[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75549-75550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods Biennial Progress Report: 2022-2023; Availability 
of Report

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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: 
2022-2023.

ADDRESSES: The report is available at https://ntp.niehs.nih.gov/go/2023iccvamreport.

FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Director, 
National Toxicology Program (NTP) Interagency Center for the Evaluation 
of Alternative Toxicological Methods (NICEATM), email: 
[email protected], telephone: 984-287-3150.

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 twelfth progress report describing 
ICCVAM activities and accomplishments from January 2022 through 
December 2023 is now available.
    Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM 
accomplishments summarized in the report include:
     Development of an updated document on ``Validation, 
Qualification, and Regulatory Acceptance of New Approach 
Methodologies,'' by the ICCVAM Validation Workgroup. This document 
describes an approach to validation of new approach methodologies 
(NAMs) that reflects modern toxicity testing, placing less emphasis on 
replacement of in vivo tests with a single alternative method and more 
emphasis on integrating results from multiple in vitro and in chemico 
assays and in silico approaches.
     Publication of articles describing U.S. and international 
information needs and testing requirements for nanomaterials, 
ecotoxicity, and acute systemic toxicity. An ICCVAM workgroup also 
published an award-winning article describing federal agency 
application of in vitro to in vivo extrapolation.
     Curation and publication of a human skin sensitization 
database.

[[Page 75550]]

ICCVAM agencies and NICEATM collaborated with the German Federal 
Institute of Risk Assessment to compile the largest existing database 
of human reference data for skin sensitization.
     Broadening applicability of defined approaches for skin 
sensitization. Following international acceptance of defined approaches 
to skin sensitization, ICCVAM agency scientists evaluated use of 
defined approaches to characterizing sensitization potential of 
agrochemical formulations and isothiazolinones, a type of preservative 
used in consumer products.
     Establishment of an ICCVAM workgroup to provide expertise 
in identifying and evaluating NAMs to predict toxicity of per- and 
polyfluoroalkyl substances (PFAS).
     Development, updates, and training on web tools and data 
resources for chemical exploration and toxicity prediction. The report 
describes tools provided by NIEHS, the U.S. Environmental Protection 
Agency, and others, as well as training that has been provided to 
support their use.
    Availability of Report: The report is available at https://ntp.niehs.nih.gov/go/2023iccvamreport. 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 18 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. ICCVAM also 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 animal use.
    The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-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 https://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 test methods and strategies for 
validation studies and technical evaluations. Additional information 
about NICEATM can be found at https://ntp.niehs.nih.gov/go/niceatm.

    Dated: September 10, 2024.
Richard P. Woychik,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program, National Institutes of Health.
[FR Doc. 2024-20970 Filed 9-13-24; 8:45 am]
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