[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57926-57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20159]


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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: 2014-2015; Availability 
of Report

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: 
2014-2015. This report, prepared in accordance with requirements of the 
ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), describes 
activities and accomplishments from January 2014 through December 2015.

ADDRESSES: The report is available at http://ntp.niehs.nih.gov/iccvamreport/2015/index.html.

FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM; 
email: [email protected]; telephone: (919) 316-4729.

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 progress report is now 
available, which describes ICCVAM activities and accomplishments from 
January 2014 through December 2015.
    Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM 
accomplishments summarized in the report include:

 A computational approach that integrates several types of data 
to predict human skin sensitization hazard without using animals 
(ICCVAM)
 A plan to adopt high throughput assays and computational 
models for detecting and measuring estrogen receptor bioactivity as an 
alternative for three Tier 1 tests currently used in the Endocrine 
Disruptor Screening Program to assess estrogen receptor activity (U.S. 
Environmental Protection Agency [EPA])
 Establishment of a Communities of Practice webinar seminar 
series discussing relevant topics (ICCVAM)
 Evaluation of acute oral and dermal toxicity data to determine 
if oral toxicity tests are sufficient to assign U.S. EPA dermal hazard 
classifications, eliminating the need for separate acute dermal 
toxicity tests (NICEATM)
 A series of workshops that drafted recommendations on use of 
an in vitro test with potential to replace animal use for pertussis 
vaccine testing (NICEATM, U.S. Food and Drug Administration, other 
ICCVAM agencies).
    Availability of Report: The report is available at http://ntp.niehs.nih.gov/iccvamreport/2015/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 15 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 NIEHS 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

[[Page 57927]]

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: August 16, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-20159 Filed 8-23-16; 8:45 am]
BILLING CODE 4140-01-P