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Notice

Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2018-2019; Availability of Report

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AGENCY:

National Institutes of Health, Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2018-2019. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2018 through December 2019.

ADDRESSES:

The report is available at http://ntp.niehs.nih.gov/​iccvamreport/​2019/​index.html.

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FOR FURTHER INFORMATION CONTACT:

Dr. Nicole Kleinstreuer, Acting Director, NICEATM, Division of NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park, NC 27709. Phone: 984-287-3150, Email: nicole.kleinstreuer@nih.gov. Hand Deliver/Courier address: 530 Davis Drive, Room K2032, Morrisville, NC 27560.

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SUPPLEMENTARY INFORMATION:

Background: The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3), established ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences (NIEHS) under NICEATM. ICCVAM's mission is to facilitate development, validation, and regulatory acceptance of new and revised regulatory test methods that reduce, refine, or replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment.

A provision of the ICCVAM Authorization Act states that ICCVAM shall prepare “reports to be made available to the public on its progress under this Act.” The tenth ICCVAM biennial progress report describing ICCVAM activities and accomplishments from January 2018 through December 2019 is now available.

Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:

  • Publication in January 2018 of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States, and progress toward goals described in the strategic roadmap.
  • Development of the Collaborative Acute Toxicity Modeling Suite, an online resource for screening organic chemicals for acute oral toxicity, and expansion of NICEATM's Integrated Chemical Environment, which provides curated data and tools for safety assessment of chemicals.
  • Initiatives by the U.S. Environmental Protection Agency to reduce animal use: A draft science policy to reduce animal use for skin sensitization testing for pesticide registration, a plan to reduce vertebrate animal testing for chemical safety information required under the Toxic Substances Control Act, and an agency-wide directive to reduce mammal study requests and funding 30% by 2025 and completely eliminating them by 2035.
  • Development of a strategic roadmap by the Department of Defense to help its laboratories better define their chemical assessment needs and collaborate on development or refinement of appropriate non-animal approaches for testing.
  • Implementation by the U.S. Food and Drug Administration of its predictive toxicity roadmap for integrating predictive toxicology methods into safety and risk assessments.

Availability of Report: The report is available at http://ntp.niehs.nih.gov/​iccvamreport/​2019/​index.html. Links to this report and all past ICCVAM annual and biennial reports are available at http://ntp.niehs.nih.gov/​go/​iccvam-bien.

Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 16 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability and promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine (enhance animal well-being and lessen or avoid pain and distress) animal use.

The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 l-3) establishes ICCVAM as a permanent interagency committee of NIEHS and provides the authority for ICCVAM involvement in activities relevant to the development of alternative test methods. Additional information about ICCVAM can be found at http://ntp.niehs.nih.gov/​go/​iccvam.

NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative testing approaches for validation studies and technical evaluations. Additional information about NICEATM can be found at http://ntp.niehs.nih.gov/​go/​niceatm.

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Dated: July 7, 2020.

Brian R. Berridge,

Associate Director, National Toxicology Program.

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[FR Doc. 2020-15341 Filed 7-15-20; 8:45 am]

BILLING CODE 4140-01-P