[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73603-73604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods Communities of Practice Webinar on Reverse 
Toxicokinetics; Notice of Public Webinar and Registration Information

SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) announces a public webinar ``Reverse 
Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be 
Associated with Adverse Effects In Vivo.'' The webinar is organized on 
behalf of ICCVAM by the National Toxicology Program Interagency Center 
for the Evaluation Alternative Toxicological Methods (NICEATM) and 
hosted by the Environmental Protection Agency's National Center for 
Computational Toxicology (NCCT). Interested persons may participate via 
Adobe[supreg] ConnectTM. Time is allotted for questions from 
participants.

DATES: Webinar: January 27, 2015, 1:00 p.m. to approximately 2:30 p.m. 
Eastern Standard Time (EST).
    Registration for Webinar: December 3, 2014, until 2:30 p.m. January 
27, 2015.

ADDRESSES:  Webinar Web page: http://ntp.niehs.nih.gov/go/ivive-webinar.

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

SUPPLEMENTARY INFORMATION:
    Background: ICCVAM promotes the development and validation of 
toxicity testing methods that protect human health and the environment 
while replacing, reducing, or refining animal use. ICCVAM also provides 
guidance to test method developers and facilitates collaborations that 
promote the development of new test methods. To address these goals, 
ICCVAM will hold the communities of practice webinar ``Reverse 
Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be 
Associated with Adverse Effects In Vivo.''
    Many commercial and environmental chemicals lack toxicity data 
necessary for users and risk assessors to make fully informed decisions 
about potential health effects. Generating these data using high 
throughput in vitro cell- or biochemical-based tests would be faster 
and less expensive than testing in animals; tests that use human cells 
or cellular components would also potentially be more relevant to human 
health. However, correlating test chemical concentrations that produce 
effects in vitro to exposure levels that cause toxicity in vivo is 
complicated, since factors that can significantly influence toxicity in 
vivo (such as plasma protein binding and metabolic clearance) are often 
not replicated in in vitro assays. Mathematical models known as reverse 
toxicokinetic models provide a framework for making these correlations. 
Reverse toxicokinetic models provide an estimate of the exposure level 
that would result in a blood concentration equal to a chemical 
concentration causing an in vitro adverse outcome.
    The ICCVAM webinar will feature presentations by two experts in the 
development and application of reverse toxicokinetic models to high 
throughput screening data: John Wambaugh, Ph.D., physical scientist at 
NCCT, and Barbara Wetmore, Ph.D., senior research investigator at the 
Hamner Institutes for Health Sciences. Their presentations will provide 
an overview of the development of reverse toxicokinetic models and 
discuss the consideration of population variability and sensitive 
subpopulations in the use of these models.
    Webinar and Registration: This webinar is open to the public with 
time scheduled following each presentation for questions by 
participants. Registration for the webinar is required and is open from 
December 3, 2014, through 2:30 p.m. on January 27, 2015. A link to 
registration is available at http://ntp.niehs.nih.gov/go/ivive-webinar. 
Registrants will receive instructions on how to access and participate 
in the webinar in the email confirming their registration.
    The preliminary agenda is available at http://ntp.niehs.nih.gov/go/ivive-webinar. Interested individuals are encouraged to visit this Web 
page to stay abreast of the most current webinar information.
    Individuals with disabilities who need accommodation to participate 
in this event should contact Ms. LaCresha Styles at phone: (919) 541-
3282 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 15 federal 
regulatory and research agencies that require, use, generate, or 
disseminate toxicological and safety testing information. The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) establishes ICCVAM as a 
permanent interagency committee of the National Institute of 
Environmental Health Sciences and provides the authority for ICCVAM's 
involvement in activities relevant to the development of new and 
revised toxicological tests.
    ICCVAM conducts technical evaluations of new, revised, and 
alternative test methods and integrated testing strategies with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of test methods that both more accurately assess 
the safety and hazards of chemicals and products and replace, reduce, 
or refine (enhance animal well-being and lessen or avoid pain and 
distress) animal use. ICCVAM acts to ensure that new and revised test 
methods are validated to meet the needs of federal agencies, to 
increase the efficiency and effectiveness of federal agency test method 
review, and to optimize utilization of scientific expertise outside the 
federal government. Additional information

[[Page 73604]]

about ICCVAM can be found at http://ntp.niehs.nih.gov/go/iccvam.
    NICEATM administers ICCVAM, provides scientific and operational 
support for ICCVAM activities, and conducts independent validation 
studies to assess the usefulness and limitations of new, revised, and 
alternative test methods and strategies. NICEATM and ICCVAM work 
collaboratively to evaluate new and improved test methods and 
strategies 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: December 5, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-29018 Filed 12-10-14; 8:45 am]
BILLING CODE 4140-01-P