SACATM: Background Materials
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- 2010-2011 ICCVAM Biennial Progress Report
- Draft Implementation Plan for the 2008-2012 NICEATM-ICCVAM Five-Year Plan. June 2012
- Proceedings from the 2010 International Workshop: Kulpa-Eddy J, McFarland R, and Stokes WS (Eds). 2011. International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions, Bethesda, MD, USA, 14–16 September 2010. Procedia in Vaccinology. 5:1-256
- NICEATM-ICCVAM Publications and Presentations
- International Collaboration on Alternative Test Method Activities (selected)
- ICCVAM Authorization Act
8th World Congress on Alternatives and Animal Use in the Life Sciences Proceedings and Abstracts (Montréal, Canada - August 21 - 25, 2011)
Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification
- January 24, 2011, CPSC request for a data analysis in support of revised classification criteria necessary to maintain equivalent eye hazard labeling when using fewer animals.
- NIEHS. 2011. Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification; Request for Comments. August 12, 2011. Federal Register 76: 50220-50221
- ICCVAM. 2012. ICCVAM Test Method Evaluation Report: Identifying Chemical Eye Hazards with Fewer Animals. NIH Publication No. 12-7930. Research Triangle Park, NC:National Institute of Environmental Health Sciences.
- Haseman JK, Allen DG, Lipscomb EA, Truax JF, Stokes WS. 2011. Using fewer animals to identify chemical eye hazards: revised criteria necessary to maintain equivalent hazard classification. Regul Toxicol Pharmacol.
Regulatory Acceptance and Availability of ICCVAM-Recommended Alternative Test Methods
BG1Luc Estrogen Receptor Transcriptional Activation Test Method: Agonist and Antagonist Protocols
- ICCVAM. 2011. Test Method Evaluation Report. The LUMI-CELL® ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. NIH Publication No. 11-7850. Research Triangle Park, NC: National Institute of Environmental Health Sciences.
- NIEHS. 2012. Availability of ICCVAM Evaluation Report and Recommendations on the Usefulness and Limitations of the LUMI-CELL (reg) ER (BG1Luc ER TA) Test Method, An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. February 14, 2012. Federal Register 77: 8258-8260
- ICCVAM Recommends Non-animal In Vitro Method to Identify Potential Endocrineactive Substances. Announcement to ICCVAM-All Email List. February 15, 2012.
- Transmittal Letter and Agency Adoption Responses
- OECD Test Guideline Program Documents
- OECD. 2009. Test Guideline No. 455. Stably Transfected Human Estrogen Receptor-α Transcriptional Activation Assay for Detection of Estrogenic Agonist- Activity of Chemicals [adopted 7 September 2009]. In: OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects. Paris: OECD Publishing.
- Draft Proposed Update to OECD Test Guideline 455: Draft Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists. 2012 (WNT approved).
- Draft Proposed Update to OECD Test Guideline 455: Performance Standards for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Agonists. 2012 (WNT approved).
- Draft Proposal for OECD Test Guideline 457: BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists. 2012 (WNT approved).
- Draft Performance Standards for the BG1Luc Estrogen Receptor (ER) Transactivation In Vitro Assay to Detect ER Antagonists (for TG 457). 2012
Use of the Murine Local Lymph Node Assay for Potency Categorization
- ICCVAM. 2011. ICCVAM Test Method Evaluation Report: Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans. NIH Publication No. 11-7709.
- ICCVAM Recommends Alternative Method to Identify Chemicals and Products with Significant Potential to Cause Allergic Contact Dermatitis. Announcement to ICCVAM-All Email List. July 28, 2011
- Federal Agencies Respond to ICCVAM Recommendations on Alternative Method to Identify Chemicals Most Likely to Cause Allergic Contact Dermatitis. Announcement to ICCVAM-All Email List. February 27, 2012.
- Transmittal Letter and Agency Adoption Responses
New and Revised OECD Test Guidelines Based on ICCVAM Recommendations
- Reference: ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing. NIH Publication No. 10- 7514.
- Updated OECD Test Guideline 405: Acute Eye Irritation/Corrosion (Updated to include ICCVAM-Recommended Protocol for reduction and/or elimination of unrelieved pain and distress and expanded humane endpoints). 2012
- CPSC. 2012. Codification of Animal Testing Policy. June 29, 2012. Federal Register 77: 38751-38754.
- NICEATM. 2012. U.S. Consumer Product Safety Commission Requests Comments on Proposed Amendments to Regulations on Animal Testing Methods. July 12, 2012. Email to ICCVAM-All Mail List.
High Throughput Screening (HTS) Adaptation and Performance of the BG1Luc ER TA Agonist and Antagonist Assays
- Tox21 Consortium Overview
- Shukla SJ, Huang R, Austin CP, Xia M. The future of toxicity testing: a focus on in vitro methods using a quantitative high-throughput screening platform. Drug Discov Today. 2010 Dec;15(23-24):997-1007.
ICCVAM Test Method Nomination
Electrophilic Contact Allergen Identification Screening Assay
- Nomination Letter from Dr. Paul Siegel, NIOSH/CDC
- Electrophilic Allergen Screen Assay Protocol
- NICEATM Preliminary Evaluation
Federal Agency Research, Development, Translation, and Validation Activities Relevant to the NICEATM-‐ICCVAM Five-‐Year Plan
NIH-‐Led Programs and Collaborations (NIH, NCATS, FDA, and DARPA) Developing Alternative Test Methods
- Agency Activities Relevant to the NICEATM-ICCVAM Five-Year Plan. July 2012.
- NIH Common Fund – Regulatory Science Website
- NIH Common Fund – NIH Director’s Transformative Research Award Program
- Funding Opportunities
- RFA-RM-11-022: Integrated Microphysiological Systems for Drug Efficacy and Toxicity Testing in Human Health and Disease (UH2/UH3)
- RFA-RM-12-001: Stem/Progenitor Cell-Derived Human Micro-organs and - tissues (U18))
- RFA-RM-10-006: Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01)
- RFA-RM-10-010: NIH Common Fund Transformative Research Projects Program (R01)
- Funded Research
- Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design (University of Michigan at Ann Arbor)
- Replacement Ocular Battery (ROBatt) (MB Research Laboratories, Inc.)
- Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions (Washington University)
- Heart-Lung Micromachine for Safety and Efficacy Testing (Harvard University Medical School)
- Mapping The Human Toxome By Systems Toxicology (Johns Hopkins University Bloomberg School of Public Health)
- 2012 Tissue Chip Projects
- NIH Press Release. NIH fnds development of tissue chips to help predict drug safety. July 24, 2012.
- 2012 Tissue Chip Project Awards
- Wyss Institute to Receive up to $37 Million from DARPA to Integrate Multiple Organ-on-Chip Systems to Mimic the Whole Human Body. July 24, 2012.
- DARPA and NIH to fund ’human body on a chip’ research: MIT-led team to receive up to $32 million from DARPA and NIH to develop technology tat could accelerate pace and efficiency of pharmaceutical testing. July 24, 2012
NIEHS SBIR Grants
Update on EDSP21 Activities at EPA
DRAFT NICEATM-‐ICCVAM Five-‐Year Plan (2013-‐2017)
- NIEHS. 2011. Update of the NICEATM-ICCVAM Five-Year Plan: Request for Comments. November 21, 2011. Federal Register 76: 71977-71978.
- Responses to 76 FR 71977 Received as of July 15, 2012
- NIEHS. 2012. Draft Five-Year Plan (2013–2017) for the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the Interagency Coordinating Committee on the Validation of Alternative Methods. June 13, 2012. Federal Register 77: 35395-35396.
- Responses to 77 FR 35395 Received as of July 15, 2012 - none
- The NICEATM-ICCVAM Five-Year Plan (2013-2017): Draft – May 14, 2012
- Public comments on the DRAFT NICEATM-–-ICCVAM Five-–-Year Plan (2013-–-2017)
International Workshops on Alternative Methods for Vaccine Testing
Report on the International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward (Complete meeting materials available at: http://iccvam.niehs.nih.gov/meetings/RabiesVaccWksp-2011/RabiesVaccWksp.htm)
International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward, September 19-‐21, U.S. Department of Agriculture Center for Veterinary Biologics National Centers for Animal Health, Ames, Iowa
International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward, November 28-‐ 29, 2012, William H. Natcher Center, National Institutes of Health, Bethesda, Maryland
- Pertussis Epidemic in Washington State- 2012 Telebriefing. Press Briefing Transcript. July 19, 2012.