[Federal Register: December 21, 2007 (Volume 72, Number 245)]
[Notices]
[Page 72727-72729]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21de07-90]
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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) niceatm@niehs.nih.gov.
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
niehsoeeo@niehs.nih.gov. 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