Prospective Grant of Exclusive License: Diagnostic Tests for Predicting the Emergence of Suicidal Ideation Subsequent to Anti-Depressant Treatment, 8558-8559 [E9-4053]
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Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
Time: 1 p.m. to 3 p.m.
Agenda: Review and evaluate the final
draft for the Environmental Factors in Cancer
2008/2009 Annual Report.
Place: National Cancer Institute, Office of
the Director, National Institutes of Health,
6116 Executive Blvd., Suite 220, Bethesda,
MD 20892 (Teleconference).
Contact Person: Abby Sandler, PhD.,
Executive Secretary, Chief, Institute Review
Office, Office of the Director, National Cancer
Institute, NIH, 6116 Executive Blvd., Suite
220, MSC 8349, Bethesda, MD 20892–8349,
301/451–9399, sandlera@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the comments to the Contact Person listed on
this notice. The comments should include
the name, address, telephone number and,
when applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/pcp/pcp.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–4048 Filed 2–24–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Co-Exclusive
License: Use Fully Human and/or
Humanized Monoclonal Antibodies
Against IGF-I and/or IGF-II for the
Treatment of Human Cancers
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
pwalker on PROD1PC71 with NOTICES
AGENCY:
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, Department of
Health and Human Services, is
contemplating the grant of a coexclusive patent license to practice the
inventions embodied in U.S. Patent
Application No. 12/296,328 entitled,
‘‘Human IGF-I-Specific and IGF-I and
IGF-II Cross-Reactive Human
Monoclonal Antibodies’’ and all foreign
VerDate Nov<24>2008
18:09 Feb 24, 2009
Jkt 217001
counterparts [HHS Ref. No. E–336–
2005/0] to Trubion Pharmaceuticals,
Inc., which is located in Seattle,
Washington. The patent rights in this
invention have been assigned to the
United States of America.
The prospective co-exclusive license
territory may be worldwide and the
field of use may be limited to the use
of the antibodies and their method of
use in the Licensed Patent Rights for the
treatment of human cancers.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
27, 2009 will be considered. This notice
updates the Federal Register Notice
published in 73 FR 32719, June 10,
2008.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated co-exclusive license
should be directed to: Whitney A.
Hastings, M.S., Licensing and Patenting
Manager, Office of Technology Transfer,
National Institutes of Health, 6011
Executive Boulevard, Suite 325,
Rockville, MD 20852–3804. Telephone:
(301) 451–7337; Facsimile: (301) 402–
0220; E-mail: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The type 1
insulin-like growth factor (IGF) receptor
(IGF1R) is over-expressed by many
tumors and mediates proliferation,
motility, and protection from apoptosis.
Agents that inhibit IGF1R expression or
function can potentially block tumor
growth and metastasis. Its major ligands,
IGF-I and IGF-II, are over-expressed by
multiple tumor types. Previous studies
indicate that inhibition of IGF-I and/or
IGF-II binding to its cognizant receptor
negatively modulates signal
transduction through the IGF pathway
and concomitant cell growth. Therefore,
use of humanized or fully human
antibodies against IGFs represents a
valid approach to inhibit tumor growth.
The above identified patent
applications discloses three (3) novel
fully human monoclonal antibodies
designated m705, m706, and m708,
which are specific for insulin-like
growth factor (IGF)-I. Two (2) of the
three (3) antibodies, m705 and m706 are
specific for IGF-I and do not cross react
with IGF-II and insulin while, m708
cross reacts with IGF-II.
These antibodies can be used to
prevent binding of IGF-I to its
concomitant receptor IGFIR,
consequently, modulating diseases such
as cancer. Additional embodiments
describe methods for treating various
human diseases associated with
aberrant cell growth and motility
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including breast, prostate, and leukemia
carcinomas. Thus, these novel
antibodies may provide a therapeutic
intervention for multiple carcinomas
without the negative side effects
associated with insulin inhibition.
The prospective co-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 co-exclusive license may be
granted unless within sixty (60) days
from the date of this published notice,
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 404.7.
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 co-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: February 17, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–4045 Filed 2–24–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Diagnostic Tests for
Predicting the Emergence of Suicidal
Ideation Subsequent to AntiDepressant Treatment
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This notice, in accordance
with 35 U.S.C. 209(c)(l) and 37 CFR
404.7(a)(l)(i), that the National Institutes
of Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
practice the inventions embodied in
U.S. Patent Application 60/854,978
[HHS Ref. E–157–2006/0–US–01], PCT
Patent Application PCT/US2007/082683
[HHS Ref. E–157–2006/1–PCT–01], U.S.
Patent Application 11/925,334 [HHS
Ref. E–157–2006/1–US–02], all entitled
‘‘Methods to Identify Patients at Risk of
Developing Adverse Events During
Treatment With Antidepressant
Medication’’, and all continuing
E:\FR\FM\25FEN1.SGM
25FEN1
Federal Register / Vol. 74, No. 36 / Wednesday, February 25, 2009 / Notices
applications and foreign counterparts, to
NeuroMark, Inc., which has offices in
Boulder, CO. The patent rights in these
inventions have been assigned to and/or
exclusively licensed to the Government
of the United States of America.
The prospective exclusive license
territory may be worldwide, licensees
will need to address the medical
usefulness of multi-gene test formats
should data be developed to support
such approaches and the term of the
agreement may be commensurate with
commercial incentives and public
health needs. The field of use may be
limited to:
pwalker on PROD1PC71 with NOTICES
FDA approved diagnostic test kits for
predicting the emergence of suicidal ideation
subsequent to anti-depressant treatment and
for screening patients to identify those
patients more likely to exhibit an increased
risk of treatment-emergent suicidal ideation
by assaying for the presence of a genotype in
the patients which is associated with an
increased risk of treatment-emergent suicidal
ideation.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
27, 2009 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: Norbert Pontzer, 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–
5502; Facsimile: (301) 402–0220; E-mail:
pontzern@mail.nih.gov.
SUPPLEMENTARY INFORMATION: Suicidal
ideation is an uncommon symptom than
can emerge during antidepressant
treatment. The Food and Drug
Administration (FDA) requires a black
box warning of worsening depression
and/or emergence of suicidality (i.e.,
development of suicidal thoughts or
behavior) for both adult and pediatric
patients taking antidepressant
medications. While use of
antidepressants fell after to the black
box warning, studies suggest that
pediatric suicides may actually be
rising. This has led to concerns that the
black box warning led to a decrease in
treatment and resulted in an overall
increase in suicides. The Sequenced
Treatment Alternatives for Depression
(STAR*D) trial at NIH found that
versions of genes coding for components
of the brain’s chemical messenger
system may be linked to suicidal
thinking associated with antidepressant
use. If links between genes and suicidal
VerDate Nov<24>2008
18:09 Feb 24, 2009
Jkt 217001
thinking are validated under a license,
depressed individuals at higher risk for
suicide could benefit from closer
monitoring, alternative treatments, or
specialty care while allowing more
aggressive treatment in individuals
without the increased risk.
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 sixty (60) days from the date of
this published notice, 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 404.7.
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.
February 18, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–4053 Filed 2–24–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Strategic Prevention
Framework State Incentive Grant (SPF
SIG) Program (OMB No. 0930–0279)
Revision
SAMHSA’s Center for Substance
Abuse Prevention (CSAP) is responsible
for the evaluation instruments of the
Strategic Prevention Framework State
Incentive Grant (SPF SIG) Program. The
program is a major national initiative
designed to: (1) Prevent the onset and
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8559
reduce the progression of substance
abuse, including childhood and
underage drinking; (2) reduce substance
abuse related problems in communities;
and (3) build prevention capacity and
infrastructure at the State/territory/tribe
and community levels.
Five steps comprise the SPF:
Step 1: Profile population needs,
resources, and readiness to address
needs and gaps.
Step 2: Mobilize and/or build capacity
to address needs.
Step 3: Develop a comprehensive
strategic plan.
Step 4: Implement evidence-based
prevention programs, policies, and
practices.
Step 5: Monitor, evaluate, sustain, and
improve or replace those that fail.
An evaluation team is currently
implementing a multi-method, quasiexperimental evaluation of the first two
SPF SIG cohorts receiving grants in FY
2004 and FY 2005. This notice invites
comment on grantee-level, communitylevel, and participant-level data
collection instruments designed for the
cross-site evaluation of 16 Cohort 3
grantees receiving grants in FY 2006 and
20 Cohort 4 grantees. Since the ultimate
goal is to fund all eligible jurisdictions,
there are no control groups at the
grantee level. The primary evaluation
objective is to determine the impact of
SPF SIG on the SAMHSA National
Outcomes Measures (NOMs). Data
collected at the grantee, community,
and participant levels using the three
instruments will be combined in an
analysis that investigates the
relationship, if any, between the SPF
process and substance use outcomes at
individual and community levels. The
instruments will be included in an OMB
review package submitted immediately
after the expiration of the comment
period and are the main focus of this
announcement.
Grantee-Level Data Collection
Two instruments were developed for
assessing grantee-level effects. Both
instruments are guides for interviews
that will be conducted by the grantees’
evaluators twice over the life of the SPF
SIG award. These instruments are
modified versions of those used in the
SPF SIG Cohort 1 and 2 Cross-Site
Evaluation Study (OMB No. 09300279).
The total burden of the original
instruments has been reduced by
deleting several questions and replacing
the majority of open-ended questions
with multiple-choice-response
questions. The Strategic Prevention
Framework Implementation Interview
Protocol will be used to assess the
relationship between SPF
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 74, Number 36 (Wednesday, February 25, 2009)]
[Notices]
[Pages 8558-8559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: Diagnostic Tests for
Predicting the Emergence of Suicidal Ideation Subsequent to Anti-
Depressant Treatment
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice, in accordance with 35 U.S.C. 209(c)(l) and 37 CFR
404.7(a)(l)(i), that the National Institutes of Health, Department of
Health and Human Services, is contemplating the grant of an exclusive
patent license to practice the inventions embodied in U.S. Patent
Application 60/854,978 [HHS Ref. E-157-2006/0-US-01], PCT Patent
Application PCT/US2007/082683 [HHS Ref. E-157-2006/1-PCT-01], U.S.
Patent Application 11/925,334 [HHS Ref. E-157-2006/1-US-02], all
entitled ``Methods to Identify Patients at Risk of Developing Adverse
Events During Treatment With Antidepressant Medication'', and all
continuing
[[Page 8559]]
applications and foreign counterparts, to NeuroMark, Inc., which has
offices in Boulder, CO. The patent rights in these inventions have been
assigned to and/or exclusively licensed to the Government of the United
States of America.
The prospective exclusive license territory may be worldwide,
licensees will need to address the medical usefulness of multi-gene
test formats should data be developed to support such approaches and
the term of the agreement may be commensurate with commercial
incentives and public health needs. The field of use may be limited to:
FDA approved diagnostic test kits for predicting the emergence of
suicidal ideation subsequent to anti-depressant treatment and for
screening patients to identify those patients more likely to exhibit
an increased risk of treatment-emergent suicidal ideation by
assaying for the presence of a genotype in the patients which is
associated with an increased risk of treatment-emergent suicidal
ideation.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
April 27, 2009 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: Norbert Pontzer, Senior Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5502; Facsimile: (301) 402-0220; E-mail:
pontzern@mail.nih.gov.
SUPPLEMENTARY INFORMATION: Suicidal ideation is an uncommon symptom
than can emerge during antidepressant treatment. The Food and Drug
Administration (FDA) requires a black box warning of worsening
depression and/or emergence of suicidality (i.e., development of
suicidal thoughts or behavior) for both adult and pediatric patients
taking antidepressant medications. While use of antidepressants fell
after to the black box warning, studies suggest that pediatric suicides
may actually be rising. This has led to concerns that the black box
warning led to a decrease in treatment and resulted in an overall
increase in suicides. The Sequenced Treatment Alternatives for
Depression (STAR*D) trial at NIH found that versions of genes coding
for components of the brain's chemical messenger system may be linked
to suicidal thinking associated with antidepressant use. If links
between genes and suicidal thinking are validated under a license,
depressed individuals at higher risk for suicide could benefit from
closer monitoring, alternative treatments, or specialty care while
allowing more aggressive treatment in individuals without the increased
risk.
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 sixty
(60) days from the date of this published notice, 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 404.7.
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.
February 18, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E9-4053 Filed 2-24-09; 8:45 am]
BILLING CODE 4140-01-P
