Prospective Grant of Exclusive License: The Development of Chimeric Antigen Receptors Targeting B-Cell Maturation Antigen To Treat or Prevent Cancer and Autoimmune Disease, 41700-41701 [2014-16764]
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Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices
TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL
Application No.
Drug product(s)
Applicant or holder
ANDA 40117 ........................
Vicodin HP (Acetaminophen and Hydrocodone
Bitartrate Tablets), 660 mg/10 mg.
Vicodin (Acetaminophen and Hydrocodone Bitartrate
Tablets), 500 mg/5 mg.
Vicodin ES (Acetaminophen and Hydrocodone
Bitartrate Tablets), 750 mg/7.5 mg.
SYNALGOS–DC–A (Acetaminophen, Caffeine, and
Dihydrocodeine Bitartrate Capsules), 356.4 mg/30
mg/16 mg.
Acetaminophen and Hydrocodone Bitartrate Oral Solution, 500 mg/15 milliliters (mL); 7.5 mg/15 mL.
Acetaminophen and Hydrocodone Bitartrate Tablets,
500 mg/10 mg.
Acetaminophen,
Caffeine,
and
Dihydrocodeine
Bitartrate Tablets, 712.8 mg/60 mg/32 mg.
AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL
60064.
AbbVie Inc.
ANDA 88058 ........................
ANDA 89736 ........................
ANDA 89166 ........................
ANDA 40366 ........................
ANDA 040148 ......................
pmangrum on DSK3VPTVN1PROD with NOTICES
ANDA 040637 ......................
With respect to the ANDAs listed in
table 1 (with the exception of ANDA
040148), for the reasons discussed in the
January 14, 2011, and March 27, 2014,
notices, the Director of CDER, under
section 505(e)(2) of the FD&C Act and
under authority delegated to her by the
Commissioner of Food and Drugs (the
Commissioner), finds that new evidence
of clinical experience, not contained in
the applications listed in table 1 and not
available at the time the applications
were approved, shows that prescription
drugs containing more than 325 mg of
acetaminophen per dosage unit are not
safe for use under the conditions of use
that formed the basis upon which the
applications were approved (21 U.S.C.
355(e)(2)). Therefore, approval of the
applications for the drug products listed
in table 1 of this document (with the
exception of ANDA 040148), and all
amendments and supplements thereto,
is withdrawn (see DATES). Distribution
of these products in interstate commerce
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).
With respect to ANDA 040148 listed
in table 1, under § 314.150(d), and
under authority delegated to the
Director of CDER by the Commissioner,
approval of ANDA 040148 and all
amendments and supplements thereto,
is withdrawn (see DATES).
The safety issue discussed in this
document and the March 27, 2014, and
January 14, 2011, Federal Register
notices is limited to products containing
more than 325 mg of acetaminophen per
dosage unit. Thus, the withdrawal of
approval of products containing more
than 325 mg of acetaminophen per
dosage unit listed in table 1 does not
change the approval status of any
products with 325 mg or less of
acetaminophen per dosage unit that
were approved under the same
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AbbVie Inc.
Leitner Pharmaceuticals LLC, 340 Edgemont Ave.,
Bristol, TN 37620.
Nesher Pharmaceuticals USA LLC, 13910 St. Charles
Rock Rd., Bridgeton, MO 63044.
Watson Laboratories, 311 Bonnie Circle, Corona, CA
92880.
West-Ward Pharmaceutical Corp., 435 Industrial Way
West, Eatontown, NJ 07724.
application. In addition, the withdrawal
of approval of products containing more
than 325 mg of acetaminophen per
dosage unit does not change the
approval status of products with 325 mg
or less of acetaminophen per dosage
unit that refer to or rely on the
withdrawn products. For example, this
withdrawal action will not affect the
approval status of an ANDA for a
product that contains 325 mg or less per
dosage unit that references a product
listed in table 1, but for which FDA
approved a suitability petition for a
lower strength under section 505(j)(2)(C)
of the FD&C Act and § 314.93 (21 CFR
314.93)).
Dated: July 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–16820 Filed 7–16–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: The Development of Chimeric
Antigen Receptors Targeting B-Cell
Maturation Antigen To Treat or Prevent
Cancer and Autoimmune Disease
AGENCY:
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 exclusive patent license to Bluebird
Bio to practice the inventions embodied
in US Provisional Patent Application
Serial No. 61/622,600, entitled
SUMMARY:
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‘‘Chimeric Antigen Receptors Targeting
B-cell Maturation Antigen’’ [HHS Ref.
E–040–2012/0–US–01], and
International (PCT) Application No.
PCT/US13/32029, entitled ‘‘Chimeric
Antigen Receptors Targeting B-cell
Maturation Antigen’’ [HHS Ref. E–040–
2012/0–PCT–02], and all continuing
applications and foreign counterparts.
The patent rights in these inventions
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:
Use of the Patent Rights to make and have
made, to sell, to offer for sale, to import, and
to use in humans, human autologous
peripheral blood T-cells modified by
recombinant human immunodeficiency virus
(‘‘HIV’’)-based lentiviral vectors or murine
leukemia virus (‘‘MLV’’)-based gammaretroviral vectors to express chimeric antigen
receptors that recognize B-cell Maturation
Antigen (‘‘BCMA’’) for the treatment or
prevention of cancer and autoimmune
diseases.
Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before
August 18, 2014 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 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–
4632; Facsimile: (301) 402–0220; Email:
mccuepat@od.nih.gov.
SUPPLEMENTARY INFORMATION: These
inventions concern a series of chimeric
antigen receptors (CARs) that
specifically target BCMA, a protein that
is highly expressed on the surface of
DATES:
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Federal Register / Vol. 79, No. 137 / Thursday, July 17, 2014 / Notices
multiple myeloma cells. The pending
patent application includes claims to
compositions and vectors incorporating
the CARs, as well as methods of
destroying multiple myeloma cells
using T-cells engineered to express a
CAR.
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. 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
within thirty (30) days from the date of
this published notice.
Applications for a license in the field
of use that are 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.
Dated: July 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16764 Filed 7–16–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
pmangrum on DSK3VPTVN1PROD with NOTICES
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The 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. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; North
American Prodrome Longitudinal Study-3
[NAPLS].
Date: July 25, 2014.
Time: 11:30 a.m. to 1:30 p.m.
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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: David I. Sommers, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892–9606, 301–443–7861,
dsommers@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: July 11, 2014.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–16746 Filed 7–16–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Small
Grants Program for Epidemiology.
Date: July 23, 2014.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
2E032, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Gerald G. Lovinger, Ph.D.,
Scientific Review Officer, Research
Technology and Contract Review Branch,
Division of Extramural Activities, National
Cancer Institute, 9609 Medical Center Drive,
Room 7W266, Bethesda, MD 20892–8329,
240–276–6385, lovingeg@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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limitations imposed by the review and
funding cycle.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI U01
Review.
Date: August 26, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
3W032/034, Rockville, MD 20850.
Contact Person: Ben Prickril, Ph.D.,
Scientific Review Officer, Research Program
and Review Branch, DEA, Division of
Extramural Activities, National Cancer
Institute, 9609 Medical Center Drive, Room
7W634, Rockville, MD 20850, 240–276–5794,
prickril@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Program Project Meeting II (P01).
Date: September 30–October 1, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Rockville Hotel, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Majed M. Hamawy, Ph.D.,
MBA, Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
7W120, Rockville, MD 20850, 240–276–6457,
mh101v@nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
J—Career Development.
Date: October 29, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W640, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Ilda F. S. Melo, Ph.D.,
Scientific Review Officer, Resources and
Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W122, Rockville, MD 20850, 240–
276–6468, ilda.melo@mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/sep/sep.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: July 11, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–16744 Filed 7–16–14; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41700-41701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16764]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive License: The Development of
Chimeric Antigen Receptors Targeting B-Cell Maturation Antigen To Treat
or Prevent Cancer and Autoimmune Disease
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 exclusive patent
license to Bluebird Bio to practice the inventions embodied in US
Provisional Patent Application Serial No. 61/622,600, entitled
``Chimeric Antigen Receptors Targeting B-cell Maturation Antigen'' [HHS
Ref. E-040-2012/0-US-01], and International (PCT) Application No. PCT/
US13/32029, entitled ``Chimeric Antigen Receptors Targeting B-cell
Maturation Antigen'' [HHS Ref. E-040-2012/0-PCT-02], and all continuing
applications and foreign counterparts. The patent rights in these
inventions 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:
Use of the Patent Rights to make and have made, to sell, to
offer for sale, to import, and to use in humans, human autologous
peripheral blood T-cells modified by recombinant human
immunodeficiency virus (``HIV'')-based lentiviral vectors or murine
leukemia virus (``MLV'')-based gamma-retroviral vectors to express
chimeric antigen receptors that recognize B-cell Maturation Antigen
(``BCMA'') for the treatment or prevention of cancer and autoimmune
diseases.
DATES: Only written comments or applications for a license (or both)
which are received by the NIH Office of Technology Transfer on or
before August 18, 2014 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 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) 435-4632; Facsimile: (301) 402-0220; Email:
mccuepat@od.nih.gov.
SUPPLEMENTARY INFORMATION: These inventions concern a series of
chimeric antigen receptors (CARs) that specifically target BCMA, a
protein that is highly expressed on the surface of
[[Page 41701]]
multiple myeloma cells. The pending patent application includes claims
to compositions and vectors incorporating the CARs, as well as methods
of destroying multiple myeloma cells using T-cells engineered to
express a CAR.
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. 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 within thirty (30) days from the date of
this published notice.
Applications for a license in the field of use that are 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.
Dated: July 14, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-16764 Filed 7-16-14; 8:45 am]
BILLING CODE 4140-01-P
