Notices. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report 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: 2014-2015. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285 *l* -3), describes activities and accomplishments from January 2014 through December 2015. ADDRESSES: The report is available at *http://ntp.niehs.nih.gov/iccvamreport/2015/index.html.* FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; email: *warren.casey@nih.gov;* telephone:
(919)316-4729. SUPPLEMENTARY INFORMATION: Background: The ICCVAM Authorization Act of 2000 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 eighth ICCVAM progress report is now available, which describes ICCVAM activities and accomplishments from January 2014 through December 2015. Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include: • A computational approach that integrates several types of data to predict human skin sensitization hazard without using animals (ICCVAM) • A plan to adopt high throughput assays and computational models for detecting and measuring estrogen receptor bioactivity as an alternative for three Tier 1 tests currently used in the Endocrine Disruptor Screening Program to assess estrogen receptor activity (U.S. Environmental Protection Agency [EPA]) • Establishment of a Communities of Practice webinar seminar series discussing relevant topics (ICCVAM) • Evaluation of acute oral and dermal toxicity data to determine if oral toxicity tests are sufficient to assign U.S. EPA dermal hazard classifications, eliminating the need for separate acute dermal toxicity tests (NICEATM) • A series of workshops that drafted recommendations on use of an *in vitro* test with potential to replace animal use for pertussis vaccine testing (NICEATM, U.S. Food and Drug Administration, other ICCVAM agencies). Availability of Report: The report is available at *http://ntp.niehs.nih.gov/iccvamreport/2015/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 15 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. ICCVAM acts to ensure that new and revised test methods are validated to meet the needs of federal agencies, increase the efficiency and effectiveness and federal agency test method review, and optimize utilization of scientific expertise outside the federal government. 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.* Dated: August 16, 2016. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2016-20159 Filed 8-23-16; 8:45 am]
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