Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Activators of Human Pyruvate Kinase To Treat Cancer, 25876-25877 [2014-10309]
Download as PDF
<![CDATA[
sroberts on DSK5SPTVN1PROD with NOTICES
25876
Federal Register / Vol. 79, No. 87 / Tuesday, May 6, 2014 / Notices
of opportunities to provide input into
the guidance development process.
Interested parties may provide input by:
(1) Submitting Comments on
Guidance Topics Listed in CDRH’s
Proposed Guidance Development lists:
FDA announces annually in the Federal
Register the Web site location where the
Agency posts lists of prioritized medical
device guidance documents that CDRH
intends to publish in the fiscal year.
This information for fiscal year 2014
may be found in the Federal Register at
78 FR 66746 (November 6, 2013) and on
the Internet at https://www.gpo.gov/
fdsys/pkg/FR-2013-11-06/pdf/201326547.pdf and at https://www.fda.gov/
medicaldevices/
deviceregulationandguidance/overview/
mdufaiii/ucm321367.htm. In addition,
FDA establishes a docket where CDRH
invites interested persons to submit
comments on any or all of the guidance
documents identified in the annual
Proposed Guidance Development lists.
Comments may include draft language
on the proposed topics, suggestions for
new or different guidance documents,
and/or the relative priority of guidance
documents.
(2) Submitting Proposed Draft
Guidance to FDA for Consideration:
Submitting proposed draft guidance,
rather than a guidance topic, enables
FDA to review and consider a fully
developed approach to an issue of
interest to a stakeholder. FDA may then
adopt that approach, in full or in part,
in a draft guidance that would be issued
for public comment. This process holds
the potential to shorten the total time for
guidance development and facilitate
consensus on novel, complex, or
controversial issues. FDA solicits
proposed draft guidances at a variety of
different venues, such as trade
association meetings and on the FDA
Web site. Interested parties may submit
proposed draft guidances on unsolicited
topics, as well. While some stakeholders
have developed proposed draft
guidances for FDA’s consideration, few
have used this approach.
(3) Commenting on Draft Level 1
Guidance: Generally, FDA solicits
public input on Level 1 guidances prior
to implementation. The Agency posts
draft Level 1 guidances on its Web site,
and it publicizes the draft guidance by
issuing a notice of availability (NOA) in
the Federal Register. Generally, the
Agency requests that public comments
on the guidance be provided within 60
days of publication of the draft
guidance. Once the comment period has
closed, the Agency reviews the
comments and considers them as it
finalizes the policy at issue and
publishes the final guidance. The
VerDate Mar<15>2010
17:34 May 05, 2014
Jkt 232001
Agency posts the final Level 1 guidance
on its Web site and publicizes the final
guidance by publishing an NOA in the
Federal Register. In some instances,
FDA may hold public meetings or
workshops prior to issuing a draft Level
1 guidance or after issuing the draft but
prior to finalizing the guidance to solicit
additional comments or perspectives on
the policy at issue.
(4) Commenting on Level 2 Guidance
and Level 1 Immediately in Effect
Guidance: Generally, FDA does not
solicit public input on Level 2 guidance
or on Level 1 Immediately in Effect
guidance prior to implementing the
guidance. Level 2 guidance documents
are guidance documents that set forth
existing practices or minor changes in
interpretation or policy (§ 10.115(c)(2))
Level 1 Immediately in Effect guidances
are issued when prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). However,
FDA posts both types of guidance on its
Web site, and interested parties may
comment on them at any time after they
have been issued. FDA will review the
comments and revise the guidances, as
appropriate. These streamlined options
permit FDA to issue guidance more
expeditiously than standard Level 1
guidance, while still providing
stakeholders with an opportunity to
comment. The additional administrative
steps required for standard Level 1
guidance (i.e., issuing draft guidance,
providing a comment period, and
issuing final guidance) generally make
the issuance of standard Level 1
guidance a longer process.
(5) Suggesting that FDA Revise or
Withdraw an Existing Guidance
Document: The Agency accepts and
considers suggestions for revising or
withdrawing existing guidance
documents at any time. FDA is
committed to updating its Web site in a
timely manner to reflect the Agency’s
review of previously issued guidance
documents, including the deletion of
guidance documents that no longer
represent the Agency’s interpretation of,
or policy on, a regulatory issue. CDRH
encourages stakeholders to provide
information concerning why a guidance
should be revised or withdrawn, and, if
applicable, provide comments about
how a guidance should be revised.
This public workshop and the
opening of a docket requesting
comments and suggestions provide
stakeholders with an additional
opportunity to actively engage with
CDRH regarding the level of public
participation and other best practices in
guidance development as well as how
CDRH should develop its guidance
priorities. To facilitate transparency, the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
workshop will also include information
about the development and practical
implementation of CDRH’s internal
guidance development process. CDRH
encourages collaborative efforts with the
public in the development of guidance
documents and believes this workshop
will help advance these efforts. CDRH is
committed to exploring ways to
facilitate stakeholder participation in
guidance development within the
confines of applicable statutes and
regulations, considering the need to
provide all interested parties access to
the process, issuing documents in a
timely manner, and balancing internal
resources effectively to accomplish its
public health mission.
II. Topics for Discussion at the Public
Workshop
The topics to be discussed include
CDRH’s guidance development process,
guidance development best practices for
FDA, CDRH, and CDRH stakeholders,
and CDRH guidance priorities and
priority development.
Dated: April 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10262 Filed 5–5–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation Option License
Agreement: Activators of Human
Pyruvate Kinase To Treat Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This 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 a
Start-up Exclusive Evaluation Option
License Agreement to TeamedOn
International, LLC., a company having a
place of business in Rockville, MD, to
practice the inventions embodied in the
following applications:
SUMMARY:
1. U.S. Provisional Patent Application No.
61/104,091, filed October 9, 2008
HHS Ref. No.: E–326–2008/0–US–01
Titled: Activators of Human Pyruvate
Kinase
Inventors: Craig J. Thomas, Douglas S. Auld,
James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
2. PCT Application No. PCT/US2009/60237,
filed October 9, 2009
E:\FR\FM\06MYN1.SGM
06MYN1
Federal Register / Vol. 79, No. 87 / Tuesday, May 6, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
HHS Ref. No.: E–326–2008/0–PCT–02
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
3. Australian Patent Application No.
2009303335, filed October 9, 2009
HHS Ref. No.: E–326–2008/0–AU–03
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
4. Canadian Patent Application No.
2,740,148, filed October 9, 2009
HHS Ref. No.: E–326–2008/0–CA–04
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
5. European Patent Application No.
09740795.1, filed October 9, 2009
HHS Ref. No.: E–326–2008/0–EP–05
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
6. Japanese Patent Application No. 531221–
2011, filed October 9, 2009
HHS Ref. No.: E–326–2008/0–JP–06
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
7. U.S. Patent Application No. 13/123,297,
filed October 9, 2009
HHS Ref. No.: E–326–2008/0–US–07
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian-Kang Jiang, and
Matthew Boxer (NCATS)
8. U.S. Patent Application No. 13/433,656,
filed March 29, 2012
HHS Ref. No.: E–326–2008/0–US–08
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S.
Auld, James Inglese, Amanda P.
Skoumbourdis, Jian- Kang Jiang, and
Matthew Boxer (NCATS)
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 ‘‘Use of
PK–M2 activators for treatment of
cancer in humans.’’
Upon the expiration or termination of
the Start-up Exclusive Evaluation
Option License Agreement, TeamedOn
International will have 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-
VerDate Mar<15>2010
17:34 May 05, 2014
Jkt 232001
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
21, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated Start-up Exclusive
Evaluation Option License Agreement
should be directed to: Suryanarayana
Vepa, Ph.D., J.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) 435–5020; Facsimile:
(301) 402–0220; Email: vepas@
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: The fetal
form of Pyruvate Kinase, called PK–M2,
is expressed in all cancer cells but is
normally inactive. The products and
methods sought in the prospective
evaluation option license agreement
activate PK–M2 and result in inhibition
of tumor development. This invention
relates to products and methods of
administering PK–M2 activators of
various types and methods of treating
cancer and diseases susceptible to PK–
M2 activators. 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. 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.
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
25877
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 2, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–10309 Filed 5–5–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development (NICHD); Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Child Health and
Human Development Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available. A
portion of this meeting will be closed to
the public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review and
discussion of grant applications.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the contact person listed below in
advance of the meeting.
Name of Committee: National Advisory
Child Health and Human Development
Council.
Date: June 5, 2014.
Open: June 5, 2014, 8 a.m. to 12:30 p.m.
Agenda: The agenda will include: Report
of the Director, NICHD; Report of the
Director, DER, NICHD; Statement of
Understanding; Assistive Devices for
Children Update; and the Human Placenta
Project Update.
Closed: June 5, 2014, 1:30 p.m. to
Adjournment.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, Center Drive, C-Wing,
Conference Room 10, Bethesda, MD 20892.
Contact Person: Cathy Y. Spong, M.D.,
Director, Division of Extramural Research,
Eunice Kenney Shriver National Institute of
Child Health and Human Development, NIH,
6100 Executive Blvd., Room 4A05, MSC
7510, Bethesda, MD 20892, (301) 435–6894.
Any interested person may file written
comments with the committee by forwarding
the statement to the contact person listed on
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Notices]
[Pages 25876-25877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10309]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Exclusive Evaluation Option License
Agreement: Activators of Human Pyruvate Kinase To Treat Cancer
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This 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 a Start-up Exclusive
Evaluation Option License Agreement to TeamedOn International, LLC., a
company having a place of business in Rockville, MD, to practice the
inventions embodied in the following applications:
1. U.S. Provisional Patent Application No. 61/104,091, filed October
9, 2008
HHS Ref. No.: E-326-2008/0-US-01
Titled: Activators of Human Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese, Amanda
P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
2. PCT Application No. PCT/US2009/60237, filed October 9, 2009
[[Page 25877]]
HHS Ref. No.: E-326-2008/0-PCT-02
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
3. Australian Patent Application No. 2009303335, filed October 9,
2009
HHS Ref. No.: E-326-2008/0-AU-03
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
4. Canadian Patent Application No. 2,740,148, filed October 9, 2009
HHS Ref. No.: E-326-2008/0-CA-04
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
5. European Patent Application No. 09740795.1, filed October 9, 2009
HHS Ref. No.: E-326-2008/0-EP-05
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
6. Japanese Patent Application No. 531221-2011, filed October 9,
2009
HHS Ref. No.: E-326-2008/0-JP-06
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
7. U.S. Patent Application No. 13/123,297, filed October 9, 2009
HHS Ref. No.: E-326-2008/0-US-07
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian-Kang Jiang, and Matthew Boxer (NCATS)
8. U.S. Patent Application No. 13/433,656, filed March 29, 2012
HHS Ref. No.: E-326-2008/0-US-08
Titled: Activators of Pyruvate Kinase
Inventors: Craig J. Thomas, Douglas S. Auld, James Inglese,
Amanda P. Skoumbourdis, Jian- Kang Jiang, and Matthew Boxer (NCATS)
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 ``Use of PK-M2
activators for treatment of cancer in humans.''
Upon the expiration or termination of the Start-up Exclusive
Evaluation Option License Agreement, TeamedOn International will have
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
21, 2014 will be considered.
ADDRESSES: Requests for copies of the patent application, inquiries,
comments, and other materials relating to the contemplated Start-up
Exclusive Evaluation Option License Agreement should be directed to:
Suryanarayana Vepa, Ph.D., J.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) 435-5020; Facsimile: (301) 402-0220; Email:
vepas@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: The fetal form of Pyruvate Kinase, called
PK-M2, is expressed in all cancer cells but is normally inactive. The
products and methods sought in the prospective evaluation option
license agreement activate PK-M2 and result in inhibition of tumor
development. This invention relates to products and methods of
administering PK-M2 activators of various types and methods of treating
cancer and diseases susceptible to PK-M2 activators. 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. 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.
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 2, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-10309 Filed 5-5-14; 8:45 am]
BILLING CODE 4140-01-P
