Prospective Grant of Exclusive License; The Development of Ulipristal Acetate for the Treatment of Symptomatic Uterine Fibroids, 36556-36557 [2011-15486]
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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Statistical
Genetics.
Date: July 28, 2011.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Michael K Schmidt, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2214,
MSC 7890, Bethesda, MD 20892, (301) 435–
1147, mschmidt@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Endocrinology and Metabolism.
Date: July 28, 2011.
Time: 10:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6705
Rockledge Drive, Bethesda, MD 20817,
(Virtual Meeting).
Contact Person: Krish Krishnan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, (301) 435–
1041, krishnak@csr.nih.gov.
(Catalog 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)
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Institutional Postdoctoral Training
Programs.
Date: July 15, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott Chevy Chase,
5520 Wisconsin Avenue, Chevy Chase, MD
20815.
Contact Person: Brian R. Pike, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892, 301–594–3907, pikbr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Contact Person: Guo Zhang, PhD, MD,
Scientific Review Administrator, National
Center for Research Resources, or National
Institutes of Health, 6701 Democracy
Boulevard, 1 Democracy Plaza, Room 1064,
MSC 4874, Bethesda, MD 20892–4874, 301–
435–0812, zhanggu@mail.nih.gov.
Name of Committee: National Center for
Research Resources Special Emphasis Panel;
Research Centers in Minority Institutions
(RCMI).
Date: August 2, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Blvd., Bethesda, MD 20817.
Contact Person: Steven Birken, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources, 1
Democracy Plaza, Room 1078, 6701
Democracy Blvd., Bethesda, MD 20892, 301–
435–0815, birkens@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333; 93.702, ARRA Related
Construction Awards, National Institutes of
Health, HHS)
Dated: June 16, 2011.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: June 16, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2011–15635 Filed 6–21–11; 8:45 am]
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[FR Doc. 2011–15634 Filed 6–21–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 15, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
National Institutes of Health
National Center for Research
Resources; Notice of Closed Meetings
[FR Doc. 2011–15489 Filed 6–21–11; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Prospective Grant of Exclusive
License; The Development of Ulipristal
Acetate for the Treatment of
Symptomatic Uterine Fibroids
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
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,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
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Name of Committee: National Center for
Research Resources Special Emphasis Panel.
Date: July 27–28, 2011.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health/NCRR/
OR, Democracy 1, 6701 Democracy Blvd.,
1064, Bethesda, MD 20892 (Virtual Meeting).
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National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant to PregLem SA
of an exclusive patent license to practice
the inventions embodied in US Patent
Application 12/021,610 entitled,
‘‘Method for Treating Uterine Fibroids’’
[HHS Ref. E–057–2008/0–US–01], and
all continuing applications and foreign
counterparts. The patent rights in this
invention have been assigned to the
Government of the United States of
America and to Laboratoire HRA
Pharma. The exclusive license
contemplated in this notice is solely to
the patent rights assigned to the
SUMMARY:
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Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Notices
Government of the United States of
America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to:
The use of ulipristal acetate for the
treatment of symptomatic uterine
fibroids.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
22, 2011 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Patrick P. McCue, PhD,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5560; Facsimile: (301) 402–0220; E-mail:
mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns methods for the
treatment of symptomatic uterine
fibroids using a selective progesterone
receptor modulator compound,
ulipristal acetate (a.k.a. CDB–2914).
Ulipristal acetate reversibly binds the
progesterone receptor with high affinity
and little or no anti-glucocorticoid
activity. Proposed clinical indications
for ulipristal acetate include emergency/
daily contraception, treatment of uterine
fibroids, endometriosis, dysfunctional
uterine bleeding, and cancer.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless the NIH 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 404.7
within thirty (30) days from the date of
this published notice.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: June 15, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–15486 Filed 6–21–11; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License; Devices for Clearing Mucus
From Endotracheal Tubes
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
contemplating the grant of a worldwide
exclusive license, to practice the
invention embodied in: HHS Ref. No.
E–074–2005/0 ‘‘Mucus Slurping
Endotracheal Tube’’; U.S. Patent
7,503,328 to Oculus Innovative
Sciences, Inc., a company incorporated
under the laws of the State of California
having its headquarters in Petaluma,
California. The United States of America
is the assignee of the rights of the above
inventions. The contemplated exclusive
license may be granted in a field of use
limited to devices for clearing mucus
from endotracheal tubes.
DATES: Only written comments and/or
applications for a license received by
the NIH Office of Technology Transfer
on or before July 22, 2011 will be
considered.
SUMMARY:
Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael A. Shmilovich, Esq., Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5019; Facsimile: (301) 402–0220; E-mail:
shmilovm@mail.nih.gov. A signed
confidentiality nondisclosure agreement
will be required to receive copies of any
patent applications that have not been
published or issued by the United States
Patent and Trademark Office or the
World Intellectual Property
Organization.
ADDRESSES:
The patent
intended for licensure covers a mucus
slurping device used to remove mucus
before it reaches the tip of the
endotracheal tube (ETT). A continuous
aspiration endotracheal tube for
subglottic secretions is fitted at its
distal-most tip with a molded, hollow,
concentric plastic ring with 3–4 (or
more) small (less than l mm in diameter)
suction ports, the latter positioned in
the most dependent part of the ETT. A
SUPPLEMENTARY INFORMATION:
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36557
suction line is extended to the tip of the
ETT and suction was activated for
approximately half of a second,
synchronized to the early part of
expiration; and repeated once a minute,
or as desired. Studies involving
intubated sheep showed that all mucus
was cleared from test animal and that
mucus samples collected showed no
infections that typically put patients at
risk for ventilator associated
pneumonia.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within thirty (30) days from the date of
this published notice, NIH 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 404.7.
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: June 14, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–15480 Filed 6–21–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Prevention; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of the meeting of
the Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention
(CSAP) Drug Testing Advisory Board
(DTAB) on July 12 and 13, 2011. The
DTAB will convene in both open and
closed sessions over these two days.
On July 13 from 10 a.m. to 12:30 p.m.
E.D.T., the meeting will be open to the
public to review public responses to
SAMHSA’s Request for Information on
oral fluid as a potential alternative
specimen under the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs. In addition, the
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[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Pages 36556-36557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15486]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License; The Development of
Ulipristal Acetate for the Treatment of Symptomatic Uterine Fibroids
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37
CFR part 404.7(a)(1)(i), that the National Institutes of Health,
Department of Health and Human Services, is contemplating the grant to
PregLem SA of an exclusive patent license to practice the inventions
embodied in US Patent Application 12/021,610 entitled, ``Method for
Treating Uterine Fibroids'' [HHS Ref. E-057-2008/0-US-01], and all
continuing applications and foreign counterparts. The patent rights in
this invention have been assigned to the Government of the United
States of America and to Laboratoire HRA Pharma. The exclusive license
contemplated in this notice is solely to the patent rights assigned to
the
[[Page 36557]]
Government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to:
The use of ulipristal acetate for the treatment of symptomatic
uterine fibroids.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before July
22, 2011 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated exclusive
license should be directed to: Patrick P. McCue, PhD, Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5560; Facsimile: (301) 402-0220; E-mail:
mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns methods for the
treatment of symptomatic uterine fibroids using a selective
progesterone receptor modulator compound, ulipristal acetate (a.k.a.
CDB-2914). Ulipristal acetate reversibly binds the progesterone
receptor with high affinity and little or no anti-glucocorticoid
activity. Proposed clinical indications for ulipristal acetate include
emergency/daily contraception, treatment of uterine fibroids,
endometriosis, dysfunctional uterine bleeding, and cancer.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part
404.7. The prospective exclusive license may be granted unless the NIH
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 404.7 within thirty (30) days from the date
of this published notice.
Applications for a license in the field of use filed in response to
this notice will be treated as objections to the grant of the
contemplated exclusive license. Comments and objections submitted to
this notice will not be made available for public inspection and, to
the extent permitted by law, will not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: June 15, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-15486 Filed 6-21-11; 8:45 am]
BILLING CODE 4140-01-P
