[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Notices]
[Pages 48662-48663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institute of Environmental Health Sciences, National
Toxicology Program, Request for Data and Suggested Expert Panelists for
Evaluation of the Current Status of the Frog Embryo Teratogenesis
Assay--Xenopus (FETAX)
Background
The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM), with participation by 14 Federal
regulatory and research agencies and programs, was established in 1997
to facilitate cross-agency communication and coordination on issues
relating to validation, acceptance, and national/international
harmonization of toxicological test methods. The Committee seeks to
promote the scientific validation and regulatory acceptance of
toxicological test methods that will enhance agencies' ability to
assess risks and make decisions, and that will refine, reduce, and
replace animal use whenever possible. The National Toxicology Program
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM), provides administrative and technical support for
ICCVAM, and serves as a communication and information resource. NICEATM
and ICCVAM collaborate to carry out related activities needed to
develop, validate, and achieve regulatory acceptance of new and
improved test methods applicable to Federal agencies. These activities
may include:
Test Method Workshops, which are convened as needed to evaluate the
adequacy of current methods for assessing specific toxicities, to
identify areas in need of improved or new testing methods, and to
identify research efforts that may be needed to develop a new test
method.
Expert Panel Meetings, which are typically convened to evaluate the
validation status of a method following the completion of initial
development and pre-validation studies. An Expert Panel is asked to
recommend additional validation studies that might be helpful in
further characterizing the usefulness of a method, and to identify any
additional research and development efforts that might enhance the
effectiveness of a method.
Independent Peer Review Panel Meetings, which are typically
convened following the completion of comprehensive validation studies
on a test method. Peer review panels are asked to develop scientific
consensus on the usefulness and limitations of test methods to generate
information for specific human health and/or ecological risk assessment
purposes. Following the independent peer review of a test method,
ICCVAM forwards recommendations on their usefulness to agencies for
their consideration. Federal agencies then determine the regulatory
acceptability of a method according to their mandates.
Evaluation of FETAX
ICCVAM and NICEATM are currently planning an Expert Panel Meeting
to assess the current validation status of the Frog Embryo
Teratogenesis Assay--Xenopus (FETAX), a method proposed for evaluating
the developmental toxicity potential of chemicals (Bantle JA, 1995,
FETAX--A Developmental Toxicity Assay Using Frog Embryos, Fundamentals
of Aquatic Toxicology, 2nd ed., G.M. Rand, ed, Taylor and Francis, USA.
pp. 207-230). Possible applications of FETAX to human health and
environmental assessments may include screening and prioritizing
compounds for further testing, evaluating complex mixtures and
environmental samples, and as supplemental information in a weight-of-
evidence evaluation of toxicity hazards. NICEATM is preparing a
background document summarizing the initial studies and the performance
characteristics of FETAX. The Expert Panel will evaluate the
conclusions presented in the background document
[[Page 48663]]
and address the potential uses of FETAX. The Expert Panel will address
additional test method development and validation efforts that should
be considered that might further enhance and characterize the
usefulness of FETAX for various applications and other relevant aspects
of the Xenopus model.
Request for Data and Expert Names
The Center would welcome receiving data and information from
completed, ongoing, or planned studies using or evaluating FETAX.
Information should address the criteria for validation and regulatory
acceptance provided in NIH publication 97-3981, ``Validation and
Regulatory Acceptance of Toxicological Test Methods: A Report of the ad
hoc Interagency Coordinating Committee on the Validation of Alternative
Methods'' (http://ntp-server.niehs.nih.gov/htdocs/ICCVAM/iccvam.html).
Where possible, data and information should adhere to the guidance
provided in the document, ``Evaluation of the Validation Status of
Toxicological Methods: General Guidelines for Submissions to ICCVAM''
(http://iccvam.niehs.nih.gov/doc1.htm), which is available on request
from the NTP Center at the address provided below. Information
submitted in response to this request will be incorporated into the
background material provided to the Expert Panel. Meeting information,
including date, location, and availability of the background document,
will be announced in a future notice.
The ICCVAM also welcomes suggestions of scientists with relevant
knowledge and experience who might be considered for the Expert Panel.
For each person suggested, their name, address, and a brief summary of
relevant experience and qualifications should be provided. Where
possible, telephone, fax number, and/or e-mail addresses should also be
provided. Information should be sent by mail, fax, or e-mail to the NTP
Interagency Center for the Evaluation of Alternative Toxicological
Methods by October 7, 1999. Correspondence should be directed to: Dr.
William S. Stokes, NTP Interagency Center for the Evaluation of
Alternative Toxicological Methods, Environmental Toxicology Program,
NIEHS/NTP, MD EC-17, PO Box 12233, Research Triangle Park, NC 27709;
919-541-3398 (phone); 919-541-0947 (fax); iccvam@niehs.nih.gov (e-
mail).
Dated: August 27, 1999.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.
[FR Doc. 99-23219 Filed 9-3-99; 8:45 am]
BILLING CODE 4140-01-P
