Government-Owned Inventions; Availability for Licensing, 27068-27069 [2017-12147]
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Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
entities to meet requirements that are at
least as stringent as the Medicare
conditions. Our regulations concerning
the approval of AOs are set forth at
§ 488.5.
nlaroche on DSK30NT082PROD with NOTICES
II. CMS Approval of Accreditation
Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of an AO’s requirements
consider, among other factors, the
applying AO’s requirements for
accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this notice of
proposed recognition is to inform the
public of the American Osteopathic
Association/Healthcare Facilities
Accreditation Program’s (AOA–HFAP’s)
request for continued CMS approval of
its ASC accreditation program. This
notice also solicits public comment on
whether AOA–HFAP’s requirements
meet or exceed the Medicare conditions
for coverage (CfCs) for ASCs.
III. Evaluation of an AO’s Accreditation
Program
AOA–HFAP submitted all the
necessary materials to enable us to make
a determination concerning its request
for continued CMS approval of its ASC
accreditation program. This application
was determined to be complete on April
14, 2017. Under section 1865(a)(2) of the
Act and our regulations at § 488.5, our
review and evaluation of AOA–HFAP
will be conducted in accordance with,
but not necessarily limited to, the
following factors:
• The equivalency of AOA–HFAP’s
standards for ASCs as compared with
Medicare’s CfCs for ASCs.
• AOA–HFAP’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
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++ The comparability of AOA–
HFAP’s processes to those of State
agencies, including survey frequency,
and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ AOA–HFAP’s processes and
procedures for monitoring an ASC
found out of compliance with AOA–
HFAP’s program requirements. These
monitoring procedures are used only
when AOA–HFAP identifies
noncompliance. If noncompliance is
identified through validation reviews or
complaint surveys, the State survey
agency monitors corrections as specified
at § 488.9(c)(1).
++ AOA–HFAP’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ AOA–HFAP’s capacity to provide
CMS with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of AOA–HFAP’s
staff and other resources, and its
financial viability.
++ AOA–HFAP’s capacity to
adequately fund required surveys.
++ AOA–HFAP’s policies with
respect to whether surveys are
announced or unannounced, to assure
that surveys are unannounced.
++ AOA–HFAP’s agreement to
provide CMS with a copy of the most
current accreditation survey, together
with any other information related to
the survey as CMS may require
(including corrective action plans).
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
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with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: June 7, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–12193 Filed 6–12–17; 8:45 am]
BILLING CODE 4120–01–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
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT: Dr.
Natalie Greco, 301–761–7898;
Natalie.Greco@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.
SUMMARY:
Human and Veterinary Cancer
Therapeutic Agent Utilizing Anthrax
Toxin-Based Technology
Description of Technology
Due to the disorganized nature of
blood vessels that run through tumors,
chemotherapeutic agents often fail to
penetrate tumors and kill cancer cells at
the tumor’s center. This can lead to
ineffective chemotherapeutic
treatments, because tumors can quickly
grow back if the entire tumor is not
destroyed. NIH researchers have
developed a therapeutic agent that
solves this problem facing current
chemotherapy treatments. By elegantly
E:\FR\FM\13JNN1.SGM
13JNN1
Federal Register / Vol. 82, No. 112 / Tuesday, June 13, 2017 / Notices
exploiting cell surface proteases present
at high levels in tumors, they have
developed a tumor-targeted anthrax
based toxin that inactivates the blood
vessels within tumors. While in some
cases cancer cells are also killed by the
tumor-targeted toxin, the primary
mechanism of action is thought to be a
decrease in blood flow to the center of
tumors, causing cancer cell death and
tumor necrosis. Preliminary and ongoing studies have demonstrated that
the targeted toxins have antitumor
effects on melanomas, lung cancers and
colon cancer in mouse models, and on
feline and canine oral tumors.
Interestingly, this therapy does not
target a specific type of cancer cell,
rather it targets the vasculature in and
around tumors. Therefore, it has great
potential to treat a wide range of solid
tumors. Additionally, because few nonsurgical treatments are available to treat
many human and veterinary solid
tumors, this technology would fill an
unmet need in cancer therapy.
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
Therapeutic agent for a wide range of
human and veterinary solid tumors,
including:
• Melanomas
• Lung and colon cancers
• Oral squamous carcinomas
Competitive Advantages
• Proven effective in a variety of
models, including models of important
veterinary cancers.
• Agent is only active in tumor microenvironments, resulting in low toxicity
to healthy tissue.
• Cancer cells are not directly
targeted, so this agent can be used to
treat a broad spectrum of solid tumors
and resistance is unlikely to arise.
• Fills an unmet need in cancer
therapy, because few non-surgical
treatments exist.
nlaroche on DSK30NT082PROD with NOTICES
Development Stage
• in vitro data available
• in vivo data available (animal)
• prototype
Inventors: S. Leppla (NIAID); S.-H.
Liu (NIAID); T. Bugge (NIDCR); A.Wein
(NIAID); D. Peters (NIDCR); J. Liu
(NHLBI); K.-H.Chen (NIAID); H.
Birkedal-Hansen (NIDCR); S. NetzelArnett (NIDCR); D. Phillips (NIAID); C.
Leysath (NIAID); C. Bachran (NIAID)
VerDate Sep<11>2014
14:58 Jun 12, 2017
Jkt 241001
Publications
Chen KH, et al., Selection of anthrax
toxin protective antigen variants
that discriminate between the
cellular receptors tem8 and cmg2
and achieve targeting of tumor cells.
J Biol Chem. 2007 Mar 30; 282(13):
9834–9845 [PMID: 17251181
PMCID: PMC2530824]
Liu S, et al., Solid tumor therapy by
selectively targeting stromal
endothelial cells. Proc Natl Acad
Sci U S A. 2016 Jul 12; 113(28):
E4079–E4087 [PMID: 27357689
PMCID: PMC4948345]
Wein AN, et al., An anthrax toxin
variant with an improved activity in
tumor targeting. Sci Rep. 2015; 5:
16267 [PMID: 26584669 PMCID:
PMC4653645]
Peters DE, et al., Comparative toxicity
and efficacy of engineered anthrax
lethal toxin variants with broad
anti-tumor activities. Toxicol Appl
Pharmacol. 2014 Sep 1; 279(2):
220–229 [PMID: 24971906 PMCID:
PMC4137396]
Bachran C, et al., Cytolethal distending
toxin B as a cell-killing component
of tumor-targeted anthrax toxin
fusion proteins. Cell Death Dis.
2014 Jan; 5(1): e1003 [PMID:
24434511 PMCID: PMC4040664]
Wein AN, et al., Tumor therapy with a
urokinase plasminogen activatoractivated anthrax lethal toxin alone
and in combination with paclitaxel.
Invest New Drugs. 2013 Feb; 31(1):
206–212 [PMID: 22843210 PMCID:
PMC3757568]
Phillips DD, et al., Engineering Anthrax
Toxin Variants That Exclusively
Form Octamers and Their
Application to Targeting Tumors. J
Biol Chem. 2013 Mar 29; 288(13):
9058–9065 [PMID: 23393143
PMCID: PMC3610978]
Liu S, et al., Intermolecular
complementation achieves high
specificity tumor targeting by
anthrax toxin. Nat Biotechnol. 2005
Jun; 23(6): 725–730 [PMID:
15895075 PMCID: PMC2405912]
Intellectual Property
HHS E–256–2015—US Application Nos.
62/210,771, filed 27 Aug 2015; 62/
323,218, filed 15 Apr 2016; PCT App.
No. PCT/US16/48706, filed 25 Aug
2016.
HHS E–120–2013—US App. No. 14/
898,248, filed 14 Dec 2015; PCT App.
No. PCT/US2014/043131, filed 19 Jun
2014.
HHS E–246–2012—US App. No. 14/
423,408, filed 23 Feb 2015; PCT App.
No. PCT/US13/56205
HHS E–059–2004—US Patent No.
7,947,289, filed 09 Feb 2005.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
27069
HHS E–293–1999—US Patent Nos.
7,468,352, filed 22 Mar 2002;
8,791,074, filed 20 Oct 2008, and
9,403,872 filed 24 Jun 2014.
Licensing Contact: Dr. Natalie Greco,
301–761–7898; Natalie.Greco@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 anthrax toxin-based
cancer therapeutics. For collaboration
opportunities, please contact Dr. Natalie
Greco, 301–761–7898; Natalie.Greco@
nih.gov.
Dated: June 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–12147 Filed 6–12–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Advisory
Committee to the Director, National
Institutes of Health, was renewed for an
additional two-year period on May 31,
2017.
It is determined that the Advisory
Committee to the Director, National
Institutes of Health, is in the public
interest in connection with the
performance of duties imposed on the
National Institutes of Health by law, and
that these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: June 7, 2017.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12143 Filed 6–12–17; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\13JNN1.SGM
13JNN1
Agencies
[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Pages 27068-27069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12147]
-----------------------------------------------------------------------
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: Dr. Natalie Greco, 301-761-7898;
Natalie.Greco@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.
Human and Veterinary Cancer Therapeutic Agent Utilizing Anthrax Toxin-
Based Technology
Description of Technology
Due to the disorganized nature of blood vessels that run through
tumors, chemotherapeutic agents often fail to penetrate tumors and kill
cancer cells at the tumor's center. This can lead to ineffective
chemotherapeutic treatments, because tumors can quickly grow back if
the entire tumor is not destroyed. NIH researchers have developed a
therapeutic agent that solves this problem facing current chemotherapy
treatments. By elegantly
[[Page 27069]]
exploiting cell surface proteases present at high levels in tumors,
they have developed a tumor-targeted anthrax based toxin that
inactivates the blood vessels within tumors. While in some cases cancer
cells are also killed by the tumor-targeted toxin, the primary
mechanism of action is thought to be a decrease in blood flow to the
center of tumors, causing cancer cell death and tumor necrosis.
Preliminary and on-going studies have demonstrated that the targeted
toxins have antitumor effects on melanomas, lung cancers and colon
cancer in mouse models, and on feline and canine oral tumors.
Interestingly, this therapy does not target a specific type of cancer
cell, rather it targets the vasculature in and around tumors.
Therefore, it has great potential to treat a wide range of solid
tumors. Additionally, because few non-surgical treatments are available
to treat many human and veterinary solid tumors, this technology would
fill an unmet need in cancer therapy.
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
Therapeutic agent for a wide range of human and veterinary solid
tumors, including:
Melanomas
Lung and colon cancers
Oral squamous carcinomas
Competitive Advantages
Proven effective in a variety of models, including models
of important veterinary cancers.
Agent is only active in tumor micro-environments,
resulting in low toxicity to healthy tissue.
Cancer cells are not directly targeted, so this agent can
be used to treat a broad spectrum of solid tumors and resistance is
unlikely to arise.
Fills an unmet need in cancer therapy, because few non-
surgical treatments exist.
Development Stage
in vitro data available
in vivo data available (animal)
prototype
Inventors: S. Leppla (NIAID); S.-H. Liu (NIAID); T. Bugge (NIDCR);
A.Wein (NIAID); D. Peters (NIDCR); J. Liu (NHLBI); K.-H.Chen (NIAID);
H. Birkedal-Hansen (NIDCR); S. Netzel-Arnett (NIDCR); D. Phillips
(NIAID); C. Leysath (NIAID); C. Bachran (NIAID)
Publications
Chen KH, et al., Selection of anthrax toxin protective antigen variants
that discriminate between the cellular receptors tem8 and cmg2 and
achieve targeting of tumor cells. J Biol Chem. 2007 Mar 30; 282(13):
9834-9845 [PMID: 17251181 PMCID: PMC2530824]
Liu S, et al., Solid tumor therapy by selectively targeting stromal
endothelial cells. Proc Natl Acad Sci U S A. 2016 Jul 12; 113(28):
E4079-E4087 [PMID: 27357689 PMCID: PMC4948345]
Wein AN, et al., An anthrax toxin variant with an improved activity in
tumor targeting. Sci Rep. 2015; 5: 16267 [PMID: 26584669 PMCID:
PMC4653645]
Peters DE, et al., Comparative toxicity and efficacy of engineered
anthrax lethal toxin variants with broad anti-tumor activities. Toxicol
Appl Pharmacol. 2014 Sep 1; 279(2): 220-229 [PMID: 24971906 PMCID:
PMC4137396]
Bachran C, et al., Cytolethal distending toxin B as a cell-killing
component of tumor-targeted anthrax toxin fusion proteins. Cell Death
Dis. 2014 Jan; 5(1): e1003 [PMID: 24434511 PMCID: PMC4040664]
Wein AN, et al., Tumor therapy with a urokinase plasminogen activator-
activated anthrax lethal toxin alone and in combination with
paclitaxel. Invest New Drugs. 2013 Feb; 31(1): 206-212 [PMID: 22843210
PMCID: PMC3757568]
Phillips DD, et al., Engineering Anthrax Toxin Variants That
Exclusively Form Octamers and Their Application to Targeting Tumors. J
Biol Chem. 2013 Mar 29; 288(13): 9058-9065 [PMID: 23393143 PMCID:
PMC3610978]
Liu S, et al., Intermolecular complementation achieves high specificity
tumor targeting by anthrax toxin. Nat Biotechnol. 2005 Jun; 23(6): 725-
730 [PMID: 15895075 PMCID: PMC2405912]
Intellectual Property
HHS E-256-2015--US Application Nos. 62/210,771, filed 27 Aug 2015; 62/
323,218, filed 15 Apr 2016; PCT App. No. PCT/US16/48706, filed 25 Aug
2016.
HHS E-120-2013--US App. No. 14/898,248, filed 14 Dec 2015; PCT App. No.
PCT/US2014/043131, filed 19 Jun 2014.
HHS E-246-2012--US App. No. 14/423,408, filed 23 Feb 2015; PCT App. No.
PCT/US13/56205
HHS E-059-2004--US Patent No. 7,947,289, filed 09 Feb 2005.
HHS E-293-1999--US Patent Nos. 7,468,352, filed 22 Mar 2002; 8,791,074,
filed 20 Oct 2008, and 9,403,872 filed 24 Jun 2014.
Licensing Contact: Dr. Natalie Greco, 301-761-7898;
Natalie.Greco@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 anthrax toxin-based cancer
therapeutics. For collaboration opportunities, please contact Dr.
Natalie Greco, 301-761-7898; Natalie.Greco@nih.gov.
Dated: June 1, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-12147 Filed 6-12-17; 8:45 am]
BILLING CODE 4140-01-P