Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments, 40072-40074 [2019-17269]
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Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
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as ‘‘confidential’’ will not be disclosed
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and other applicable disclosure law. For
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FOR FURTHER INFORMATION CONTACT:
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Administration, 7500 Standish Pl.
(HFV–131), Rockville, MD, 20855, 240–
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In the
Federal Register of July 9, 2019 (84 FR
32749), FDA published a notice of
public meeting and request for comment
with a 30-day comment period to
request comments on the use of
complex adaptive and other novel
investigation designs, data from foreign
countries, real world evidence, and
biomarkers and surrogate endpoints in
animal drug development and
regulatory decision making. Comments
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development as required under section
305 of the Animal Drug and Animal
Generic Drug User Fee Amendments of
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directs FDA to develop guidance to
address several alternative approaches
in clinical investigations for new animal
drugs.
The Agency has received a request for
a 30-day extension of the comment
period for the notice of meeting. The
request conveyed concern that the
current 30-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
alternative approaches in clinical
investigations for new animal drugs.
FDA has considered the request and
is extending the comment period for the
notice of public meeting for 30 days,
until September 16, 2019. The Agency
believes that a 30-day extension allows
adequate time for interested persons to
submit comments without significantly
delaying the development of guidance
on these important issues.
jspears on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17258 Filed 8–12–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Novel and
Exceptional Technology and Research
Advisory Committee was renewed for
an additional two-year period on June
30, 2019. Prior to this renewal, the
Charter was amended to reflect the
Committee’s name change from the
Recombinant DNA Advisory Committee
to the Novel and Exceptional
Technology and Research Advisory
Committee.
It is determined that the Novel and
Exceptional Technology and Research
Advisory Committee is in the public
interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or harriscl@mail.nih.gov.
Dated: August 7, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17244 Filed 8–12–19; 8:45 am]
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; PAR17–097:
Planning for Non-Communicable Diseases
and Disorders Research Training Programs.
Date: August 20, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Brian H. Scott, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–7490, brianscott@mail.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,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 7, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17246 Filed 8–12–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Scientific Advisory Committee on
Alternative Toxicological Methods;
Announcement of Meeting; Request
for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) 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.,
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SUMMARY: This notice announces the
next meeting of the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM). SACATM, a
federally chartered external advisory
group of scientists from the public and
private sectors, including
representatives of regulated industry
and national animal protection
organizations, 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
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Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
Environmental Sciences (NIEHS) and
NTP regarding statutorily mandated
duties of ICCVAM and activities of
NICEATM. The meeting is open to the
public and registration is requested for
both attendance and oral comments and
required to access the webcast.
Information about the meeting and
registration are available at https://
ntp.niehs.nih.gov/go/32822.
DATES:
Meeting: September 19–20, 2019;
begins at 9:00 a.m. (EDT) each day and
continues until adjournment.
Written Public Comment
Submissions: Deadline is September 12,
2019.
Register to Present Oral Comments:
Deadline is September 12, 2019.
Registration for Meeting: Deadline is
September 12, 2019 to attend in person
and September 20, 2019 to view the
webcast.
Registration to view the meeting via
the webcast is required.
ADDRESSES:
Meeting Location: Crowne Plaza
Crystal City—Washington, DC, 1480
Crystal Drive, Arlington, Virginia 22202.
Meeting Web Page: The preliminary
agenda, registration, and other meeting
materials are at https://
ntp.niehs.nih.gov/go/32822.
Webcast: The meeting will be
webcast; the URL will be provided to
those who register for viewing.
FOR FURTHER INFORMATION CONTACT: Dr.
Elizabeth Maull, Designated Federal
Official for SACATM, Office of Liaison,
Policy and Review, Division of NTP,
NIEHS, P.O. Box 12233, K2–17,
Research Triangle Park, NC 27709.
Phone: 984–287–3157, Fax: 301–480–
3008, Email: maull@niehs.nih.gov. Hand
Deliver/Courier address: 530 Davis
Drive, Room K2021, Morrisville, NC
27560.
jspears on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Meeting and Registration: The
meeting is open to the public with time
scheduled for oral public comments;
attendance at the meeting is limited
only by the space available.
SACATM will provide input to
ICCVAM, NICEATM, and NIEHS on
programmatic activities and issues.
Preliminary agenda items for the
upcoming meeting include: (1) New
approaches to the principles and
practice of validation, (2) developing a
next generation data infrastructure to
support the development and
implementation of new approach
methodologies (NAMs) for complex
endpoints, and (3) translational impact
and human relevance of NAMs. Please
see the preliminary agenda for
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information about the specific
presentations.
The preliminary agenda, roster of
SACATM members, background
materials, public comments, and any
additional information will be posted
when available on the SACATM
meeting website (https://
ntp.niehs.nih.gov/go/32822) or may be
requested in hardcopy from the
Designated Federal Official for
SACATM. Following the meeting,
summary minutes will be prepared and
made available on the SACATM
meeting website.
Interested persons may attend the
meeting in person or view the webcast.
Registration is required to view the
webcast; the URL for the webcast will be
provided in the email confirming
registration. Individuals who plan to
provide oral comments (see below) are
encouraged to register online at the
SACATM meeting website (https://
ntp.niehs.nih.gov/go/32822) by
September 12, 2019, to facilitate
planning for the meeting. Individuals
are encouraged to visit the website often
to stay abreast of the most current
information regarding the meeting.
Individuals with disabilities who need
accommodation to participate in this
event should contact Ms. Robbin Guy at
phone: (984) 287–3136 or email: guyr2@
niehs.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.
Written Public Comments: Written
and oral public comments are invited
for the agenda topics. Guidelines for
public comments are available at
https://ntp.niehs.nih.gov/ntp/about_
ntp/guidelines_public_comments_
508.pdf. The deadline for submission of
written comments is September 12,
2019. Written public comments should
be submitted through the meeting
website. Persons submitting written
comments should include name,
affiliation, mailing address, phone,
email, and sponsoring organization (if
any). Written comments received in
response to this notice will be posted on
the NTP website, and the submitter will
be identified by name, affiliation, and
sponsoring organization (if any).
Oral Public Comment Registration:
The preliminary agenda allows for
several public comment periods, each
allowing up to four commenters a
maximum of five minutes per speaker.
Oral comments may be presented in
person at Crowne Plaza Crystal City—
Washington, DC, 1480 Crystal Drive,
Arlington, Virginia 22202 or by
teleconference line. Registration for oral
comments is on or before September 12,
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2019, at https://ntp.niehs.nih.gov/go/
32822. Registration is on a first-come,
first-served basis, and each registrant
will be assigned a number in their
confirmation email. Each organization is
allowed one time slot per comment
period. After 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 12, 2019, about the actual
time allotted per speaker, and the
teleconference number will be sent to
those registered to give oral comments
by teleconference line. If possible, oral
public commenters should send a copy
of their slides and/or statement or
talking points to Robbin Guy by email:
guyr2@niehs.nih.gov by September 12,
2019.
Meeting Materials: The preliminary
meeting agenda will be posted when
available on the meeting web page
https://ntp.niehs.nih.gov/go/32822 and
will be updated one week before the
meeting. Individuals are encouraged to
visit this web page often to stay abreast
of the most current information
regarding the meeting.
Background Information on ICCVAM,
NICEATM, and SACATM: ICCVAM is
an interagency committee composed of
representatives from 16 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 and 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 (enhance animal wellbeing and lessen or avoid pain and
distress) 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
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Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
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.
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. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/go/167.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2019–17269 Filed 8–12–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Center for
Advancing Translational Sciences
Advisory Council, which was published
in the Federal Register on June 27,
2019, 84 FR 30740, Pg. 30744.
Amendment to change start time of
the closed session from 9 a.m. to 8:30
a.m. and to change the start time of the
open session from 11 a.m. to 10 a.m.
The meeting is partially Closed to the
public.
jspears on DSK3GMQ082PROD with NOTICES
Dated: August 7, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17245 Filed 8–12–19; 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
Pursuant to section 10(d) 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; NIH Support for
Conferences and Scientific Meetings (Parent
R13 Clinical Trial Not Allowed).
Date: August 28, 2019.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Steven F. Santos, Ph.D.,
Scientific Review Officer, SRP, DEA, NIAID–
NIH, DHHS, 5601 Fishers Lane, 3G33,
Rockville, MD 20852, Phone: 301–761–7049,
Cell: 202–306–4207, steven.santos@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: August 7, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–17247 Filed 8–12–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
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Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Protection and Advocacy for
Individuals With Mental Illness
(PAIMI) Final Rule, 42 CFR Part 51
(OMB No. 0930–0172)—Extension
These regulations meet the directive
under 42 U.S.C. 10826(b) requiring the
Secretary to promulgate final
regulations to carry out the PAIMI Act
(42 U.S.C. 10801 et seq.). The
regulations contain information
collection requirements associated with
the rule. The Act authorizes funds to
support activities on behalf of
individuals with significant (severe)
mental illness (adults) or significant
(severe) emotional impairment
(children/youth) as defined by the Act
at 42 U.S.C. 10802(4) and 10804(d).
Only entities designated by the governor
of each state, including the American
Samoa, Guam, Commonwealth of the
Northern Mariana Islands,
Commonwealth of Puerto Rico, U.S.
Virgin Islands, District of Columbia
(Mayor), and the tribal councils of the
American Indian Consortium (the Hopi
Tribe and the Navajo Nation located in
the Four Corners region of the
Southwest), to protect and advocate the
rights of persons with developmental
disabilities are eligible to receive PAIMI
Program grants [ibid at 42 U.S.C. at
10802(2)]. These grants are based on a
formula prescribed by the Secretary
[ibid at 42 U.S.C. at 10822(a)(1)(A)].
On January 1, each eligible state
protection and advocacy (P&A) system
is required to prepare an annual PAIMI
Program Performance Report (PPR).
Each annual PPR describes a P&A
system’s activities, accomplishments
and expenditures to protect the rights of
individuals with mental illness
supported with payments from PAIMI
program allotments during the most
recently completed fiscal year. Each
P&A system transmit a copy of its
annual report to the Secretary (via
SAMHSA) and to the State Mental
Health Agency where the system is
located per the PAIMI Act at 42 U.S.C.
10824(a). Each annual PPR must
provide the Secretary with the following
information:
• The number of (PAIMI-eligible)
individuals with mental illness served;
• A description of the types of
activities undertaken;
• A description of the types of
facilities providing care or treatment to
which such activities are undertaken;
• A description of the manner in
which the activities are initiated;
E:\FR\FM\13AUN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40072-40074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Scientific Advisory Committee on Alternative Toxicological
Methods; Announcement of Meeting; Request for Comments
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, a federally chartered external advisory group of scientists
from the public and private sectors, including representatives of
regulated industry and national animal protection organizations,
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
[[Page 40073]]
Environmental Sciences (NIEHS) and NTP regarding statutorily mandated
duties of ICCVAM and activities of NICEATM. The meeting is open to the
public and registration is requested for both attendance and oral
comments and required to access the webcast. Information about the
meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.
DATES:
Meeting: September 19-20, 2019; begins at 9:00 a.m. (EDT) each day
and continues until adjournment.
Written Public Comment Submissions: Deadline is September 12, 2019.
Register to Present Oral Comments: Deadline is September 12, 2019.
Registration for Meeting: Deadline is September 12, 2019 to attend
in person and September 20, 2019 to view the webcast.
Registration to view the meeting via the webcast is required.
ADDRESSES:
Meeting Location: Crowne Plaza Crystal City--Washington, DC, 1480
Crystal Drive, Arlington, Virginia 22202.
Meeting Web Page: The preliminary agenda, registration, and other
meeting materials are at https://ntp.niehs.nih.gov/go/32822.
Webcast: The meeting will be webcast; the URL will be provided to
those who register for viewing.
FOR FURTHER INFORMATION CONTACT: Dr. Elizabeth Maull, Designated
Federal Official for SACATM, Office of Liaison, Policy and Review,
Division of NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park,
NC 27709. Phone: 984-287-3157, Fax: 301-480-3008, Email:
[email protected]. Hand Deliver/Courier address: 530 Davis Drive,
Room K2021, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Meeting and Registration: The meeting is open to the public with
time scheduled for oral public comments; attendance at the meeting is
limited only by the space available.
SACATM will provide input to ICCVAM, NICEATM, and NIEHS on
programmatic activities and issues. Preliminary agenda items for the
upcoming meeting include: (1) New approaches to the principles and
practice of validation, (2) developing a next generation data
infrastructure to support the development and implementation of new
approach methodologies (NAMs) for complex endpoints, and (3)
translational impact and human relevance of NAMs. Please see the
preliminary agenda for information about the specific presentations.
The preliminary agenda, roster of SACATM members, background
materials, public comments, and any additional information will be
posted when available on the SACATM meeting website (https://ntp.niehs.nih.gov/go/32822) or may be requested in hardcopy from the
Designated Federal Official for SACATM. Following the meeting, summary
minutes will be prepared and made available on the SACATM meeting
website.
Interested persons may attend the meeting in person or view the
webcast. Registration is required to view the webcast; the URL for the
webcast will be provided in the email confirming registration.
Individuals who plan to provide oral comments (see below) are
encouraged to register online at the SACATM meeting website (https://ntp.niehs.nih.gov/go/32822) by September 12, 2019, to facilitate
planning for the meeting. Individuals are encouraged to visit the
website often to stay abreast of the most current information regarding
the meeting. Individuals with disabilities who need accommodation to
participate in this event should contact Ms. 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.
Written Public Comments: Written and oral public comments are
invited for the agenda topics. Guidelines for public comments are
available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. The deadline for submission of
written comments is September 12, 2019. Written public comments should
be submitted through the meeting website. Persons submitting written
comments should include name, affiliation, mailing address, phone,
email, and sponsoring organization (if any). Written comments received
in response to this notice will be posted on the NTP website, and the
submitter will be identified by name, affiliation, and sponsoring
organization (if any).
Oral Public Comment Registration: The preliminary agenda allows for
several public comment periods, each allowing up to four commenters a
maximum of five minutes per speaker. Oral comments may be presented in
person at Crowne Plaza Crystal City--Washington, DC, 1480 Crystal
Drive, Arlington, Virginia 22202 or by teleconference line.
Registration for oral comments is on or before September 12, 2019, at
https://ntp.niehs.nih.gov/go/32822. Registration is on a first-come,
first-served basis, and each registrant will be assigned a number in
their confirmation email. Each organization is allowed one time slot
per comment period. After 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
12, 2019, about the actual time allotted per speaker, and the
teleconference number will be sent to those registered to give oral
comments by teleconference line. 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 12, 2019.
Meeting Materials: The preliminary meeting agenda will be posted
when available on the meeting web page https://ntp.niehs.nih.gov/go/32822 and will be updated one week before the meeting. Individuals are
encouraged to visit this web page often to stay abreast of the most
current information regarding the meeting.
Background Information on ICCVAM, NICEATM, and SACATM: ICCVAM is an
interagency committee composed of representatives from 16 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 and 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
(enhance animal well-being and lessen or avoid pain and distress)
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
[[Page 40074]]
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.
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. Additional information about SACATM,
including the charter, roster, and records of past meetings, can be
found at https://ntp.niehs.nih.gov/go/167.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-17269 Filed 8-12-19; 8:45 am]
BILLING CODE 4140-01-P
