Government-Owned Inventions; Availability for Licensing, 36757-36758 [2021-14820]
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
substantially benefit rural or
underserved populations, or help meet
public health nursing needs in state or
local health departments; special
consideration is given to an eligible
entity that agrees to extend the award to
train advanced education nurses who
will practice in designated health
professional shortage areas.
The ANE Program Specific Form will
allow HRSA to effectively target funding
and measure the impact of the ANE
programs in meeting the legislative
intent and program goals of supporting
the enhancement of advanced nursing
education and creating opportunities for
individuals in advanced nursing
education programs to increase the
number of advanced practice nurses,
especially in rural and underserved
areas. The proposed updates to this
information collection will assist HRSA
in: streamlining the application
submission process across programs;
enabling an efficient award
determination process; and facilitating
HRSA’s ability to monitor the use of
funds and analyze program outcomes.
Additionally, collecting this data assists
HRSA in carrying out the most
impactful program and ensuring
resources are used responsibly.
More specifically, the changes include
the following:
• Form name change from ANEW to
ANE Program Specific Form.
• Additional instructions for
applicants are provided in each funding
opportunity.
• Modifications to both Table #1 and
Table #2:
Æ Revision to instructions to
incorporate elements for added
programs. Instructions about completion
of each table are included within the
electronic application materials.
Æ Table titles are rephrased for
clarity.
Æ New ‘‘Additional Specialty’’
column is created to yield a flexible data
collection option.
• Table #1 rows are numbered for
clarity and more rows are added to:
Æ Capture auto-tabulation, and
Æ Reformat/separate Statutory
Funding Preference data from Special
Consideration data.
• Table #2 has:
o ‘‘Students’’ reworded to
‘‘participants/trainees’’;
Æ One column labeled, ‘‘Budget
Year,’’ to identify the project budget
year;
Æ One column to create a space for
entering the sum for each row;
Æ Rows to more clearly indicate the
budget year for up to five years; and,
Æ One final row to create a space for
entering the total for each column.
• Frequency of data collection: Data
is collected (through the two tables)
once during the application period for
each funding announcement.
• Information determines:
Æ If applicants meet the funding
preference or special consideration for
funding; and
Æ Projected target and baseline
numbers of trainees/participants to be
supported throughout the project
period.
Likely Respondents: Likely
respondents will be current ANE
Programs awardees and new applicants
to the ANE Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
jbell on DSKJLSW7X2PROD with NOTICES
Form name
(includes the ANE program specific tables
and attachments
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
ANEW ..................................................................................
NAT ......................................................................................
ANE–NPR ............................................................................
ANE–NPRIP .........................................................................
ANE–SANE ..........................................................................
236
115
101
15
54
1
1
1
1
1
236
115
101
15
54
7
7
7
7
7
1,652
805
707
105
378
Total ..............................................................................
521
........................
521
........................
3,647
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–14804 Filed 7–12–21; 8:45 am]
BILLING CODE 4165–15–P
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Jkt 253001
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
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13JYN1.SGM
13JYN1
36758
Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
jbell on DSKJLSW7X2PROD with NOTICES
Mononegavirales Vectors Expressing
Chimeric Antigens
Description of Technology
Human respiratory syncytial virus
(RSV) continues to be the leading viral
cause of severe acute lower respiratory
tract disease in infants and children
worldwide, and also is an important
cause of morbidity and mortality in the
elderly. A licensed vaccine or antiviral
drug suitable for routine use remains
unavailable. This invention relates to
the use of murine pneumonia virus
(MPV—previously known as pneumonia
virus of mice, PVM—of family
Pneumoviridae) as a vaccine vector
expressing the RSV fusion protein F, the
most important protective antigen of
RSV. MPV is not a human pathogen and
is not restricted by immunity to
common human viruses. MPV replicates
in the superficial epithelial cells of the
respiratory mucosa and is expected to
be attenuated in humans based on the
strong host range restriction observed in
non-human primates. To generate these
MPV/RSV vector vaccine candidates,
the RSV F ORF was codon optimized,
placed under the control of MPV
transcription signals, and inserted at the
first (rMPV–F1), third (rMPV29 F3), or
fourth (rMPV–F4) gene position of a
version of the MPV genome that
contained a codon-pair optimized L
polymerase gene. The recovered viruses
replicated in vitro as efficiently as the
empty vector, with stable expression of
RSV F protein. Replication and
immunogenicity of rMPV–F1 and
rMPV–F3 were evaluated in rhesus
macaques following administration by
the combined intranasal and
intratracheal routes. Both viruses
replicated at low levels in the upper and
lower respiratory tract, maintained
stable RSV F expression, and induced
similarly high levels of RSVneutralizing serum antibodies that
reached peak titers by fourteen (14) days
post-vaccination. Thus, rMPV provides
a highly attenuated yet immunogenic
vector for the expression of RSV F
protein, with potential application in
RSV-naı¨ve and RSV-experienced
populations. RSV F was expressed in
the wild-type form, but can readily be
engineered to be stabilized in the highly
immunogenic prefusion form, as has
been done with parainfluenza virus
vectors.
The invention relates to live, chimeric
non-human Mononegavirales vectors
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17:47 Jul 12, 2021
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that allow a cell to express at least one
protein from at least one human
pathogen as well as compositions
comprising the vectors, methods and
kits for eliciting an immune response in
a host, and methods of making the
vectors.
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
• Viral diagnostics
• Vaccine research
Competitive Advantages
•
•
•
•
Ease of manufacture
Multivalent live attenuated vaccines
B cell and T cell activation
Low-cost vaccines
Development Stage
• In vivo data assessment (animal)
Inventors: Shirin Munir (NIAID),
Linda Brock (NIAID), Ursula Buchholz
(NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference
No. E–018–2018/0—U.S. Provisional
Application No. 62/661,320, filed April
23, 2018 (expired), PCT Patent
Application No. PCT/US2019/028771,
filed April 23, 2019 (expired),
Taiwanese Patent Application No.
108114132, filed April 23, 2019
(pending), Brazilian Patent Application
No. BR112020021652–6, filed October
22, 2020 (pending), Australian Patent
Application No. 2019261570, filed
October 21, 2020 (pending), Canadian
Patent Application No. 3097888, filed
October 20, 2020 (pending), Chinese
Patent Application No. 201980039372.6,
filed December 15, 2020 (pending),
European Patent Application No.
19729386.3, filed November 13, 2020
(pending), Indian Patent Application
No. 20204706248, filed October 23,
2020, Japanese Patent Application No.
2020–558967, filed October 22, 2020,
South Korean Patent Application No.
2020–7033157, filed November 18,
2020, and United States Patent
Application No. 17/049,916, filed
October 22, 2020.
Licensing Contact: Peter Soukas, J.D.,
301–496–2644; 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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Soukas, J.D., 301–496–2644;
peter.soukas@nih.gov.
Dated: July 8, 2021.
Anna V. Ganelina,
Senior Technology Transfer and Patenting
Specialist, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–14820 Filed 7–12–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Revision of Agency Information
Collection Activity Under OMB Review:
TSA Customer Comment Tools
Transportation Security
Administration, Homeland Security
(DHS).
ACTION: 30-Day notice.
AGENCY:
This notice announces that
the Transportation Security
Administration (TSA) has forwarded the
Information Collection Request (ICR),
Office of Management and Budget
(OMB) control number 1652–0030,
abstracted below to OMB for a revision
of the currently approved collection
under the Paperwork Reduction Act
(PRA). The ICR describes the nature of
the information collection and its
expected burden. This collection allows
customers to provide feedback to TSA
about their experiences with TSA’s
processes and procedures, to request
information or request assistance at the
TSA checkpoint, and to report security
threats and vulnerabilities.
DATES: Send your comments by August
12, 2021. A comment to OMB is most
effective if OMB receives it within 30
days of publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the find
function.
FOR FURTHER INFORMATION CONTACT:
Christina A. Walsh, TSA PRA Officer,
Information Technology (IT), TSA–11,
Transportation Security Administration,
6595 Springfield Center Drive,
Springfield, VA 20598–6011; telephone
(571) 227–2062; email TSAPRA@
dhs.gov.
SUPPLEMENTARY INFORMATION: TSA
published a Federal Register notice,
SUMMARY:
E:\FR\FM\13JYN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36757-36758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14820]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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;
[email protected]. 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
[[Page 36758]]
Disclosure Agreement will be required to receive copies of unpublished
patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
Mononegavirales Vectors Expressing Chimeric Antigens
Description of Technology
Human respiratory syncytial virus (RSV) continues to be the leading
viral cause of severe acute lower respiratory tract disease in infants
and children worldwide, and also is an important cause of morbidity and
mortality in the elderly. A licensed vaccine or antiviral drug suitable
for routine use remains unavailable. This invention relates to the use
of murine pneumonia virus (MPV--previously known as pneumonia virus of
mice, PVM--of family Pneumoviridae) as a vaccine vector expressing the
RSV fusion protein F, the most important protective antigen of RSV. MPV
is not a human pathogen and is not restricted by immunity to common
human viruses. MPV replicates in the superficial epithelial cells of
the respiratory mucosa and is expected to be attenuated in humans based
on the strong host range restriction observed in non-human primates. To
generate these MPV/RSV vector vaccine candidates, the RSV F ORF was
codon optimized, placed under the control of MPV transcription signals,
and inserted at the first (rMPV-F1), third (rMPV29 F3), or fourth
(rMPV-F4) gene position of a version of the MPV genome that contained a
codon-pair optimized L polymerase gene. The recovered viruses
replicated in vitro as efficiently as the empty vector, with stable
expression of RSV F protein. Replication and immunogenicity of rMPV-F1
and rMPV-F3 were evaluated in rhesus macaques following administration
by the combined intranasal and intratracheal routes. Both viruses
replicated at low levels in the upper and lower respiratory tract,
maintained stable RSV F expression, and induced similarly high levels
of RSV-neutralizing serum antibodies that reached peak titers by
fourteen (14) days post-vaccination. Thus, rMPV provides a highly
attenuated yet immunogenic vector for the expression of RSV F protein,
with potential application in RSV-na[iuml]ve and RSV-experienced
populations. RSV F was expressed in the wild-type form, but can readily
be engineered to be stabilized in the highly immunogenic prefusion
form, as has been done with parainfluenza virus vectors.
The invention relates to live, chimeric non-human Mononegavirales
vectors that allow a cell to express at least one protein from at least
one human pathogen as well as compositions comprising the vectors,
methods and kits for eliciting an immune response in a host, and
methods of making the vectors.
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
Viral diagnostics
Vaccine research
Competitive Advantages
Ease of manufacture
Multivalent live attenuated vaccines
B cell and T cell activation
Low-cost vaccines
Development Stage
In vivo data assessment (animal)
Inventors: Shirin Munir (NIAID), Linda Brock (NIAID), Ursula
Buchholz (NIAID), Peter Collins (NIAID).
Intellectual Property: HHS Reference No. E-018-2018/0--U.S.
Provisional Application No. 62/661,320, filed April 23, 2018 (expired),
PCT Patent Application No. PCT/US2019/028771, filed April 23, 2019
(expired), Taiwanese Patent Application No. 108114132, filed April 23,
2019 (pending), Brazilian Patent Application No. BR112020021652-6,
filed October 22, 2020 (pending), Australian Patent Application No.
2019261570, filed October 21, 2020 (pending), Canadian Patent
Application No. 3097888, filed October 20, 2020 (pending), Chinese
Patent Application No. 201980039372.6, filed December 15, 2020
(pending), European Patent Application No. 19729386.3, filed November
13, 2020 (pending), Indian Patent Application No. 20204706248, filed
October 23, 2020, Japanese Patent Application No. 2020-558967, filed
October 22, 2020, South Korean Patent Application No. 2020-7033157,
filed November 18, 2020, and United States Patent Application No. 17/
049,916, filed October 22, 2020.
Licensing Contact: Peter Soukas, J.D., 301-496-2644;
[email protected].
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., 301-496-2644; [email protected].
Dated: July 8, 2021.
Anna V. Ganelina,
Senior Technology Transfer and Patenting Specialist, Technology
Transfer and Intellectual Property Office, National Institute of
Allergy and Infectious Diseases.
[FR Doc. 2021-14820 Filed 7-12-21; 8:45 am]
BILLING CODE 4140-01-P
