[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Page 54342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17120]



[[Page 54342]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods: Request for Comment on Draft Report on Validation, 
Qualification, and Acceptance of New Approach Methodologies

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) announces availability of the draft 
document, ``Validation, Qualification, and Regulatory Acceptance of New 
Approach Methodologies.'' ICCVAM will accept public comments on the 
document through September 5, 2023; 5:00 p.m. EDT.

DATES: 
    Document Availability: The draft document is available at https://ntp.niehs.nih.gov/go/ICCVAM-submit.
    Written Public Comments Submissions: Submit comments to 
[email protected] by September 5, 2023; 5:00 p.m. EDT.

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: ICCVAM, a congressionally mandated committee, promotes 
the scientific validation and regulatory acceptance or qualification of 
testing methods that accurately assess the chemical safety and hazards 
of relevant products in an effort to replace, reduce, or refine 
(enhance animal well-being and lessen or avoid pain and distress) 
animal use.
    Shortly after its establishment as a standing committee in 1997, 
ICCVAM published a report, ``Validation and Regulatory Acceptance of 
Toxicological Test Methods,'' which outlined criteria for the 
validation and regulatory acceptance for new and alternative test 
methods (62 FR 11901). This and subsequent related documents described 
a validation model that, while being initially useful, has lately 
demonstrated limitations such as being lengthy and resource-intensive 
and not being compatible with many modern approaches to toxicity 
testing. Furthermore, for some contexts of use, methods may not need to 
undergo every step of the validation process described by these 
documents to yield valuable data for a federal agency.
    In 2021, ICCVAM established its Validation Workgroup to update the 
1997 document and align it with the principles articulated in the 2018 
ICCVAM publication, ``A Strategic Roadmap for Establishing New 
Approaches to Evaluate the Safety of Chemicals and Medical Products in 
the United States'' (83 FR 7487). The Strategic Roadmap provides a 
conceptual framework promoting better communication between agencies 
and test method developers and more flexibility in how confidence is 
established, to help ensure the adoption of new methods by federal 
agencies and regulated industries once validated for a specific purpose 
or context of use.
    A draft version of the new document, ``Validation, Qualification, 
and Regulatory Acceptance of New Approach Methodologies,'' is now 
available for public comment.
    Requests for Comments:  ICCVAM invites public comments from all 
ICCVAM stakeholders on the draft document. The document can be found on 
the NICEATM website at https://ntp.niehs.nih.gov/go/ICCVAM-submit.
    Stakeholders may submit comments via email to Ms. Amber Daniel at 
[email protected]. Commenters should include their name, 
affiliation (if any), mailing address, telephone, email, and sponsoring 
organization (if any) with their comments. Guidelines for public 
statements submitted to NTP are available at at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. All 
comments received will be posted on the NICEATM website and identified 
by the individual's name, affiliation, and sponsoring organization. 
Comments should be received by September 5, 2023; 5:00 p.m. EDT, to 
ensure consideration as the draft document is finalized.
    Responses to this notice are voluntary. No proprietary, classified, 
confidential, or sensitive information should be included in statements 
submitted in response to this notice. This request for input is for 
planning purposes only and is not a solicitation for applications or an 
obligation on the part of the U.S. Government to provide support for 
any ideas identified in response to the request. Please note that the 
U.S. Government will not pay for the preparation of any information 
submitted or for its use of that information.
    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 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: August 4, 2023.
Richard P. Woychik,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program, National Institutes of Health.
[FR Doc. 2023-17120 Filed 8-9-23; 8:45 am]
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