Government-Owned Inventions; Availability for Licensing, 46606-46607 [E9-21787]
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46606
Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices
Dated: September 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–21786 Filed 9–9–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Applications
• Bacterial detection and diagnostics,
including clinical or environment
samples.
• Food safety and biodefense.
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
Advantages
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
erowe on DSK5CLS3C1PROD with NOTICES
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 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.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Rapid Diagnostic Applications of Phage
Description of Technology: The NIH
has available for licensing two
techniques for rapid detection of a
particular bacteria strain. Similar
detection using currently available
technologies take 1–2 days; this
technology reduces the time to less than
one hour. These technologies utilize
phage, which has no pathogenic effect
on higher plants and animals and are
part of approved food-preparation
formulations, indicating their known
safety profile and an existing regulatory
pathway. The first technique involves a
phage that incorporates a reporter gene
(e.g., luciferase) that will be expressed
only when the phage successfully
infects a bacterium. This technique is
particularly useful where only bacteriakilling (‘‘lytic’’) phages are known
because the method also deactivates the
lytic genes, enabling infection and
subsequent detection. The second
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15:13 Sep 09, 2009
Jkt 217001
technique involves an engineered phage
that will bind with quantum dots upon
infection of bacteria; if a sample is
treated first with this phage and then
with quantum dots, the sample will
only respond if the bacteria are present.
Both techniques can be used to diagnose
a clinical sample (tissue, blood, etc.) or
an environmental isolate.
• Detection methods are novel, rapid,
and potentially applicable in many
contexts (e.g., clinic, food preparation,
bioterror response).
• Phage is easy and inexpensive to
cultivate.
• Phage is on sale in the US for foodpreparation formulations and thus has a
known regulatory pathway.
Development Status: A range of
phages have been synthesized, many of
which have been tested proof-ofprinciple using major standardized
testing systems.
Inventors: Dr. Carl Merrill (NIMH), Dr.
Sankar Adhya (NCI), et al.
commercialize this technology. Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Therapeutic Antibacterial Applications
of Phage
Description of Technology: The NIH,
in collaboration with others, has
developed three groups of inventions
related to the use of bacteriophages in
therapeutic situations. The first group is
a method of adapting phages to survive
in the body substantially longer than
wild-type phages, using serial passaging
and/or genetic engineering. The second
group involves phages designed to bind
the toxins and cytokines that killed
bacteria release into the bloodstream,
reducing the pathogenic properties of
the bacteria. The third group is a
method of engineering a phage to have
multiple binding sites, such that a single
phage can target multiple types of
bacteria.
Application: Therapeutic applications
of phage to treat bacterial infection.
Advantages
1. R Edgar et al. High-sensitivity
bacterial detection using biotin-tagged
phage and quantum-dot nanocomplexes.
Proc Natl Acad Sci. USA 2006 Mar
28;103(13):4841–4845.
2. C Merril et al. The prospect for
bacteriophage therapy in Western
medicine. Nat Rev Drug Discov. 2003
Jun;2(6):489–497.
• Improved efficacy through longer
circulation.
• Additional antibacterial functions.
• Can be used independently or as an
adjuvant to another antibacterial
therapy.
Development Status: A range of
phages have been synthesized and
tested in vivo. A Phase 1 study of a
phage targeting vancomycin-resistant
Enterococcus faecium was completed by
Exponential Biotherapies, Inc., with no
adverse effects reported.
Inventors: Dr. Carl Merrill (NIMH), Dr.
Sankar Adhya (NCI), et al.
Patent Status
Publications
HHS Reference No. E–169–2004—U.S.
Patent Application No. 11/547,587 filed
05 Oct 2006.
HHS Reference No. E–281–2005—U.S.
Patent Application No. 11/884,604 filed
17 Aug 2007.
HHS Reference No. E–318–2000—
Research Materials (patent protection is
not being pursued for this technology):
‘‘Method for Determining Sensitivity to
a Bacteriophage.’’
Licensing Status: Technologies are
available for licensing, either
individually or as a package.
Licensing Contact: Bruce Goldstein,
J.D., M.S.; 301–435–5470;
goldsteb@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Laboratory of Molecular
Biology is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
1. C Merril et al. The prospect for
bacteriophage therapy in Western
medicine. Nat Rev Drug Discov. 2003
Jun;2(6):489–497.
2. B Biswas et al. Bacteriophage
therapy rescues mice bacteremic from a
clinical isolate of vancomycin-resistant
Enterococcus faecium. Infect Immun.
2002 Jan;70(1):204–210.
3. C Merrill et al. Long-circulating
bacteriophage as antibacterial agents.
Proc Natl Acad Sci. USA 1996 Apr
16;93(8):3188–3192.
Publications
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Patent Status
HHS Reference No. E–110–1993—U.S.
Patent No. 5,688,601 issued 19 Jun
1997; U.S. Patent No. 7,332,307 issued
19 Feb 2008.
HHS Reference No. E–257–2000—U.S.
Patent No. 7,163,818 issued 16 Jan 2007.
HHS Reference No. E–178–1996—
Research Materials (patent protection is
E:\FR\FM\10SEN1.SGM
10SEN1
Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices
not being pursued for this technology):
‘‘Deletion of Lysogeny Genes and Toxin
Genes from Bacteriophage Used in the
Epidemiologic Control of Bacterial
Illness.’’
HHS Reference No. E–179–1996—
Research Materials (patent protection is
not being pursued for this technology):
‘‘Therapeutics Use of Phage Expressing
Toxin-Binding and/or Cytokine-Binding
Proteins and Elimination of Genes
Associate with Lysogeny.’’
HHS Reference No. E–196–1997—
Research Materials (patent protection is
not being pursued for this technology):
‘‘Antibacterial Therapy with
Bacteriophage Genotypically Modified
to Delay Inactivation by the Host
Defense System.’’
HHS Reference Nos. E–089–1998 and
E–257–2003—Research Materials (patent
protection is not being pursued for this
technology): ‘‘Two Enterocin-Producing
Strains of Bacteria and Their Enterocins,
Both of Which Are Lethal to
Vancomycin-Resistant Enterococcus
faecium.’’
HHS Reference No. E–012–1999—
Research Materials (patent protection is
not being pursued for this technology):
‘‘Long Circulating Phage Vectors.’’
Licensing Status: Technologies are
available for licensing, either
individually or as a package.
Licensing Contact: Bruce Goldstein,
J.D., M.S.; 301–435–5470;
goldsteb@mail.nih.gov.
Collaborative Research Opportunity:
The NCI Laboratory of Molecular
Biology is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Dated: September 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–21787 Filed 9–9–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
erowe on DSK5CLS3C1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2009–N–0392]
Medical Devices: Neurological
Devices; Electroconvulsive Therapy
Device; Establishing a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
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15:13 Sep 09, 2009
Jkt 217001
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
opening of a public docket to receive
information and comments regarding
the current classification process related
to electroconvulsive therapy devices
(ECT). The current classification process
for this device pertains to the ‘‘Order for
Certain Class III Devices; Submission of
Safety and Effectiveness,’’ published in
the Federal Register of April 9, 2009 (74
FR 16214). Under the Order, FDA
required manufacturers of certain Class
III devices, including ECT, to submit a
summary of, and citation to, any
information known or otherwise
available to them respecting such
devices, including adverse safety or
effectiveness information which has not
been submitted under the Federal Food,
Drug, and Cosmetic Act (the act). For
each device subject to the Order, FDA
is reviewing the submitted information
to determine whether FDA should
maintain the device as class III and
require the submission of a premarket
approval application (PMA) or a notice
of completion of a product development
protocol (PDP), or whether FDA should
reclassify the device into class II or class
I. FDA is now inviting interested
persons to submit comments that relate
to the safety and effectiveness of ECT.
DATES: Submit written or electronic
comments and information by January
8, 2010.
ADDRESSES: Submit written comments
and information to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments and
information to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Victor Krauthamer, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., W066–1106, Silver Spring, MD
20993, 301–796–2474.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 9,
2009 (74 FR 16214), FDA published an
‘‘Order for Certain Class III Devices;
Submission of Safety and Effectiveness
Information’’ (‘‘515(i) Order’’). Under
this Order, as mandated by section
515(i) of the act (21 U.S.C. 360e(i)), FDA
required manufacturers of certain class
III devices that were in commercial
distribution before May 28, 1976, and
devices found to be substantially
equivalent to them that were marketed
on or after that date, including ECT, to
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Fmt 4703
Sfmt 4703
46607
submit to FDA by August 7, 2009, a
summary of, and citation to, any
information known, or otherwise
available to them respecting those
devices including, adverse safety or
effectiveness data that had not been
submitted under section 519 of the act
(21 U.S.C. 360i). In addition,
manufacturers were encouraged by FDA
to submit a summary of the information
previously sent to FDA under section
519 of the act. Currently, the agency is
in the process of reviewing the
information that has been submitted by
the manufacturers subject to the 515(i)
Order.
Based upon the review of this
submitted information, FDA is
considering whether to issue a proposed
rule requiring the device to remain in
class III, followed by the issuance of a
regulation requiring submission of a
PMA or PDP, or to revise the
classification of the devices into class II,
requiring the designation of special
controls, or into class I, requiring only
general controls. In determining
whether to revise the classification of a
device, or to require a device to remain
in class III, FDA will apply the criteria
set forth in section 513(a) of the act. If
FDA decides to reclassify the device,
FDA must determine that general
controls alone (class I) or general
controls plus special controls (class II)
would provide reasonable assurance of
the safety and effectiveness of the
device. FDA’s proposed classification of
ECT devices will be subject to notice
and comment rulemaking to allow for
additional public comment.
FDA has received a significant
number of inquiries from members of
the public and the health care
community in response to this order to
ECT manufacturers. In recognition of
this significant public interest, FDA is
opening this docket to permit
individuals other than manufacturers to
submit information related to the safety
and effectiveness of ECT. If individuals
wish to report an adverse event
associated with the use of an ECT
device, please use the MedWatch
Online Voluntary Reporting Form
available at https://
www.accessdata.fda.gov/scripts/
medwatch/medwatch-online.htm. FDA
will review information submitted
through the MedWatch program prior to
making any changes to the classification
of ECT devices.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 74, Number 174 (Thursday, September 10, 2009)]
[Notices]
[Pages 46606-46607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 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.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Rapid Diagnostic Applications of Phage
Description of Technology: The NIH has available for licensing two
techniques for rapid detection of a particular bacteria strain. Similar
detection using currently available technologies take 1-2 days; this
technology reduces the time to less than one hour. These technologies
utilize phage, which has no pathogenic effect on higher plants and
animals and are part of approved food-preparation formulations,
indicating their known safety profile and an existing regulatory
pathway. The first technique involves a phage that incorporates a
reporter gene (e.g., luciferase) that will be expressed only when the
phage successfully infects a bacterium. This technique is particularly
useful where only bacteria-killing (``lytic'') phages are known because
the method also deactivates the lytic genes, enabling infection and
subsequent detection. The second technique involves an engineered phage
that will bind with quantum dots upon infection of bacteria; if a
sample is treated first with this phage and then with quantum dots, the
sample will only respond if the bacteria are present. Both techniques
can be used to diagnose a clinical sample (tissue, blood, etc.) or an
environmental isolate.
Applications
Bacterial detection and diagnostics, including clinical or
environment samples.
Food safety and biodefense.
Advantages
Detection methods are novel, rapid, and potentially
applicable in many contexts (e.g., clinic, food preparation, bioterror
response).
Phage is easy and inexpensive to cultivate.
Phage is on sale in the US for food-preparation
formulations and thus has a known regulatory pathway.
Development Status: A range of phages have been synthesized, many
of which have been tested proof-of-principle using major standardized
testing systems.
Inventors: Dr. Carl Merrill (NIMH), Dr. Sankar Adhya (NCI), et al.
Publications
1. R Edgar et al. High-sensitivity bacterial detection using
biotin-tagged phage and quantum-dot nanocomplexes. Proc Natl Acad Sci.
USA 2006 Mar 28;103(13):4841-4845.
2. C Merril et al. The prospect for bacteriophage therapy in
Western medicine. Nat Rev Drug Discov. 2003 Jun;2(6):489-497.
Patent Status
HHS Reference No. E-169-2004--U.S. Patent Application No. 11/
547,587 filed 05 Oct 2006.
HHS Reference No. E-281-2005--U.S. Patent Application No. 11/
884,604 filed 17 Aug 2007.
HHS Reference No. E-318-2000--Research Materials (patent protection
is not being pursued for this technology): ``Method for Determining
Sensitivity to a Bacteriophage.''
Licensing Status: Technologies are available for licensing, either
individually or as a package.
Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470;
goldsteb@mail.nih.gov.
Collaborative Research Opportunity: The NCI Laboratory of Molecular
Biology is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize this technology. Please contact John D. Hewes, PhD at
301-435-3121 or hewesj@mail.nih.gov for more information.
Therapeutic Antibacterial Applications of Phage
Description of Technology: The NIH, in collaboration with others,
has developed three groups of inventions related to the use of
bacteriophages in therapeutic situations. The first group is a method
of adapting phages to survive in the body substantially longer than
wild-type phages, using serial passaging and/or genetic engineering.
The second group involves phages designed to bind the toxins and
cytokines that killed bacteria release into the bloodstream, reducing
the pathogenic properties of the bacteria. The third group is a method
of engineering a phage to have multiple binding sites, such that a
single phage can target multiple types of bacteria.
Application: Therapeutic applications of phage to treat bacterial
infection.
Advantages
Improved efficacy through longer circulation.
Additional antibacterial functions.
Can be used independently or as an adjuvant to another
antibacterial therapy.
Development Status: A range of phages have been synthesized and
tested in vivo. A Phase 1 study of a phage targeting vancomycin-
resistant Enterococcus faecium was completed by Exponential
Biotherapies, Inc., with no adverse effects reported.
Inventors: Dr. Carl Merrill (NIMH), Dr. Sankar Adhya (NCI), et al.
Publications
1. C Merril et al. The prospect for bacteriophage therapy in
Western medicine. Nat Rev Drug Discov. 2003 Jun;2(6):489-497.
2. B Biswas et al. Bacteriophage therapy rescues mice bacteremic
from a clinical isolate of vancomycin-resistant Enterococcus faecium.
Infect Immun. 2002 Jan;70(1):204-210.
3. C Merrill et al. Long-circulating bacteriophage as antibacterial
agents. Proc Natl Acad Sci. USA 1996 Apr 16;93(8):3188-3192.
Patent Status
HHS Reference No. E-110-1993--U.S. Patent No. 5,688,601 issued 19
Jun 1997; U.S. Patent No. 7,332,307 issued 19 Feb 2008.
HHS Reference No. E-257-2000--U.S. Patent No. 7,163,818 issued 16
Jan 2007.
HHS Reference No. E-178-1996--Research Materials (patent protection
is
[[Page 46607]]
not being pursued for this technology): ``Deletion of Lysogeny Genes
and Toxin Genes from Bacteriophage Used in the Epidemiologic Control of
Bacterial Illness.''
HHS Reference No. E-179-1996--Research Materials (patent protection
is not being pursued for this technology): ``Therapeutics Use of Phage
Expressing Toxin-Binding and/or Cytokine-Binding Proteins and
Elimination of Genes Associate with Lysogeny.''
HHS Reference No. E-196-1997--Research Materials (patent protection
is not being pursued for this technology): ``Antibacterial Therapy with
Bacteriophage Genotypically Modified to Delay Inactivation by the Host
Defense System.''
HHS Reference Nos. E-089-1998 and E-257-2003--Research Materials
(patent protection is not being pursued for this technology): ``Two
Enterocin-Producing Strains of Bacteria and Their Enterocins, Both of
Which Are Lethal to Vancomycin-Resistant Enterococcus faecium.''
HHS Reference No. E-012-1999--Research Materials (patent protection
is not being pursued for this technology): ``Long Circulating Phage
Vectors.''
Licensing Status: Technologies are available for licensing, either
individually or as a package.
Licensing Contact: Bruce Goldstein, J.D., M.S.; 301-435-5470;
goldsteb@mail.nih.gov.
Collaborative Research Opportunity: The NCI Laboratory of Molecular
Biology is seeking statements of capability or interest from parties
interested in collaborative research to further develop, evaluate, or
commercialize this technology. Please contact John D. Hewes, PhD at
301-435-3121 or hewesj@mail.nih.gov for more information.
Dated: September 1, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-21787 Filed 9-9-09; 8:45 am]
BILLING CODE 4140-01-P
