Interagency Coordinating Committee on the Validation of Alternative Methods: Request for Comment on Draft Report on Validation, Qualification, and Acceptance of New Approach Methodologies, 54342 [2023-17120]
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54342
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
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.
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
amber.daniel@inotivco.com 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: nicole.kleinstreuer@nih.gov,
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 wellbeing 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
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
amber.daniel@inotivco.com.
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 https://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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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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HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
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The meeting will be closed to the
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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 [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.
-----------------------------------------------------------------------
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 https://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]
BILLING CODE 4140-01-P
