E7-8290. National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Draft NICEATM-ICCVAM 5-Year Plan and ...

AGENCY:

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

ACTION:

Meeting announcement and request for comments.

SUMMARY:

The NIEHS and NICEATM request public comments that can be considered by NICEATM, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and relevant program offices on the draft NICEATM-ICCVAM 5-Year Plan. The draft plan addresses: (a) Research, development, translation, and validation of new and revised non-animal and other alternatives assays for integration of relevant and reliable methods into federal agency testing programs and (b) identification of areas of high priority for new and revised non-animal and alternative assays for the replacement, reduction, and refinement (less pain and distress) of animal tests. The draft plan will be available on or before May 7, 2007, at the NICEATM-ICCVAM 5-Year Plan Web site (http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm). Copies of the draft plan may also be obtained by contacting NICEATM (see ADDRESSES below). NICEATM and ICCVAM will hold a public Town Meeting at the National Institutes of Health, Bethesda, Maryland on June 11, 2007, beginning at 1 p.m. to adjournment (~5 p.m.) to receive oral comments on the draft NICEATM-ICCVAM 5-Year Plan.

DATES:

The draft NICEATM-ICCVAM 5-Year Plan will be available by May 7, 2007. Registration to attend the meeting and written comments on the draft NICEATM-ICCVAM 5-Year Plan should be received by June 7, 2007. The Town Meeting will be held June 11, 2007.

ADDRESSES:

The Town Meeting will be held at the William H. Natcher Conference Center, Room E, NIH, 9000 Rockville Pike, Bethesda, Maryland. 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 send e-mail to [e-mail]. Requests should be made at least 7 days in advance of the meeting. Written comments should be submitted preferably electronically at the NICEATM-ICCVAM 5-Year Plan Web site: http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm. Comments can also be submitted by e-mail to [e-mail].

FOR FURTHER INFORMATION CONTACT:

Other correspondence should be directed to Dr. William S. Stokes, NICEATM Director (NIH/NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709; telephone: [phone], fax: [phone] or e-mail: [e-mail]. Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709).

SUPPLEMENTARY INFORMATION:

Background

Congress established ICCVAM to promote development, validation, and regulatory acceptance of new or revised alternative toxicological test methods that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness (42 U.S.C. 285 l-3). Congress has requested that NICEATM and ICCVAM, in partnership with relevant federal agencies, develop a five-year plan that addresses (1) research, development, translation, and validation of new and revised non-animal and other alternative assays for integration into federal agency testing programs and (2) identification of areas of high priority for new and revised non-animal and alternative assays for replacement, reduction, and refinement (less pain and distress) of animal tests. At this time, the NIEHS and NICEATM seek public comments on the draft plan. NICEATM and ICCVAM in partnership with relevant agency program offices will consider these comments in development of the final plan. A Town Meeting on June 11 will provide the public an opportunity to present oral comments on the draft plan (see below) to NICEATM staff, ICCVAM Agency Representatives, and other agency program staff. In addition, some members of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) will also attend. On June 12, 2007, SACATM will meet at the Marriott Bethesda North Hotel and Conference Center in Bethesda, Maryland, where the agenda also includes discussion of the draft plan (http://ntp.niehs.nih.gov/​go/​7441) and opportunity for oral comments. The SACATM meeting will be announced in a separate Federal Register notice.

Registration for the Town Meeting

The Town Meeting will be held on June 11, 2007, at the William H. Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. Persons planning to attend are asked to register by June 7, 2007 by completing the online registration at the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/​meetings/​5YPlanTM/​townmtg.htm) or by contacting NICEATM (see ADDRESSES above). The agenda is available on the NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/​meetings/​5YPlanTM/​townmtg.htm) or can be obtained by contacting NICEATM (see ADDRESSES above).

Request for Comments

The NIEHS and NICEATM invite public comments on the draft NICEATM-ICCVAM 5-Year Plan. Written comments should be submitted preferably electronically at the NICEATM-ICCVAM 5-Year Plan Web site (http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm). Comments can also be submitted by e-mail to [e-mail]. Individuals submitting comments are asked to include appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, if applicable). All comments received by June 7, 2007, will be posted on the ICCVAM-NICEATM Web site (http://iccvam.niehs.nih.gov/​docs/​5yearplan.htm) and identified by the individual's name, affiliation (if applicable), and/or sponsoring organization (if any).

Persons registering to make oral comments at the Town Meeting are asked to contact NICEATM (see ADDRESSES above) and send a copy of their statement by June 7. Written statements can supplement and may expand the oral presentation. Each organization is allowed one speaker. 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 moderator. 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. 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 and NICEATM

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 scientific validation and regulatory acceptance of toxicological test methods that more accurately assess 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. 285 l-3, available at http://iccvam.niehs.nih.gov/​docs/​about_​docs/​PL106545.pdf) establishes 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 federal agencies. SACATM is a federally chartered advisory committee that provides advice to NICEATM, ICCVAM, and NIEHS on ICCVAM and NICEATM activities. Additional information about ICCVAM and NICEATM can be found at the following Web site: http://iccvam.niehs.nih.gov. Information about SACATM is available at http://ntp.niehs.nih.gov/​go/​167.

Dated: April 20, 2007.

Samuel H. Wilson,

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