[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Page 47501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Workshop on Alternative Approaches for Identifying Acute Systemic 
Toxicity: Moving From Research to Regulatory Testing; Notice of Public 
Meeting; Registration Information

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) announces 
the workshop ``Alternative Approaches for Identifying Acute Systemic 
Toxicity: Moving from Research to Regulatory Testing.'' Workshop 
attendees will discuss the state of the science of alternative 
approaches for identifying acute systemic toxicity and explore ways to 
facilitate their implementation.

DATES: Meeting: September 24-25, 2015, from 9:00 a.m. to approximately 
5:00 p.m. Eastern Daylight Time (EDT).
    Meeting Registration: Deadline is September 11, 2015.

ADDRESSES: Meeting Location: Porter Neuroscience Conference Center, 
National Institutes of Health, Bethesda, MD 20892.
    Meeting Web page: The preliminary agenda, registration, and other 
meeting materials are at http://ntp.niehs.nih.gov/go/atwksp-2015.

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

SUPPLEMENTARY INFORMATION:

Background

    Acute systemic toxicity tests, which evaluate the propensity of a 
substance to produce lethality when administered orally, dermally, or 
by inhalation, are the most commonly performed type of safety test 
worldwide. This workshop 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.
    During the workshop, participants will (1) review the regulatory 
guidelines to define when and how acute systemic toxicity data are 
used; (2) review the science of alternative approaches for identifying 
acute systemic toxicity, including mechanism-based models, in vitro and 
in silico approaches, and lower vertebrate and invertebrate models; and 
(3) identify mechanisms of acute toxicity for promoting development of 
adverse outcome pathways (AOPs) for acute toxicity. The workshop 
steering committee is comprised of members from government and 
nongovernment stakeholder organizations including NICEATM, Physicians 
Committee for Responsible Medicine, People for the Ethical Treatment of 
Animals International Science Consortium Ltd., The Dow Chemical 
Company, U.S. Environmental Protection Agency, and Rutgers University.

Preliminary Agenda and Other Meeting Information

    A preliminary agenda and additional information are available at 
http://ntp.niehs.nih.gov/go/atwksp-2015.

Meeting and Registration

    This meeting is open to the public, free of charge, with attendance 
limited only by available meeting space. Individuals who plan to attend 
should register at http://ntp.niehs.nih.gov/go/atwksp-2015 by September 
11, 2015, to facilitate planning. Interested individuals are encouraged 
to visit this Web page to stay abreast of the most current information 
about the meeting.
    Visitor and security information for visitors to NIH is available 
at http://www.nih.gov/about/visitor/index.htm. 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: August 3, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-19379 Filed 8-6-15; 8:45 am]
BILLING CODE 4140-01-P