Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input, 14953-14954 [2019-07269]
Download as PDF
jbell on DSK30RV082PROD with NOTICES
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
Place: Crowne Plaza Washington National
Airport, 1480 Crystal Drive, Arlington, VA
22202.
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7178, Bethesda, MD
20892–7924, 301–827–7938, johnsonw@
nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Mechanisms of Blood Pressure Regulation
Program Project Grant Review.
Date: May 23, 2019.
Time: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Shelley S. Sehnert, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7206, Bethesda, MD
20892–7924, 301–435–0303, ssehnert@
nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Short-Term Experience in Research.
Date: May 29, 2019.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Giuseppe Pintucci, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7192, Bethesda, MD
20892, 301–827–7969, Pintuccig@
nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Institutional Training Grants.
Date: May 30, 2019.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Giuseppe Pintucci, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7192, Bethesda, MD
20892, 301–827–7969, Pintuccig@
nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
Dated: April 8, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
14953
the environment while replacing,
reducing, or refining animal use.
ICCVAM’s goals include promotion of
national and international partnerships
between governmental and
[FR Doc. 2019–07250 Filed 4–11–19; 8:45 am]
nongovernmental groups, including
BILLING CODE 4140–01–P
academia, industry, advocacy groups,
and other key stakeholders. To foster
DEPARTMENT OF HEALTH AND
these partnerships ICCVAM initiated
HUMAN SERVICES
annual public forums in 2014 to share
information and facilitate direct
National Institutes of Health
communication of ideas and suggestions
from stakeholders (79 FR 25136).
Interagency Coordinating Committee
This year’s meeting will be held on
on the Validation of Alternative
May 23, 2019, at the National Institutes
Methods; Notice of Public Meeting;
of Health (NIH) in Bethesda, MD. The
Request for Public Input
meeting will include presentations by
NICEATM and ICCVAM members on
AGENCY: National Institutes of Health,
current activities related to the
HHS.
development and validation of
ACTION: Notice.
alternative test methods and
SUMMARY: The Interagency Coordinating
approaches, including activities relevant
Committee on the Validation of
to implementation of the strategic
Alternative Methods (ICCVAM) will
roadmap for establishing new
hold a public forum to share
approaches to evaluate the safety of
information and facilitate direct
chemicals and medical products in the
communication of ideas and suggestions United States (83 FR 7487).
from stakeholders. Interested persons
Following each presentation, there
may attend in person or view the
will be an opportunity for participants
meeting remotely by webcast. Time will to ask questions of the ICCVAM
be set aside for questions and public
members. Instructions for submitting
statements on the topics discussed.
questions will be provided to remote
Registration is requested for both public participants prior to the webcast. The
attendance and oral statements, and
agenda will also include time for
required for remote access. Information
participants to make public oral
about the meeting and registration are
statements relevant to the ICCVAM
available at https://ntp.niehs.nih.gov/go/ mission and current activities.
iccvamforum-2019.
Preliminary Agenda and Other
DATES: Meeting: May 23, 2019, 9:00 a.m. Meeting Information: The preliminary
to approximately 4:00 p.m. Eastern
agenda, list of discussion topics,
Daylight Time (EDT).
background materials, ICCVAM roster,
Registration for Onsite Meeting:
and public statements submitted prior
Deadline is May 10, 2019.
to the meeting will be posted by May 17
Registration for Webcast: Deadline is
at https://ntp.niehs.nih.gov/go/
May 23, 2019.
iccvamforum-2019. Interested
Submission of Oral Public Statements: individuals are encouraged to visit this
Deadline is May 10, 2019.
web page to stay abreast of the most
ADDRESSES: Meeting Location: William
current meeting information.
H. Natcher Conference Center, National
Meeting and Registration: This
Institutes of Health, Bethesda, MD
meeting is open to the public with time
20892.
scheduled for questions and oral public
Meeting web page: The preliminary
statements following presentations from
agenda, registration, and other meeting
ICCVAM and NICEATM. The public
materials are at https://ntp.niehs.nih.gov/ may attend the meeting at NIH, where
go/iccvamforum-2019.
attendance is limited only by the space
FOR FURTHER INFORMATION CONTACT: Dr.
available, or view remotely by webcast.
Warren Casey, Director, National
Those planning to attend the meeting in
Toxicology Program Interagency Center
person are encouraged to register at
for the Evaluation of Alternative
https://ntp.niehs.nih.gov/go/
Toxicological Methods (NICEATM);
iccvamforum-2019 by May 10, 2019, to
email: warren.casey@nih.gov; telephone: facilitate planning for appropriate
(984) 287–3118.
meeting space. Those planning to view
the webcast must register at https://
SUPPLEMENTARY INFORMATION:
ntp.niehs.nih.gov/go/iccvamforumBackground: ICCVAM, a
2019; registration will be available
congressionally mandated committee,
through May 23, 2019. The URL for the
promotes the development and
webcast will be provided in the email
validation of alternative testing
strategies that protect human health and confirming registration.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
E:\FR\FM\12APN1.SGM
12APN1
jbell on DSK30RV082PROD with NOTICES
14954
Federal Register / Vol. 84, No. 71 / Friday, April 12, 2019 / Notices
NIH visitor and security information
is available at https://www.nih.gov/
about/visitor/index.htm. Individuals
with disabilities who need
accommodation to participate in this
event should contact Dr. Elizabeth
Maull at phone: (984) 287–3157 or
email: maull@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.
Request for Oral Public Statements:
Each presentation will be followed by
an opportunity for participants to ask
questions of the presenter. Attendees
need not register in advance for the
opportunity to ask questions or make
comments specific to presentations.
Instructions for submitting questions or
comments will be provided to remote
participants prior to the webcast.
In addition to time for questions or
comments following each scheduled
presentation, time will be allotted
during the meeting for oral public
statements with associated slides on
topics relevant to ICCVAM’s mission.
The number and length of presentations
may be limited based on available time.
Submitters will be identified by their
name and affiliation and/or sponsoring
organization, if applicable. Persons
submitting public statements and/or
associated slides should include their
name, affiliation (if any), mailing
address, telephone, email, and
sponsoring organization (if any) with
the document. National Toxicology
Program guidelines for public
statements are at https://
ntp.niehs.nih.gov/ntp/about_ntp/
guidelines_public_comments_508.pdf.
Persons wishing to present oral public
statements should email their statement
to ICCVAMquestions@niehs.nih.gov by
May 10, 2019, to allow time for review
by NICEATM and ICCVAM and posting
to the meeting page prior to the forum.
Written statements may supplement and
expand the oral presentation. Public
statements will be distributed to
NICEATM and ICCVAM members
before the meeting.
Registration for oral public statements
will be available onsite, although onsite
registration and time allotted for these
statements may be limited based on the
number of individuals who register to
make statements and available time. If
registering onsite and reading from
written text, please bring 20 copies of
the statement for distribution and to
supplement the record.
Persons wishing to present oral public
statements are strongly encouraged to
present their comments in person to
facilitate effective interaction with
ICCVAM members. However, there will
VerDate Sep<11>2014
18:18 Apr 11, 2019
Jkt 247001
also be the opportunity to present
public statements by teleconference
line. Persons who are unable to attend
the meeting in person and wish to
present oral public statements should
email ICCVAMquestions@niehs.nih.gov
by May 10, 2019 to arrange to present
statements via teleconference line.
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
and NICEATM: 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. 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
(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 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 technical
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
evaluations. Additional information
about NICEATM can be found at https://
ntp.niehs.nih.gov/go/niceatm.
Dated: April 8, 2019.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2019–07269 Filed 4–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. to achieve
expeditious commercialization of
results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Licensing information may be obtained
by emailing the indicated licensing
contact at the National Heart, Lung, and
Blood, Office of Technology Transfer
and Development Office of Technology
Transfer, 31 Center Drive, Room 4A29,
MSC2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive any unpublished
information.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Medical Device for Vascular Dilation
A vascular dilator is commonly used
in transcatheter cardiovascular
intervention procedures. Commercially
available vascular dilators have
introducer sheaths with a finite
thickness and mismatched diameter
with the dilators. This causes uneven
stretching of the trailing edge of the
sheath and severe damage to the target
vessels. This technology produces the
specialized sheath with a shoulder that
can be introduced percutaneously with
an enhanced dilator into a broad range
of diseased target vessels and chambers
with reduced vascular injury. The
shoulder helps to match the diameter of
the introducer sheath so that there is a
smooth transition between the dilator
and the introducer sheath. The
invention allows the dilator to be
withdrawn in segments without
disrupting the introducer sheath.
E:\FR\FM\12APN1.SGM
12APN1
Agencies
[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Notices]
[Pages 14953-14954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee on the Validation of
Alternative Methods; Notice of Public Meeting; Request for Public Input
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) will hold a public forum to share
information and facilitate direct communication of ideas and
suggestions from stakeholders. Interested persons may attend in person
or view the meeting remotely by webcast. Time will be set aside for
questions and public statements on the topics discussed. Registration
is requested for both public attendance and oral statements, and
required for remote access. Information about the meeting and
registration are available at https://ntp.niehs.nih.gov/go/iccvamforum-2019.
DATES: Meeting: May 23, 2019, 9:00 a.m. to approximately 4:00 p.m.
Eastern Daylight Time (EDT).
Registration for Onsite Meeting: Deadline is May 10, 2019.
Registration for Webcast: Deadline is May 23, 2019.
Submission of Oral Public Statements: Deadline is May 10, 2019.
ADDRESSES: Meeting Location: William H. Natcher Conference Center,
National Institutes of Health, Bethesda, MD 20892.
Meeting web page: The preliminary agenda, registration, and other
meeting materials are at https://ntp.niehs.nih.gov/go/iccvamforum-2019.
FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, National
Toxicology Program Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM); email: [email protected];
telephone: (984) 287-3118.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM, a congressionally mandated committee, promotes
the development and validation of alternative testing strategies that
protect human health and the environment while replacing, reducing, or
refining animal use.
ICCVAM's goals include promotion of national and international
partnerships between governmental and nongovernmental groups, including
academia, industry, advocacy groups, and other key stakeholders. To
foster these partnerships ICCVAM initiated annual public forums in 2014
to share information and facilitate direct communication of ideas and
suggestions from stakeholders (79 FR 25136).
This year's meeting will be held on May 23, 2019, at the National
Institutes of Health (NIH) in Bethesda, MD. The meeting will include
presentations by NICEATM and ICCVAM members on current activities
related to the development and validation of alternative test methods
and approaches, including activities relevant to implementation of the
strategic roadmap for establishing new approaches to evaluate the
safety of chemicals and medical products in the United States (83 FR
7487).
Following each presentation, there will be an opportunity for
participants to ask questions of the ICCVAM members. Instructions for
submitting questions will be provided to remote participants prior to
the webcast. The agenda will also include time for participants to make
public oral statements relevant to the ICCVAM mission and current
activities.
Preliminary Agenda and Other Meeting Information: The preliminary
agenda, list of discussion topics, background materials, ICCVAM roster,
and public statements submitted prior to the meeting will be posted by
May 17 at https://ntp.niehs.nih.gov/go/iccvamforum-2019. Interested
individuals are encouraged to visit this web page to stay abreast of
the most current meeting information.
Meeting and Registration: This meeting is open to the public with
time scheduled for questions and oral public statements following
presentations from ICCVAM and NICEATM. 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/iccvamforum-2019 by May 10, 2019, to facilitate
planning for appropriate meeting space. Those planning to view the
webcast must register at https://ntp.niehs.nih.gov/go/iccvamforum-2019;
registration will be available through May 23, 2019. The URL for the
webcast will be provided in the email confirming registration.
[[Page 14954]]
NIH visitor and security information is available at https://www.nih.gov/about/visitor/index.htm. Individuals with disabilities who
need accommodation to participate in this event should contact Dr.
Elizabeth Maull at phone: (984) 287-3157 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 Oral Public Statements: Each presentation will be
followed by an opportunity for participants to ask questions of the
presenter. Attendees need not register in advance for the opportunity
to ask questions or make comments specific to presentations.
Instructions for submitting questions or comments will be provided to
remote participants prior to the webcast.
In addition to time for questions or comments following each
scheduled presentation, time will be allotted during the meeting for
oral public statements with associated slides on topics relevant to
ICCVAM's mission. The number and length of presentations may be limited
based on available time. Submitters will be identified by their name
and affiliation and/or sponsoring organization, if applicable. Persons
submitting public statements and/or associated slides should include
their name, affiliation (if any), mailing address, telephone, email,
and sponsoring organization (if any) with the document. National
Toxicology Program guidelines for public statements are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
Persons wishing to present oral public statements should email
their statement to [email protected] by May 10, 2019, to
allow time for review by NICEATM and ICCVAM and posting to the meeting
page prior to the forum. Written statements may supplement and expand
the oral presentation. Public statements will be distributed to NICEATM
and ICCVAM members before the meeting.
Registration for oral public statements will be available onsite,
although onsite registration and time allotted for these statements may
be limited based on the number of individuals who register to make
statements and available time. If registering onsite and reading from
written text, please bring 20 copies of the statement for distribution
and to supplement the record.
Persons wishing to present oral public statements are strongly
encouraged to present their comments in person to facilitate effective
interaction with ICCVAM members. However, there will also be the
opportunity to present public statements by teleconference line.
Persons who are unable to attend the meeting in person and wish to
present oral public statements should email
[email protected]hs.nih.gov by May 10, 2019 to arrange to present
statements via teleconference line.
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 and NICEATM: 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. 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 (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 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
technical evaluations. Additional information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/niceatm.
Dated: April 8, 2019.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-07269 Filed 4-11-19; 8:45 am]
BILLING CODE 4140-01-P