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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to receive copies of unpublished patent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.
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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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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
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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
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:
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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Notices
with a 60-day comment period soliciting
comments, of the following collection of
information on April 13, 2021 (86 FR
19276).
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Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation will be
made available at http://
www.reginfo.gov upon its submission to
OMB. Therefore, in preparation for
OMB review and approval of the
following information collection, TSA is
soliciting comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
Title: TSA Customer Comment Tools.
Type of Request: Revision of a
currently approved collection.
OMB Control Number: 1652–0030.
Forms(s): NA.
Affected Public: Travelling public.
Abstract: The TSA Contact Center
(TCC) continues to serve as the main
portal of communication for the
traveling public. The public may contact
the TCC via email or phone to request
information, file a complaint—general
or Civil Rights and Liberties,
compliment, or provide general
feedback. With over one million
contacts per year, it is crucial for TSA
to have the ability to capture this
information. TSA’s online submission
forms are readily available from the
Customer Service portion of tsa.gov. The
online forms are easy to use and offer
several dropdown menu choices to
reduce the burden on the public and
increase the quality of data for TSA.
Currently, there are four options for the
online forms: Complaint and
Compliment, Request for Assistance,
Request for Information, and Security
Issues. The online forms are easy to use
and offer several dropdown menu
choices to reduce the burden on the
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public and increase the quality of data
for TSA. TCC provides a receipt to any
person who submits an online form.
TSA is revising the information
collection, moving from four online
forms to six electronic forms. The online
form Complaint and Compliment has
been broken into two separate distinct
online forms. TSA PreCheckTM has been
pulled out of the drop down menu of
Complaint and given its own online
form. Request for Assistance online
form has been renamed TSA Cares. The
6 online forms are as follows:
• Complaint—passengers may
provide a complaint regarding their
experiences with TSA security
procedures. Passengers may also use
this form to file Disability or Civil
Rights and Civil Liberties complaints.
• TSA PreCheck—passengers may
share concerns about not receiving TSA
PreCheck on their boarding pass or
other concerns.
• Compliment—passengers may share
how TSA exceeded their expectations.
• Request for Information—
passengers may submit an inquiry about
TSA policies and procedures, such as
traveling with medical conditions,
prohibited & permitted items, security
screening and more.
• TSA Cares—passengers may request
assistance through the TSA screening
checkpoint.
• Security Issue—passengers may
identify and report suspicious activities
and threats. The TCC provides a receipt
to any person who submits an electronic
form or email to TSA as required by 49
CFR 1503.3(a).
Also, TSA is changing the name of
OMB control number 1652–0030 from
‘‘TSA Customer Comment Card’’ to
‘‘TSA Customer Comment Tools’’ to
more accurately represent the
information collection. In addition, TSA
is making non-substantive changes to
the paper comment card, updating the
appearance—font, TSA insignia and
spacing.
Number of Respondents: An
estimated 88,352 respondents annually.
Estimated Annual Burden Hours: An
estimated 7,518 hours annually.
Christina A. Walsh,
TSA Paperwork Reduction Act Officer,
Information Technology.
[FR Doc. 2021–14886 Filed 7–12–21; 8:45 am]
BILLING CODE 9110–05–P
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–HQ–MB–2021–N170; FF09M13200/
201/FXMB12330900000; OMB Control
Number 1018–0172]
Agency Information Collection
Activities; Submission to the Office of
Management and Budget for Review
and Approval; Federal Migratory Bird
Hunting and Conservation Stamp
(Duck Stamp) and Junior Duck Stamp
Contests
Fish and Wildlife Service,
Interior.
ACTION: Notice of information collection;
request for comment.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995
(PRA), we, the U.S. Fish and Wildlife
Service (Service), are proposing to
renew an information collection with
revisions.
DATES: Interested persons are invited to
submit comments on or before August
12, 2021.
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 clicking on
the link ‘‘Currently under Review—
Open for Public Comments’’ or by using
the search function. Please provide a
copy of your comments to the Service
Information Collection Clearance
Officer, U.S. Fish and Wildlife Service,
MS: PRB/PERMA (JAO/3W), 5275
Leesburg Pike, Falls Church, VA 22041–
3803 (mail); or by email to Info_Coll@
fws.gov. Please reference OMB Control
Number 1018–0172 in the subject line of
your comments.
FOR FURTHER INFORMATION CONTACT:
Madonna L. Baucum, Service
Information Collection Clearance
Officer, by email at [email protected],
or by telephone at (703) 358–2503.
Individuals who are hearing or speech
impaired may call the Federal Relay
Service at 1–800–877–8339 for TTY
assistance. You may also view the
information collection request (ICR) at
http://www.reginfo.gov/public/do/
PRAMain.
SUPPLEMENTARY INFORMATION: In
accordance with the Paperwork
Reduction Act of 1995 (PRA, 44 U.S.C.
3501 et seq.) and 5 CFR 1320.8(d)(1), we
provide the general public and other
Federal agencies with an opportunity to
comment on new, proposed, revised,
and continuing collections of
SUMMARY:
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File Modified | 2021-07-13 |
File Created | 2021-07-13 |