[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56476-56477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


In Vitro to In Vivo Extrapolation for High Throughput 
Prioritization and Decision Making; Notice of Webinars and Public 
Workshop; Registration Information

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) and the 
U.S. Environmental Protection Agency (EPA) announce the workshop, ``In 
Vitro to In Vivo Extrapolation for High Throughput Prioritization and 
Decision Making.'' Attendees at the in-person workshop and four webinar 
presentations leading up to the workshop will discuss the state of the 
science and best practices for using in vitro to in vivo extrapolation 
(IVIVE) in a tiered risk decision context.

DATES: Webinars: October 7, 2015, at 11:00 a.m. Eastern Daylight Time 
(EDT); and November 4, 2015; December 2, 2015; and January 6, 2016; at 
11:00 a.m. Eastern Standard Time (EST).
    Webinar Registration: Deadline is two business days prior to each 
webinar.
    Workshop: February 17-18, 2016, from 9:00 a.m. to approximately 
5:00 p.m. (EST).
    Workshop Registration: Deadline is February 5, 2016 at 5:00 p.m. 
(EST).

ADDRESSES:
    Workshop Location: U.S. Environmental Protection Agency, 109 T.W. 
Alexander Dr., Durham, NC, 27709.
    Web page: The preliminary agenda, registration, and other meeting 
materials will be available at http://ntp.niehs.nih.gov/go/ivive-wksp-2016.

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

SUPPLEMENTARY INFORMATION:
    Background: Data from high throughput in vitro tests are being 
generated for many chemicals of environmental and commercial interest, 
with the expectation that in vitro assay data could ultimately be used 
to predict adverse effects of chemical exposures in vivo. Translating 
values obtained from in vitro assays into estimates of in vivo outcomes 
is a complex process involving the use of mathematical modeling and 
increasingly complex test systems. The series of four webinars and in-
person workshop aim to address the capabilities and limitations of 
IVIVE within the context of risk decision-making.
    The webinar series will present the current science, and the in-
person workshop will facilitate discussions that follow-up and build on 
information presented in the webinars. During the workshop, 
participants will (1) review the state of the science to form 
recommendations on best practices for using IVIVE in chemical screening 
and risk-based decision making, (2) identify areas that require 
additional data and/or research, and (3) highlight examples of how best 
to apply IVIVE in a tiered risk decision-making strategy.
    Preliminary Agenda and Other Meeting Information: A preliminary 
agenda and additional information will

[[Page 56477]]

be available at http://ntp.niehs.nih.gov/go/ivive-wksp-2016.
    Meeting and Registration: This workshop is open to the public, free 
of charge, with attendance limited only by the space available. 
Registration is required to attend both the webinars and the workshop. 
Those persons attending the workshop should plan to participate in all 
four webinars. However, viewing the webinars does not require 
attendance at the workshop. Individuals who plan to attend the workshop 
must register at http://ntp.niehs.nih.gov/go/ivive-wksp-2016 by 
February 5, 2016. Individuals who plan to participate in the webinars 
must register at http://ntp.niehs.nih.gov/go/ivive-wksp-2016 two 
business days prior to the webinar date to ensure access. Please visit 
this Web page for the most current information about the webinars and 
workshop. For those who register, information about how to access the 
webinar will be emailed within two business days of each webinar.
    Individuals with disabilities who need accommodation to participate 
in these events should contact Dr. Elizabeth Maull at phone: (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. Visitor and security 
information for those attending the workshop can be found at http://www2.epa.gov/aboutepa/about-epas-campus-research-triangle-park-rtp-north-carolina.
    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: September 14, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-23386 Filed 9-17-15; 8:45 am]
BILLING CODE 4140-01-P