[Federal Register: November 13, 2006 (Volume 71, Number 218)]
[Notices]
[Page 66172-66173]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no06-37]
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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.
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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 5yearplan@niehs.nih.gov. 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