[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7750-7751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Predictive Models for Acute Oral Systemic Toxicity; Notice of 
Meeting; Registration Information

AGENCY: National Institutes of Health, HHS.

[[Page 7751]]


ACTION: Notice.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) announces the workshop ``Predictive Models 
for Acute Oral System Toxicity.'' Workshop attendees will discuss 
development of in silico models for acute oral system toxicity and the 
next steps to encourage appropriate use of these models in regulatory 
contexts. Interested persons may attend in person or view the meeting 
remotely by webcast. Registration is requested to attend in person and 
required to view the webcast. Information about the workshop and 
registration links are available at http://ntp.niehs.nih.gov/go/atwksp-2018.

DATES: 
    Meeting: April 11-12, 2018; from 9:00 a.m. to approximately 5:00 
p.m. Eastern Daylight Time (EDT) on April 11 and from 8:30 a.m. to 
approximately 3:00 p.m. EDT on April 12, 2018.
    Registration for Onsite Meeting: Deadline is April 6, 2018.
    Registration for Webcast: Deadline is April 12, 2018.

ADDRESSES: 
    Meeting Location: Natcher Conference Center, National Institutes of 
Health, Bethesda, MD 20984.
    Meeting web page: Registration links and other information are 
available at http://ntp.niehs.nih.gov/go/atwksp-2018.

FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Deputy 
Director, NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM), at telephone: (984) 287-3150 or email: 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Background: The development of test methods that reduce or replace 
animal use for acute toxicity tests required by regulatory authorities 
is one of ICCVAM's high priority activities. To this end, the ICCVAM 
Acute Toxicity Workgroup, with support from NICEATM, sponsored a global 
project to develop in silico models of acute oral systemic toxicity 
that predict five specific endpoints identified by regulatory agencies. 
These endpoints included identification of ``very toxic'' chemicals 
(LD50 less than 50 mg/kg), ``nontoxic'' chemicals (LD50 greater than or 
equal to 2000 mg/kg), and point estimates for LD50s, and categorization 
of toxicity hazard using the U.S. Environmental Protection Agency's and 
United Nations Globally Harmonized System of Classification and 
Labelling's classification schemes. NICEATM invited scientists to 
develop and submit in silico models that predict any or all of these 
endpoints. This workshop will provide an opportunity for project 
participants to present their submitted models. Workshop participants 
will also discuss development of a consensus model for predicting acute 
oral toxicity as well as next steps needed to encourage appropriate use 
of these models in regulatory contexts.
    Workshop and Registration: The workshop is open to the public, free 
of charge, with attendance limited only by space available. Webcast 
viewing will be offered for all plenary presentation sessions. Links to 
registration and additional information about the workshop are 
available at http://ntp.niehs.nih.gov/go/atwksp-2018. Individuals 
planning to attend the workshop in person should register by April 6, 
2018. Walk-in registration will be available only as space permits. 
Registration is required to view the webcast and will be open through 
the end of the workshop. The URL for the webcast will be provided in 
the email confirming registration.
    Security information for visitors to NIH is available at https://www.nih.gov/about-nih/visitor-information. Individuals with 
disabilities who need accommodation to participate in this event should 
contact Dr. Elizabeth Maull at telephone: (984) 287-3157 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 ICCVAM and NICEATM: ICCVAM is an 
interagency committee composed of representatives from 16 federal 
regulatory and research agencies that require, use, generate, or 
disseminate toxicological and safety testing information. ICCVAM 
conducts technical evaluations of new, revised, and alternative safety 
testing methods and integrated testing strategies with regulatory 
applicability. ICCVAM also promotes the scientific validation and 
regulatory acceptance of testing methods that more accurately assess 
the safety and hazards of chemicals and products and replace, reduce, 
or refine animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 
285l-3) establishes ICCVAM as a permanent interagency committee of 
NIEHS and provides the authority for ICCVAM involvement in activities 
relevant to the development of alternative test methods. Additional 
information about ICCVAM can be found at http://ntp.niehs.nih.gov/go/iccvam.
    NICEATM administers ICCVAM, provides scientific and operational 
support for ICCVAM-related activities, and conducts and publishes 
analyses and evaluations of data from new, revised, and alternative 
testing approaches. NICEATM and ICCVAM work collaboratively to evaluate 
new and improved testing approaches applicable to the needs of U.S. 
federal agencies.
    NICEATM and ICCVAM welcome the public nomination of new, revised, 
and alternative test methods and strategies for validation studies and 
technical evaluations.
    Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/go/niceatm.

    Dated: February 9, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-03559 Filed 2-21-18; 8:45 am]
 BILLING CODE 4140-01-P