Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: In Vitro Diagnostics for Prediction of Therapeutic Efficacy in Cancer and Other Angiogenesis-Mediated Diseases, 28864-28865 [2013-11609]
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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
Process for Registration and Submitting
an Entry
To register for this Challenge, Solvers
must access the www.challenge.gov Web
site and search for ‘‘Propose New Ideas
For Prescription Drugs Oral Overdose
Protection.’’ A registration link for the
Challenge can be found on the landing
page under this Challenge description.
Amount of the Prize
Up to three prizes worth a total of
$15,000 ($5,000 each) will be awarded
to submission(s) that satisfy all the
Challenge criteria (below) and receive
the highest cumulative scores.
tkelley on DSK3SPTVN1PROD with NOTICES
Payment of the Prize
Prizes awarded under this Challenge
will be paid by electronic funds transfer
and may be subject to Federal income
taxes. HHS will comply with the
Internal Revenue Service withholding
and reporting requirements, where
applicable.
Basis Upon Which the Winner Will Be
Selected
This Challenge is formulated to elicit
new ideas, similar to a global brainstorm
for producing a breakthrough.
Submissions will be received and
reviewed by the judging panel
comprised of the experts in the area of
prescription drug abuse research and
pain management. The judging panel
will evaluate each submission based on
the following equally-weighted criteria:
1. Scientific foundation for the
proposed idea, e.g. well-founded line of
thought that is supported by the
scientific literature or otherwise found
to be accurate;
2. Idea novelty and originality;
3. Potential for development,
including whether the submission will
or is likely to:
(1) Preserve the original drug efficacy;
(2) Avoid new safety issues for the
intended population of pain patients;
(3) Avoid harming a potential abuser;
(4) Be suitable for further research
development and be commercially
viable.
Scores from each criterion will be
weighted equally for a maximum score
of 120 (40 points each). Entry Materials
from all submissions will be held until
after the deadline is reached for a
simultaneous review process. The
evaluation process will begin by deidentifying the submissions and
removing those that are not responsive
to this Challenge or not in compliance
with all rules of eligibility. NIDA
reserves the right to disqualify and
remove any submission which is
deemed, in the judging panel’s
discretion, inappropriate, offensive,
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18:13 May 15, 2013
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defamatory, or demeaning. Judges will
examine all submissions in accordance
with the criteria outlined above and
meet to discuss all responsive
submissions. Final ranking and
recommendations will be determined by
a vote.
obtain liability insurance or
demonstrate financial responsibility in
order to participate in this Challenge.
Dated: May 10, 2013.
Nora Volkow,
Director, National Institute on Drug Abuse,
National Institutes of Health.
Additional Information
[FR Doc. 2013–11689 Filed 5–15–13; 8:45 am]
Submission Rights
Solvers must agree that their
submission is their original work, and
that all proposed ideas must be the
Solver’s original effort. The Entry
Materials must not violate or infringe
the rights of other parties, including, but
not limited to privacy, publicity, or
intellectual property rights, or material
that constitutes copyright or license
infringement.
BILLING CODE 4140–01–P
Intellectual Property (IP)
NIDA does not wish to receive or hold
any IP related to submitted ideas.
Solvers will retain all IP rights;
however, each Solver may be asked to
grant to NIDA a royalty-free nonexclusive worldwide license to use,
copy for use, perform publicly, and
display publicly all parts of the
submission for the purposes of the
Challenge. This statement serves as a
notice to Solvers that granting this
license to NIDA, if asked, is a condition
of participation.
Liability
By participating in this Challenge,
Solvers agree to assume any and all
risks and waive claims against the
Federal Government and its related
entities, except in the case of willful
misconduct, for any injury, death,
damage, or loss of property, revenue, or
profits, whether direct, indirect, or
consequential, arising from their
participation in the Challenge, whether
the injury, death, damage, or loss arises
through negligence or otherwise.
Indemnification
By participating in this Challenge,
Solvers agree to indemnify the Federal
Government against third party claims
for damages arising from or related to
Challenge activities. This statement
serves as a notice to Solvers that they
are obligated to indemnify the
government as a condition of
participation.
Insurance
Based on the subject matter of the
Challenge, the type of work that it will
possibly require, as well as an analysis
of the likelihood of any claims for death,
bodily injury, or property damage, or
loss potentially resulting from Challenge
participation, solvers are not required to
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation Option License
Agreement: In Vitro Diagnostics for
Prediction of Therapeutic Efficacy in
Cancer and Other AngiogenesisMediated Diseases
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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 of a Start-Up
Exclusive Evaluation Option License
Agreement to Advanced Personalized
Diagnostics, LLC, a company having a
place of business in Alexandria,
Virginia, to practice the inventions
embodied in U.S. Provisional Patent
Application No. 60/976,732, entitled
‘‘Stably Transfected Multicolored
Fluorescent Cells’’, filed October 1, 2007
(HHS Ref. No. E–281–2007/0–US–01);
U.S. Patent Application No. 12/060,752,
entitled ‘‘Multiplex Assay Method for
Mixed Cell Populations’’, filed April 1,
2008, (HHS Ref. No. E–281–2007/0–US–
02); and U.S. Patent Application No. 12/
802,666, entitled ‘‘Methods of
Monitoring Angiogenesis and Metastasis
in Three Dimensional Co-Cultures’’,
filed June 10, 2010 (HHS Ref. No. E–
281–2007/1–US–01). The patent rights
in these inventions have been assigned
to the Government of the United States
of America. The territory of the
prospective Start-Up Exclusive
Evaluation Option License Agreement
may be worldwide, and the field of use
may be limited to ‘‘The use of the
Licensed Patent Rights limited to an
FDA-approved Class III in vitro
diagnostic device for prediction of
therapeutic efficacy in cancer and other
angiogenesis-mediated diseases.’’
Upon the expiration or termination of
the Start-up Exclusive Evaluation
Option License Agreement, Advanced
Personalized Diagnostics, LLC will have
SUMMARY:
E:\FR\FM\16MYN1.SGM
16MYN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
the exclusive right to execute a Start-Up
Exclusive Patent License Agreement
which will supersede and replace the
Start-up Exclusive Evaluation Option
License Agreement, with no greater field
of use and territory than granted in the
Start-up Exclusive Evaluation Option
License Agreement.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before May
31, 2013 will be considered.
ADDRESSES: Requests for copies of the
patent application(s), inquiries,
comments, and other materials relating
to the contemplated Start-Up Exclusive
Evaluation Option License Agreement
should be directed to: Tara L. Kirby,
Ph.D., Senior Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–4426; Facsimile: (301) 402–
0220; Email: tarak@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.
SUPPLEMENTARY INFORMATION: This
technology relates to a threedimensional co-culture system that can
be used to assay cellular activity relating
to angiogenesis (formation of new blood
vessels) and metastasis (spread of
cancer). The co-culture system is
designed to mimic the in vivo
environment of a tumor and consists of
fluorescently-labeled tumor cells,
endothelial cells, and other component
cell types (e.g. macrophages, mast cells,
fibroblasts, adipocytes, and pericytes).
The co-culture system can be used to
identify, monitor, and measure changes
in morphology, migration, proliferation,
and apoptosis of cells involved in
angiogenesis and/or metastasis. The cocultures are developed in 96-well plates
to allow rapid and efficient screening
for angiogenic agents and/or therapeutic
agents for cancer. This technology may
be used to develop diagnostic tests for
personalized therapies for cancer and
other angiogenesis-mediated diseases.
The prospective Start-Up Exclusive
Evaluation Option License Agreement is
being considered under the small
business initiative launched on October
1, 2011 and will comply with the terms
and conditions of 35 U.S.C. 209 and 37
CFR Part 404.7. The prospective StartUp Exclusive Evaluation Option License
Agreement and a subsequent Start-Up
Exclusive Patent License Agreement
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
may be granted unless the NIH receives
written evidence and argument, within
fifteen (15) days from the date of this
published notice, that establishes that
the grant of the contemplated Start-Up
Exclusive Evaluation Option License
Agreement would not be consistent with
the requirements of 35 U.S.C. 209 and
37 CFR Part 404.7.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Start-Up Exclusive
Evaluation Option License Agreement.
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: May 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–11609 Filed 5–15–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Request for Comment on the Federal
Guidelines for Opioid Treatment
Substance Abuse and Mental
Health Services Administration
(SAMHSA), HHS.
ACTION: Request for comment.
AGENCY:
This document is a request for
comment on the revised draft of the
Federal Guidelines for Opioid
Treatment. These guidelines elaborate
upon the Federal opioid treatment
standards set forth under 42 CFR part 8.
DATES: Comment Close Date: To be
assured consideration, comments must
be received at one of the addresses
provided below, no later than 60
calendar days from the date of
publication in the Federal Register.
ADDRESSES: The draft guideline may be
obtained directly from https://
www.dpt.samhsa.gov or by contacting
the Division of Pharmacologic
Therapies. You may submit comments
in one of four ways (please choose only
one of the ways listed):
• Electronically. You may submit
electronic comments to
DPT@samhsa.hhs.gov.
• By regular mail. You may mail
written comments to the following
address ONLY: Substance Abuse and
SUMMARY:
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28865
Mental Health Services Administration,
Attention: DPT Federal Register
Representative, Division of
Pharmacologic Therapies, 1 Choke
Cherry Road, Room 7–1044, Rockville,
MD 20857. Please allow sufficient time
for mailed comments to be received
before the close of the comment period.
• By express or overnight mail. You
may send written comments to the
following address ONLY: Substance
Abuse and Mental Health Services
Administration, Attention: DPT Federal
Register Representative, Division of
Pharmacologic Therapies, 1 Choke
Cherry Road, Room 7–1044, Rockville,
MD 20850.
• By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following address prior to the close of
the comment period:
• For delivery in Rockville, MD:
Substance Abuse and Mental Health
Services Administration, Attention: DPT
Federal Register Representative,
Division of Pharmacologic Therapies, 1
Choke Cherry Road, Room 7–1044,
Rockville, MD 20850. To deliver your
comments to the Rockville address, call
telephone number (240) 276–2700 in
advance to schedule your delivery with
one of our staff members.
FOR FURTHER INFORMATION CONTACT:
Nichole Smith, Division of
Pharmacologic Therapies, CSAT,
SAMHSA, 1 Choke Cherry Road, Room
7–1044, Rockville, Maryland 20857,
(240) 276–2700 (phone) or email at
nichole.smith@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. Comments received by the
deadline will be available for public
inspection at the Substance Abuse and
Mental Health Services Administration,
Division of Pharmacologic Therapies, 1
Choke Cherry Road, Rockville, MD
20850, Monday through Friday of each
week from 8:30 a.m. to 4:00 p.m. To
schedule an appointment to view public
comments, phone (240) 276–2700.
Background: Federal Regulations
codified under 42 CFR part 8 set forth
requirements for opioid treatment
programs (‘‘OTPs’’), also known as
methadone treatment programs. The
regulations, which were the subject of a
Final Rule published in the Federal
Register on January 17, 2001, (‘‘Final
Rule’’ 66 FR 4075–4102, January 17,
2001) include standards for opioid
treatment. OTPs are required to provide
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28864-28865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: In Vitro Diagnostics for Prediction of Therapeutic Efficacy
in Cancer and Other Angiogenesis-Mediated Diseases
AGENCY: National Institutes of Health, 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 of
a Start-Up Exclusive Evaluation Option License Agreement to Advanced
Personalized Diagnostics, LLC, a company having a place of business in
Alexandria, Virginia, to practice the inventions embodied in U.S.
Provisional Patent Application No. 60/976,732, entitled ``Stably
Transfected Multicolored Fluorescent Cells'', filed October 1, 2007
(HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/
060,752, entitled ``Multiplex Assay Method for Mixed Cell
Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02);
and U.S. Patent Application No. 12/802,666, entitled ``Methods of
Monitoring Angiogenesis and Metastasis in Three Dimensional Co-
Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The
patent rights in these inventions have been assigned to the Government
of the United States of America. The territory of the prospective
Start-Up Exclusive Evaluation Option License Agreement may be
worldwide, and the field of use may be limited to ``The use of the
Licensed Patent Rights limited to an FDA-approved Class III in vitro
diagnostic device for prediction of therapeutic efficacy in cancer and
other angiogenesis-mediated diseases.''
Upon the expiration or termination of the Start-up Exclusive
Evaluation Option License Agreement, Advanced Personalized Diagnostics,
LLC will have
[[Page 28865]]
the exclusive right to execute a Start-Up Exclusive Patent License
Agreement which will supersede and replace the Start-up Exclusive
Evaluation Option License Agreement, with no greater field of use and
territory than granted in the Start-up Exclusive Evaluation Option
License Agreement.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before May
31, 2013 will be considered.
ADDRESSES: Requests for copies of the patent application(s), inquiries,
comments, and other materials relating to the contemplated Start-Up
Exclusive Evaluation Option License Agreement should be directed to:
Tara L. Kirby, Ph.D., Senior Licensing and Patenting Manager, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
4426; Facsimile: (301) 402-0220; Email: tarak@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.
SUPPLEMENTARY INFORMATION: This technology relates to a three-
dimensional co-culture system that can be used to assay cellular
activity relating to angiogenesis (formation of new blood vessels) and
metastasis (spread of cancer). The co-culture system is designed to
mimic the in vivo environment of a tumor and consists of fluorescently-
labeled tumor cells, endothelial cells, and other component cell types
(e.g. macrophages, mast cells, fibroblasts, adipocytes, and pericytes).
The co-culture system can be used to identify, monitor, and measure
changes in morphology, migration, proliferation, and apoptosis of cells
involved in angiogenesis and/or metastasis. The co-cultures are
developed in 96-well plates to allow rapid and efficient screening for
angiogenic agents and/or therapeutic agents for cancer. This technology
may be used to develop diagnostic tests for personalized therapies for
cancer and other angiogenesis-mediated diseases.
The prospective Start-Up Exclusive Evaluation Option License
Agreement is being considered under the small business initiative
launched on October 1, 2011 and will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR Part 404.7. The prospective
Start-Up Exclusive Evaluation Option License Agreement and a subsequent
Start-Up Exclusive Patent License Agreement may be granted unless the
NIH receives written evidence and argument, within fifteen (15) days
from the date of this published notice, that establishes that the grant
of the contemplated Start-Up Exclusive Evaluation Option License
Agreement would not be consistent with the requirements of 35 U.S.C.
209 and 37 CFR Part 404.7.
Complete applications for a license in the prospective field of use
that are filed in response to this notice will be treated as objections
to the grant of the contemplated Start-Up Exclusive Evaluation Option
License Agreement. 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: May 10, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2013-11609 Filed 5-15-13; 8:45 am]
BILLING CODE 4140-01-P
