Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Use of Animal-Free Affinity Reagents; Notice of Public Webinar; Registration Information, 65167-65168 [2019-25667]
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Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices
other unwanted small molecules
accumulate in the vessel with a
potential to disrupt the cell growth,
protein production, and the stability of
the generated protein of interest.
Second, necessary buffer exchange and/
or cell concentration steps must be
performed outside of the culturing
vessel. These steps are more involved
and increase the risk of contamination.
Lastly, even with the addition of daily
supplementation in the fed-batch
process, there are limitations in length
of time that the transfected cells remain
viable and productive.
Researchers at the Vaccine Research
Center (VRC) of the National Institute of
Allergy and Infectious Diseases (NIAID)
developed a new transient gene
expression (TGE) bioprocess using a
perfusion system that resolves the
current fed-batch limitations for
influenza vaccine production. The
major components of this technology are
two-fold: the optimization of conditions
for polyethylenimine (PEI)-mediated
gene transfection in the bioreactor
without the interference of
microbubbles; and the implementation
of a perfusion-based alternating
tangential flow (ATF) system for singlesystem, prolonged cell culture,
combining the steps of cell
concentration, waste clearance,
culturing/media replenishment, and
protein expression within a single
vessel.
The development of the TGE
bioprocess included optimization of
conditions for HEK293 cell growth in
the bioreactor, optimized transfection
mediated by PEI, and protein expression
for an extended period to achieve
reproducibility and high protein yield.
Due to high improvement in cell
growth and protein production without
external handling, this bioprocess could
lead to substantial cost saving and other
benefits in vaccine and drug
manufacturing of clinical grade
materials.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications
• Bioprocess—A single-use protein
production platform for transient gene
expression (TGE) with potential
applications in rapid protein expression
as well as vaccine and drug
manufacturing.
Competitive Advantages
The new transient gene expression
(TGE) bioprocess for vaccine
manufacturing has the following
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features compared to commonly used
related processes such as fed-batch:
• Robust, prolonged cell growth.
• High levels of protein production
and reproducibility.
• Cost efficiency.
• Reduction in contamination risk.
Development Stage: Final Product.
Inventors: Jinsung Hong, Ph.D.
(NIAID); Jacob Demirji, Ph.D. (NIAID);
Daniel Blackstock, Ph.D. (NIAID); and
Joe Horwitz, Ph.D. (NIAID).
Intellectual Property: HHS Reference
Number E–187–2018 includes U.S.
Provisional Patent Application Number
62/751,204 filed 10/26/2018.
Licensing Contact: To license this
technology, please contact Dianca
Finch, Ph.D., 240–669–5503;
dianca.finch@nih.gov.
Dated: October 10, 2019.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2019–25620 Filed 11–25–19; 8:45 am]
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Miguelina Perez,
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Committee Policy.
[FR Doc. 2019–25687 Filed 11–25–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods Communities of Practice
Webinar on Use of Animal-Free Affinity
Reagents; Notice of Public Webinar;
Registration Information
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
announces a public webinar ‘‘Use of
Animal-free Affinity Reagents.’’ The
webinar is organized on behalf of
ICCVAM by the National Toxicology
Program Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM). Interested persons
may participate via WebEx. Time will
be allotted for questions from the
audience. Information about the
webinar and registration are available at
https://ntp.niehs.nih.gov/go/commprac2020.
SUMMARY:
DATES:
Webinar: January 21, 2020, 11:00 a.m.
to approximately 12:30 p.m. EST.
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65168
Federal Register / Vol. 84, No. 228 / Tuesday, November 26, 2019 / Notices
Registration for Webinar: December 9,
2019, until 12:30 p.m. EST January 21,
2020.
Registration to view the webinar is
required.
ADDRESSES: Webinar web page https://
ntp.niehs.nih.gov/go/commprac-2020.
FOR FURTHER INFORMATION CONTACT: Dr.
Warren Casey, Director, NICEATM,
Division of NTP, NIEHS, P.O. Box
12233, K2–17, Research Triangle Park,
NC 27709. Phone: 984–287–3118, Email:
warren.casey@nih.gov. Hand Deliver/
Courier address: 530 Davis Drive, Room
K2021, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM promotes the
development and validation of toxicity
testing methods that protect human
health and the environment while
replacing, reducing, or refining animal
use. ICCVAM also provides guidance to
test method developers and facilitates
collaborations that promote the
development of new test methods. To
address these goals, ICCVAM will hold
a Communities of Practice webinar on
‘‘Use of Animal-free Affinity Reagents.’’
Affinity reagents such as antibodies
are used in a range of research,
diagnostic, and regulatory applications.
However, traditional methods for
producing such reagents require
immunization of laboratory animals.
Therefore, even when applied to
nonanimal test methods, their use is
inconsistent with the spirit of replacing,
reducing, or refining animal use. Use of
animal-based affinity reagents also
introduces variability into the methods
that use them.
This webinar will present a review of
the usefulness and limitations of
nonanimal-derived affinity reagents and
their potential to replace animal-derived
reagents. The preliminary agenda and
additional information about
presentations will be posted at https://
ntp.niehs.nih.gov/go/commprac-2020 as
available.
Webinar and Registration: This
webinar is open to the public with time
scheduled for questions by participants
following each presentation.
Registration for the webinar is required
and is open through 12:30 p.m. EST on
January 21, 2020. Registration is
available at https://ntp.niehs.nih.gov/
go/commprac-2020. Interested
individuals are encouraged to visit this
web page to stay abreast of the most
current webinar information. Registrants
will receive instructions on how to
access and participate in the webinar in
the email confirming their registration.
Individuals with disabilities who
need accommodation to participate in
this event should contact Elizabeth
VerDate Sep<11>2014
16:47 Nov 25, 2019
Jkt 250001
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.
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 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
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 18, 2019.
Brian R. Berridge,
Associate Director, National Toxicology
Program.
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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; HIV/AIDS Maternal,
Adolescent and Pediatric Therapeutics
Clinical Trials Network Leadership and
Operations Center (UM1—Clinical Trial
Required).
Date: December 18, 2019.
Time: 10:00 a.m. to 2:00 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: Roberta Binder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G21A, National Institute of Allergy
and Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5050,
rbinder@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
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Research, National Institutes of Health, HHS)
Dated: November 21, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25684 Filed 11–25–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2019–25667 Filed 11–25–19; 8:45 am]
National Institutes of Health
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Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 84, Number 228 (Tuesday, November 26, 2019)]
[Notices]
[Pages 65167-65168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25667]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee on the Validation of
Alternative Methods Communities of Practice Webinar on Use of Animal-
Free Affinity Reagents; Notice of Public Webinar; Registration
Information
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) announces a public webinar ``Use of
Animal-free Affinity Reagents.'' The webinar is organized on behalf of
ICCVAM by the National Toxicology Program Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM). Interested
persons may participate via WebEx. Time will be allotted for questions
from the audience. Information about the webinar and registration are
available at https://ntp.niehs.nih.gov/go/commprac-2020.
DATES:
Webinar: January 21, 2020, 11:00 a.m. to approximately 12:30 p.m.
EST.
[[Page 65168]]
Registration for Webinar: December 9, 2019, until 12:30 p.m. EST
January 21, 2020.
Registration to view the webinar is required.
ADDRESSES: Webinar web page https://ntp.niehs.nih.gov/go/commprac-2020.
FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Director, NICEATM,
Division of NTP, NIEHS, P.O. Box 12233, K2-17, Research Triangle Park,
NC 27709. Phone: 984-287-3118, Email: [email protected]. Hand
Deliver/Courier address: 530 Davis Drive, Room K2021, Morrisville, NC
27560.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM promotes the development and validation of
toxicity testing methods that protect human health and the environment
while replacing, reducing, or refining animal use. ICCVAM also provides
guidance to test method developers and facilitates collaborations that
promote the development of new test methods. To address these goals,
ICCVAM will hold a Communities of Practice webinar on ``Use of Animal-
free Affinity Reagents.''
Affinity reagents such as antibodies are used in a range of
research, diagnostic, and regulatory applications. However, traditional
methods for producing such reagents require immunization of laboratory
animals. Therefore, even when applied to nonanimal test methods, their
use is inconsistent with the spirit of replacing, reducing, or refining
animal use. Use of animal-based affinity reagents also introduces
variability into the methods that use them.
This webinar will present a review of the usefulness and
limitations of nonanimal-derived affinity reagents and their potential
to replace animal-derived reagents. The preliminary agenda and
additional information about presentations will be posted at https://ntp.niehs.nih.gov/go/commprac-2020 as available.
Webinar and Registration: This webinar is open to the public with
time scheduled for questions by participants following each
presentation. Registration for the webinar is required and is open
through 12:30 p.m. EST on January 21, 2020. Registration is available
at https://ntp.niehs.nih.gov/go/commprac-2020. Interested individuals
are encouraged to visit this web page to stay abreast of the most
current webinar information. Registrants will receive instructions on
how to access and participate in the webinar in the email confirming
their registration.
Individuals with disabilities who need accommodation to participate
in this event should contact 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.
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 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 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: November 18, 2019.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2019-25667 Filed 11-25-19; 8:45 am]
BILLING CODE 4140-01-P
