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

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Information about this document as published in the Federal Register.

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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.

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FOR FURTHER INFORMATION CONTACT:

Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316-4729.

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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: 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. 285 l-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.

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Dated: August 3, 2015.

John R. Bucher,

Associate Director, National Toxicology Program.

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[FR Doc. 2015-19379 Filed 8-6-15; 8:45 am]

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