[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Notices]
[Pages 35395-35396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14435]



[[Page 35395]]

-----------------------------------------------------------------------

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

-----------------------------------------------------------------------

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) 
niceatm@niehs.nih.gov. 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 niceatm@niehs.nih.gov. 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

[[Page 35396]]

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]
BILLING CODE 4140-01-P