Prospective Grant of Exclusive License: Ocular Therapeutics Agent Delivery Devices and Methods for Making and Using Such Devices, 26772-26773 [2012-10836]
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Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
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Scientific Review, National Institutes of
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Dated: May 1, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–10969 Filed 5–4–12; 8:45 am]
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Dated: April 27, 2012.
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Committee Policy.
[FR Doc. 2012–10964 Filed 5–4–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Ocular Therapeutics Agent
Delivery Devices and Methods for
Making and Using Such Devices
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, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in Patent Applications USSN
09/808,149, filed Mar 15, 2001, issued
Mar 30, 2004; PCT/US02/07836, filed
Mar 14, 2002, designated EP,
02723446,7 and US 10/471,468, issued
Feb 9, 2010; USSN 11/739,540, filed
Apr 29, 2007; and USSN 12/647,980,
filed Dec 28, 2009; entitled ‘‘Ocular
Therapeutic Agent Delivery Devices and
Methods For Making and Using Such
Devices’’, by Michael R. Robinson et al
(NEI, CC, and NIBIB) (E–241–1999/0), to
ODIN Biotech having a place of business
in 4000 Hanover Street, Dallas, TX. The
patent rights in this invention have been
assigned to the United States of
America. The exclusive patent license is
one which qualifies under the Start-up
Exclusive Patent License Agreement
program, which is in place from October
1, 2011 through September 30, 2012.
DATES: Only written comments and/or
application for a license that are
received by the NIH Office of
Technology Transfer on or before May
22, 2012 will be considered.
SUMMARY:
E:\FR\FM\07MYN1.SGM
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Federal Register / Vol. 77, No. 88 / Monday, May 7, 2012 / Notices
FOR FURTHER INFORMATION CONTACT:
Requests for a copy of the patent
application, inquiries, and comments
relating to the contemplated license
should be directed to: Susan Ano, Ph.D.,
Branch Chief, IDME, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Email: anos@mail.nih.gov; Telephone:
301–435–5515; Facsimile: 301–402–
0220.
The
invention relates to a drug delivery
system, compositions of, methods of
making the drug delivery system, and
methods of use as a drug delivery
platform. Ocular therapeutics that
require repeated intravitreal injections
are associated with eye infections,
retinal detachment, hemorrhaging,
endophthalmitis, and/or cataracts, while
topical solutions that require daily
application are associated with patient
non-compliance. This technology
describes a drug delivery platform that
can be designed to deliver therapeutics
to the eye over months to years.
Therefore, this technology can be used
to design a therapeutic implant that
reduces or eliminates patient noncompliance and/or improve patient
safety. The therapeutic implant has the
following advantages: (a) It is
bioerodible which makes it more
noninvasive than repeated intravitreal
injections and non-bioerodible
implants; (b) has a dual release system
that allows the release of two distinct
therapeutics or a single therapeutic at
different rates; (c) prolongs the
therapeutic dose of an agent across the
surface of the eye compared to topical
solutions; (d) reduces the risk of
additional eye damage compared to
repeated intravitreal injections; (e)
dispenses a therapeutic agent over a
long period of time resulting in increase
patient compliance and patient health;
and (f) is associated with reduced
systemic drug side-effects compared to
drugs applied systemically. Data are
available for rodents, rabbits, dogs, and
horses.
The field of use may be limited to
‘‘Episcleral Therapeutic Implant for
Ophthalmic Diseases’’.
The prospective worldwide 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 fifteen (15) 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
sroberts on DSK5SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:11 May 04, 2012
Jkt 226001
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: May 1, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–10836 Filed 5–4–12; 8:45 am]
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Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
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Proposed Project: Healthy Transitions
Initiative Cross-Site Evaluation—NEW
The Substance Abuse and Mental
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(SAMHSA), Center of Mental Health
Services is responsible for the cross-site
evaluation of the Cooperative
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Agreements for State/Community
Partnerships to Integrate Services and
Supports for Youth and Young Adults
16–25 with Serious Emotional
Disturbances (SED) or Serious Mental
Illness (SMI), and Their Families
(Healthy Transitions Initiative—HTI)
that will collect data on program
implementation and youth and young
adult outcomes in the areas of
education, employment, housing,
mental health and co-occurring
disorders, and involvement with the
juvenile and criminal justice systems.
This cross-site evaluation design
includes a process and an outcome
evaluation and data will be collected
over a 3-year period from 7 grantee sites.
The cross-site evaluation is designed
to address the following questions.
Process Evaluation Questions
1. How closely does implementation
match the plan proposed in the grant?
2. What types of deviation from the
plan occur?
3. What effect do the deviations have
on the planned intervention and
performance assessment?
4. What facilitates a successful
transition between youth and adult
systems?
5. Is there a change from a ‘‘youthguided’’ model to a ‘‘youth and young
adult consumer-driven’’ model?
6. What is the extent of interagency
coordination and collaboration?
7. How are state and local-level
systems changing in response to the HTI
implementation? How does state and
local-level policy change affect the
implementation of the Initiative?
8. Who provides services (i.e.,
program staff, agency site)?
9. What services are being provided
(i.e., modality, type, intensity,
duration)?
10. Is there a viable cultural and
linguistic competence plan?
11. What are the individual
characteristics of the youth and young
adults (i.e., who is being served)?
12. In what settings (i.e., system,
community) are they being served?
Outcome Evaluation Questions
1. What is the effect of the HTI
intervention on the participants?
2. What is the effect of the HTI
intervention, compared to a sample of
similar young adults not participating in
the HTI intervention?
3. What program factors are associated
with the observed outcomes?
4. What individual factors are
associated with the observed outcomes?
5. How durable are the effects over 24
months?
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]]>Agencies
[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26772-26773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10836]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Ocular Therapeutics Agent
Delivery Devices and Methods for Making and Using Such Devices
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 404.7(a)(1)(i), that the National Institutes of Health (NIH),
Department of Health and Human Services, is contemplating the grant of
an exclusive patent license to practice the inventions embodied in
Patent Applications USSN 09/808,149, filed Mar 15, 2001, issued Mar 30,
2004; PCT/US02/07836, filed Mar 14, 2002, designated EP, 02723446,7 and
US 10/471,468, issued Feb 9, 2010; USSN 11/739,540, filed Apr 29, 2007;
and USSN 12/647,980, filed Dec 28, 2009; entitled ``Ocular Therapeutic
Agent Delivery Devices and Methods For Making and Using Such Devices'',
by Michael R. Robinson et al (NEI, CC, and NIBIB) (E-241-1999/0), to
ODIN Biotech having a place of business in 4000 Hanover Street, Dallas,
TX. The patent rights in this invention have been assigned to the
United States of America. The exclusive patent license is one which
qualifies under the Start-up Exclusive Patent License Agreement
program, which is in place from October 1, 2011 through September 30,
2012.
DATES: Only written comments and/or application for a license that are
received by the NIH Office of Technology Transfer on or before May 22,
2012 will be considered.
[[Page 26773]]
FOR FURTHER INFORMATION CONTACT: Requests for a copy of the patent
application, inquiries, and comments relating to the contemplated
license should be directed to: Susan Ano, Ph.D., Branch Chief, IDME,
Office of Technology Transfer, National Institutes of Health, 6011
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Email:
anos@mail.nih.gov; Telephone: 301-435-5515; Facsimile: 301-402-0220.
SUPPLEMENTARY INFORMATION: The invention relates to a drug delivery
system, compositions of, methods of making the drug delivery system,
and methods of use as a drug delivery platform. Ocular therapeutics
that require repeated intravitreal injections are associated with eye
infections, retinal detachment, hemorrhaging, endophthalmitis, and/or
cataracts, while topical solutions that require daily application are
associated with patient non-compliance. This technology describes a
drug delivery platform that can be designed to deliver therapeutics to
the eye over months to years. Therefore, this technology can be used to
design a therapeutic implant that reduces or eliminates patient non-
compliance and/or improve patient safety. The therapeutic implant has
the following advantages: (a) It is bioerodible which makes it more
noninvasive than repeated intravitreal injections and non-bioerodible
implants; (b) has a dual release system that allows the release of two
distinct therapeutics or a single therapeutic at different rates; (c)
prolongs the therapeutic dose of an agent across the surface of the eye
compared to topical solutions; (d) reduces the risk of additional eye
damage compared to repeated intravitreal injections; (e) dispenses a
therapeutic agent over a long period of time resulting in increase
patient compliance and patient health; and (f) is associated with
reduced systemic drug side-effects compared to drugs applied
systemically. Data are available for rodents, rabbits, dogs, and
horses.
The field of use may be limited to ``Episcleral Therapeutic Implant
for Ophthalmic Diseases''.
The prospective worldwide 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 fifteen (15) 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: May 1, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-10836 Filed 5-4-12; 8:45 am]
BILLING CODE 4140-01-P
