E8-10010. National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)

AGENCY:

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

ACTION:

Meeting announcement and request for comment.

SUMMARY:

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 18-19, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709. The meeting is scheduled from 8:30 a.m. to 5:30 p.m. on June 18 and 8:30 a.m. until adjournment on June 19. The meeting is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

DATES:

The SACATM meeting will be held on June 18 and 19, 2008. All individuals who plan to attend are encouraged to register online at the NTP Web site (http://ntp.niehs.nih.gov/​go/​7441) by June 10, 2008. In order to facilitate planning, persons wishing to make an oral presentation are asked to notify Dr. Lori White, NTP Executive Secretary, via online registration, phone, or email by June 10, 2008 (see ADDRESSES below). Written comments should also be received by June 10 to enable review by SACATM and NIEHS/NTP staff before the meeting.

ADDRESSES:

The SACATM meeting will be held at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 [hotel: [phone]]. Public comments and other correspondence should be directed to Dr. Lori White (NTP Office of Liaison, Policy and Review, NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709; telephone: [phone] or e-mail: [e-mail]). Courier address: NIEHS, 111 T.W. Alexander Drive, Room A326, Research Triangle Park, NC 27709. Persons needing interpreting services in order to attend should contact 301-402-8180 (voice) or 301-435-1908 (TTY). Requests should be made at least 7 days in advance of the meeting.

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

Preliminary agenda topics include:

• NICEATM-ICCVAM Update;
• Overview of NICEATM-ICCVAM 5-Year Plan;
• NRC Report: Toxicity Testing in the 21st Century;
• Presentations from Federal Agencies on Research, Development, Translation, and Validation Activities Relevant to the NICEATM-ICCVAM Five-Year Plan;
• Report on the ICCVAM-NICEATM Independent Scientific Peer Review Meeting: Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA), a Test Method for Assessing the Contact Dermatitis Potential of Chemicals and Products;
• Report on the ICCVAM-NICEATM-ECVAM-JACVAM Scientific Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations;
• Nominations to ICCVAM: NTP Rodent Bioassay for Carcinogenicity;
• Proposal for International Cooperation on Alternative Test Methods;
• Update from the Japanese Center for the Validation of Alternative Methods;
• Update from the European Center for the Evaluation of Alternative Methods,

A copy of the preliminary agenda, committee roster, and additional information, when available will be posted on the NTP Web site (http://ntp.niehs.nih.gov/​go/​7441) or available upon request (see ADDRESSES above). Following the SACATM meeting, summary minutes will be prepared and available on the NTP website or upon request.

Request for Comments

Both written and oral public input on the agenda topics is invited. Written comments received in response to this notice will be posted on the NTP Web site. Persons submitting written comments should include their name, affiliation (if applicable), and sponsoring organization (if any) with the document. Time is allotted during the meeting for presentation of oral comments and each organization is allowed one time slot per public comment period. At least 7 minutes will be allotted for each speaker, and if time permits, may be extended up to 10 minutes at the discretion of the chair. Registration for oral comments will also be available on-site, although time allowed for presentation by on-site registrants may be less than for pre-registered speakers and will be determined by the number of persons who register at the meeting.

Persons registering to make oral comments are asked to do so through the online registration form (http://ntp.niehs.nih.gov/​go/​7441) and to send a copy of their statement to Dr. White (see ADDRESSES above) by June 10 to enable review by SACATM, NICEATM-ICCVAM, and NIEHS/NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation. If registering on-site and reading from written text, please bring 40 copies of the statement for distribution and to supplement the record.

Background Information on ICCVAM, NICEATM, and SACATM

ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use, generate, or disseminate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the development, scientific validation, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, and replace animal use. The ICCVAM Authorization Act of 2000 [42 U.S.C. 285l-3] established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of U.S. Federal agencies. Additional information about ICCVAM and NICEATM can be found on their Web site (http://iccvam.niehs.nih.gov).

SACATM was established in response to the ICCVAM Authorization Act [Section 285l-3(d)] and is composed of scientists from the public and private sectors. SACATM advises ICCVAM, NICEATM, and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods. Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/​go/​167.

Dated: April 28, 2008.

Samuel H. Wilson,

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