83 FR 38717 - Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2016-2017; Availability of Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 152 (August 7, 2018)

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: 2016-2017. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2016 through December 2017.

[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38717-38718]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16837]


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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: 2016-2017; 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: 
2016-2017. This report, prepared in accordance with requirements of the 
ICCVAM Authorization Act of 2000, describes activities and 
accomplishments from January 2016 through December 2017.

ADDRESSES: The report is available at http://ntp.niehs.nih.gov/iccvamreport/2017/index.html.

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

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 biennial progress report 
describing ICCVAM activities and accomplishments from January 2016 
through December 2017 is now available.
    Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM 
accomplishments summarized in the report include:
     Development of a strategic roadmap for incorporating new 
approaches into safety testing of chemicals and medical products in the 
United States.
     Publication of two guidance documents by the U.S. 
Environmental Protection Agency (EPA) in 2016. One included a policy 
statement to waive all acute dermal lethality studies for pesticide 
formulations. The other described a transparent, stepwise process for 
evaluating and implementing alternative methods for six-pack studies, 
which test for acute systemic toxicity by the oral, dermal, and 
inhalation routes; skin and eye irritation; and skin sensitization.
     Publication of notices permitting removal of back-
titration hamsters for potency testing of vaccines containing 
Leptospira pomona and Leptospira grippotyphosa by the U.S. Department 
of Agriculture, further reducing the number of hamsters required for 
leptospirosis vaccine potency testing.
     Publication by the U.S. Food and Drug Administration of 
the Predictive Toxicology Roadmap for integrating predictive toxicology 
methods into safety and risk assessments.
     Development by NICEATM and EPA scientists of a defined 
approach that combines data from 11 high-throughput screening assays 
with a computational model to identify chemicals with the potential to 
interact with the androgen receptor pathway.
     Development by NICEATM and ICCVAM scientists of a defined 
approach that uses non-animal approaches to predict murine local lymph 
node assay outcomes and human skin sensitization hazard and potency.
     Submission of a proposal to develop a performance-based 
test guideline for defined approaches to skin sensitization testing and 
assessment to the Organisation for Economic Co-operation and 
Development (OECD) by partners in the International Cooperation on 
Alternative Test Methods in 2016. The proposal was approved as part of 
the OECD workplan in 2017.
     Launch of the Integrated Chemical Environment, a publicly 
accessible online resource developed to provide high-quality curated 
data and

[[Page 38718]]

computational workflows to facilitate chemical safety assessment, by 
NICEATM.
    Availability of Report: The report is available at http://ntp.niehs.nih.gov/iccvamreport/2017/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 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. 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 (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 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 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: July 24, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-16837 Filed 8-6-18; 8:45 am]
 BILLING CODE 4140-01-P