[Federal Register Volume 71, Number 218 (Monday, November 13, 2006)]
[Notices]
[Pages 66172-66173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19094]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institute of Environmental Health Sciences; National 
Toxicology Program; NTP Interagency Center for the Evaluation of 
Alternative Toxicological Methods; Development of a NICEATM/ICCVAM 5-
Year Plan To Research, Develop, Translate, and Validate New and Revised 
Non-animal and Other Alternative Assays for Integration of Relevant and 
Reliable Methods Into Federal Agency Testing Programs: Request for 
Public Comments

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH)m HHS.

ACTION: Request for comments.

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

SUMMARY: The NIEHS and the National Toxicology Program (NTP) 
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 agency program offices in development of a 
NICEATM/ICCVAM 5-year plan that addresses: (1) Research, development, 
translation, and validation of new and revised non-animal and other 
alternatives assays for integration of relevant and reliable methods 
into federal agency testing programs and (2) identification of areas of 
high priority for new and revised non-animal and alternative assays for 
the replacement, reduction, and refinement (less pain and distress) of 
animal tests.

DATES: Submit comments on or before December 31, 2006.

ADDRESSES: Comments should preferably be submitted electronically at 
the NICEATM/ICCVAM 5-Year Plan Web site: http://iccvam.niehs.nih.gov/docs/5yearplan.htm. Comments can also be submitted by e-mail to 
[email protected]. Written comments may also be sent by mail or 
fax to Dr. William S. Stokes, NICEATM Director, NIH/NIEHS, P.O. Box 
12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-541-
2384, (fax) 919-541-0947. Courier address: NICEATM, 79 T.W. Alexander 
Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION:

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, or replacing animal tests and ensuring human safety 
and product effectiveness (42 U.S.C. 285l-3). Congress requests of 
NIEHS that NICEATM and ICCVAM in partnership with relevant federal 
agencies develop a 5-year plan that addresses (1) research, 
development, translation, and validation of new and revised non-animal 
and other alternative assays for integration into federal agency 
testing programs and (2) identification of areas of high priority for 
new and revised non-animal and alternative assays for replacement, 
reduction, and refinement (less pain and distress) of animal tests. At 
this time, the NIEHS and NICEATM seek public comments that can be 
considered by the ICCVAM and agency program offices in development of 
the plan. The Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM) meeting at the NIEHS on November 30 will 
also provide an additional opportunity for public input (http://ntp.niehs.nih.gov/go/7441).

Request for Comments

    The NIEHS and NICEATM invite public comments for consideration by 
ICCVAM and agency program offices in development of the NICEATM/ICCVAM 
5-year plan. With regard to refining, reducing, and replacing animal 
use, ICCVAM has previously identified and ranked the types of 
regulatory safety tests that it considers should have the highest 
priority for the development and validation of alternative test 
methods.
    1. Acute eye irritation and corrosion
    2. Biologics/vaccines
    3. Acute skin toxicity (including irritation/corrosion, 
sensitization, absorption)
    4. Acute systemic toxicity (oral/dermal/inhalation)
    5. Chronic toxicity/carcinogenicity
    6. Reproductive/developmental toxicity
    7. Endocrine disruptors
    8. Neurotoxicity
    9. Immunotoxicity
    The NIEHS and NICEATM seek public input on the following questions. 
One of the elements that might be considered in answering questions 2-4 
is the priority areas listed above.
    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 refining, reducing, or 
replacing animal use?
    3. What research and development activities hold the greatest 
promise in the long-term for refining, reducing, or replacing animal 
use?
    4. What are appropriate measures for evaluating progress in 
enhancing the development and use of alternative test methods?
    Individuals submitting comments are asked to include appropriate 
contact information (name, affiliation, mailing address, phone, fax, 
email and sponsoring organization, if applicable). All comments 
received by December 31, 2006, will be posted on the ICCVAM-NICEATM Web 
site (http://iccvam.niehs.nih.gov/docs/5yearplan.htm) and identified by 
the individual's name and affiliation and/or sponsoring organization, 
if applicable.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 federal regulatory and research agencies that use, generate, or 
disseminate toxicological information. ICCVAM conducts technical 
evaluations of new, revised, and alternative methods with regulatory 
applicability and promotes scientific validation and regulatory 
acceptance of toxicological test methods that more accurately assess 
safety and hazards of chemicals and products and that refine, reduce, 
and replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 
285l-3, available at http://iccvam.niehs.nih.gov/about/PL106545.htm) 
establishes ICCVAM as a permanent interagency committee of the NIEHS 
under NICEATM. NICEATM administers ICCVAM and provides scientific and 
operational support for ICCVAM-related activities. NICEATM and ICCVAM 
work collaboratively to evaluate new and improved test methods 
applicable to the needs of Federal agencies. SACATM is a federally 
chartered advisory committee that provides advice to NICEATM, ICCVAM, 
and NIEHS on ICCVAM and NICEATM activities. Additional information 
about ICCVAM and NICEATM can be found at the following Website: http://iccvam.niehs.nih.gov.

[[Page 66173]]

Information about SACATM is available at http://ntp.niehs.nih.gov/go/167.

    Dated: November 2, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E6-19094 Filed 11-9-06; 8:45 am]
BILLING CODE 4140-01-P