2011-10020. Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)

AGENCY:

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

ACTION:

Meeting announcement and request for comments.

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 16-17, 2011, at the Hilton Arlington Hotel, 950 North Stafford Street, Arlington, VA 22203. The meeting is open to the public with attendance limited only by the space available. The meeting will be videocast through a link at (http://www.niehs.nih.gov/​news/​video/​live). 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 16 and 17, 2011. The meeting is scheduled from 8:30 a.m. Eastern Daylight Time to 5:30 p.m. on June 16 and 8:30 a.m. until adjournment on June 17. All individuals who plan to attend are encouraged to register online at the NTP Web site (http://ntp.niehs.nih.gov/​go/​32822) by June 9, 2011. In order to facilitate planning, persons wishing to make an oral presentation are asked to notify Dr. Lori White, NTP Designated Federal Officer, via online registration, phone, or email by June 9, 2011 (see ADDRESSES below). Written comments should also be received by June 9, 2011, to enable review by SACATM and NIEHS/NTP staff before the meeting.

ADDRESSES:

The SACATM meeting will be held at the Hilton Arlington Hotel, 950 North Stafford Street, Arlington, VA 22203. 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 K2-03, Research Triangle Park, NC 27709; telephone: [phone] or e-mail: [e-mail]). Courier address: NIEHS, 530 Davis Drive, Room 2136, Morrisville, NC 27560. 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
• Regulatory Acceptance of ICCVAM-Recommended Alternative Test Methods
• Report on Peer Review Panel Meeting: Evaluation of an In Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical Screening
• Federal Agency Research, Development, Translation, and Validation Activities Relevant to the NICEATM-ICCVAM Five-Year Plan
• Nominations to ICCVAM: Botulinum In Vitro Assays, In Vitro Pyrogen Assay Validation
• Outcome/Recommendations from the ICCVAM Workshop Series on Best Practices for Regulatory Safety Testing
• Outcomes/Recommendations from the International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency Testing: State of the Science and Future Directions
• Update from the Korean Center for the Validation of Alternative Methods
• Update from Health Canada
• Update from the Japanese Center for the Validation of Alternative Methods
• Update from the European Centre for the Validation 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/​32822) or available upon request (see ADDRESSES above). Following the SACATM meeting, summary minutes will be prepared and available on the NTP Web site 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. In addition to in-person oral comments at the meeting, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The available lines will be open from 8 a.m. until 5 p.m. on June 16 and 8:30 a.m. to adjournment on June 17, although public comments will be received only during the formal public comment periods, which will be indicated on the preliminary agenda. The access number for the teleconference line will be provided to registrants by email prior to the meeting.

Persons registering to make oral comments are asked to do so through the online registration form (http://ntp.niehs.nih.gov/​go/​32822) and to send a copy of their statement to Dr. White (see ADDRESSES above) by June 9, 2011, 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 require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about ICCVAM and NICEATM can be found on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov).

SACATM was established in response to the ICCVAM Authorization Act [Section 285 l-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 18, 2011.

John R. Bucher,

Associate Director, National Toxicology Program.