[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35395-35396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14435]
[[Page 35395]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Draft Five-Year Plan (2013-2017) for the National Toxicology
Program Interagency Center for the Evaluation of Alternative
Toxicological Methods and the Interagency Coordinating Committee on the
Validation of Alternative Methods
AGENCY: Division of National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH).
ACTION: Availability of Draft Plan, Request for Comments
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SUMMARY: The National Toxicology Program (NTP) Interagency Center for
the Evaluation of Alternative Toxicological Methods (NICEATM) in
collaboration with the Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) has developed a draft
NICEATM-ICCVAM Five-Year Plan. The plan describes four core strategies
to foster and promote development, validation, and regulatory
acceptance of scientifically sound alternative test methods by the
Federal government and by other governments and multinational
organizations. This document will provide strategic direction for
NICEATM and ICCVAM during 2013-2017.
NIEHS and NICEATM request public comments on the draft 2013-2017
Five-Year Plan, which is available at http://iccvam.niehs.nih.gov/docs/5yearplan.htm. NICEATM and ICCVAM in partnership with relevant agency
program offices will consider these comments during development of the
final plan.
DATES: The draft plan is available on the NICEATM-ICCVAM Web site at
http://iccvam.niehs.nih.gov/docs/5yearplan.htm. Written comments on the
draft updated NICEATM-ICCVAM Five-Year Plan should be submitted on the
Web site by August 13, 2012.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle
Park, NC, 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (email)
[email protected]. Courier address: NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
Emerging scientific advances and technology innovations are driving
transformative changes in toxicology and how safety testing is
performed. The field of toxicology is evolving from a system based
largely on animal testing toward one based on the integration of data
from a wide range of sources, including in vitro methods that evaluate
changes in biological pathways predictive of adverse outcomes and in
chemico and in silico methods.
Congress established ICCVAM to promote the regulatory acceptance of
new or revised scientifically valid toxicological test methods that
protect human and animal health and the environment while reducing,
refining (enhancing animal well-being and lessening or avoiding pain
and distress), or replacing animal tests and ensuring human safety and
product effectiveness. As directed by the ICCVAM Authorization Act (42
U.S.C. 285l-3), NICEATM and ICCVAM carry out activities that contribute
to the validation and regulatory acceptance of new test methods and
testing strategies.
In 2008, NICEATM and ICCVAM published the NICEATM-ICCVAM Five-Year
Plan (2008-2012), which addressed ICCVAM's vision to play a leading
role in fostering and promoting the development, validation, and
regulatory acceptance of scientifically sound alternative test methods
both within the Federal government and internationally (ICCVAM, 2008).
NICEATM and ICCVAM have now prepared a draft plan to provide strategic
direction for NICEATM and ICCVAM in accomplishing their purposes,
duties, and mission for the years 2013-2017. In preparing this plan,
NICEATM and ICCVAM considered information and comments submitted by
member agencies and comments submitted in response to a Federal
Register notice (76 FR 71977).
The draft plan outlines how, consistent with ICCVAM's statutory
duties and purposes, NICEATM and ICCVAM will foster and promote the
incorporation of scientific advances and innovative technologies into
new improved test methods and strategies, and contribute to the
transformation of toxicology. The draft plan describes four broad
strategic opportunities for NICEATM and ICCVAM to foster and promote
development, validation, and regulatory acceptance of scientifically
sound alternative test methods by the Federal government and other
organizations:
Promote the Application and Translation of Innovative
Science and Technology to develop predictive alternative test methods
and efficient and predictive integrated testing and decision strategies
(ITDS)
Advance Alternative Test Methods and Testing Strategies
through new evaluation activities for focus areas initially identified
in the 2008-2012 Five-Year Plan and new focus areas for 2013-2017
Facilitate Regulatory Acceptance and Use of Alternative
Methods through high quality test method evaluations and effective
outreach and communication
Develop and Strengthen Partnerships with the broad range
of ICCVAM stakeholders
The years 2013-2017 will be an essential transition period for
NICEATM and ICCVAM in this transforming regulatory toxicology
environment. For example, data from in vitro testing batteries and
integrated decision strategies that consider all available information
from in chemico, in silico, in vitro, and/or in vivo studies will be
critical to regulatory decision-making in the future.
Request for Comments
NIEHS and NICEATM invite public comments from all ICCVAM
stakeholders for consideration by ICCVAM and ICCVAM agencies' program
offices on the draft 2013-2017 Five-Year Plan. The draft plan can be
found on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/docs/5yearplan.htm. In addition, comments are sought on how NICEATM and
ICCVAM can most effectively contribute to the evolving transformation
of safety testing. Stakeholder comments will be considered in
finalization of the draft plan.
NICEATM prefers that comments be submitted electronically via a
form on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/docs/5yearplan.htm or via email to [email protected]. Individuals
submitting comments are asked to include appropriate contact
information (name, affiliation, mailing address, phone number, email,
and sponsoring organization, if applicable). All comments received will
be posted on the NICEATM-ICCVAM Web site and identified by the
individual's name, affiliation, and sponsoring organization. Comments
should be received by [insert date 60 days after publication date] to
ensure consideration as the NICEATM-ICCVAM 2013-2017 Five-Year Plan is
finalized.
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
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disseminate toxicological and safety testing information. ICCVAM
conducts technical evaluations of new, revised, and alternative safety
testing methods and strategies with regulatory applicability and
promotes the scientific validation and regulatory acceptance of
toxicological and safety testing methods that more accurately assess
the safety and hazards of chemicals and products. ICCVAM evaluations
include test methods and strategies that will reduce or replace animal
use, or refine animal use by enhancing animal welfare and avoiding or
lessening pain and distress.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established
ICCVAM as a permanent interagency committee of the NIEHS under NICEATM.
NICEATM administers ICCVAM, provides scientific and operational support
for ICCVAM-related 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 and ICCVAM
can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).
References
ICCVAM. 2008. The NICEATM-ICCVAM Five-Year Plan (2008-2012). A plan
to advance alternative test methods of high scientific quality to
protect and advance the health of people, animals, and the environment.
NIH Publication No. 08-6410. Research Triangle Park, NC: NIEHS.
Available: http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
Dated: June 4, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-14435 Filed 6-12-12; 8:45 am]
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