E5-7414. 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.

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 21/2 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 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 [e-mail]. 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: [phone], fax: [phone]; or e-mail: [e-mail]).

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.