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ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods

Prepared by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

National Institute of Environmental Health Sciences
National Institutes of Health
U.S. Public Health Service
Department of Health and Human Services

Table of Contents

Note: This document replaces the Evaluation of the Validation Status of Toxicological Methods: General Guidelines for Submissions to ICCVAM
(NIH Publication No. 99-4496; rev. Oct. 20, 1999)

Table of Contents
Agency Representatives
View ICCVAM Agency List (with link to current roster)
Preface

1.0 Introduction

2.0 ICCVAM Test Method Nomination and Submission Process

3.0 Performance Standards for Test Methods

4.0 Submission Guidelines for Proposed Test Methods

  1. Introduction and Rationale for the Proposed Test Method
  2. Test Method Protocol Components
  3. Substances Used for Validation of the Proposed Test Method
  4. In Vivo Reference Data Used to Assess the Accuracy of the Proposed Test Method
  5. Test Method Data and Results
  6. Test Method Accuracy
  7. Test Method Reliability (Repeatability/Reproducibility)
  8. Test Method Data Quality
  9. Other Scientific Reports and Reviews
  10. Animal Welfare Considerations (Refinement, Reduction, and Replacement)
  11. Practical Considerations
  12. References
  13. Supporting Materials

5.0 References

Appendices

  1. Outline for Nominations and Submissions to ICCVAM
  2. Suggested Formats for Presenting Data
  3. Glossary
  4. ICCVAM Validation and Regulatory Acceptance Criteria
  5. ICCVAM Authorization Act of 2000 (Public Law 106-545)

Submission or Nomination:

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