Alternative Approaches for Acute Inhalation Toxicity To Address Global Regulatory and Non-Regulatory Data Requirements; Notice of Webinars; Registration Information, 14864-14865 [2016-06201]

Download as PDF 14864 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Population Science (U01). Date: April 5, 2016. Time: 8:00 a.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Robert Bird, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892–9750, 240–276– 6344, birdr@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Fundamental Mechanisms of Affective and Decisional Processes in Cancer Control (U01). Date: April 6, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Robert Bird, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W110, Bethesda, MD 20892–9750, 240–276– 6344, birdr@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Oncology Co-Clinical Imaging Methods and Precision Medicine. Date: April 8, 2016. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W514, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Peter J. Wirth, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W514, Rockville, MD 20850, 240–276–6434 pw2q@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Subcommittee A—Cancer Centers. Date: May 5, 2016. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. VerDate Sep<11>2014 19:50 Mar 17, 2016 Jkt 238001 Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: Shamala K. Srinivas, Ph.D., Associate Director, Office of Referral, Review, and Program Coordination, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W530, Rockville, MD 20850, 240– 276–6442, ss537t@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: March 15, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–06194 Filed 3–17–16; 8:45 am] BILLING CODE 4140–01–P 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 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 https://ntp.niehs.nih.gov/ go/inhalation-2016. SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Dr. Warren Casey, Director, NICEATM; email: warren.casey@nih.gov; 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 https:// 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 https:// 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 https:// 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. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\18MRN1.SGM 18MRN1 Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at telephone: (919) 316–4668 or email: maull@niehs.nih.gov. 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 https:// ntp.niehs.nih.gov/go/niceatm and https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or remotely by webcast. Time will be set aside for public statements and questions on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/iccvam forum-2016. DATES: Meeting: May 25, 2016, 9:00 a.m. to approximately 4:00 p.m. Eastern Daylight Time (EDT). Registration for Onsite Meeting: Deadline is May 13, 2016. Registration for Webcast: Deadline is May 25, 2016. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:50 Mar 17, 2016 Jkt 238001 Submission of Oral Public Statements: Deadline is May 13, 2016. ADDRESSES: Meeting Location: William H. Natcher Conference Center, National Institutes of Health, Bethesda, MD 20892. Meeting Web page: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/ go/iccvamforum-2016. FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: ICCVAM promotes the development and validation of chemical safety testing methods that protect human health and the environment while replacing, reducing, or refining animal use. ICCVAM’s goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships ICCVAM initiated annual public forums in 2014 to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136). The third of these forums will be held on May 25, 2016, at the National Institutes of Health (NIH) in Bethesda, MD. The meeting will include presentations by NICEATM and ICCVAM members on current activities related to the development and validation of alternative test methods and approaches. Following each presentation, there will be an opportunity for participants to ask questions of the ICCVAM members. Instructions for submitting questions will be provided to remote participants prior to the webcast. The agenda will also include periods dedicated to discussion of specific topics relevant to the ICCVAM mission, and time for participants to make public oral statements on topics relevant to the ICCVAM mission and current ICCVAM activities. Preliminary Agenda and Other Meeting Information: The preliminary agenda, list of discussion topics, ICCVAM roster and other background materials, and public statements submitted prior to the meeting should be posted by May 18, 2016, at https:// ntp.niehs.nih.gov/go/iccvamforum2016. Interested individuals are encouraged to visit this Web page to PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 14865 stay abreast of the most current meeting information. Meeting and Registration: This meeting is open to the public with time scheduled for oral public statements and for questions following ICCVAM’s and NICEATM’s presentations. The public may attend the meeting at NIH, where attendance is limited only by the space available, or view remotely by webcast. Those planning to attend the meeting in person are encouraged to register at https://ntp.niehs.nih.gov/go/ iccvamforum-2016 by May 13, 2016, to facilitate planning for appropriate meeting space. Those planning to view the webcast must register at https:// ntp.niehs.nih.gov/go/iccvamforum-2016 by May 25, 2016. The URL for the webcast will be provided in the email confirming registration. Visitor and security information for visitors to NIH is available at https:// www.nih.gov/about/visitor/index.htm. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at phone: (919) 316–4668 or email: maull@niehs.nih.gov. 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. Request for Oral Public Statements: Time will be allotted during the meeting for oral public statements with associated slides relevant to ICCVAM’s mission and current activities. The number and length of presentations may be limited based on available time. Submitters will be identified by their name and affiliation and/or sponsoring organization, if applicable. Persons submitting public statements and/or associated slides should include their name, affiliation (if any), mailing address, telephone, email, and sponsoring organization (if any) with the document. Guidelines for public statements are at https:// ntp.niehs.nih.gov/ntp/about_ntp/ guidelines_public_comments_508.pdf. Persons wishing to present oral statements are encouraged to indicate the topic(s) on which they plan to speak on the registration form. They should also provide a copy of their statement to Dr. Elizabeth Maull at email: maull@ niehs.nih.gov by May 13, 2016, to allow time for review by NICEATM and ICCVAM and posting to the meeting page prior to the forum. Written statements may supplement and expand the oral presentation. Public statements will be distributed to NICEATM and ICCVAM members before the meeting. Registration for oral public statements will be available onsite, although onsite registration and time allotted for these E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14864-14865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06201]


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

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 https://ntp.niehs.nih.gov/go/inhalation-2016.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: warren.casey@nih.gov; 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 https://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 
https://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 https://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: maull@niehs.nih.gov. 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 https://ntp.niehs.nih.gov/go/niceatm and https://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
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