[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Notices]
[Pages 72727-72729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM): Ten-Year Anniversary Symposium and Five-Year Plan

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

ACTION: Announcement of public symposium and availability of document.

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SUMMARY: NICEATM invites attendance at a public symposium to mark the 
tenth anniversary of ICCVAM. The symposium, entitled ``Celebrating Ten 
Years of Advancing Public Health and Animal Welfare With Sound Science: 
Envisioning New Directions in Toxicology'' will be held February 5, 
2008, at the U.S. Consumer Product Safety Commission (CPSC) 
Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008-
2012) will also be discussed and made available on February 5.

DATES: The symposium will be held on February 5, 2008. Those interested 
in attending the symposium are encouraged to register with NICEATM by 
February 1, 2008, although registration will also be available on-site.

ADDRESSES: The symposium will be held in the CPSC Hearing Room, located 
at CPSC Headquarters, Bethesda Towers Bldg., 4330 East West Highway, 
Bethesda, MD. Registration information and other details about the 
symposium can be found on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/meetings/10thAnnivSymp/10thAnnivSymp.htm or by 
contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). The 
NICEATM-ICCVAM Five-Year Plan will be available at the symposium and 
electronically on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/docs/5yearplan.htm after February 5. Print copies 
may be obtained by contacting NICEATM.

[[Page 72728]]


FOR FURTHER INFORMATION CONTACT: Ms. Debbie McCarley, NICEATM, NIEHS, 
P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709, (telephone) 
919-541-2384, (fax) 919-541-0947, (e-mail) [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Director of the NIEHS established an ad hoc ICCVAM in September 
1994 to respond to requirements in the NIH Revitalization Act of 1993 
(42 U.S.C. 285l-1, Public Law 103-43). This Act required NIEHS to 
establish criteria for the validation and regulatory acceptance of 
alternative toxicological testing methods. NIEHS was also required to 
recommend a process to achieve the regulatory acceptance of 
scientifically valid alternative test methods. The ad hoc ICCVAM was 
comprised of representatives from 15 Federal agencies, which are now 
represented on ICCVAM.
    In 1997, the ad hoc ICCVAM published its final report, Validation 
and Regulatory Acceptance of Toxicological Test Methods. In the same 
year, NIEHS established a standing ICCVAM committee to implement a 
process by which new test methods of interagency interest could be 
evaluated and to coordinate cross-agency issues on development, 
validation, acceptance, and national and international harmonization of 
toxicological test methods. The ICCVAM Authorization Act of 2000 (42 
U.S.C. 285l-3, Public Law 106-545) established ICCVAM as a permanent 
interagency committee of NIEHS under NICEATM. The law was enacted ``To 
establish, wherever feasible, guidelines, recommendations, and 
regulations that promote the regulatory acceptance of new or revised 
scientifically valid toxicological tests that protect human and animal 
health and the environment while reducing, refining, or replacing 
animal tests and ensuring human safety and product effectiveness.''
    Over the last 10 years, ICCVAM, with scientific support from 
NICEATM, has evaluated over 185 test methods with the potential to 
reduce, refine or replace the use of animals in regulatory safety 
testing. ICCVAM has developed and transmitted recommendations to 
Federal agencies for alternative methods for the four most commonly 
used toxicity tests. These science-based technical evaluations have 
been used to support adoption of test methods as guidelines by the 
Organisation for Economic Co-operation and Development and other 
international organizations. NICEATM and ICCVAM have also worked with 
Federal agencies and other stakeholders to link research and 
development activities to the standardization and validation of 
alternative test methods that may be used in regulatory testing. The 
symposium on February 5, 2008, will recognize the 10-year anniversary 
of ICCVAM and discuss future directions in toxicology testing and the 
NICEATM-ICCVAM Five-Year Plan.

Preliminary Agenda

 Welcome
 ICCVAM and NICEATM: The First Ten Years
 A Vision Towards the Future: The NICEATM-ICCVAM Five-Year Plan
 The Evolution and Future of Toxicology: Where We've Come From 
and Future Prospects
 Toxicology Testing in the 21st Century: A Vision and a 
Strategy--A Report of the National Research Council of the National 
Academies
 Future Directions in Test Method Development--Toxicology 
Research, Development, Translation, and Validation: Insights and 
Activities from selected ICCVAM Agencies: NIEHS/NTP, EPA, FDA
 Panel Discussion--Toxicology Research, Development, 
Translation, and Validation: The Way Forward for ICCVAM and Its 
Stakeholders
 Closing Remarks

Symposium Attendance and Registration

    The symposium will be held on Tuesday, February 5, 2008, from 1-5 
p.m., in the CPSC Hearing Room, located at CPSC Headquarters, Bethesda 
Towers Bldg., 4330 East West Highway, Bethesda, MD. The symposium is 
open to the public and there is no charge to attend; attendance is 
limited only by the available space. Individuals who plan to attend are 
encouraged to register in advance with NICEATM. Registration 
information is available on the NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/meetings/10thAnnivSymp/10thAnnivSymp.htm or by 
contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above). Persons 
needing special assistance in order to attend, such as sign language 
interpretation or other reasonable accommodation, should contact 919-
541-2475 voice, 919-541-4644 TTY (text telephone, through the Federal 
TTY Relay System at 800-877-8339), or e-mail to 
[email protected]. Requests should be made at least seven days in 
advance of the event.

NICEATM-ICCVAM Five-Year Plan

    NICEATM and ICCVAM, working in conjunction with Federal agency 
program offices, have prepared the NICEATM-ICCVAM Five-Year Plan. The 
plan describes how NICEATM and ICCVAM will facilitate the research, 
development, translation (activities carried out to characterize if 
there is evidence of relevance and applicability of a test method for a 
specific testing purpose), validation, and regulatory acceptance of 
alternative test methods. Acceptance of such methods will reduce, 
refine, and replace the use of animals in testing, while maintaining 
scientific quality and the protection of human health, animal health, 
and the environment. Development of the plan took place over a 14-month 
period during which there were multiple opportunities for comment on 
the plan by ICCVAM stakeholders, the public, and the Scientific 
Advisory Committee on Alternative Toxicological Methods (see Federal 
Register notices: Vol. 71, No. 218, pp. 66172-73, November 13, 2006; 
Vol. 72, No. 83, pp. 23831-32, May 1, 2007; and Vol. 72, No. 83, pp. 
23832-33, May 1, 2007).
    The plan addresses 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. Implementing this plan 
involves four key challenges. The first challenge is to identify 
priority areas for the next five years and to conduct and facilitate 
activities in those areas. The second challenge involves identifying 
and promoting research initiatives that are expected to support the 
future development of innovative alternative test methods. The third 
challenge is to foster the acceptance and appropriate use of 
alternative test methods through outreach and communication. The last 
challenge is to develop partnerships and strengthen interactions with 
ICCVAM stakeholders in order to facilitate meaningful progress.
    The NICEATM-ICCVAM Five-Year Plan will be presented at the February 
symposium and copies will be available. The NICEATM-ICCVAM Five-Year 
Plan will also be available electronically after February 5 on the 
NICEATM-ICCVAM Web site at http://iccvam.niehs.nih.gov/docs/5yearplan.htm. Print copies may be obtained by contacting NICEATM (see 
FOR FURTHER INFORMATION CONTACT above).

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use or generate 
toxicological information. ICCVAM conducts

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technical evaluations of new, revised, and alternative methods with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of toxicological test methods that more 
accurately assess the safety and hazards of chemicals and products and 
that refine, reduce, or replace animal use. The ICCVAM Authorization 
Act of 2000 (available at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) 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. Additional 
information about ICCVAM and NICEATM is available on the NICEATM-ICCVAM 
Web site at http://iccvam.niehs.nih.gov.

    Dated: December 12, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-24799 Filed 12-20-07; 8:45 am]
BILLING CODE 4140-01-P