[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71977-71978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Update of the NICEATM-ICCVAM Five-Year Plan: Request for Comments

AGENCY: Division of the National Toxicology Program (DNTP), National 
Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health (NIH).

ACTION: Request for Comments.

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SUMMARY: The NIEHS and the National Toxicology Program Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM) request public comments that can be considered by the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) and agencies' program offices in updating The NICEATM-
ICCVAM Five-Year Plan (2008-2012) (ICCVAM, 2008). The current plan 
addresses: (1) Identification of areas of high priority for new and 
revised non-animal and alternative assays to reduce, refine (enhance 
animal well-being and lessen or avoid pain and distress), and replace 
the use of animals in testing and (2) research, development, 
translation, and validation of new and revised non-animal and other 
alternatives assays for integration of relevant and reliable methods 
into Federal agencies' testing programs.

DATES: Submit comments on or before January 15, 2012.

ADDRESSES: NICEATM prefers that comments be submitted electronically 
via the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via email to [email protected]. Written 
comments may also be sent by mail or fax to Dr. William S. Stokes, 
Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research 
Triangle Park, NC 27709; (fax) 919-541-0947. Courier address: NICEATM, 
NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone) 
(919) 541-2384, (fax) (919) 541-0947, or (email) [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 71978]]

Background

    Congress established ICCVAM to promote development, validation, and 
regulatory acceptance of new or revised alternative 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 (42 U.S.C. 285l-3). In 2008 
NICEATM and ICCVAM published a five-year plan for the years 2008 
through 2012. The plan addressed (1) identification of areas of high 
priority for new and revised non-animal and alternative assays for 
reduction, refinement, and replacement of animal tests and (2) 
research, development, translation, and validation of new and revised 
non-animal and other alternative assays for integration into Federal 
agency testing programs (ICCVAM, 2008). Progress relevant to the five-
year plan can be found in the Biennial Progress Report: Interagency 
Coordinating Committee on the Validation of Alternative Methods--2008-
2009 (ICCVAM, 2010) and on the ICCVAM Web site (http://iccvam.niehs.nih.gov). ICCVAM and agencies' program offices are 
preparing to update the plan and identify goals and priorities for the 
years 2013-2017.

Request for Public Comments

    The NIEHS and NICEATM invite public comments for consideration by 
ICCVAM and agencies' program offices in updating the current NICEATM-
ICCVAM five-year plan. With regard to reducing, refining, and replacing 
animal use, ICCVAM identified and ranked the types of regulatory safety 
tests in the 2008-2012 plan that it considered the highest priority for 
the development and validation of alternative test methods. These 
priorities were based on the severity of unrelieved pain and distress 
and the number of animals involved in each type of testing, as well as 
individual agency's priorities. The priorities were as follows:
     Highest priority testing areas: Acute eye irritation and 
corrosion, acute skin toxicity (including irritation/corrosion, 
sensitization, absorption), acute systemic toxicity (acute poisoning)--
oral/dermal/inhalation, and biologics/vaccines.
     Other priority testing areas: immunotoxicity, endocrine 
disruptors, pyrogenicity, reproductive/developmental toxicity, and 
chronic toxicity/carcinogenicity.
     Other testing areas of interest: neurotoxicity.
The NIEHS and NICEATM seek public input on the following questions:
    1. Do you have comments on the priority areas for the development 
and validation of alternative test methods listed above?
    2. Considering available science and technology, what development, 
translation, and validation activities are most likely to have the 
greatest impacts within the next five years on reducing, refining, or 
replacing animal use in the priority areas?
    3. What research and development activities hold the greatest 
promise in the long-term for reducing, refining, or replacing animal 
use in the priority areas?
    4. What are appropriate measures for evaluating progress in 
enhancing the development and use of alternative test methods in the 
priority areas?
    Individuals submitting comments should include appropriate contact 
information (name, affiliation, mailing address, phone, fax, email, and 
sponsoring organization, if applicable). All comments received by 
January 15, 2012, will be posted on the NICEATM-ICCVAM Web site (http://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm) and identified by 
the individual's name and affiliation, as well as sponsoring 
organization, if applicable.

Background Information on NICEATM and ICCVAM

    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. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
testing methods 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 and that reduce, refine (enhance 
animal well-being and lessen or avoid pain and distress), or replace 
animal use. 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 welcome the public nomination of new, revised, and 
alternative test methods and strategies applicable to the needs of 
Federal agencies. 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). NIH 
Publication No. 08-6410. Research Triangle Park, NC: National 
Institute of Environmental Health Sciences. Available: http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
    ICCVAM. 2010. Biennial Progress Report: Interagency Coordinating 
Committee on the Validation of Alternative Methods--2008-2009. NIH 
Publication No. 10-7612. Research Triangle Park, NC: National 
Institute of Environmental Health Sciences. Available: http://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm.


    Dated: November 10, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-30001 Filed 11-18-11; 8:45 am]
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