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SACATM: Background Meeting Materials March 2004

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NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Updates [Presentation]

  • ICCVAM Biennial Progress Report
    • Memorandum from Director, NICEATM, and Chair, ICCVAM (February 23, 2004) [PDF]
    • ICCVAM Biennial Progress Report -- Prepublication Copy (December 2003, NIH Publication No. 04-4509) [PDF]
    • Federal Register Notice of the Availability of the Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): [February 19, 2004 (Vol. 69, No. 33) page 7777] [HTML]
  • ICCVAM Guidelines for the Nominations and Submission of New, Revised, and Alternative Test Methods
    • Memorandum from Director, NICEATM, and Chair, ICCVAM (February 23, 2004) [PDF]
    • ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods (September 2003, NIH Publication No. 03-4508) [PDF or HTML]
    • Federal Register Notice Announcing Notice of the Availability of the Updated Document, "ICCVAM Guidelines for Nomination and Submission of New, Revised, and Alternative Test Methods" [November 14, 2003 (Vol. 68, No. 220) pages 64636] [PDF or HTML]
  • ICCVAM Test Recommendations and Agency Responses
    • March 21, 2003 letter to Agency Heads Seeking Response on Two ICCVAM test Recommendations: The Up-and-Down Procedure (UDP) and In Vitro Methods for Assessing Acute Systemic Toxicity (list of Agency Heads attached) [PDF]
    • Agency Responses (15) [PDF]
    • ICCVAM Test Recommendations [PDF]
    • Federal Register Notice Announcing Availability and Request for Comments on the Report on the Revised Up-and-Down Procedure: A Test Method for Determining the Acute Oral Toxicity of Chemicals [February 7, 2002 (Vol. 67, No. 26) pages 5842 - 5844] [PDF or HTML]
  • Eight NICEATM/ICCVAM abstracts for the 43rd Annual Society of Toxicology Meeting (March 21-25, 2004 in Baltimore, MD) [PDF]
    • Data Collection and Analysis Systems for an In Vitro Cytotoxicity Validation Study [Judy Strickland (presenter); Poster presentation in the Vitro/Animal Alternative Models I session: March 22, 2004 from 9:30 AM to 12:30 PM in Exhibit Hall; Abstract ID 241]
    • Phase I and II Results of a Validation Study to Evaluate In Vitro Cytotoxicity Assays for Estimating Rodent and Human Acute Systemic Toxicity [Mike Paris (presenter); Poster presentation in the Vitro/Animal Alternative Models I session: March 22, 2004 from 9:30 AM to 12:30 PM in Exhibit Hall; Abstract ID 240]
    • Estimate of False Negative Rates for the In Vivo Rabbit Dermal Corrosion Assay [Ray Tice (presenter); Poster presentation in the Vitro/Animal Alternative Models II session: March 24, 2004 from 9:30 AM to 12:30 PM in Exhibit Hall; Abstract ID 1299]
    • Estimate of False Negative Rates for the In Vivo Rabbit Dermal Irritation Assay [Neepa Choksi (presenter); Poster presentation in the Vitro/Animal Alternative Models II session: March 24, 2004 from 9:30 AM to 12:30 PM in Exhibit Hall; Abstract ID 1298]
    • The ICCVAM/NICEATM Process for Developing Test Method Performance Standards [William Stokes (presenter); Poster presentation in the Regulatory/Policy session: March 24, 2004 from 1:30 PM to 4:30 PM in Exhibit Hall; Abstract ID 1812]
    • ICCVAM Process for Nomination and Submission of New, Revised, and Alternative Test Methods [Len Schechtman (presenter); Poster presentation in the Regulatory/Policy session: March 24, 2004 from 1:30 PM to 4:30 PM in Exhibit Hall; Abstract ID 1811]
    • Assurance of Animal Welfare in Research: Coexistence of Toxicology Studies with Humane Endpoints-Veterinary Medicine and Animal Welfare Issues [William S. Stokes (presenter); Oral presentation at Workshop 10: Assurance of Animal Welfare in Research: Coexistence of Toxicology Studies with Humane Endpoints: March 22, 2004 from 9:30 AM to 12:00 PM]
    • Overview of Alternatives in Toxicology: Recent Progress and Future Opportunities [William S. Stokes (presenter); Oral presentation at Workshop 14: Current Status and Future Considerations for the Development of Skin Toxicology Alternative Methods: March 22, 2004 from 1:30 PM to 4:30 PM]

Update on Activities of the European Centre for the Validation of Alternative Methods (ECVAM) [Presentation]

  • ECVAM's response to the changing political environment for alternatives: Consequences of the European Union Chemical and Cosmetics Policies [Thomas Hartung, Susanne Bremer, Silvia Casati, Sandra Coecke, Raffaella Corvi, Salvador Fortaner, Laura Gribaldo, Marlies Halder, Annett Janusch Roi, Pilar Prieto, Enrico Sabbioni, Andrew Worth, and Valerie Zuang (2003) ATLA 31: 473-481] [Summary]

Toxicology in the 21st Century: The Role of the National Toxicology Program [Presentation]

  • Toxicology in the 21st Century: The Role of the National Toxicology Program ("NTP Vision") [PDF]
  • Timeline for Developing the Roadmap [PDF]
  • On January 29, 2004 the NTP held a public meeting in Bethesda, Maryland to discuss the NTP Vision. Information about this meeting, including copies of public comments received.

ICCVAM Strategic Planning Process [Presentation]

  • ICCVAM Mission, Vision, and Strategic Priorities
    • Memorandum from Director, NICEATM, and Chair, ICCVAM (February 23, 2004) [PDF]
    • ICCVAM Mission, Vision and Strategic Priorities, Adopted by ICCVAM February 11, 2004 [PDF]
    • ICCVAM Authorization Act of 2000

USDA: Research Facility Reporting Requirements [Presentation]

  • Animal Welfare Report for Fiscal Year 2001 [HTML - USDA site]
  • A Sample Annual Report Form to be Completed by Research Facilities [HTML - OACU site]
  • Instructions for Research Facilities to Use When Completing the Annual Report Form [PDF - USDA site]

Update on ICCVAM Recommended Performance Standards for In Vitro Dermal Corrosivity Methods [Presentation]

  • Minutes of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisor Panel Consultation Meeting "Ensuring Data Quality for In Vitro Tests Used as Alternatives to Animal Studies for Regulatory Purposes: A Consultation (October 28-29, 2003 in Arlington, Virginia) [PDF - EPA site]

Validation of Genetically Modified Mouse (GMM) Models [Presentation]

  • NTP Workshop on Transgenics [PDF]
  • The Role of Transgenic Mouse Models in Carcinogen Identification [John B. Pritchard, John E. French, Barbara J. Davis and Joseph K. Haseman (2003) Environmental Health Perspectives 111: 444-454.] [PDF]
  • The Utility of Genetically Modified Mouse Assays for Identifying Human Carcinogens: A Basic Understanding and Path Forward [James MacDonald, John E. French, Ronald J. Gerson, Jay Goodman, Tohru Inoue, Abigail Jacobs, Peter Kasper, Douglas Keller, Amy Lavin, Gerald Long, Bruce McCullough, Frank D. Sistare, Richard Storer, and Jan Willem van der Laan (2004) Toxicol Sci. 77(2):188-94] [ABSTRACT]

Update of ILSI/HESI Subcommittee's Activities on Identification of Biomarkers of Toxicity [Presentation]

  • Report from the ILSI/HESI Technical Committee on the Development and Application of Biomarkers of Toxicity [PDF]

ICCVAM Nominations [Presentation]

  • ICCVAM Guidelines for the Nominations and Submission of New, Revised, and Alternative Test Methods (September 2003) [PDF or HTML]
    • FR Notice Announcing Availability of Submission Guidelines November 14, 2003 (available under Tab 2, Update of NICEATM/ICCVAM Activities) [PDF or HTML]
  • In Vitro Endocrine Disruptor Nomination
    • Memorandum from Director, NICEATM Re: Update on ICCVAM Nominations: Validation Studies on In Vitro Endocrine Disruptor Test Methods (February 23, 2004) with an excerpt from: ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor binding and Transcriptional Activation Assays. NIH Publication No. 03-4503. [Full Report]
  • In Vitro Test Methods to Identify Substances Causing Irreversible Ocular Damage and Other Ocular Toxicity Nominations
    • Memorandum from Director, NICEATM, Re: Evaluation of In Vitro Ocular Toxicity Test Methods (February 23, 2204) [PDF]
    • EPA Nomination Letter (October 24, 2003) [PDF]
    • Eye Irritation Testing: The Way Forward. The Report and Recommendations of ECVAM Workshop 34 [Balls M, Berg N, Bruner LH, Curren RD, de Silva O, Earl LK, Esdaile DJ, Fentem JH, Liebsch M, Ohno Y, Prinsen MK, Spielmann H, and Worth AP (1999) ATLA 27, 53-77] [PDF]

Update on the in vitro vaccine potency tests for veterinary Leptospira Vaccines [Presentation]

  • Assay for measuring relative potency of leptospiral bacterins containing serovar pomona [Ruby KW, Cardella MA, Knudtson WU (1992) Biologicals 20(4):259-66] [Link to abstract at NLM website]
  • Evaluation of the Leptospira pomona ELISA and its correlation with the hamster potency assay [Rudy, KW (1996) Dev Biol Stand 86:340] [No Abstract Available]

Evaluation of the Under-Prediction Rate of In Vivo Dermal Corrosivity Test Methods [Presentation]

  • Summary Statement: ICCVAM Review of the In Vivo Rabbit Dermal Corrosivity Test (Updated 2/20/2004) [PDF]
  • Federal Register Notice Announcing NICEATM Request for Existing Dermal and Ocular Irritancy Chemical Test Data from Animal and Human Studies Using Standardized Testing Methods [July 16, 2003 (Vol. 68, No. 136) pages 42067-42068] [PDF or HTML]
  • ICCVAM Recommendations on the Peer Review Panel Report on Corrositex® - June 4, 1999
    • Memo to the Director, NTP, from the Co-Chairs of the ICCVAM Committee. Excerpt from: Corrositex® An In Vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals. NIH Publication No. 99-4495 (Appendix V) [Full Report in PDF]
  • ICCVAM Evaluation of In Vitro Methods for Assessing the Dermal Corrosivity Potential of Chemicals.
    • Excerpt from: Evaluation of EPISKIN¿, EpiDerm¿ (EPI-200), and Rat Skin Transcrutaneous Electrical Resistance (TER): In Vitro Test Methods for Assessing Dermal Corrosivity Potential of Chemicals. NIH Publication No. 02-4502 (Section 1.0) [Full report in PDF]
  • Excerpt from: United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). (Chapter 3.2: Skin Irritation/Corrosion) [ST/SG/AC.10/30] [Link to full report].

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Web page last updated on October 31, 2007