[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58363-58364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20787]


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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: 2020-2021; 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: 
2020-2021. This report, prepared in accordance with requirements of the 
ICCVAM Authorization Act of 2000, describes activities and 
accomplishments from January 2020 through December 2021.

ADDRESSES: The report is available at https://ntp.niehs.nih.gov/go/2021iccvamreport.

FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting 
Director, NICEATM, Division of Translational Toxicology, NIEHS, P.O. 
Box 12233, K2-17, Research Triangle Park, NC 27709. Phone: 984-287-
3150, Email: [email protected]. Hand Deliver/Courier address: 
530 Davis Drive, Room K2032, Morrisville, NC 27560.

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 eleventh progress report describing 
ICCVAM activities and accomplishments from January 2020 through 
December 2021 is now available.
    Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM 
accomplishments summarized in the report include:
     Publication by the Organisation for Economic Co-operation 
and Development of Guideline 497, Defined Approaches on Skin 
Sensitisation, the first internationally harmonized guideline to 
describe a non-animal approach that can be used to replace an animal 
test to identify skin sensitizers. Guideline 497 was drafted and 
sponsored by ICCVAM agency scientists and international partners.
     Recommendations in March 2021 by the ICCVAM Metrics 
Workgroup on federal agency progress in promoting alternative 
toxicological methods. The workgroup recommended each agency develop 
its own metrics relevant and practical to their own situation.
     Establishment of the Workgroup on Microphysiological 
Systems for COVID Research, an international collaborative workgroup to 
coordinate use of microphysiological systems to reduce animal use in 
COVID-19 studies and future emerging infectious diseases. A key 
accomplishment of the workgroup was the establishment of a COVID-19 
disease portal in an existing microphysiological systems database.
     Further development of the Collaborative Acute Toxicity 
Modeling Suite (CATMoS), an online resource for in silico screening of 
organic chemicals for acute oral toxicity. During 2020 and 2021, the 
utility of CATMoS for predicting acute oral toxicity in research and 
regulatory contexts was explored in projects conducted by ICCVAM 
agencies, including the U.S. Department of Defense and the U.S. 
Environmental Protection Agency.
     Updates of the Integrated Chemical Environment Search tool 
during 2020 and 2021 to enable search results to be sent to query other 
data resources. Updates also allowed users to explore similarities 
among chemicals, find information on chemical use categories, search 
for structurally similar chemicals, and view and interact with 
concentration-response curves from curated high-throughput screening 
data.
    Availability of Report: The report is available at https://ntp.niehs.nih.gov/go/2021iccvamreport. 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 17 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

[[Page 58364]]

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.

    Dated: September 21, 2022.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2022-20787 Filed 9-23-22; 8:45 am]
BILLING CODE 4140-01-P