National Toxicology Program (NTP); Notice of a Meeting of the NTP Board of Scientific Counselors

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the National Toxicology Program (NTP) Board of Scientific Counselors on October 26, 2004, in the Rodbell Auditorium, Rall Building at the National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709.

The NTP Board of Scientific Counselors (“the NTP Board”) is composed of scientists from the public and private sector and provides primary scientific oversight to the NTP.

Agenda

The meeting being held on October 26, 2004, begins at 8:30 a.m. and is open to the public from 8:30 a.m. to adjournment with attendance limited only by the space available. Persons needing special assistance should contact the NTP Executive Secretary (contact information below) at least seven business days in advance of the meeting. A draft agenda with a tentative schedule is provided below. Primary agenda topics include: (1) NTP initiatives to enhance toxicology, (2) substances nominated to the NTP for study and recommendations of the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC), (3) new approaches for statistical analyses for chronic tests, (4) a proposed process for evaluating chemicals with limited data sets by the Center for the Evaluation of Risks to Human Reproduction, and (5) a research program on Caenorhabditis elegans. The NTP Board will also review three concept proposals for the conduct of research through the use of a contract mechanism. These concepts include: (1) The evaluation of chemicals for their potential to modulate immune responses, (2) chemical characterization of substances for testing in high-throughput screening and chronic assays, and (3) application of automated techniques to toxicity testing. Time is allotted during the meeting for the public to present comments to the NTP Board and NTP staff on any agenda topic.

The agenda and background materials on agenda topics, as available, will be posted on the NTP Web site ( http://ntp-server.niehs.nih.gov,, see What's New) or available upon request to the NTP Executive Secretary (contact information below). The NTP is making plans to videocast the meeting through the Internet at http://www.niehs.nih.gov/external/video.htm. Following the meeting, summary minutes will be prepared and available through the NTP Web site and upon request to Central Data Management, NIEHS, P.O. Box 12233, MD E1-02, Research Triangle Park, NC 27709; telephone: 919-541-3419, fax: 919-541-3687, and e-mail: CDM@niehs.nih.gov.

ICCEC Recommendations for Substances Nominated for Future NTP Studies

Information about substances nominated to the NTP for toxicology and carcinogenicity studies and the ICCEC's recommendations were published in the Federal Register on August 20, 2004 (Vol. 69, No. 161, pages 51691-51693). This notice is available on the Web ( http://ntp-server.niehs.nih.gov/htdocs/liason/04JuneICCECFR.html ) along with the list of nominations ( http://ntp-server.niehs.nih.gov/NomPage/2004Noms.html ) and supporting documents for each nomination ( http://ntp-server.niehs.nih.gov/NomPage/BkgrSum04June.html ) or is available by contacting the NTP Executive Secretary (contact information below). This meeting provides an additional opportunity for the public to provide comment on these nominations and study recommendations to the NTP Board and NTP staff. Comments submitted to the NTP in response to the August 20, 2004, Federal Register notice are under consideration and do not need to be resubmitted or readdressed.

Public Comment Encouraged

Public input at this meeting is invited and time is set aside for the presentation of public comments on any agenda topic. At least 7 minutes will be allotted to each speaker and, if time permits, may be extended to 10 minutes. Each organization is allowed one time slot per agenda topic. Persons registering to make oral comments are asked to provide their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any). To facilitate planning for the meeting, persons interested in providing formal oral comments are asked to notify Dr. Barbara Shane, NTP Executive Secretary, NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: 919-541-0530; and e-mail: shane@niehs.nih.gov by October 18, 2004. Persons may also submit written comments in lieu of making oral comments. Written comments should be sent to the NTP Executive Secretary and must be received by October 18, 2004, to enable review by the NTP Board and NTP staff prior to the meeting.

Persons submitting written comments should include their name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization (if any) with the document. Individuals will also be able to register to give oral public comments on-site at the meeting. However, if registering on-site and reading from written text, please bring 30 copies of the statement for distribution to the NTP Board and NTP staff and to supplement the record.

Registration

The NTP Board meeting is open to the public. Due to changes in security policies at the NIEHS, individuals who plan to attend are asked to pre-register with the NTP Executive Secretary (contact information above). The names of those registered will be given to the NIEHS Security Office in order to gain access to the campus. Persons attending who have not pre-registered may be asked to provide pertinent information about the meeting such as the title or host of the meeting before gaining access to the campus. All visitors (whether or not you are pre-registered) will need to be prepared to show 2 forms of identification (ID), for example, a driver's license and one other form of ID, such as company ID, government ID, or university ID.

NTP Board of Scientific Counselors

The NTP Board is a technical advisory body comprised of scientists from the public and private sectors who provide primary scientific oversight to the overall program and its centers. Specifically, the NTP Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purposes of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields, such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and minority and female representation on the NTP Board. Its members are invited to serve overlapping terms of up to four years and meetings are held once or twice annually for the NTP Board and its two standing subcommittees (the Report on Carcinogens Subcommittee and the Technical Reports Review Subcommittee).

Preliminary Agenda

National Toxicology Program (NTP) Board of Scientific Counselors

October 26, 2004

National Institute of Environmental Health Sciences, Rodbell Auditorium, Rall Building, 111 T.W. Alexander Drive, Research Triangle Park, NC.

8:30 a.m. Welcome and Opening Comments.

NTP Update.

NTP Initiatives to Enhance Toxicology.

Concept Review.

• Evaluation of Chemicals for Their Potential to Modulate Immune Responses.
• Chemical Characterization of Substances for Testing in NTP Studies.
• Application of Automated Techniques to Toxicity Testing.

12 p.m. Lunch.

12:45 p.m. NTP Testing Program.

• Study Nominations.
• New Approaches to Statistical Analyses for 2-year Toxicology and Carcinogenicity Studies.
• Center for the Evaluation of Risks to Human Reproduction—Proposed Process for Evaluating Chemicals with Limited Data Sets.
• Research Program on Caenorhabditis elegans.

4:45 p.m. Adjourn.