Scientific Advisory Committee on Alternative Toxicological Methods; Notice of Public Meeting; Request for Public Input, 63207-63209 [2024-17099]
Download as PDF
Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
Dated: July 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17103 Filed 8–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Advisory Committee;
Psychopharmacologic Drugs Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Psychopharmacologic Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Psychopharmacologic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
June 4, 2026, expiration date.
DATES: Authority for the
Psychopharmacologic Drugs Advisory
Committee will expire on June 4, 2026,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: PDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Psychopharmacologic
Drugs Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
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SUMMARY:
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investigational human drug products for
use in the practice of psychiatry and
related fields and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
Pursuant to its Charter, the Committee
shall consist of a core of nine voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Non-Federal members of this
committee will serve as Special
Government Employees or
representatives. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
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Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
psychopharmacologic-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). For general
information related to FDA advisory
committees, please visit us at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
Dated: July 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17089 Filed 8–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Scientific Advisory Committee on
Alternative Toxicological Methods;
Notice of Public Meeting; Request for
Public Input
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM). SACATM is a
federally chartered external advisory
group of scientists from the public and
private sectors, including
representatives of regulated industry
and national animal protection
organizations. SACATM advises the
Interagency Coordinating Committee on
the Validation of Alternative Methods
(ICCVAM), the National Toxicology
Program (NTP) Interagency Center for
the Evaluation of Alternative
Toxicological Methods (NICEATM), and
the Director of the National Institute of
Environmental Health Sciences (NIEHS)
and NTP regarding statutorily mandated
duties of ICCVAM and activities of
NICEATM.
SUMMARY:
DATES:
Meeting: September 17, 2024, 10 a.m.
to approximately 4 p.m. EDT;
September 18, 2024, 9:30 a.m. to
approximately 4 p.m. EDT.
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Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
Registration for Onsite Meeting:
Deadline is September 11, 2024, 5 p.m.
EDT.
Registration for Webcast Viewing:
Deadline is September 18, 2024, 4 p.m.
EDT.
Registration for Oral Statements:
Deadline is September 11, 2024, 5 p.m.
EDT.
Registration to attend in person, view
the webcast, and present oral public
statements is required.
ADDRESSES: Interested individuals may
attend the meeting in person or view the
meeting webcast. Registration is
required to attend in person, view the
webcast, and/or present oral comments.
Written public comments will be
accepted. Information about the meeting
and registration are available at https://
ntp.niehs.nih.gov/go/32822.
Meeting Location: Building 35A,
Room 620/630, National Institutes of
Health (NIH), 35 Convent Dr., Bethesda,
MD 20892.
Meeting Web Page: The preliminary
agenda, registration, and other meeting
materials will be available at https://ntp.
niehs.nih.gov/go/32822.
Virtual Meeting: A link to access the
meeting webcast will be emailed to
registrants with their registration
confirmation.
Dr.
Milene Brownlow, Designated Federal
Officer for SACATM, Office of Policy,
Review, and Outreach, Division of
Translational Toxicology, NIEHS.
Phone: 984–287–3364, Email:
milene.brownlow@nih.gov.
SUPPLEMENTARY INFORMATION:
Meeting and Registration: SACATM
will provide input to ICCVAM,
NICEATM, and NIEHS on programmatic
activities and issues. Preliminary
agenda items for the upcoming meeting
include: (1) a review of the 2022–2023
ICCVAM Biennial Progress Report with
a focus on activity gaps and future
directions; (2) updates on validation and
consideration of the new approach
methodologies pipeline; (3) ICCVAM
agency activities in the area of
developmental neurotoxicity; and (4)
update on NICEATM computational
resources.
The preliminary agenda, roster of
SACATM members, background
materials, public comments, and any
additional information will be posted
when available on the SACATM
meeting web page (https://ntp.niehs.
nih.gov/go/32822) or may be requested
from the Designated Federal Officer for
SACATM. Individuals are encouraged to
visit this web page often to stay abreast
of the most current information
regarding the meeting. Following the
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FOR FURTHER INFORMATION CONTACT:
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meeting, summary minutes will be
prepared and made available on the
SACATM meeting web page. Slides and
video from the meeting will also be
posted on this page once they have been
formatted to meet government
accessibility standards.
This meeting is open to the public.
The public may attend the meeting at
NIH, where attendance is limited only
by the space available, or view remotely
by webcast. Those planning to attend
the meeting in person are encouraged to
register at https://ntp.niehs.nih.gov/go/
32822 by September 11, 2024, to
facilitate planning for appropriate
meeting space. Those planning to view
the webcast may register at https://ntp.
niehs.nih.gov/go/32822 any time before
the meeting ends on September 18,
2024. A link to access the meeting
webcast will be provided to registrants
in a confirmation email.
NIH visitor and security information
is available at https://www.nih.gov/
about-nih/visitor-information.
Individuals with disabilities who need
accommodation to participate in this
event should contact Robbin Guy at
phone: 984–287–3136 or email:
robbin.guy@nih.gov. TTY users should
contact the Federal TTY Relay Service
at 800–877–8339. Requests should be
made at least five business days in
advance of the event.
Request for Public Comments: The
preliminary agenda allows for several
public comment periods, each allowing
up to six commenters a maximum of
five minutes per speaker. Registration
for those wishing to provide oral public
comments is required and is open
through September 11, 2024, 5 p.m.
EDT, at https://ntp.niehs.nih.gov/go/
32822. Registration is on a first-come,
first-served basis. If the maximum
number of speakers per comment period
is exceeded, individuals registering to
submit an oral comment for the topic
will be placed on a wait list and notified
should an opening become available.
Commenters will be notified after
September 11, 2024, to provide
logistical information for their
presentations. Submitters will be
identified by their name and affiliation
and/or sponsoring organization, if
applicable. If possible, oral public
commenters should send a copy of their
slides and/or statement or talking points
to Robbin Guy by email: robbin.guy@
nih.gov by September 11, 2024, 5 p.m.
EDT.
Written statements on topics relevant
to ICCVAM’s mission may be submitted
to support an oral public comment or as
standalone documents. These should be
emailed to Robbin Guy at robbin.guy@
nih.gov by September 11, 2024, 5 p.m.
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EDT. Materials submitted to accompany
oral public statements or standalone
written statements should include the
submitter’s name, affiliation (if any),
mailing address, telephone, email, and
sponsoring organization (if any) with
the document. Guidelines for public
statements are at https://ntp.niehs.
nih.gov/ntp/about_ntp/guidelines_
public_comments_508.pdf.
Responses to this notice are
voluntary. No proprietary, classified,
confidential, or sensitive information
should be included in statements
submitted in response to this notice or
presented during the meeting. 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,
NICEATM, and SACATM: ICCVAM is
an interagency committee composed of
representatives from 18 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 the National Institute of
Environmental Health Sciences 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
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Federal Register / Vol. 89, No. 149 / Friday, August 2, 2024 / Notices
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
SACATM, established by the ICCVAM
Authorization Act [Section 285l-3(d)],
provides advice on priorities and
activities related to the development,
validation, scientific review, regulatory
acceptance, implementation, and
national and international
harmonization of new, revised, and
alternative toxicological test methods to
ICCVAM, NICEATM, and Director of
NIEHS and NTP. SACATM is governed
by the provisions of the Federal
Advisory Committee Act, as amended (5
U.S.C. ch.10), which sets forth standards
for the formation and use of advisory
committees.
Additional information about
SACATM, including link to the charter,
roster, and records of past meetings, can
be found at https://ntp.niehs.nih.gov/go/
167.
Dated: July 30, 2024.
Richard P. Woychik,
Director, National Institute of Environmental
Health Sciences and National Toxicology
Program, National Institutes of Health.
[FR Doc. 2024–17099 Filed 8–1–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
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Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 29, 2024.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Samita S. Andreansky,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E71,
Rockville, MD 20852, 240–669–2915,
samita.andreansky@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 29, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17048 Filed 8–1–24; 8:45 am]
BILLING CODE 4140–01–P
63209
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 29, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17049 Filed 8–1–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Collaboration Opportunity for
Combination of Vaccine With Adoptive
Cell Therapies Made at NCI for the
Treatment of Solid Cancers
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Surgery Branch (SB) at
the National Cancer Institute (NCI), is
seeking a partner in the private sector to
provide Good Manufacturing Practicegrade vaccine directed against cancer
neo-antigens with the goal of
conducting a Phase-I human clinical
trial for solid cancers.
FOR FURTHER INFORMATION CONTACT:
Inquiries relating to this collaboration
opportunity should be directed to: Aida
Cremesti, Ph.D., Senior Technology
Transfer Manager, NCI Technology
Transfer Center, Telephone: (240) 276–
5530; Email: aida.cremesti@
mail.nih.gov. Inquiries related to
licensing the related technology E–046–
2022 should be directed to: Andrew
Burke, Ph.D., Senior Technology
Transfer Manager, NCI Technology
Transfer Center, Telephone: (240)–276–
5484; Email: andy.burke@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Biomedical
Technology Optimization and Dissemination
Center (BTOD).
Date: September 26, 2024.
Time: 10:00 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Joseph Thomas Peterson,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9694, petersonjt@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
PO 00000
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Collaboration Opportunity Summary
The Surgery Branch (SB) at the
National Cancer Institute (NCI), under
the direction of Dr. Steven Rosenberg, is
seeking a partner in the private sector to
provide a GMP-grade vaccine directed
against cancer neo-antigens, either
private (patient-specific neo-antigens) or
shared common tumor antigens (such as
KRAS or P–53), with the goal of
conducting a Phase-I human clinical
trial for solid cancers. The trial would
involve the combination of NCIengineered cell therapies with a vaccine
to be provided by the partner. The NCI
SB has extensive expertise in the latest
technology of tumor infiltrating
lymphocyte (TIL) development, as well
as T-Cell Receptor (TCR)-transduced
Peripheral Blood Lymphocytes (PBL)
development using NCI proprietary
E:\FR\FM\02AUN1.SGM
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Agencies
[Federal Register Volume 89, Number 149 (Friday, August 2, 2024)]
[Notices]
[Pages 63207-63209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Scientific Advisory Committee on Alternative Toxicological
Methods; Notice of Public Meeting; Request for Public Input
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the next meeting of the Scientific
Advisory Committee on Alternative Toxicological Methods (SACATM).
SACATM is a federally chartered external advisory group of scientists
from the public and private sectors, including representatives of
regulated industry and national animal protection organizations. SACATM
advises the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM), the National Toxicology Program (NTP)
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM), and the Director of the National Institute of
Environmental Health Sciences (NIEHS) and NTP regarding statutorily
mandated duties of ICCVAM and activities of NICEATM.
DATES:
Meeting: September 17, 2024, 10 a.m. to approximately 4 p.m. EDT;
September 18, 2024, 9:30 a.m. to approximately 4 p.m. EDT.
[[Page 63208]]
Registration for Onsite Meeting: Deadline is September 11, 2024, 5
p.m. EDT.
Registration for Webcast Viewing: Deadline is September 18, 2024, 4
p.m. EDT.
Registration for Oral Statements: Deadline is September 11, 2024, 5
p.m. EDT.
Registration to attend in person, view the webcast, and present
oral public statements is required.
ADDRESSES: Interested individuals may attend the meeting in person or
view the meeting webcast. Registration is required to attend in person,
view the webcast, and/or present oral comments. Written public comments
will be accepted. Information about the meeting and registration are
available at https://ntp.niehs.nih.gov/go/32822.
Meeting Location: Building 35A, Room 620/630, National Institutes
of Health (NIH), 35 Convent Dr., Bethesda, MD 20892.
Meeting Web Page: The preliminary agenda, registration, and other
meeting materials will be available at https://ntp.niehs.nih.gov/go/32822.
Virtual Meeting: A link to access the meeting webcast will be
emailed to registrants with their registration confirmation.
FOR FURTHER INFORMATION CONTACT: Dr. Milene Brownlow, Designated
Federal Officer for SACATM, Office of Policy, Review, and Outreach,
Division of Translational Toxicology, NIEHS. Phone: 984-287-3364,
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Meeting and Registration: SACATM will provide input to ICCVAM,
NICEATM, and NIEHS on programmatic activities and issues. Preliminary
agenda items for the upcoming meeting include: (1) a review of the
2022-2023 ICCVAM Biennial Progress Report with a focus on activity gaps
and future directions; (2) updates on validation and consideration of
the new approach methodologies pipeline; (3) ICCVAM agency activities
in the area of developmental neurotoxicity; and (4) update on NICEATM
computational resources.
The preliminary agenda, roster of SACATM members, background
materials, public comments, and any additional information will be
posted when available on the SACATM meeting web page (https://ntp.niehs.nih.gov/go/32822) or may be requested from the Designated
Federal Officer for SACATM. Individuals are encouraged to visit this
web page often to stay abreast of the most current information
regarding the meeting. Following the meeting, summary minutes will be
prepared and made available on the SACATM meeting web page. Slides and
video from the meeting will also be posted on this page once they have
been formatted to meet government accessibility standards.
This meeting is open to the public. The public may attend the
meeting at NIH, where attendance is limited only by the space
available, or view remotely by webcast. Those planning to attend the
meeting in person are encouraged to register at https://ntp.niehs.nih.gov/go/32822 by September 11, 2024, to facilitate
planning for appropriate meeting space. Those planning to view the
webcast may register at https://ntp.niehs.nih.gov/go/32822 any time
before the meeting ends on September 18, 2024. A link to access the
meeting webcast will be provided to registrants in a confirmation
email.
NIH visitor and security information is available at https://www.nih.gov/about-nih/visitor-information. Individuals with
disabilities who need accommodation to participate in this event should
contact Robbin Guy at phone: 984-287-3136 or email: [email protected].
TTY users should contact the Federal TTY Relay Service at 800-877-8339.
Requests should be made at least five business days in advance of the
event.
Request for Public Comments: The preliminary agenda allows for
several public comment periods, each allowing up to six commenters a
maximum of five minutes per speaker. Registration for those wishing to
provide oral public comments is required and is open through September
11, 2024, 5 p.m. EDT, at https://ntp.niehs.nih.gov/go/32822.
Registration is on a first-come, first-served basis. If the maximum
number of speakers per comment period is exceeded, individuals
registering to submit an oral comment for the topic will be placed on a
wait list and notified should an opening become available. Commenters
will be notified after September 11, 2024, to provide logistical
information for their presentations. Submitters will be identified by
their name and affiliation and/or sponsoring organization, if
applicable. If possible, oral public commenters should send a copy of
their slides and/or statement or talking points to Robbin Guy by email:
[email protected] by September 11, 2024, 5 p.m. EDT.
Written statements on topics relevant to ICCVAM's mission may be
submitted to support an oral public comment or as standalone documents.
These should be emailed to Robbin Guy at [email protected] by
September 11, 2024, 5 p.m. EDT. Materials submitted to accompany oral
public statements or standalone written statements should include the
submitter's name, affiliation (if any), mailing address, telephone,
email, and sponsoring organization (if any) with the document.
Guidelines for public statements are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
Responses to this notice are voluntary. No proprietary, classified,
confidential, or sensitive information should be included in statements
submitted in response to this notice or presented during the meeting.
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, NICEATM, and SACATM: ICCVAM is an
interagency committee composed of representatives from 18 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 the National Institute
of Environmental Health Sciences 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
[[Page 63209]]
technical evaluations. Additional information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/niceatm.
SACATM, established by the ICCVAM Authorization Act [Section 285l-
3(d)], provides advice on priorities and activities related to the
development, validation, scientific review, regulatory acceptance,
implementation, and national and international harmonization of new,
revised, and alternative toxicological test methods to ICCVAM, NICEATM,
and Director of NIEHS and NTP. SACATM is governed by the provisions of
the Federal Advisory Committee Act, as amended (5 U.S.C. ch.10), which
sets forth standards for the formation and use of advisory committees.
Additional information about SACATM, including link to the charter,
roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/go/167.
Dated: July 30, 2024.
Richard P. Woychik,
Director, National Institute of Environmental Health Sciences and
National Toxicology Program, National Institutes of Health.
[FR Doc. 2024-17099 Filed 8-1-24; 8:45 am]
BILLING CODE 4140-01-P