National Toxicology Program

Appendix A: ICCVAM - Mission, Vision and Strategic Priorities Appendix B: Federal Agencies and Programs with Authority to Require or Use Toxicological Testing Information Appendix C: Process For Development of the NICEATM-ICCVAM Five-Year Plan Appendix D: U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Appendix E: The ICCVAM Authorization Act of 2000 Appendix F: Test Methods Reviewed or Under Consideration by ICCVAM

Appendix C: Process For Development of the NICEATM-ICCVAM Five-Year Plan

This document, prepared by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), in partnership with relevant Federal agency program offices, describes a five-year plan to:

• Research, develop, translate, and validate new and revised non-animal and other alternative assays for integration of relevant and reliable methods into Federal agency testing programs
• Identify areas of high priority for new and revised non-animal and alternative assays or batteries of those assays to create a path forward for the replacement, reduction, and refinement of animal tests, when this is scientifically valid and appropriate

Consistent with all ICCVAM and NICEATM document publications, the process of producing the report was planned from the outset to also allow for transparency and multiple opportunities for public comment consistent with the deadline for providing the report. A timeline was developed to provide six separate opportunities for public comments. This included two opportunities during the early, planning stages of the report and four opportunities for comment on the draft report to be considered before it was finalized.

The timeline also included multiple opportunities for review and comment on the plan by SACATM, a Federally chartered advisory committee for NICEATM and ICCVAM. SACATM includes members from industries (for example, pharmaceuticals, pesticides) regulated by ICCVAM agencies, academic institutions, state government agencies, and at least one member of a national animal protection organization. SACATM was provided two opportunities for comment; one during the planning process and one following the release of the draft report. These opportunities also allowed SACATM to consider public comments provided prior to and during their two public meetings.

The process for development of the plan included three phases (as diagrammed above). The first phase involved information gathering, during which input was solicited and received from all 15 of the ICCVAM agencies. Specifically, each agency was asked to provide

1. Information regarding research, development, translation, validation activities currently in progress or planned during the next five years
2. Areas of high priority for new and revised non-animal and alternative assays or batteries of those assays to create a path forward for the replacement, reduction, and refinement (reduced pain and distress) of animal tests, when this is scientifically valid and appropriate

This initial phase also included requests for comments from the public and SACATM.

During the second phase, an ICCVAM five-year plan subcommittee considered the input received and, in conjunction with NICEATM, prepared an initial draft of the plan for review and comment by the full ICCVAM committee and the 15 ICCVAM agencies. Following this review, comments and suggestions were incorporated into a draft plan released to the public for comment on May 7, 2007. A Federal Register notice announcing availability of the draft plan and formally requesting public comment accompanied the release. On June 11, 2007, a town meeting was held specifically to allow an opportunity for public comment. The SACATM met on June 12 to consider and comment on the draft plan and consider comments from the town meeting. The public was provided an additional opportunity to comment during the SACATM meeting.

The final phase of the process involved ICCVAM and NICEATM finalizing the draft plan after taking into consideration public and SACATM comments on the draft plan. The plan was then sent to ICCVAM agency heads for concurrence. NIEHS then forwarded the plan through NIH and the Department of Health and Human Services to the U.S. House of Representatives and U.S. Senate Appropriations Committees. In February 2008, the plan will be released to the public and will be available at the NICEATM and ICCVAM website.