requests                                                                           and NICEATM’s presentations. The
                                                                                                              Meeting Web page: The preliminary
                                                    should be made at least five business                                                                         public may attend the meeting at NIH,
                                                                                                            agenda, registration, and other meeting
                                                    days in advance of the event.                                                                                 where attendance is limited only by the
                                                                                                            materials are at http://ntp.niehs.nih.gov/
                                                       Background Information on                                                                                  space available, or view remotely by
                                                    NICEATM: NICEATM conducts data                          go/iccvamforum-2016.                                  webcast. Those planning to attend the
                                                    analyses, workshops, independent                        FOR FURTHER INFORMATION CONTACT: Dr.                  meeting in person are encouraged to
                                                    validation studies, and other activities                Warren Casey, Director, National                      register at http://ntp.niehs.nih.gov/go/
                                                    to assess new, revised, and alternative                 Toxicology Program Interagency Center                 iccvamforum-2016 by May 13, 2016, to
                                                    test methods and strategies. NICEATM                    for the Evaluation of Alternative                     facilitate planning for appropriate
                                                    also provides support for the                           Toxicological Methods (NICEATM);                      meeting space. Those planning to view
                                                    Interagency Coordinating Committee on                   email: warren.casey@nih.gov; telephone:               the webcast must register at http://
                                                    the Validation of Alternative Methods                   (919) 316–4729.                                       ntp.niehs.nih.gov/go/iccvamforum-2016
                                                    (ICCVAM). The ICCVAM Authorization                      SUPPLEMENTARY INFORMATION:                            by May 25, 2016. The URL for the
                                                    Act of 2000 (42 U.S.C. 285l–3) provides                    Background: ICCVAM promotes the                    webcast will be provided in the email
                                                    authority for ICCVAM and NICEATM in                     development and validation of chemical                confirming registration.
                                                    the development of alternative test                     safety testing methods that protect                     Visitor and security information for
                                                    methods. Information about NICEATM                      human health and the environment                      visitors to NIH is available at http://
                                                    and ICCVAM is found at http://                          while replacing, reducing, or refining                www.nih.gov/about/visitor/index.htm.
                                                    ntp.niehs.nih.gov/go/niceatm and                        animal use.                                           Individuals with disabilities who need
                                                    http://ntp.niehs.nih.gov/go/iccvam,                        ICCVAM’s goals include promotion of                accommodation to participate in this
                                                    respectively.                                           national and international partnerships               event should contact Dr. Elizabeth
                                                      Dated: March 15, 2016.                                between governmental and                              Maull at phone: (919) 316–4668 or
                                                                                                            nongovernmental groups, including                     email: maull@niehs.nih.gov. TTY users
                                                    John R. Bucher,
                                                                                                                                                                  should contact the Federal TTY Relay
                                                    Associate Director, National Toxicology                 academia, industry, advocacy groups,
                                                                                                                                                                  Service at 800–877–8339. Requests
                                                    Program.                                                and other key stakeholders. To foster
                                                                                                                                                                  should be made at least five business
                                                    [FR Doc. 2016–06201 Filed 3–17–16; 8:45 am]             these partnerships ICCVAM initiated
                                                                                                                                                                  days in advance of the event.
                                                    BILLING CODE 4140–01–P                                  annual public forums in 2014 to share                   Request for Oral Public Statements:
                                                                                                            information and facilitate direct                     Time will be allotted during the meeting
                                                                                                            communication of ideas and suggestions                for oral public statements with
                                                    DEPARTMENT OF HEALTH AND                                from stakeholders (79 FR 25136).                      associated slides relevant to ICCVAM’s
                                                    HUMAN SERVICES                                             The third of these forums will be held             mission and current activities. The
                                                                                                            on May 25, 2016, at the National                      number and length of presentations may
                                                    National Institutes of Health                           Institutes of Health (NIH) in Bethesda,               be limited based on available time.
                                                                                                            MD. The meeting will include                          Submitters will be identified by their
                                                    Interagency Coordinating Committee
                                                                                                            presentations by NICEATM and                          name and affiliation and/or sponsoring
                                                    on the Validation of Alternative
                                                    Methods; Notice of Public Meeting;                      ICCVAM members on current activities                  organization, if applicable. Persons
                                                    Request for Public Input                                related to the development and                        submitting public statements and/or
                                                                                                            validation of alternative test methods                associated slides should include their
                                                    SUMMARY:   The Interagency Coordinating                 and approaches. Following each                        name, affiliation (if any), mailing
                                                    Committee on the Validation of                          presentation, there will be an                        address, telephone, email, and
                                                    Alternative Methods (ICCVAM) will                       opportunity for participants to ask                   sponsoring organization (if any) with
                                                    hold a public forum to share                            questions of the ICCVAM members.                      the document. Guidelines for public
                                                    information and facilitate direct                       Instructions for submitting questions                 statements are at http://
                                                    communication of ideas and suggestions                  will be provided to remote participants               ntp.niehs.nih.gov/ntp/about_ntp/
                                                    from stakeholders. Interested persons                   prior to the webcast.                                 guidelines_public_comments_508.pdf.
                                                    may attend in person or remotely by                        The agenda will also include periods                 Persons wishing to present oral
                                                    webcast. Time will be set aside for                     dedicated to discussion of specific                   statements are encouraged to indicate
                                                    public statements and questions on the                  topics relevant to the ICCVAM mission,                the topic(s) on which they plan to speak
                                                    topics discussed. Registration is                       and time for participants to make public              on the registration form. They should
                                                    requested for both public attendance                    oral statements on topics relevant to the             also provide a copy of their statement to
                                                    and oral statements, and required for                   ICCVAM mission and current ICCVAM                     Dr. Elizabeth Maull at email: maull@
                                                    remote access. Information about the                    activities.                                           niehs.nih.gov by May 13, 2016, to allow
                                                    meeting and registration are available at                  Preliminary Agenda and Other                       time for review by NICEATM and
                                                    http://ntp.niehs.nih.gov/go/iccvam                      Meeting Information: The preliminary                  ICCVAM and posting to the meeting
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    forum-2016.                                             agenda, list of discussion topics,                    page prior to the forum. Written
                                                    DATES: Meeting: May 25, 2016, 9:00 a.m.                 ICCVAM roster and other background                    statements may supplement and expand
                                                    to approximately 4:00 p.m. Eastern                      materials, and public statements                      the oral presentation. Public statements
                                                    Daylight Time (EDT).                                    submitted prior to the meeting should                 will be distributed to NICEATM and
                                                       Registration for Onsite Meeting:                     be posted by May 18, 2016, at http://                 ICCVAM members before the meeting.
                                                    Deadline is May 13, 2016.                               ntp.niehs.nih.gov/go/iccvamforum-                       Registration for oral public statements
                                                       Registration for Webcast: Deadline is                2016. Interested individuals are                      will be available onsite, although onsite
                                                    May 25, 2016.                                           encouraged to visit this Web page to                  registration and time allotted for these


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Document Created: 2018-02-02 15:13:56
Document Modified: 2018-02-02 15:13:56
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
DatesFirst Webinar: March 29, 2016, from 11 a.m. to 12 p.m. Eastern Daylight Time (EDT).
ContactDr. Warren Casey, Director, NICEATM; email: [email protected]; telephone: (919) 316-4729.
FR Citation81 FR 14864 

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