Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000 Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 13304-13305 [2019-06549]
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13304
Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
Our estimate is based on our
experience with the submission of
labeling materials for human
prescription drugs. Because this is a
new collection of information, we are
specifically interested in receiving
comments from respondents to the
information collection regarding our
burden estimate.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06565 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–3883]
Determination That CORTISPORIN
(Hydrocortisone/Neomycin Sulfate/
Polymyxin B Sulfate) Otic Solution, 10
Milligrams/Milliliter Hydrocortisone, 3.5
Milligrams Base/Milliliter Neomycin
Sulfate, 10,000 Units/Milliliter
Polymyxin B Sulfate, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
milligrams (mg)/milliliter (mL)
hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6286, Silver Spring,
MD 20993–0002, 240–402–1748.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
jbell on DSK30RV082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Apr 03, 2019
Jkt 247001
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate, is
the subject of NDA 050479, held by
Monarch Pharmaceuticals LLC, and
initially approved on December 9, 1975.
CORTISPORIN is indicated for the
treatment of superficial bacterial
infections of the external auditory canal
caused by organisms susceptible to the
action of the antibiotics.
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Foley & Lardner LLP submitted a
citizen petition dated October 11, 2018
(Docket No. FDA–2018–P–3883), under
§ 10.30 (21 CFR 10.30), requesting that
the Agency determine whether
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate,
was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs.
If FDA determines that labeling for
this drug product should be revised to
meet current standards, the Agency will
advise ANDA applicants to submit such
labeling.
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
grant of an Exclusive/Co-Exclusive
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the
Supplementary Information section of
this Notice to Senti Bio (‘‘Senti’’),
located in South San Francisco, CA.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before April 19, 2019 will be
considered.
[FR Doc. 2019–06549 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Charter Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Frederick
National Laboratory Advisory
Committee to the National Cancer
Institute was renewed for an additional
two-year period on March 30, 2019.
It is determined that the Frederick
National Laboratory Advisory
Committee to the National Cancer
Institute is in the public interest in
connection with the performance of
duties imposed on the National Cancer
Institute and National Institutes of
Health by law, and that these duties can
best be performed through the advice
and counsel of this group.
Inquiries may be directed to Claire
Harris, Acting Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or harriscl@nih.gov.
Dated: April 1, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–06569 Filed 4–3–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive/CoExclusive Patent License:
Development and Commercialization
of Next Generation Chimeric Antigen
Receptor (CAR) Therapies for the
Treatment of FMS-Like tyrosine kinase
3 (FLT3) Expressing Cancers
jbell on DSK30RV082PROD with NOTICES
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
SUMMARY:
VerDate Sep<11>2014
17:25 Apr 03, 2019
Jkt 247001
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive/Co-Exclusive Patent License
should be directed to: Jim Knabb, Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)–276–7856;
Facsimile: (240)–276–5504; Email:
jim.knabb@nih.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Intellectual Property
E–133–2016: FLT3-Specific Chimeric
Antigen Receptors and Methods Using
Same
1. US Provisional Patent Application
62/342,394, filed May 27, 2016 (E–133–
2016–0–US–01);
2. International Patent Application
PCT/US2017/034,691, filed May 26,
2017 (E–133–2016–0–PCT–02)
3. EP Patent Application
No.:17729627.4, filed December 11,
2018 (E–133–2016/0–EP–03)
4. US Patent Application No.: 16/
304,552, filed November 26, 2018 (E–
133–2016/0–US–05
5. Australia Patent Application No.:
2017271606, filed November 13, 2018
(E–133–2016/0–AU–06)
6. Canadian Patent Application No.:
3025516, filed November 23, 2018 (E–
133–2016/0–CA–07)
7. Japan Patent Application No.:
2018–561669, filed November 22, 2018
(E–133–2016/0–JP–08)
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive/coexclusive license territory may be
worldwide, and the fields of use may be
limited to the following:
An exclusive license to: ‘‘the
development of a universal/split
chimeric antigen receptor (CAR)-based
immunotherapy using autologous or
allogeneic human lymphocytes (T cells
or NK cells) transduced with lentiviral
vectors, for the prophylaxis or treatment
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
13305
of cancers expressing FMS-like tyrosine
kinase 3 (FLT3; also known as CD135),
wherein the CAR construct binds to the
FLT3-binding domain referenced as
NC7 in the invention, but NC7 is not
included in the CAR construct.
Specifically excluded from the field of
use for this exclusive license are FLT3specific CAR -based immunotherapies
wherein the CAR construct comprises
the FLT3-binding domain referenced as
NC7 in the invention as well as an
intracellular signaling domain.’’ The
proposed territory is worldwide.
A co-exclusive license to: ‘‘the
development of a multi-specific FLT3
CAR-based immunotherapy using
autologous or allogeneic human
lymphocytes (T cells or NK cells)
transduced with lentiviral vectors,
wherein the viral transduction leads to
the expression of a CAR that targets
FLT3 (comprised of the FLT3-binding
domain referenced as NC7 in the
invention as well as an intracellular
signaling domain), for the prophylaxis
or treatment of FLT3-expressing
cancers.’’ The proposed territory is
worldwide.
A co-exclusive license to: ‘‘the
development of a FLT3-specific
Regulated/Switch/Logic-Gated CARbased immunotherapy using autologous
or allogeneic human lymphocytes (T
cells or NK cells) transduced with
lentiviral vectors, wherein the viral
transduction leads to the expression of
a CAR that targets FLT3 (comprised of
the FLT3-binding domain referenced as
NC7 in the invention as well as an
intracellular signaling domain), for the
prophylaxis or treatment of FLT3expressing cancers.’’ The proposed
territory is worldwide.
This technology discloses a CAR
therapy that targets FLT3 by utilizing
the anti-FLT3 binder known as NC7.
FLT3 (CD135) is a cytokine receptor
expressed on hematopoietic progenitor
cells and is one of the most frequently
mutated genes in acute myeloid
leukemia (AML) and infant acute
lymphoblastic leukemia (ALL). FLT3
mutation leads to increased cell surface
expression and therefore on leukemic
cells, which makes it an attractive
candidate for cellular therapies such as
CAR–T.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive/co-exclusive
license will be royalty bearing, and the
prospective exclusive/co-exclusive
license may be granted unless within
fifteen (15) days from the date of this
published Notice, the National Cancer
Institute receives written evidence and
argument that establishes that the grant
of the license would not be consistent
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13304-13305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06549]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-3883]
Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/
Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter
Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000
Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin
B sulfate) otic solution, 10 milligrams (mg)/milliliter (mL)
hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not withdrawn from sale for reasons of safety
or effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is the subject of NDA
050479, held by Monarch Pharmaceuticals LLC, and initially approved on
December 9, 1975. CORTISPORIN is indicated for the treatment of
superficial bacterial infections of the external auditory canal caused
by organisms susceptible to the action of the antibiotics.
CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
Foley & Lardner LLP submitted a citizen petition dated October 11,
2018 (Docket No. FDA-2018-P-3883), under Sec. 10.30 (21 CFR 10.30),
requesting that the Agency determine whether CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that CORTISPORIN (hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone, 3.5 mg
base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CORTISPORIN (hydrocortisone/neomycin
sulfate/polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, in the ``Discontinued Drug Product List'' section
of the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. FDA will not
begin procedures to withdraw approval of approved ANDAs that refer to
this drug product. Additional ANDAs for this drug product may also be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs.
If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
[[Page 13305]]
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06549 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P