83 FR 7487 - A Strategic Roadmap for Establishing New Approaches To Evaluate the Safety of Chemicals and Medical Products in the United States; Availability of Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 35 (February 21, 2018)

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinated the development of a strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States. This document, prepared with support from the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is now available.

[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)]
[Notices]
[Page 7487]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


A Strategic Roadmap for Establishing New Approaches To Evaluate 
the Safety of Chemicals and Medical Products in the United States; 
Availability of Report

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) coordinated the development of a strategic 
roadmap for establishing new approaches to evaluate the safety of 
chemicals and medical products in the United States. This document, 
prepared with support from the National Toxicology Program Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM), is now available.

ADDRESSES: The report is available at https://ntp.niehs.nih.gov/go/natl-strategy.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (984) 287-3118.

SUPPLEMENTARY INFORMATION: 
    Background: Scientific and technological advances in toxicology can 
significantly improve and protect public health. However, a national 
strategy is required to ensure the safe, effective, and timely 
implementation of human-based, predictive approaches in toxicity 
testing.
    The goal of the U.S. Strategic Roadmap is to realize the vision set 
forth in the seminal National Research Council report ``Toxicity 
Testing in the 21st Century: A Vision and a Strategy.'' This 2007 
report envisioned using human-based assays and model information to 
provide a more efficient, predictive, and economic system for assessing 
the effects of chemicals on human health.
    The U.S. Strategic Roadmap was developed with participation from 
the 16 ICCVAM member agencies and multiple interagency workgroups, as 
well as input from a broad range of stakeholder groups. It describes a 
new framework that will enable development, establish confidence in, 
and ensure use of new approaches to toxicity testing that improve human 
health relevance and reduce or eliminate the need for testing in 
animals.
    Summary of Report Contents: The successful development and 
implementation of new approaches to toxicity testing will require 
coordinated efforts that address three strategic goals:

 Connect end users with developers of new approach 
methodologies
 Foster the use of efficient, flexible, and robust practices to 
establish confidence in new methods
 Encourage the adoption and use of new methods and approaches 
by federal agencies and regulated industries

    Implementation of the roadmap goals, already underway in specific 
testing areas, will include key elements needed for advancement of 
alternative methods.
    Availability of Report: The report is available at https://ntp.niehs.nih.gov/go/natl-strategy.
    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. 285l-3) establishes 
ICCVAM as a permanent interagency committee of the National Institute 
of Environmental Health Sciences 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: February 9, 2018.
Brian Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-03476 Filed 2-20-18; 8:45 am]
 BILLING CODE 4140-01-P