Notice2024-20970
Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2022-2023; Availability of Report
Primary source
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Published
September 16, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)</title>
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[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75549-75550]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://ntp.niehs.nih.gov/go/2023iccvamreport">https://ntp.niehs.nih.gov/go/2023iccvamreport</a>.
FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Director,
National Toxicology Program (NTP) Interagency Center for the Evaluation
of Alternative Toxicological Methods (NICEATM), email:
<a href="/cdn-cgi/l/email-protection#513f38323e3d347f3a3d34383f22252334243423113f38397f363e27"><span class="__cf_email__" data-cfemail="7b15121814171e5510171e1215080f091e0e1e093b151213551c140d">[email protected]</span></a>, 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Establishment of an ICCVAM workgroup to provide expertise
in identifying and evaluating NAMs to predict toxicity of per- and
polyfluoroalkyl substances (PFAS).
<bullet> 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 <a href="https://ntp.niehs.nih.gov/go/2023iccvamreport">https://ntp.niehs.nih.gov/go/2023iccvamreport</a>. Links to this report and all
past ICCVAM annual and biennial reports are available at <a href="http://ntp.niehs.nih.gov/go/iccvam-bien">http://ntp.niehs.nih.gov/go/iccvam-bien</a>.
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 <a href="https://ntp.niehs.nih.gov/go/iccvam">https://ntp.niehs.nih.gov/go/iccvam</a>.
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 <a href="https://ntp.niehs.nih.gov/go/niceatm">https://ntp.niehs.nih.gov/go/niceatm</a>.
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]
BILLING CODE 4140-01-P
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