National Center for Complementary & Integrative Health; Notice of Closed Meeting, 27855 [2021-10870]
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Federal Register / Vol. 86, No. 98 / Monday, May 24, 2021 / Notices
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: May 19, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–10907 Filed 5–21–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
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 Center for
Complementary and Integrative Health
Special Emphasis Panel; NCCIH Training and
Education Review Panel (CT).
Date: June 17th–18th, 2021.
Time: 10:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIH/NCCIH Democracy II, 6707
Democracy Blvd., Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Patrick Colby Still, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, Division of Extramural Activities,
NCCIH/NIH, 6707 Democracy Boulevard,
Suite 401, Bethesda, MD 20892–5475,
patrick.still@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
VerDate Sep<11>2014
17:32 May 21, 2021
Jkt 253001
Dated: May 18, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–10870 Filed 5–21–21; 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 invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Peter Soukas, J.D., 301–496–2644;
peter.soukas@nih.gov. Licensing
information and copies of the patent
applications listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
SUMMARY:
Recombinant Chimeric Bovine/Human
Parainfluenza Virus 3 Expressing
SARS–CoV–2 Spike Protein and Its Use
Description of Technology
Vaccines for SARS–CoV–2 are
increasingly available under emergency
use authorizations; however, indications
are currently limited to individuals
twelve (12) years or older. They also
involve intramuscular immunization,
which does not directly stimulate local
immunity in the respiratory tract, the
primary site of SARS–CoV–2 infection,
shedding and spread. While the major
burden of COVID–19 disease is in
adults, infection and disease also occur
in infants and young children,
contributing to viral transmission.
Therefore, the development of safe and
effective pediatric COVID–19 vaccines
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27855
is important. Ideally, a vaccine should
be effective as a single dose, should
induce mucosal immunity with the
ability to restrict SARS–CoV–2 infection
and respiratory shedding, and should
easily coordinate with vaccines for other
illnesses, such as HPIV3.
The live-attenuated vaccine
candidates are based on a recombinant
chimeric bovine/human parainfluenza
virus 3 (rB/HPIV3) vector expressing
prefusion-stabilized versions of the
Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS–CoV–2) Spike (S)
protein. The B/HPIV3–SARS CoV–2
vaccine candidates are designed to be
administered intranasally by drops or
spray to infants and young children.
The vaccines are expected to induce
durable and broad systemic and
respiratory mucosal immunity against
SARS–CoV–2 and HPIV3.
Immunogenicity and protective efficacy
against SARS–CoV–2 challenge was
confirmed in experimental animals
including non-human primates. Based
on experience with this B/HPIV3
platform and other live-attenuated PIV
vaccine candidates in previous pediatric
clinical studies, the present candidates
are anticipated to be well-tolerated in
humans, including infants and young
children, and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
evaluating live-attenuated respiratory
virus vaccine candidates in pediatric
clinical studies, including PIV vaccine
candidates, and opportunity for
collaboration exists.
This technology is available for
nonexclusive licensing for commercial
development in accordance with 35
U.S.C. 209 and 37 CFR part 404, as well
as for further development and
evaluation under a research
collaboration.
Potential Commercial Applications
• Viral diagnostics
• Vaccine research
Competitive Advantages
•
•
•
•
Ease of manufacture
B cell and T cell activation
Low-cost vaccines
Intranasal administration/needle-free
delivery
Development Stage
• In vivo data assessment (animal)
Inventors: Ursula Buchholz (NIAID),
Shirin Munir (NIAD), Cyril Le Nouen
(NIAID), Xueqiao Liu (NIAID), Cindy
Luongo (NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–239–2020–0—U.S. Provisional
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]]>Agencies
[Federal Register Volume 86, Number 98 (Monday, May 24, 2021)]
[Notices]
[Page 27855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10870]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Integrative Health; 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 Center for Complementary and
Integrative Health Special Emphasis Panel; NCCIH Training and
Education Review Panel (CT).
Date: June 17th-18th, 2021.
Time: 10:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: NIH/NCCIH Democracy II, 6707 Democracy Blvd., Bethesda,
MD 20817 (Virtual Meeting).
Contact Person: Patrick Colby Still, Ph.D., Scientific Review
Officer, Office of Scientific Review, Division of Extramural
Activities, NCCIH/NIH, 6707 Democracy Boulevard, Suite 401,
Bethesda, MD 20892-5475, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.213,
Research and Training in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: May 18, 2021.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-10870 Filed 5-21-21; 8:45 am]
BILLING CODE 4140-01-P
