[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74835-74836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program; Hormonally-Induced Reproductive 
Tumors: Relevance of Rodent Bioassays Workshop

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Workshop announcement.

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SUMMARY: For more than a quarter century, the National Toxicology 
Program (NTP) testing program has provided extensive and useful 
scientific information for predicting human health hazards and 
protecting public health. The NTP periodically conducts reviews of 
animal models used in its bioassays to critically analyze their 
predictive power and determine whether the protocols for these studies 
should be altered. As part of this effort, the NTP is convening a 
workshop titled ``Hormonally-Induced Reproductive Tumors: Relevance of 
Rodent Bioassays.'' The 2\1/2\ day workshop will be held on May 22-24, 
2006, at the Marriott Raleigh Crabtree Valley, 4500 Marriott Drive, 
Raleigh, NC 27612.
    The workshop's overall goal is to determine the adequacy and 
relevance to human disease outcome of rodent models for four types of 
hormonally-induced reproductive tumors (ovary, mammary gland, prostate, 
and testis). Other topics for discussion include proposed modes of 
action (for each tumor type and for hormonal tumors in general), dose 
response for tumor induction, predictiveness of rodent pre-neoplastic 
events for humans, the importance of the inclusion of an in utero 
exposure in the etiology of specific tumors, and the concept of 
``additivity to background'' when normal hormones are present with 
homeostatic control mechanisms. The program will include plenary 
sessions as well as four breakout group sessions for in-depth 
discussions.
    This meeting is open to the public with time set aside for public 
comments. Attendance is limited by the space available to approximately 
100 public attendees. Individuals may register to attend the workshop 
on a first-come, first-served basis per the procedures outlined below. 
A copy of the agenda and any additional information about the workshop, 
including background materials, public comments, and invited 
participants, will be posted on the NTP Web site when available (see 
NTP Web site

[[Page 74836]]

http://ntp.niehs.nih.gov select ``Meetings and Workshops'').

DATES: The workshop will be held on May 22-24, 2006. The workshop will 
begin each day at 8:30 a.m. and end at approximately 5 p.m. on May 22-
23 and approximately 12 p.m. on May 24.
    Comments: Written comments should be received by May 12, 2006, to 
allow time for adequate review before the meeting (see FOR FURTHER 
INFORMATION CONTACT below). Individuals wishing to make oral public 
comments are asked to contact Dr. Paul Foster (see FOR FURTHER 
INFORMATION CONTACT below) by March 12, 2006, and if possible, also to 
send a copy of the statement or talking points at that time.
    Registration: Individuals who plan to attend are encouraged to 
register online at the NTP Web site http://ntp.niehs.nih.gov/ select 
``Meetings and Workshops'' as soon as possible because seating is 
limited to approximately 100 public attendees. Persons needing special 
assistance, such as sign language interpretation or other reasonable 
accommodation in order to attend, should contact 919-541-2475 voice, 
919-541-4644 TTY (text telephone), through the Federal TTY Relay System 
at 800-877-8339, or by e-mail to [email protected]. Requests 
should be made at least 7 days in advance of the event.

ADDRESSES: The workshop will be held at the Marriott Raleigh Crabtree 
Valley, 4500 Marriott Drive, Raleigh, North Carolina 27612.

FOR FURTHER INFORMATION CONTACT: Correspondence should be submitted to 
Dr. Paul Foster (NIEHS, P. O. Box 12233, MD EC-34, Research Triangle 
Park, NC, 27709; telephone: 919-541-2513, fax: 919-541-4255; or e-mail: 
[email protected]).

SUPPLEMENTARY INFORMATION:

Background

    The workshop will include plenary sessions as well as four 
simultaneous breakout group sessions for in-depth discussion of the 
topics mentioned above. Each breakout group will address the following 
topics for a specific tumor type (ovary, mammary gland, prostate, or 
testis), relevance to human disease outcome of rodent models, proposed 
modes of action, dose response for tumor induction, predictiveness of 
rodent pre-neoplastic events for humans, the importance of the 
inclusion of an in utero exposure in the etiology of specific tumors, 
and the concept of ``additivity to background'' when normal hormones 
are present with homeostatic control mechanisms. The NTP will prepare a 
workshop report following the meeting.

Request for Comments

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments during the plenary session on May 
22, 2006. Each organization is allowed one speaker during the public 
comment period. At least 7 minutes will be allotted to each speaker, 
and if time permits, may be extended to 10 minutes. Registration for 
oral comments will also be available on-site, although time allowed for 
presentation by on-site registrants may be less than that for pre-
registered speakers and will be determined by the number of persons who 
register at the meeting.
    Written statements can supplement and may expand the oral 
presentation. If registering on-site and reading from written text, 
please bring 50 copies of the statement for distribution and to 
supplement the record. Written comments received in response to this 
notice will be posted on the NTP Web site (http://ntp.niehs.nih.gov 
select ``Meetings and Workshops''). Persons submitting written comments 
should include their name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization (if any) with the document.

    Dated: December 5, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. E5-7414 Filed 12-15-05; 8:45 am]
BILLING CODE 4140-01-P