Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2020-2021; Availability of Report, 58363-58364 [2022-20787]
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Federal Register / Vol. 87, No. 185 / Monday, September 26, 2022 / Notices
Dated: September 9, 2022.
Paul Reed,
Deputy Assistant Secretary for Health,
(Disease Prevention and Health Promotion).
[FR Doc. 2022–20693 Filed 9–23–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Assistant Secretary for Administration
for Strategic Preparedness and
Response; Delegation of Authority
Notice is hereby given that I have
delegated to the Assistant Secretary for
Preparedness and Response (ASPR), or
their successor, the priorities authority
under Section 101 of the Defense
Production Act (DPA) of 1950, as
amended (50 U.S.C. 4501, et seq.), as
delegated to the Secretary of the U.S.
Department of Health and Human
Services (HHS) by section 201 of
Executive Order 13603, dated March 16,
2012 (77 FR 16651; 3 CFR, 2012, Comp.,
p. 225), subject to the limitation stated
herein. The delegation authorizes the
ASPR, on behalf of the Secretary, to
approve DO–HR 1 priority rating
requests for health resources that
promote the national defense. The
delegation excludes the authority to
approve all priorities provisions for
health resources that require DX–HR
priority ratings. This delegation does
not confer authority to issue regulations.
FOR FURTHER INFORMATION CONTACT:
Paige Ezernack; Defense Production Act
Office; Administration for Strategic
Preparedness and Response; U.S.
Department of Health and Human
Services; phone: (202) 260–0365; email:
Paige.Ezernack@hhs.gov.
Xavier Becerra,
Secretary.
[FR Doc. 2022–20737 Filed 9–23–22; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Biennial Progress Report:
2020–2021; Availability of Report
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Toxicology
Program (NTP) Interagency Center for
SUMMARY:
1 Or
another equivalent rating designation.
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16:43 Sep 23, 2022
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the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces availability of the
Interagency Coordinating Committee on
the Validation of Alternative Methods
(ICCVAM) Biennial Progress Report:
2020–2021. This report, prepared in
accordance with requirements of the
ICCVAM Authorization Act of 2000,
describes activities and
accomplishments from January 2020
through December 2021.
ADDRESSES: The report is available at
https://ntp.niehs.nih.gov/go/
2021iccvamreport.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Acting Director,
NICEATM, Division of Translational
Toxicology, NIEHS, P.O. Box 12233,
K2–17, Research Triangle Park, NC
27709. Phone: 984–287–3150, Email:
nicole.kleinstreuer@nih.gov. Hand
Deliver/Courier address: 530 Davis
Drive, Room K2032, Morrisville, NC
27560.
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 eleventh progress
report describing ICCVAM activities and
accomplishments from January 2020
through December 2021 is now
available.
Summary of Report Contents: Key
ICCVAM, ICCVAM agency, and
NICEATM accomplishments
summarized in the report include:
• Publication by the Organisation for
Economic Co-operation and
Development of Guideline 497, Defined
Approaches on Skin Sensitisation, the
first internationally harmonized
guideline to describe a non-animal
approach that can be used to replace an
animal test to identify skin sensitizers.
Guideline 497 was drafted and
sponsored by ICCVAM agency scientists
and international partners.
• Recommendations in March 2021
by the ICCVAM Metrics Workgroup on
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58363
federal agency progress in promoting
alternative toxicological methods. The
workgroup recommended each agency
develop its own metrics relevant and
practical to their own situation.
• Establishment of the Workgroup on
Microphysiological Systems for COVID
Research, an international collaborative
workgroup to coordinate use of
microphysiological systems to reduce
animal use in COVID–19 studies and
future emerging infectious diseases. A
key accomplishment of the workgroup
was the establishment of a COVID–19
disease portal in an existing
microphysiological systems database.
• Further development of the
Collaborative Acute Toxicity Modeling
Suite (CATMoS), an online resource for
in silico screening of organic chemicals
for acute oral toxicity. During 2020 and
2021, the utility of CATMoS for
predicting acute oral toxicity in research
and regulatory contexts was explored in
projects conducted by ICCVAM
agencies, including the U.S. Department
of Defense and the U.S. Environmental
Protection Agency.
• Updates of the Integrated Chemical
Environment Search tool during 2020
and 2021 to enable search results to be
sent to query other data resources.
Updates also allowed users to explore
similarities among chemicals, find
information on chemical use categories,
search for structurally similar
chemicals, and view and interact with
concentration-response curves from
curated high-throughput screening data.
Availability of Report: The report is
available at https://ntp.niehs.nih.gov/
go/2021iccvamreport. Links to this
report and all past ICCVAM annual and
biennial reports are available at https://
ntp.niehs.nih.gov/go/iccvam-bien.
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
E:\FR\FM\26SEN1.SGM
26SEN1
58364
Federal Register / Vol. 87, No. 185 / Monday, September 26, 2022 / Notices
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 testing
approaches for validation studies and
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
Dated: September 21, 2022.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2022–20787 Filed 9–23–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Andrew Hooper, National
Institute of Mental Health (NIMH)
Project Clearance Liaison, Science
Policy and Evaluation Branch, Office of
Science Policy, Planning and
Communications, NIMH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Bethesda, Maryland 20892, call
(301) 480–8433, or email your request,
including your mailing address, to
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
SUPPLEMENTARY INFORMATION:
Proposed Collection; 60-Day Comment
Request; Regular Clearance for Autism
Spectrum Disorder (ASD) Research
Portfolio Analysis, National Institute of
Mental Health
National Institutes of Health,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
SUMMARY:
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Autism
Spectrum Disorder (ASD) Research
Portfolio Analysis, NIMH, 0925–0682,
expiration date 1/31/2023, EXTENSION,
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of the ASD
research portfolio analysis is to collect
research funding data from U.S. and
international ASD research funders, to
assist the Interagency Autism
Coordinating Committee (IACC) in
fulfilling the requirements of the
Combating Autism Act, and to inform
the committee and interested
stakeholders of the funding landscape
and current directions for ASD research.
Specifically, these analyses will
continue to examine the extent to which
current funding and research topics
align with the IACC Strategic Plan for
ASD Research. The findings will help
guide future funding priorities by
outlining current gaps and opportunities
in ASD research as well as serving to
highlight annual activities and research
progress.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
408.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Number of
projects per
respondent
Average time
per response
(in hours)
Total
burden hours
U.S. Federal .....................................................................................................
U.S. Private ......................................................................................................
International Government ................................................................................
International Private .........................................................................................
31
15
1
2
28
45
61
13
15/60
15/60
15/60
15/60
217
169
15
7
Total ..........................................................................................................
49
1,630
........................
408
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]]>Agencies
[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58363-58364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee on the Validation of
Alternative Methods Biennial Progress Report: 2020-2021; Availability
of Report
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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:
2020-2021. This report, prepared in accordance with requirements of the
ICCVAM Authorization Act of 2000, describes activities and
accomplishments from January 2020 through December 2021.
ADDRESSES: The report is available at https://ntp.niehs.nih.gov/go/2021iccvamreport.
FOR FURTHER INFORMATION CONTACT: Dr. Nicole Kleinstreuer, Acting
Director, NICEATM, Division of Translational Toxicology, NIEHS, P.O.
Box 12233, K2-17, Research Triangle Park, NC 27709. Phone: 984-287-
3150, Email: [email protected]. Hand Deliver/Courier address:
530 Davis Drive, Room K2032, Morrisville, NC 27560.
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 eleventh progress report describing
ICCVAM activities and accomplishments from January 2020 through
December 2021 is now available.
Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM
accomplishments summarized in the report include:
Publication by the Organisation for Economic Co-operation
and Development of Guideline 497, Defined Approaches on Skin
Sensitisation, the first internationally harmonized guideline to
describe a non-animal approach that can be used to replace an animal
test to identify skin sensitizers. Guideline 497 was drafted and
sponsored by ICCVAM agency scientists and international partners.
Recommendations in March 2021 by the ICCVAM Metrics
Workgroup on federal agency progress in promoting alternative
toxicological methods. The workgroup recommended each agency develop
its own metrics relevant and practical to their own situation.
Establishment of the Workgroup on Microphysiological
Systems for COVID Research, an international collaborative workgroup to
coordinate use of microphysiological systems to reduce animal use in
COVID-19 studies and future emerging infectious diseases. A key
accomplishment of the workgroup was the establishment of a COVID-19
disease portal in an existing microphysiological systems database.
Further development of the Collaborative Acute Toxicity
Modeling Suite (CATMoS), an online resource for in silico screening of
organic chemicals for acute oral toxicity. During 2020 and 2021, the
utility of CATMoS for predicting acute oral toxicity in research and
regulatory contexts was explored in projects conducted by ICCVAM
agencies, including the U.S. Department of Defense and the U.S.
Environmental Protection Agency.
Updates of the Integrated Chemical Environment Search tool
during 2020 and 2021 to enable search results to be sent to query other
data resources. Updates also allowed users to explore similarities
among chemicals, find information on chemical use categories, search
for structurally similar chemicals, and view and interact with
concentration-response curves from curated high-throughput screening
data.
Availability of Report: The report is available at https://ntp.niehs.nih.gov/go/2021iccvamreport. Links to this report and all
past ICCVAM annual and biennial reports are available at https://ntp.niehs.nih.gov/go/iccvam-bien.
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
[[Page 58364]]
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 testing approaches for validation studies
and technical evaluations. Additional information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/niceatm.
Dated: September 21, 2022.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2022-20787 Filed 9-23-22; 8:45 am]
BILLING CODE 4140-01-P
