Prospective Grant of Exclusive License: The Development of a Companion Diagnostic Kit for Predicting Therapeutic Efficacy of Anti-Cancer Agents, 65518-65519 [2011-27308]
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65518
Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Notices
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel,
Research Education Program for Clinical
Researchers and Clinicians.
Date: November 1, 2011.
Time: 11 a.m. to 2 p.m.
Agenda To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Gerald L. McLaughlin,
PhD, Chief, Grants Review Branch and
Contracts Review Branch, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4238, MSC 9550, Bethesda, MD
20892–9550, 301–402–6626,
gm145a@nih.gov.
This notice is being published less than 15
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limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, B/
START Review Committee.
Date: November 4, 2011.
Time: 8 a.m. to 8 p.m.
Agenda To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Mark Swieter, PhD, Chief,
Extramural Activities Branch, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 4235, MSC
9550, 6001 Executive Blvd., Bethesda, MD
20892–9550, 301–435–1389, ms80x@nih.gov.
This notice is being published less than 15
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limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, HIV/
AIDS Implementation Science Targeting Drug
Using Populations: PEPFAR (R01).
Date: November 15, 2011.
Time: 9 a.m. to 5:30 p.m.
Agenda To review and evaluate grant
applications.
Place: Hilton Garden Inn—Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Nadine Rogers, PhD,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD
20892–9550, 301–402–2105,
rogersn2@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, Remote
Monitoring System for Cocaine Ingestion.
Date: November 17, 2011.
Time: 10 a.m. to 1 p.m.
Agenda To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
VerDate Mar<15>2010
18:11 Oct 20, 2011
Jkt 226001
Contact Person: Gerald L. McLaughlin,
PhD, Chief, Grants Review Branch and
Contracts Review Branch, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4238, MSC 9550, Bethesda, MD
20892–9550, 301–402–6626,
gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, DIDARP
Review.
Date: December 13, 2011.
Time: 9 a.m. to 5 p.m.
Agenda To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Nadine Rogers, PhD,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD
20892–9550, 301–402–2105,
rogersn2@nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: October 17, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–27294 Filed 10–20–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of a
Companion Diagnostic Kit for
Predicting Therapeutic Efficacy of
Anti-Cancer Agents
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
Part 404.7(a)(1)(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 US Patent Application 61/
144,501 entitled ‘‘Ratio Based
Biomarker of Survival Utilizing PTEN
and Phospho-AKT’’ [HHS Ref. E–025–
2009/0–US–01], and all continuing
applications and foreign counterparts, to
20/20 GeneSystems, Inc. The patent
rights in this invention have been
assigned to the Government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to:
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
the use of the Licensed Patent Rights limited
to an FDA-approved (i) Laboratory Developed
Test (LDT) offered as a service or (ii) in vitro
diagnostic (IVD) kit distributed in commerce
for human use of a protein panel predictive
of the therapeutic effect of an anti-cancer
agent in the treatment of kidney, lung, and
breast cancers that includes at least one of
the following proteins (phosphorylated or
unphosphorylated): PTEN, Akt, mTOR.
Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
November 21, 2011 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: Patrick P. McCue, Ph.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5560; Facsimile: (301) 402–0220; E-mail:
mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention concerns methods for the
prognosis for a subject with cancer and
to evaluate therapeutic regimes through
the comparison of normalized
expression values of two or more
cancer-associated proteins. Several
specific cancer-associated proteins are
covered by this technology, including
PTEN, phosphorylated Akt,
phosphorylated mTOR, EGFR,
phosphorylated MAPK, HER2, and
HER3. Examined individually, these
proteins do not provide discrimination
of survival. However, examined together
as protein ratios, the prognostic function
survived multivariate analysis. The
approach has been demonstrated for
biliary tract, kidney, lung, and stomach
cancers.
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 part 404.7. The
prospective exclusive license may be
granted unless 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 part 404.7
within thirty (30) days from the date of
this published notice.
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.
DATES:
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 76, No. 204 / Friday, October 21, 2011 / Notices
Dated: October 13, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2011–27308 Filed 10–20–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Statement of Organization, Functions,
and Delegations of Authority
sroberts on DSK5SPTVN1PROD with NOTICES
Part M of the Substance Abuse and
Mental Health Services Administration
(SAMHSA) Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (DHHS) at 75, Number
157, pages 49942–49943, August 16,
2010, is amended to revise the
functional statements for the Office of
Policy, Planning, and Innovation (OPPI)
and the Office of the Director (OD).
These changes are necessary to
strengthen the Office of Policy,
Planning, and Innovation’s cross-cutting
policy role in the Agency as well as
externally on a regional and national
level. The changes are as follows:
Section M.20, Functions is amended
as follows:
The functional statements for the
Office of Policy, Planning and
Innovation (MD) and the Office of the
Director (MD1) are replaced with the
following:
Office of Policy, Planning, and
Innovation (MD)
The mission of the Office of Policy,
Planning, and Innovation (OPPI) is to
develop, coordinate, and communicate
SAMHSA policy to improve behavioral
health in America’s communities.
The Office represents SAMHSA at
meetings, both internal and external,
while promoting SAMHSA’s profile in
health services research by collaborating
with other Departments and Agencies.
These include, but are not limited to
other operational divisions within the
U.S. Department of Health and Human
Services (such as the National Institutes
of Health, the Centers for Disease
Control and Prevention, and the Centers
for Medicare and Medicaid Services).
The primary intent is to facilitate the
adoption of data-driven policies and
practices by those working in the field
to improve behavioral health outcomes.
While SAMHSA’s primary mission is to
serve those with behavioral health
needs and foster health improvements,
many partners and allies exist within
VerDate Mar<15>2010
18:11 Oct 20, 2011
Jkt 226001
other fields that also play a crucial role
in supporting and improving behavioral
health. OPPI will seek to influence these
partners and allies to encourage
inclusion of behavioral health within
their policy initiatives. These objectives
are accomplished, in part, by the
following OPPI functions and associated
directives. OPPI:
1. Facilitates the exchange of
information and coordinates activity
between SAMHSA and State, Regional,
Tribal, Federal, National, and
International partners.
2. Works with SAMHSA’s Office of
the Administrator (OA), and SAMHSA’s
Offices and Centers to foster a unified
understanding and operationalization of
policy and budget directions for
SAMHSA.
3. Partners with SAMHSA’s Centers
and Offices to achieve policy alignment
in communications, evaluation,
operations, and programs.
4. Provides policy advice to the
Administrator.
5. Provides policy leadership in crosscutting issue areas (e.g., Disparities,
Tribal Issues, Health Reform, Trauma &
Justice, Women’s Services, etc.).
6. Provides staff support, portfolio
tracking, and coordination services for
the Strategic Initiatives leaders and/or
teams.
Office of the Director (MD1)
As the chief policy advisor to the
Administrator, SAMHSA, the OPPI
Director leads the review and
development of policy in close
coordination with the Administrator,
SAMHSA Centers and Offices, DHHS
and other Federal Agencies, Tribal,
State and local governments, Congress
and private constituents and groups.
The Office of the Director serves in
other duties designed to promote the
organizational mission. These are
detailed below:
1. Provides leadership and
coordination of strategic planning and
provides an integrated and structured
approach to program policy analysis,
coordination, development, and
communication.
2. Coordinates and collaborates with
the Office of Financial Resources (OFR)
to assure consistency and integration of
Agency program policy in budget
formulation, and coordinates and
collaborates with Centers and programs
to assure consistency and integration of
Agency policy across programs.
3. Coordinates and collaborates with
the OFR on appropriations
presentations, analyses, implementation
plans and reporting, and with Center
and Office leadership on SAMHSA and
program authority.
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Fmt 4703
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65519
4. Manages and directs the staff and
all programmatic activity in the Office
of Policy, Planning and Innovation.
Delegation of Authority
All delegations and re-delegations of
authority to officers and employees of
SAMHSA which were in effect
immediately prior to the effective date
of this reorganization shall continue to
be in effect pending further redelegations, provided they are
consistent with this reorganization.
These organizational changes are
effective: October 21, 2011.
Rose Shannon,
Director, Division of Executive
Correspondence.
[FR Doc. 2011–27235 Filed 10–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5484–N–32]
Notice of Proposed Information
Collection: Comment Request;
Construction Complaint—Request for
Financial Assistance
Office of the Assistant
Secretary for Housing, HUD.
ACTION: Notice.
AGENCY:
The proposed information
collection requirement described below
will be submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
DATES: Comments Due Date: December
20, 2011.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
Reports Liaison Officer, Department of
Housing and Urban Development, 451
7th Street, SW., Washington, DC 20410,
Room 9120 or the number for the
Federal Information Relay Service (1–
800–877–8339).
FOR FURTHER INFORMATION CONTACT:
Karin Hill, Director, Office of Single
Family Program Development,
Department of Housing and Urban
Development, 451 7th Street, SW.,
Washington, DC 20410, telephone (202)
708–2121 (this is not a toll free number)
for copies of the proposed forms and
other available information.
SUPPLEMENTARY INFORMATION: The
Department is submitting the proposed
SUMMARY:
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Notices]
[Pages 65518-65519]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27308]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of a
Companion Diagnostic Kit for Predicting Therapeutic Efficacy of Anti-
Cancer Agents
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 Part 404.7(a)(1)(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 US
Patent Application 61/144,501 entitled ``Ratio Based Biomarker of
Survival Utilizing PTEN and Phospho-AKT'' [HHS Ref. E-025-2009/0-US-
01], and all continuing applications and foreign counterparts, to 20/20
GeneSystems, Inc. The patent rights in this invention have been
assigned to the Government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the field of use may be limited to:
the use of the Licensed Patent Rights limited to an FDA-approved (i)
Laboratory Developed Test (LDT) offered as a service or (ii) in
vitro diagnostic (IVD) kit distributed in commerce for human use of
a protein panel predictive of the therapeutic effect of an anti-
cancer agent in the treatment of kidney, lung, and breast cancers
that includes at least one of the following proteins (phosphorylated
or unphosphorylated): PTEN, Akt, mTOR.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
November 21, 2011 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: Patrick P. McCue, Ph.D., Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5560; Facsimile: (301) 402-0220; E-mail:
mccuepat@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This invention concerns methods for the
prognosis for a subject with cancer and to evaluate therapeutic regimes
through the comparison of normalized expression values of two or more
cancer-associated proteins. Several specific cancer-associated proteins
are covered by this technology, including PTEN, phosphorylated Akt,
phosphorylated mTOR, EGFR, phosphorylated MAPK, HER2, and HER3.
Examined individually, these proteins do not provide discrimination of
survival. However, examined together as protein ratios, the prognostic
function survived multivariate analysis. The approach has been
demonstrated for biliary tract, kidney, lung, and stomach cancers.
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 part
404.7. The prospective exclusive license may be granted unless 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 part 404.7 within thirty (30) days from the date
of this published notice.
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.
[[Page 65519]]
Dated: October 13, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development & Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-27308 Filed 10-20-11; 8:45 am]
BILLING CODE 4140-01-P
