Center for Scientific Review; Notice of Closed Meetings, 53886-53887 [2018-23265]
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53886
Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Category of respondent
Average time
per response
(in hours)
Total annual
burden hours
Individuals (DARF-Oral) ...................................................................................
711
16
4/60
758
Total ..........................................................................................................
2,844
45,504
........................
3,033
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–23313 Filed 10–24–18; 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., 301–594–8730;
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to receive copies of unpublished patent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 Respiratory Syncytial
Virus Challenge Strain
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Number of
responses per
respondent
Description of Technology
RSV is the most important viral agent
of severe respiratory tract disease
worldwide, especially in infants and
young children, and it also causes
severe disease in the elderly and in
immunocompromised individuals.
There are no licensed vaccines or
antivirals suitable for routine use.
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This invention relates to a reverse
genetics system and cDNA-derived virus
for a contemporary wild-type clinical
isolate of RSV of antigenic subgroup A,
termed RSV strain A/Maryland/001/11,
that was isolated in 2011 from an adult
with respiratory illness. The genomic
sequence was determined. A reverse
genetics system was created encoding a
recombinant, replication competent
RSV that contains a codon-optimized G
ORF, which was done to stabilize the
cDNA for replication in bacteria.
Because this virus was generated by
reverse genetics, it is a ‘‘clean’’ virus
with a well-defined passage history.
Clinical study material of this challenge
virus has been manufactured and is
available for use as an U.S. Food and
Drug Administration (FDA) regulated
Investigational New Drug (IND) in
clinical studies in adult volunteers
within and outside of the United States.
Preliminary clinical data confirmed that
this virus efficiently infects and
replicates in 95% of study participants
pre-selected for pre-existing RSV
antibody titers in the bottom 50% of the
range. The challenge virus causes mild
upper respiratory illness in the majority
of infected participants, typical for RSV
illness in otherwise healthy adults. This
provides a suitable challenge system for
evaluating antivirals, as well as vaccines
for older children and adults. This also
could be used for developing liveattenuated RSV vaccine candidates
based on this contemporary strain, using
the stabilized point mutations,
stabilized codon-deletions, and genedeletions that were previously used in
RSV strain A2.
This invention relates to a reverse
genetics system and the encoded RSV
vaccine challenge strain that infects and
causes disease in RSV-experienced
adults and is available for antiviral and
vaccine research.
This technology is available for
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
PO 00000
• Vaccine development
• Viral diagnostics
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• Vaccine research
Competitive Advantages
• Ease of manufacture
• Clinical trial material
• Low-cost vaccines
• Intranasal administration/needlefree delivery
Development Stage
• In vivo data assessment (human)
Inventors: Ursula Buchholz (NIAID),
Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–235–2018–0.
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize for development of a
vaccine for respiratory or other
infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov.
Dated: October 12, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–23311 Filed 10–24–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
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Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: October 18, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Chronic Disease and Epidemiology.
Date: November 1, 2018.
Time: 11:00 a.m. to 1:30 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: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
Related Research.
Date: November 9, 2018.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Barna Dey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
Bethesda, MD 20892, 301–451–2796, bdey@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Review of Aging Applications.
Date: November 20, 2018.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–18–
727: Molecular Profiles and Biomarkers of
Food and Nutrient Intake.
Date: November 20, 2018.
Time: 1:00 p.m. to 4:30 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: Gregory S. Shelness, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6156,
Bethesda, MD 20892–7892, (301) 435–0492,
shelnessgs@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,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
[FR Doc. 2018–23265 Filed 10–24–18; 8:45 am]
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Office
of AIDS Research Advisory Council.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Office of AIDS
Research Advisory Council.
Date: November 15, 2018.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: The forty-ninth OARAC meeting
will include review of the DHHS HIV/AIDS
Treatment and Prevention Guidelines; the
OAR Director’s Report; updates on the OAR
cost sharing activities with the National
Institute on Aging, the FY2019/2020 TransNIH Plan for HIV-Related Research; other
HIV/AIDS research activities across selected
NIH Institutes; and public comment.
Place: National Institutes of Health,
Conference Room 1D13, 5601 Fishers Lane,
Rockville, MD 20892.
Contact Person: Jay R. Radke, Ph.D.,
Scientific Review Officer, Office of AIDS
Research, National Institutes of Health, Ofc of
the Director, 5601 Fishers Lane, Room 2E61
MSC–9834, Bethesda, MD 20892–9834, (240)
669–5046, jay.radke@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.
Information is also available on the
Institute’s/Center’s home page:
www.oar.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(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
PO 00000
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53887
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: October 19, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–23263 Filed 10–24–18; 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., 301–594–8730;
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:
Use of Rostafuroxin To Inhibit Viral
Infection
Description of Technology: Acute
respiratory infections during early
childhood constitute a major human
health burden. Human respiratory
syncytial virus (RSV) is the most
common and important viral cause of
severe acute pediatric respiratory
infections worldwide. Mortality due to
RSV in the post-neonatal (28 days to 1
year old) population is second only to
malaria. It is estimated that RSV causes
34 million lower respiratory tract
infections, 4 million hospitalizations,
and 66,000–199,000 deaths every year
in children less than 5 years of age.
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[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53886-53887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings 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
[[Page 53887]]
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; Member Conflict: Chronic Disease and Epidemiology.
Date: November 1, 2018.
Time: 11:00 a.m. to 1:30 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: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AIDS and Related Research.
Date: November 9, 2018.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Barna Dey, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3184, Bethesda, MD 20892, 301-451-2796,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Review of Aging Applications.
Date: November 20, 2018.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Seetha Bhagavan, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD
20892, (301) 237-9838, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-18-727: Molecular Profiles and Biomarkers of Food and
Nutrient Intake.
Date: November 20, 2018.
Time: 1:00 p.m. to 4:30 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: Gregory S. Shelness, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6156, Bethesda, MD 20892-7892,
(301) 435-0492, [email protected].
(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: October 18, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-23265 Filed 10-24-18; 8:45 am]
BILLING CODE 4140-01-P
