Prospective Grant of an Exclusive Patent License: N-butyldeoxynojirimycin To Treat Smith-Lemli Opitz Syndrome (SLOS) and Diseases That Exhibit a Similar NPC-Like Cellular Phenotype, 18545-18546 [2021-07316]
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18545
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
OMB No. 0990–NEW—Office of
Population Affairs—OASH–OS
Abstract
The Office of Population Affairs
(OPA), U.S. Department of Health and
Human Services (HHS) is requesting 3
years of approval by OMB on a new
collection. The Components Study of
REAL Essential Curriculum will identify
the components that matter the most for
promoting positive health behaviors and
outcomes among adolescents. The study
will examine program components (for
example, content and dosage),
implementation components (for
example, attendance and engagement),
and contextual components (for
example, participant characteristics) to
determine which components influence
participant outcomes the most. In
addition, the study will measure youth
engagement in programming from
various perspectives and examine the
role of engagement as a mediating factor
to achieving youth outcomes. Sites
participating in the study will use the
REAL Essentials Advance (REA)
relationship curriculum, a popular
program among federal pregnancy
prevention grantees. The study will
enroll schools from spring to fall 2022
(and possibly spring 2023, if necessary).
The study will collect youth outcomes
surveys at baseline, at program exit and
6 months following the completion of
the program. The study will also collect
extensive implementation data, which
includes youth engagement exit ticket
surveys after REA sessions, focus groups
with youth and program facilitator logs
and attendance records. Study staff will
also interview facilitators and site
leadership.
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Respondents
(if necessary)
Youth Outcome Survey Baseline ......
Youth Outcome Survey—Program
Exit.
Youth Outcome Survey—Six Month
Follow-up.
Youth Focus Group Topic Guide ......
Youth Engagement Exit ticket ..........
Fidelity Log ........................................
Facilitator Interview Topic Guide ......
District/CBO Leadership Interview
Topic Guide.
Youth ................................................
Youth ................................................
507
507
1
1
40/60
40/60
338
338
Youth ................................................
480
1
40/60
320
Youth ................................................
Youth ................................................
Program Facilitators .........................
Facilitators ........................................
District/School/CBO leadership ........
133
533
13
5
11
1
12
24
2
2
90/60
2/60
10/60
1
45/60
200
213
52
10
17
Total ...........................................
...........................................................
........................
44
........................
1488
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–07285 Filed 4–8–21; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Nbutyldeoxynojirimycin To Treat SmithLemli Opitz Syndrome (SLOS) and
Diseases That Exhibit a Similar NPCLike Cellular Phenotype
AGENCY:
National Institutes of Health,
DHHS.
ACTION:
Notice.
17:45 Apr 08, 2021
this notice to SubRed Pty Ltd located in
Australia, registered in Victoria.
DATES: Only written comments and/or
applications for a license which are
received by the National Institute of
Child Health and Human Development
c/o National Cancer Institute’s
Technology Transfer Center on or before
April 26, 2021 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Alan Hubbs, Ph.D., Senior
Technology Transfer Manager at
Telephone (240)–276–5530 or at Email:
hubbsa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
Intellectually Property
The National Institute of
Child Health and Human Development,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and foreign Patents and Patent
Applications listed in the
Supplementary Information section of
SUMMARY:
VerDate Sep<11>2014
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
Jkt 253001
1. Great Britain Patent Application
No. 712494.4, filed on June 27, 2007
[HHS Reference No. E–206–2007–0–GB–
01];
2. PCT Patent Application No. PCT/
GB2008/002207, filed June 26, 2008
[HHS Reference No. E–206–2007–0–
PCT–02];
3. Issued Australian Patent No.
2008269585, filed on June 26, 2008,
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Total burden
hours
Issued July 2, 2015 [HHS Reference No.
E–206–2007–0–AU–03];
4. Issued Canadian Patent No.
2691937, filed on June 26, 2008, Issued
January 23, 2018 [HHS Reference No. E–
206–2007–0–CA–04];
5. Issued European Patent No.
2182936, filed on June 26, 2008, Issued
April 1, 2020 [HHS Reference No. E–
206–2007–0–EP–05];
6. Issued US Patent No. 8,557,844,
filed January 19, 2010, Issued October
15, 2013 [HHS Reference No. E–206–
2007/0–US–06];
7. Issued United States Patent No.
9,428,541, filed on September 13, 2013,
Issued August 30, 2016 [HHS Reference
No. E–206–2007–0–US–09]
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America. The prospective exclusive
license territory may be world-wide,
and the field of use may be limited to
the use of Licensed Patent Rights for the
following: ‘‘The use of Nbutyldeoxynojirimycin in humans to
treat Smith-Lemli Opitz Syndrome
(SLOS) and diseases that exhibit a
similar NPC-like cellular phenotype.’’
E:\FR\FM\09APN1.SGM
09APN1
18546
Federal Register / Vol. 86, No. 67 / Friday, April 9, 2021 / Notices
This technology discloses
pharmaceutical compositions and
methods of use to treat SLOS and
diseases having a secondary NPC like
cellular phenotype or wherein the
disease is an inborn error in cholesterol
synthesis.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Institute of Child Health and Human
Development receives written evidence
and argument that establishes that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: March 22, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
and personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering, NACBIB, May 2021.
Date: May 19, 2021.
Open: 12:00 p.m. to 2:50 p.m.
Agenda: Report from the Institute Director,
Council members and other Institute Staff.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Closed: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: David T. George, Ph.D.,
Associate Director, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 920,
Bethesda, MD 20892, georged@mail.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: https://
www.nibib.nih.gov/about-nibib/advisorycouncil, where an agenda and any additional
information for the meeting will be posted
when available.
Dated: April 6, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–07316 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2021–07341 Filed 4–8–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Biomedical Imaging and
Bioengineering.
The meeting will be open to the
public by videocast as indicated below.
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,
VerDate Sep<11>2014
17:45 Apr 08, 2021
Jkt 253001
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.
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Elizabeth Pitts, Ph.D., 240–669–5299;
elizabeth.pitts@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
information related to the invention.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Polyvalent Influenza Virus-Like
Particles (VLPs) and Use as Vaccines
Description of Technology
Influenza virus is a major public
health concern, causing up to 500,000
deaths annually. The current strategy of
reformulating vaccines annually against
dominant circulating strains leads to
variable protective efficacy and is
unlikely to protect against novel
influenza viruses with pandemic
potential. Thus, there is a great need for
a vaccine that provides ‘‘universal’’
protection against influenza viruses.
This technology relates to a broadly
protective, universal influenza vaccine
candidate composed of a mixture of
virus-like particles (VLPs) expressing
the hemagglutinin protein or the
neuraminidase protein from influenza
virus strains belonging to different virus
subtypes. Vaccinating animals with a
mixture of VLPs expressing four or more
hemagglutinin subtypes provides broad
and heterosubtypic protection against
lethal challenge with influenza virus
strains in both mice and ferrets. This
vaccine technology has great potential
to provide protection against both
annual epidemic and pandemicpotential influenza viruses.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications
• Vaccines against influenza virus
• Universal influenza virus vaccine
Competitive Advantages
• Broad/universal protection against
both seasonal and pandemic-potential
influenza viruses
• Does not require yearly reformulation
as is necessary with current
commercially available influenza
vaccines
Development Stage
• In vivo data assessment (animal)
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18545-18546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07316]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: N-
butyldeoxynojirimycin To Treat Smith-Lemli Opitz Syndrome (SLOS) and
Diseases That Exhibit a Similar NPC-Like Cellular Phenotype
AGENCY: National Institutes of Health, DHHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Child Health and Human Development,
an institute of the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an Exclusive Patent
License to practice the inventions embodied in the U.S. and foreign
Patents and Patent Applications listed in the Supplementary Information
section of this notice to SubRed Pty Ltd located in Australia,
registered in Victoria.
DATES: Only written comments and/or applications for a license which
are received by the National Institute of Child Health and Human
Development c/o National Cancer Institute's Technology Transfer Center
on or before April 26, 2021 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Alan Hubbs, Ph.D., Senior Technology Transfer
Manager at Telephone (240)-276-5530 or at Email: [email protected].
SUPPLEMENTARY INFORMATION: The following represents the intellectual
property to be licensed under the prospective agreement:
Intellectually Property
1. Great Britain Patent Application No. 712494.4, filed on June 27,
2007 [HHS Reference No. E-206-2007-0-GB-01];
2. PCT Patent Application No. PCT/GB2008/002207, filed June 26,
2008 [HHS Reference No. E-206-2007-0-PCT-02];
3. Issued Australian Patent No. 2008269585, filed on June 26, 2008,
Issued July 2, 2015 [HHS Reference No. E-206-2007-0-AU-03];
4. Issued Canadian Patent No. 2691937, filed on June 26, 2008,
Issued January 23, 2018 [HHS Reference No. E-206-2007-0-CA-04];
5. Issued European Patent No. 2182936, filed on June 26, 2008,
Issued April 1, 2020 [HHS Reference No. E-206-2007-0-EP-05];
6. Issued US Patent No. 8,557,844, filed January 19, 2010, Issued
October 15, 2013 [HHS Reference No. E-206-2007/0-US-06];
7. Issued United States Patent No. 9,428,541, filed on September
13, 2013, Issued August 30, 2016 [HHS Reference No. E-206-2007-0-US-09]
With respect to persons who have an obligation to assign their
right, title and interest to the Government of the United States of
America, the patent rights in these inventions have been assigned to
the Government of the United States of America. The prospective
exclusive license territory may be world-wide, and the field of use may
be limited to the use of Licensed Patent Rights for the following:
``The use of N-butyldeoxynojirimycin in humans to treat Smith-Lemli
Opitz Syndrome (SLOS) and diseases that exhibit a similar NPC-like
cellular phenotype.''
[[Page 18546]]
This technology discloses pharmaceutical compositions and methods
of use to treat SLOS and diseases having a secondary NPC like cellular
phenotype or wherein the disease is an inborn error in cholesterol
synthesis.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published notice, the National
Institute of Child Health and Human Development receives written
evidence and argument that establishes that the grant of the license
would not be consistent with the requirements of 35 U.S.C. 209 and 37
CFR part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information in these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: March 22, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2021-07316 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P
