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NICEATM-ICCVAM Home

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About NICEATM

About ICCVAM
- Annual and Biennial Reports
- Awards
- Mission and Vision Statement
- ICCVAM Agencies
  - Agency Representatives (ICCVAM roster)
  - Links to Member Agency home pages
- NICEATM-ICCVAM Brochure (PDF)
- NICEATM-ICCVAM Five-Year Plan
- International Cooperation
- Regulatory Acceptance of Alternative Methods
- NIH Revitalization Act of 1993 (PDF)
- ICCVAM Authorization Act (PDF)
- Validation and Regulatory Acceptance of Toxicological Test Methods (final report of ad hoc ICCVAM - 1997 - PDF)
- ICCVAM Test Method Evaluation Process
  - Development, Evaluation, and Acceptance of Test Methods

Advisory Commitee (SACATM) (Page on National Toxicology Program website)

International Cooperation (ICATM)
- ICATM Framework (Page on U.S. FDA website)
Frequently Asked Questions (FAQs) about NICEATM and ICCVAM

Meetings and Workshop Schedule

Alternative Test Method Evaluations
- Summary of Test Methods Evaluated by ICCVAM
- Acute Oral Toxicity
  - Evaluation of In Vitro Cytotoxicity Test Methods
    - Background Materials for Workshop Participants
      - List of Participants
      - Background Materials
      - List of References
    - Guidance Document
    - Overview and Agency Responses
    - References
    - Workshop Report and Test Method Recommendations
  - Validation Study of In Vitro Cytotoxicity Test Methods
    - Background Review Document
    - Overview
      - Nomination for Future Study (PDF)
      - Planned Future Studies/Activities
    - Other Validation Study Documents
      - Validation Study Protocols
      - Validation Study Management
      - Photographs
      - List of Test Chemicals
    - Peer Review Documents
      - Peer Review Panel Report
      - Materials for Peer Panel Meeting
    - Presentations
    - Test Method Evaluation Report
  - Scientific Workshop on Acute Chemical Safety Testing
  - Up-and-Down Procedure
- Biologics and Vaccines
- Dermal Corrosivity
  and Irritation
  - Corrositex Assay
    - Proposed Minimum in vitro Test Performance Standards (PDFs)
    - Peer Panel Report (PDF)
    - Sample Protocol
  - EPISKIN, EpiDerm (EPI-200) and the Rat Skin Transcutaneous Electrical Resistance (TER) Assay
    - Background Review Document and Test Method Evaluation
      - Test Method Evaluation Report
      - Background Review Documents
    - Overview and Performance Standards
      - Recommended Performance Standards: Working Group and NICEATM Reports (PDFs)
    - Presentations and References
- Developmental Toxicity: FETAX
  - Expert Panel Meeting Minutes
  - Background Review Document
  - Related Regulations and Guidelines
- Endocrine Disruptor
  - Review of In Vitro Endocrine Disruptor Screening Assays
    - Background Review Documents
      - Proposed List of Test Substances
    - Expert Panel Report
      - Expert Panel Report
      - Expert Panel Meeting Materials
    - Overview and Related Links
    - Presentations
    - Test Method Evaluation Report
  - Validation Studies of Nominated Endocrine Disruptor Screening Assays
    - Xenobiotic Detection Systems, Inc. LUMI-CELL® Assay of Estrogenic Activity
    - CertiChem Inc. MCF-7 Cell Proliferation Assay of Estrogenic Activity
  - ICCVAM Participation in OECD Test Guidelines for the Detection of Endocrine-Disrupting Substances
- Genetic Toxicity
- Immunotoxicity: LLNA
  - Overview
    - Draft Performance Standards for the LLNA
    - 2007 LLNA Nomination
    - Request for Data
  - Background Review Documents (draft)
  - Test Method Recommendations (draft>
  - Peer Review Panel (2008)
    - Peer Review Panel Documents
    - Information about the Peer Review Panel Meeting
  - Peer Review Panel (1998)
    - ICCVAM Peer Review Report
    - Implementation Workshop
  - References
  - Related Documents
    - LLNA Protocol (PDF)
    - ECETOC Monograph
    - SOT Dermal Toxicology page
    - ECVAM Scientific Advisory Committee Statement
    - Peer Panel Meeting Minutes
    - Press Releases and Articles (PDFs)
- Ocular Toxicity
  - In Vitro Test Methods for Detecting Ocular Corrosives and Severe Irritants
    - Background Review Documents
      - Background Review Documents
      - Nomination for Future Study/Planned Future Activities
    - Expert Panel Report
      - Expert Panel Report (PDF)
      - Addendum to Expert Panel Report
      - Presentations: Expert Panel Meeting
      - Supplemental Information for Expert Panel Meeting (PDFs)
      - Draft Report: Analysis of the Estimated Underclassification and Overclassification Likelihoods of the Current In Vivo Rabbit Eye test for Hazard Classification (PDF)
      - NICEATM Draft Technical Summary
      - Background and Additional Information
    - OECD Test Guideline Proposals
    - Overview
    - Presentations
    - Recommendations and Agency Responses
    - Recommendations for Future Studies
    - Test Method Evaluation Report
  - In Vitro Test Methods for Detecting Nonsevere Ocular Irritants
    - Request for Data Submission
  - Nonanimal Assessment Approach for Evaluating Eye Irritation Potential of Antimicrobial Cleaning Products
  - Effects of Topical Anesthetic Pre-treatment on In Vivo Ocular Irritation Hazard Classification
    - Request for Data Submission
    - NICEATM Presentations
    - Symposium on Minimizing Pain and Distress in Ocular Toxicity Testing
  - Scientific Symposia on Ocular Toxicity
- Pyrogenicity
  - Background Review Document
  - Overview and Recommendations
    - Draft ICCVAM Test Method Recommendations (PDFs)
  - Peer Review Panel
    - Peer Panel Report
    - Peer Panel Meeting Materials
  - Presentations and References
  - Test Method Evaluation Report

Nominations and Submissions
- NTP Online Nomination Form
- Contact NICEATM/ICCVAM
- NICEATM/ICCVAM Nomination and Submissions Guidelines (PDF)
- Lists of nominations and submissions with appropriate links

Testing Regulations and Guidelines
- Links to General U.S. Federal Regulations and Rules
- Links to International Guidances and Documents
  - OECD Health Effects Test Guidelines and Guidance Documents
  - ICCVAM Comments on OECD Health Effects Test Guidelines and Guidance Documents
- Method-Specific Guidelines, Regulations and Laws
- ICCVAM Guidelines and Processes
Search NICEATM-ICCVAM Documents

Search Federal Register Notices

Search Agency Guidelines/Regulations

Search Public Comments

Related Links

Contact NICEATM
- Contact NICEATM-ICCVAM (mailing address, phone numbers, email link)
- NICEATM Staff
- Subscribe to ICCVAM-All Mail List
- General Questions or Comments
- Contact the Webmaster (E-mail link)

Right Announcements Field

Announcements
- List of breaking news items - updated regularly
- More Announcements - Archive
Quick Links

NICEATM-ICCVAM:
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The National Institute of Environmental Health Sciences is one of the National Institutes of Health within the U.S. Department of Health and Human Services. The National Toxicology Program is headquartered on the NIEHS campus in Research Triangle Park, NC.

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