[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); [email protected] (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