E6-8172. National Toxicology Program (NTP); NTP Workshop: Biomarkers for Toxicology Studies

AGENCY:

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

ACTION:

Workshop announcement and request for comments.

SUMMARY:

For more than a quarter century, the 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 models used in its testing program to critically analyze their predictive power and determine whether study protocols should be altered. As part of this effort, the NTP is convening a workshop titled “Biomarkers for Toxicology Studies.” The meeting will be held on September 20-21, 2006, at the NIEHS in Research Triangle Park, NC.

The workshop will include plenary sessions and three simultaneous breakout group sessions for in-depth discussion. The workshop's overall goal is to identify biomarkers for carbohydrate/lipid metabolism and lung and cardiac function and then evaluate their utility for inclusion in rodent toxicology studies to better characterize endpoints of environmentally induced diseases or biological processes related to disease etiology. This meeting is open to the public with time set aside for public comments during the plenary session on the first day. The public is invited to attend the breakout groups as observers.

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 “Calendar of Upcoming Events”).

DATES:

The workshop will be held on September 20-21, 2006, and begin each day at 8:30 a.m. and end at approximately 5 p.m. on September 20 and approximately 12:30 p.m. on September 21.

Comments: Written comments should be received by September 6, 2006, to allow time for adequate review before the meeting. Individuals wishing to make oral public comments are asked to contact Ms. Denise Lasko (see FOR FURTHER INFORMATION CONTACT below) by September 6, 2006, and if possible, 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 “Calendar of Upcoming Events” as soon as possible because seating is limited.

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 in the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT:

Requests for public comment and any other correspondence should be submitted to Ms. Denise Lasko (NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: [phone], fax: [phone]; or e-mail: [e-mail]).

SUPPLEMENTARY INFORMATION:

Background

The term biomarker is often used to refer to indicators of exposure and response in biological systems. Biomarker measurements can potentially be used as indicators of disease etiology or biological function; however, their utility is a function of how well the biomarker is understood. In addition, biomarkers measured in animal models should be applicable to humans.

The plenary session on the first day will include overview talks. Each breakout group will address the identification of biomarkers for lung function, cardiac function, or carbohydrate/lipid metabolism and discuss their possible inclusion in rodent toxicology studies to better characterize endpoints of environmentally induced diseases or biological processes related to disease etiology. The breakout groups will present their findings during plenary on September 21 followed by a general, open discussion.

Request for Comments

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 onsite, 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 onsite 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 meeting page for this event on the NTP Web site (http://ntp.niehs.nih.gov select “Calendar of Upcoming Events.” Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document.

Dated: May 17, 2006.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program.