Government-Owned Inventions; Availability for Licensing, 11546-11547 [2021-03872]
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11546
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
Divided into two comprehensive
activity categories: ‘‘State-level
Activities’’ and ‘‘State Leadership
Activities,’’ according to Section 4 of the
AT Act, as a condition of receiving a
grant to support their Statewide AT
Programs, the 56 states and outlying
areas must provide to ACL: (1)
Applications and (2) annual progress
reports on their activities.
Applications: The application
required of states and outlying areas is
a three-year State Plan for Assistive
Technology (State Plan for AT or State
Plan) (OMB No. 0985–0048). The
content of the State Plan for AT is based
on the requirements in Section 4(d) of
the AT Act.
Annual Reports: In addition to
submitting a State Plan, every three
years, states and outlying areas are
required to submit annual progress
reports on their activities. The data
required in that progress report is
specified in Section 4(f) of the AT Act
(OMB No. 0985–0042).
National aggregation of data related to
measurable goals is necessary for the
Government Performance and Results
Modernization Act of 2010 (GPRAMA)
(Pub. L. 111–352), as well as an Annual
Report to Congress (see ‘‘Section 7
Requirements Necessitating Collection’’
below). Therefore, this data collection
instrument provides a way for all 56
grantees—50 U.S. states, DC, Puerto
Rico, the U.S. Virgin Islands, Guam,
American Samoa, and the
Commonwealth of the Northern Mariana
Islands to collect and report data on
their activities in a consistent manner,
including a uniform survey to be given
to consumers. This uniform survey is
included as part of the data collection
package.
Section 7(d) of the AT Act requires
that ACL submit to Congress an annual
report on the activities conducted under
the Act and an analysis of the progress
of the states and outlying areas in
meeting their measurable goals. This
report must include a compilation and
summary of the data collected under
Section 4(f). In order to make this
possible, states and outlying areas must
provide their data uniformly. This data
collection instrument was developed to
ensure that all 56 states and outlying
areas report data in a consistent manner
in alignment with the requirements of
Section 4(f).
As stated above, ACL will use the
information collected via this
instrument to:
(1) Complete the annual report to
Congress required by the AT Act;
(2) Comply with reporting
requirements under the Government
Performance and Results Modernization
Act of 2010 (GPRAMA) (Pub. L. 111–
352); and
(3) Assess the progress of states and
outlying areas regarding measurable
goals. Data collected from the grantees
will provide a national description of
activities funded under the AT Act to
increase the access to and acquisition of
AT devices and services through
statewide AT programs for individuals
with disabilities. Data collected from
grantees will also provide information
for usage by Congress, the Department,
and the public. In addition, ACL will
use this data to inform program
management, monitoring, and technical
assistance efforts. States will be able to
use the data for internal management
and program improvement.
To review the proposed data
collection tools please visit the ACL
website at: https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
Respondent/data collection activity
Number of
respondents
Responses
per
respondent
Hours per
response
Annual burden
hours
State Plan for Assistive Technology ................................................................
56
1
73.0
4,088
Dated: February 19, 2021.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2021–03868 Filed 2–24–21; 8:45 am]
BILLING CODE 4154–01–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
SUMMARY:
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Jkt 253001
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.
Improved Live-Attenuated Vaccine for
Respiratory Syncytial Virus (RSV)
Bearing Codon-Pair Deoptimized NS1,
NS2, N, P, M and SH Genes and
Additional Point Mutations in the P
Gene
Description of Technology:
RSV is the most important viral agent
of severe respiratory disease in infants
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and young children worldwide and also
causes substantial morbidity and
mortality in older adults. RSV is
estimated to cause more than 33 million
lower respiratory tract illnesses, three
million hospitalizations, and nearly
200,000 childhood deaths worldwide
annually, with many deaths occurring
in developing countries. However,
despite the prevalence of RSV and the
dangers associated with infection, no
RSV vaccine has been successfully
developed to date. Accordingly, there is
a public health need for RSV vaccines.
This vaccine candidate comprises live
RSV that was attenuated by subjecting
the protein-coding sequences of the
viral NS1, NS2, N, P, M, and SH genes
to codon-pair deoptimization, which
resulted in many nucleotide
substitutions that were silent at the
amino acid level but conferred
attenuation. In addition, specific amino
acid substitutions were identified and
introduced into the P protein that
improved attenuation and genetic
stability. Genetic stability was
confirmed in vitro, and attenuation was
confirmed in experimental animals.
E:\FR\FM\25FEN1.SGM
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Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
This live-attenuated RSV vaccine is
designed to be administered intranasally
by drops or spray to infants and young
children. Based on experience with
other live-attenuated RSV vaccine
candidates, the present candidates are
anticipated to be well tolerated in
humans and are available for clinical
evaluation. The National Institute of
Allergy and Infectious Diseases has
extensive experience and capability in
evaluating live-attenuated RSV vaccine
candidates in pediatric clinical studies,
and opportunity for collaboration exists.
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
B cell and T cell activation
Low-cost vaccines
Intranasal administration/needle-free
delivery
Development Stage:
• In vivo data assessment (animal)
Inventors: Cyril Le Nouen (NIAID),
Ursula Buchholz (NIAID), Peter Collins
(NIAID).
Intellectual Property: HHS Reference
No. E–104–2020–0—U.S. Provisional
Application No. 63/023,949, filed May
13, 2020.
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: February 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2021–03872 Filed 2–24–21; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
To Support the Safe to Sleep®
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Lorena Kaplan,
M.P.H., CHES, Office of
Communications, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A32, Bethesda, Maryland
20892, or call non-toll free number (301)
496–6670 or Email your request,
including your address to
lorena.kaplan@nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on December 11, 2020, page
80123–80124 (85 FR 80123–80124) and
allowed 60 days for public comment. No
public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The Eunice Kennedy Shriver National
Institute for Child Health and Human
Development, National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
ADDRESSES:
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11547
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Generic
Clearance to Support the Safe to Sleep®
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD), 0925–0701, exp., date 02/28/
2021, REVISION, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a
revision to a generic clearance used for
submissions specific to the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD) Safe to Sleep® (STS) public
education campaign. Submissions for
the STS campaign will be used to assess
the understanding and reach of STS
campaign materials and messages, and
to monitor and improve campaign
activities such as training workshops
and overall implementation. The
purpose of this information collection is
to monitor and modify campaign
activities, to plan future campaign
activities, to develop messages and
materials, and to develop distribution
and outreach strategies that are effective
at communicating their message to bring
about the intended response, awareness,
and/or behavioral change for the target
audiences. This generic clearance will
enable the NICHD to: (1) More
efficiently assess the implementation of
campaign activities; (2) better
understand the target audiences’
knowledge, attitudes, and beliefs toward
STS messages and materials; (3) better
understand how the campaign activities
have influenced the target audiences’
behaviors and practices; and (4) monitor
and improve activities such as trainings,
materials, and messages. Having a way
to gather feedback on the STS campaign
activities is critical to assessing the
reach and effect of campaign efforts.
Data collected for the campaign can
inform where future STS campaign
resources can produce the most
meaningful results. Data collected for
the STS campaign generic clearance will
be used by a number of audiences,
including STS campaign staff, NICHD
leadership, STS campaign collaborators,
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]]>Agencies
[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11546-11547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03872]
-----------------------------------------------------------------------
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., 301-594-8730;
[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 Disclosure Agreement will be required to receive copies of
unpublished patent applications.
SUPPLEMENTARY INFORMATION: Technology description follows.
Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus (RSV)
Bearing Codon-Pair Deoptimized NS1, NS2, N, P, M and SH Genes and
Additional Point Mutations in the P Gene
Description of Technology:
RSV is the most important viral agent of severe respiratory disease
in infants and young children worldwide and also causes substantial
morbidity and mortality in older adults. RSV is estimated to cause more
than 33 million lower respiratory tract illnesses, three million
hospitalizations, and nearly 200,000 childhood deaths worldwide
annually, with many deaths occurring in developing countries. However,
despite the prevalence of RSV and the dangers associated with
infection, no RSV vaccine has been successfully developed to date.
Accordingly, there is a public health need for RSV vaccines.
This vaccine candidate comprises live RSV that was attenuated by
subjecting the protein-coding sequences of the viral NS1, NS2, N, P, M,
and SH genes to codon-pair deoptimization, which resulted in many
nucleotide substitutions that were silent at the amino acid level but
conferred attenuation. In addition, specific amino acid substitutions
were identified and introduced into the P protein that improved
attenuation and genetic stability. Genetic stability was confirmed in
vitro, and attenuation was confirmed in experimental animals.
[[Page 11547]]
This live-attenuated RSV vaccine is designed to be administered
intranasally by drops or spray to infants and young children. Based on
experience with other live-attenuated RSV vaccine candidates, the
present candidates are anticipated to be well tolerated in humans and
are available for clinical evaluation. The National Institute of
Allergy and Infectious Diseases has extensive experience and capability
in evaluating live-attenuated RSV vaccine candidates in pediatric
clinical studies, and opportunity for collaboration exists.
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
B cell and T cell activation
Low-cost vaccines
Intranasal administration/needle-free delivery
Development Stage:
In vivo data assessment (animal)
Inventors: Cyril Le Nouen (NIAID), Ursula Buchholz (NIAID), Peter
Collins (NIAID).
Intellectual Property: HHS Reference No. E-104-2020-0--U.S.
Provisional Application No. 63/023,949, filed May 13, 2020.
Licensing Contact: Peter Soukas, J.D., 301-594-8730;
[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., 301-594-8730; [email protected].
Dated: February 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-03872 Filed 2-24-21; 8:45 am]
BILLING CODE 4140-01-P
