[Federal Register Volume 68, Number 2 (Friday, January 3, 2003)]
[Notices]
[Pages 381-382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-35]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program, National Institute of Environmental 
Health Sciences, National Institutes of Health: Notice of Workshop

Summary

    The National Toxicology Program (NTP) is sponsoring a workshop 
entitled ``Genetically Modified Rodent Models for Cancer Hazard 
Identification: Selecting Substances for Study and Interpreting and 
Communicating Results' on February 21, 2003, at the Hamilton Crowne 
Hotel, 14th and K Street, NW., Washington, DC. Registration starts at 8 
a.m. and the meeting begins at 8:30 a.m. and is open to the public with 
attendance limited only by the available space. Persons interested in 
attending are asked, if possible, to preregister with the NTP Liaison 
and Scientific Review Office (contact information below). As 
information about this workshop becomes available, it will be posted on 
the NTP web site (http://ntp-server.niehs.nih.gov).

Background

    The NTP has invested considerable time and resources in addressing 
whether cancer bioassay results from studies conducted in genetically 
modified or ``transgenic'' rodent models are useful for identifying 
chemicals presumed to be of carcinogenic risk to humans, in order to 
determine whether these models might be integrated into NTP research 
and testing activities. After reviewing available information on the 
use of selected models in carcinogen identification, the NTP recognizes 
that important issues of experimental design and data interpretation 
need further attention to enable future regulatory acceptance and

[[Page 382]]

eventual use in human risk assessment. Therefore, to begin to address 
these areas the NTP is sponsoring a workshop with the following 
objectives:
    [sbull] Solicit comment on a process for selection of appropriate 
nominated substances to undergo cancer hazard evaluation in genetically 
modified or ``transgenic'' models.
    [sbull] Solicit comment on issues related to the proper 
interpretation of results of ``transgenic'' cancer models, the 
implications of these findings for public health decisions, and the 
most appropriate interpretive language to describe the results of such 
studies to the scientific/regulatory communities and the public.

Preliminary Agenda

8 a.m. Registration
8:30 a.m. Introduction and Welcome
8:45 a.m. Plenary Session
    [sbull] Overview of Selected Transgenic Models
    [sbull] Experience with Transgenic Models in the NTP Bioassay
    [sbull] Workshop Charge
    [sbull] Public Comment
10 a.m. Break
10:30 a.m. Breakout Groups
    [sbull] Group 1: Solicit comment on a process for selection of 
appropriate nominated substances to undergo cancer hazard evaluation in 
genetically modified or ``transgenic'' models.
    [sbull] Group 2: Solicit comment on issues related to the proper 
interpretation of results of ``transgenic'' cancer models, the 
implications of these findings for public health decisions, and the 
most appropriate interpretive language to describe the results of such 
studies to the scientific/regulatory communities and the public.
Noon Lunch (on your own)
1:00 p.m. Breakout Groups continued
2:30 p.m. Break
3:15 p.m. Plenary Session
    [sbull] Breakout Group Reports
    [sbull] Open Discussion
4:30 p.m. Adjourn
    As additional details and materials for this workshop become 
available, they will be posted on the NTP web site (http://ntp-server.niehs.nih.gov) or can be obtained by contacting Ms. Diane 
Spencer, NTP Liaison and Scientific Review Office (T: 919-541-2759, F: 
919-541-0295, [email protected]).

Registration and Public Comment

    The workshop is open to the public and interested individuals are 
invited to attend as observers. The number of observers will be limited 
only by the space available. Due to space limitations, persons 
interested in attending are asked to pre-register by contacting Ms. 
Spencer (contact information above).
    The NTP invites public comment and time is set-aside during the 
morning session for presentation of oral comments. Persons wishing to 
make oral comment are asked to contact Ms. Spencer in advance of the 
meeting and provide contact information (name, affiliation, telephone, 
e-mail, and sponsoring organization, if any); however, registration for 
oral comments will also be accepted on-site. Observers are also welcome 
to participate in the open discussion in the afternoon plenary session.
    The NTP also welcomes receipt of written comments. If sending 
written comments, please include contact information (name, 
affiliation, telephone, e-mail, and sponsoring organization, if any) 
and send to Dr. Mary S. Wolfe, NTP Executive Secretary (P.O. Box 12233, 
MD A3-01. 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 or 
[email protected]) by Friday, February 14, 2003. Any comments 
received will be provided to invited attendees at the meeting and made 
available for the public.

Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-35 Filed 1-2-03; 8:45 am]
BILLING CODE 4140-01-P