Prospective Grant of an Exclusive Commercial License Agreement: Development of 5T4 Antibody-Drug Conjugates for the Treatment of Human Cancers, 15220-15221 [2015-06488]
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
Type of
respondent
Form name
Risk Factor Assessment ..........................................................
Dated: March 11, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
BILLING CODE 4141–01–P
Background
Agency for Healthcare Research and
Quality
Patient Safety Organizations: Expired
Listing From Premerus PSO, LLC
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b–21 to b–26, (Patient Safety
Act) and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, (73 FR 70732–
70814), provide for the formation of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of healthcare
delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
The listing from the Premerus PSO, LLC
has expired and AHRQ has delisted the
PSO accordingly.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on January 10, 2015.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
mstockstill on DSK4VPTVN1PROD with NOTICES
16:51 Mar 20, 2015
Jkt 235001
Dated: March 17, 2015.
Sharon B. Arnold,
Deputy Director, AHRQ.
[FR Doc. 2015–06454 Filed 3–20–15; 8:45 am]
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Average
burden per
response
(in hours)
Total
annual
burden
hour
19/60
40
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Commercial License Agreement:
Development of 5T4 Antibody-Drug
Conjugates for the Treatment of
Human Cancers
AGENCY:
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
the PSO’s listing expires. Section
3.108(d) of the Patient Safety Rule
requires AHRQ to provide public notice
when it removes an organization from
the list of federally approved PSOs.
Premerus PSO, LLC, PSO number
P0120, a component entity of Premerus,
Inc., chose to let its listing expire by not
seeking continued listing. Accordingly,
Premerus PSO, LLC was delisted
effective at 12:00 Midnight ET (2400) on
January 10, 2015.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov/
index.html.
PO 00000
Number of
responses per
respondent
100
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Adult Donors
Improvement and Patient Safety, AHRQ,
540 Gaither Road, Rockville, MD 20850;
Telephone (toll free): (866) 403–3697;
Telephone (local): (301) 427–1111; TTY
(toll free): (866) 438–7231; TTY (local):
(301) 427–1130; Email: PSO@
AHRQ.hhs.gov.
[FR Doc. 2015–06565 Filed 3–20–15; 8:45 am]
SUMMARY:
Number of
respondents
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant of
an start-up exclusive commercial
license to practice the inventions
embodied in U.S. Patent Application
No. 62/034,995 entitled ‘‘Human
Monoclonal Antibodies Specific for 5T4
and Methods of Their Use’’ filed August
8, 20014 [HHS Ref. E–158–2014/0–US–
01] and all related continuing and
foreign patents/patent applications for
the technology family to Concortis, Inc.
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
prospective start-up exclusive
commercial license territory may be
worldwide and the field of use may be
limited to the development of 5T4
antibody drug conjugate therapeutics for
the treatment of human cancers using
Concortis’ proprietary conjugation
technologies.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before April
7, 2015 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive
evaluation option license should be
directed to: Whitney Hastings, 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) 451–7337; Facsimile: (301) 402–
0220; Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: 5T4 is an
antigen expressed in a number of
SUMMARY:
E:\FR\FM\23MRN1.SGM
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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices
carcinomas. Its expression is limited in
normal tissue, but is prevalent in
malignant tumors throughout their
development. This confined expression
makes it an attractive target for cancer
immunotherapy. 5T4 is often found in
colorectal, ovarian, and gastric tumors
and thus has been used as a prognostic
aid for these cancers. In addition, its
role in antibody-directed
immunotherapy for delivering response
modifiers to tumors has been studied
using murine monoclonal antibodies
(mAbs) and the cancer vaccine TroVax
(currently in clinical trials for multiple
solid tumors) targets 5T4. The present
invention describes the identification
and characterization of two fully human
mAbs (m1001 and m1002) that bind to
5T4. Since the mAbs are fully human,
they could have less immunogenicity
and better safety profiles than the
existing mouse and humanized
antibodies.
The prospective start-up exclusive
commercial license 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.
The prospective start-up exclusive
commercial license may be granted
unless within fifteen (15) 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 part 404.
Any additional, properly filed, and
complete 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
commercial 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: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–06488 Filed 3–20–15; 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: Grantee Data Technical
Assistance (GDTA) Training Needs
Assessment Survey for SAMHSA
Grantees-NEW
In 2014, the Center for Behavioral
Health Statistics and Quality (CBHSQ)
funded the GDTA contract to provide
training and technical assistance to all
grantees receiving funding from the
Center for Substance Abuse Treatment
(CSAT), the Center for Mental Health
Services (CMHS), and some grantees
receiving funding from the Center for
Substance Abuse Prevention (CSAP)
that fall under the GDTA contract. This
currently only includes discretionary
grants but is expected to include block
grants in future years. Training and
technical assistance from the GDTA
contract will focus on helping grantees
use their Government and Performance
Results Act of 1993 (GPRA) data for
performance management and
monitoring, and services improvement.
The information being collected in this
needs assessment will inform CBHSQ
regarding the types of activities
SAMHSA’s grants use their funding for
and what types of training activities
they would like to receive in the future.
Description of Forms: Forms will
include two questions. The first
question asks about the services
provided under the grant. Answer
options include activities such as
behavioral health care services,
screening, prevention activities, and
services to specific populations. The
second question asks respondents to
identify topics for training and technical
assistance they would like to receive
from a pre-populated list. Answer
options include items such as data
collection, data entry, and using data in
creative ways. Both questions have an
option for respondents to write-in an
answer that is not included in the list.
Description of Respondents: The
respondent universe for this data
collection effort is one Project Director
from each SAMHSA-funded grants
being served by the GDTA contract. This
currently only includes discretionary
grants but is expected to include block
grants in future years. There are
currently 2,670 SAMHSA-funded
discretionary grants served by the GDTA
contract, therefore this is the number of
respondents expected for this data
collection effort.
TABLE 1—ANNUAL BURDEN ESTIMATE
Number of
respondents
Annual
responses per
respondent
Total annual
responses
Hours per
response
Total annual
hour burden
Grantee Needs Assessment ................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
2,670
1
2,670
0.1
267
Written comments and
recommendations concerning the
proposed information collection should
be sent by April 22, 2015 to the
SAMHSA Desk Officer at the Office of
Information and Regulatory Affairs,
Office of Management and Budget
(OMB). To ensure timely receipt of
comments, and to avoid potential delays
in OMB’s receipt and processing of mail
sent through the U.S. Postal Service,
commenters are encouraged to submit
VerDate Sep<11>2014
16:51 Mar 20, 2015
Jkt 235001
their comments to OMB via email to:
OIRA_Submission@omb.eop.gov.
Although commenters are encouraged to
send their comments via email,
commenters may also fax their
comments to: 202–395–7285.
Commenters may also mail them to:
Office of Management and Budget,
Office of Information and Regulatory
PO 00000
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Affairs, New Executive Office Building,
Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2015–06532 Filed 3–20–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15220-15221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Commercial License Agreement:
Development of 5T4 Antibody-Drug Conjugates for the Treatment of Human
Cancers
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
part 404, that the National Institutes of Health, Department of Health
and Human Services, is contemplating the grant of an start-up exclusive
commercial license to practice the inventions embodied in U.S. Patent
Application No. 62/034,995 entitled ``Human Monoclonal Antibodies
Specific for 5T4 and Methods of Their Use'' filed August 8, 20014 [HHS
Ref. E-158-2014/0-US-01] and all related continuing and foreign
patents/patent applications for the technology family to Concortis,
Inc. The patent rights in these inventions have been assigned to the
Government of the United States of America. The prospective start-up
exclusive commercial license territory may be worldwide and the field
of use may be limited to the development of 5T4 antibody drug conjugate
therapeutics for the treatment of human cancers using Concortis'
proprietary conjugation technologies.
DATES: Only written comments and/or applications for a license which
are received by the NIH Office of Technology Transfer on or before
April 7, 2015 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
comments, and other materials relating to the contemplated exclusive
evaluation option license should be directed to: Whitney Hastings,
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) 451-7337;
Facsimile: (301) 402-0220; Email: hastingw@mail.nih.gov.
SUPPLEMENTARY INFORMATION: 5T4 is an antigen expressed in a number of
[[Page 15221]]
carcinomas. Its expression is limited in normal tissue, but is
prevalent in malignant tumors throughout their development. This
confined expression makes it an attractive target for cancer
immunotherapy. 5T4 is often found in colorectal, ovarian, and gastric
tumors and thus has been used as a prognostic aid for these cancers. In
addition, its role in antibody-directed immunotherapy for delivering
response modifiers to tumors has been studied using murine monoclonal
antibodies (mAbs) and the cancer vaccine TroVax (currently in clinical
trials for multiple solid tumors) targets 5T4. The present invention
describes the identification and characterization of two fully human
mAbs (m1001 and m1002) that bind to 5T4. Since the mAbs are fully
human, they could have less immunogenicity and better safety profiles
than the existing mouse and humanized antibodies.
The prospective start-up exclusive commercial license 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. The prospective start-up exclusive commercial license
may be granted unless within fifteen (15) 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 part 404.
Any additional, properly filed, and complete 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
commercial 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: March 17, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-06488 Filed 3-20-15; 8:45 am]
BILLING CODE 4140-01-P
