Notice2023-17120
Interagency Coordinating Committee on the Validation of Alternative Methods: Request for Comment on Draft Report on Validation, Qualification, and Acceptance of New Approach Methodologies
Primary source
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Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Page 54342]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://ntp.niehs.nih.gov/go/ICCVAM-submit">https://ntp.niehs.nih.gov/go/ICCVAM-submit</a>.
Written Public Comments Submissions: Submit comments to
<a href="/cdn-cgi/l/email-protection#9dfcf0fff8efb3f9fcf3f4f8f1ddf4f3f2e9f4ebfef2b3fef2f0"><span class="__cf_email__" data-cfemail="d7b6bab5b2a5f9b3b6b9beb2bb97beb9b8a3bea1b4b8f9b4b8ba">[email protected]</span></a> 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:
<a href="/cdn-cgi/l/email-protection#caa4a3a9a5a6afe4a1a6afa3a4b9beb8afbfafb88aa4a3a2e4ada5bc"><span class="__cf_email__" data-cfemail="6907000a06050c4702050c00071a1d1b0c1c0c1b29070001470e061f">[email protected]</span></a>, 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 <a href="https://ntp.niehs.nih.gov/go/ICCVAM-submit">https://ntp.niehs.nih.gov/go/ICCVAM-submit</a>.
Stakeholders may submit comments via email to Ms. Amber Daniel at
<a href="/cdn-cgi/l/email-protection#10717d7275623e74717e79757c50797e7f647966737f3e737f7d"><span class="__cf_email__" data-cfemail="0d6c606f687f23696c636468614d64636279647b6e62236e6260">[email protected]</span></a>. 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 <a href="http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf">http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf</a>. 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 <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: 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]
BILLING CODE 4140-01-P
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