[Federal Register Volume 65, Number 49 (Monday, March 13, 2000)]
[Notices]
[Pages 13289-13290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6013]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; National Institute of Environmental 
Health Sciences (NIEHS), National Institutes of Health (NIH): Notice of 
Expert Panel Meeting on the Frog Embryo Teratogenesis Assay--Xenopus

SUMMARY: Pursuant to Public Law 103-43, notice is hereby given of a 
public meeting sponsored by the NIEHS and the National Toxicology 
Program (NTP), and coordinated by the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) and the NTP 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM). The agenda topic is an expert panel assessment on 
the current validation status of the frog embryo teratogenesis assay 
(FETAX), an in vitro method proposed for evaluating the developmental 
toxicity potential of chemicals. The meeting will take place at the 
Sheraton Imperial Hotel and Convention Center, 4700 Emperor Blvd., 
Durham, NC 27703 on May 16-17, 2000 from 8:00 a.m. to 5:30 p.m. and May 
18 from 8:00 a.m. to noon and is open to the public.

Background

    ICCVAM, with participation by 14 Federal regulatory and research 
agencies and programs, was established in 1997 to coordinate issues 
relating to validation, acceptance, and national/international 
harmonization of toxicological test methods. ICCVAM 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. NICEATM provides administrative and scientific 
support of ICCVAM-related activities. NICEATM and ICCVAM collaborate to 
carry out 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 that are convened, as needed, to evaluate the 
adequacy of current methods for assessing specific toxicities, to 
identify

[[Page 13290]]

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 that 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, which 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 that 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 its 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 coordinating an Expert Panel Meeting to 
assess the current validation status of FETAX which is proposed as a 
screening method for evaluating the developmental toxicity potential of 
chemicals (Bantle, J.A., 1995, FETAX--A Developmental Toxicity Assay 
Using Frog Embryos, in: Fundamentals of Aquatic Toxicology, 2nd Ed., 
(Rand, G.M., ed), Taylor and Francis:USA, pp. 207-230). An ICCVAM 
Developmental Toxicity Working Group composed of Federal employees 
determined that the assay may have potential for use in 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 has prepared a 
comprehensive Background Review Document (BRD) summarizing available 
FETAX data and performance characteristics.

Agenda

    During the morning session on the first day of the meeting, May 16, 
the Expert Panel will meet in a plenary session and then divide into 
five Breakout Groups that will meet on the afternoon of May 16 and all 
day on May 17. For these sessions, the Breakout Groups will address 
potential uses of FETAX and develop recommendations for research, 
additional test method development, and validation efforts that might 
be considered to further enhance and/or characterize the usefulness of 
FETAX. On May 18 in a plenary session, the Breakout Groups will 
individually present their conclusions and recommendations for 
consideration and discussion by the entire panel. A final report from 
the Expert Review Panel will be prepared and made publicly available 
(see below). The public is invited to attend all sessions of the Expert 
Panel Meeting, and designated times throughout the meeting will be set 
aside for presentation of public comments.
    Summary minutes for the meeting and the final report from the 
Expert Panel will be prepared and made available upon request to 
NICEATM and on the web at http://iccvam.niehs.nih.gov. Copies of the 
FETAX BRD and supporting materials may be obtained from NICEATM, MD: 
EC-17, P.O. Box 12233, Research Triangle Park, NC, 27709 (919-541-
3398), FAX (919-541-0947), e-mail:
    [email protected]. Additionally, the FETAX BRD will be available 
for viewing Monday through Friday, from noon to 4:00 p.m. EST at: 
Office of Prevention, Pesticides and Toxic Substances, Non-Confidential 
Information Center, Room 607B, Northeast Mall, 401 M Street SW, 
Washington, DC 20406. Thirty days prior to the meeting, a detailed 
agenda will be available online at: http://iccvam.niehs.nih.gov or by 
contacting NICEATM.

Public Comment

    NICEATM invites the submission of written comments on the FETAX 
test method and BRD, as well as other available information regarding 
the usefulness of FETAX including information about completed, ongoing, 
or planned studies. Written comments and additional information should 
include name, affiliation, mailing address, phone, fax, e-mail and 
sponsoring organization (if any). This material should be sent by mail, 
fax, or e-mail to NICEATM at the address given. Information and 
comments may be sent at any time prior to the meeting; however, 
materials should be received by April 15, 2000 in order to ensure 
adequate review by the Expert Panel. This information will be added to 
the resource materials assembled on FETAX. Copies of written comments 
will be available for attendees at the meeting.
    The Expert Panel Meeting will be open to the public, and time will 
be provided for presentation of public oral comments at designated 
times during the meeting. Speakers will be assigned on a first-come, 
first-serve basis, and at least seven minutes will be allotted to each 
speaker. In order to facilitate planning for the meeting, persons 
requesting time for an oral presentation should notify NICEATM at the 
address given above no later than May 1, 2000. Persons registering to 
make comments are asked to provide, if possible, a written copy of 
their statement by May 1st so copies can be made and distributed to the 
Expert Panel and ICCVAM representatives and experts for their timely 
review prior to the meeting. Written statements can supplement and 
expand the oral presentation, and each speaker is asked to provide his/
her name, affiliation, mailing address, phone, fax, e-mail and 
supporting organization (if any). Registration for making public 
comments will also be available on-site. If registering on-site to 
speak and reading oral comments from printed copy, the speaker is asked 
to bring 50 copies of the text. These copies will be distributed to the 
Chair and Expert Panel members and supplement the record.
    Persons needing special assistance, such as sign language 
interpretation or other special accommodations should contact NICEATM 
(contact information given above).

    Dated: March 6, 2000.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 00-6013 Filed 3-10-00; 8:45 am]
BILLING CODE 4140-01-P