Determination That OPHTHAINE (proparacaine hydrochloride) Solution and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75867-75868 [2015-30628]
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
conditions that an ASC must meet in
order to participate in the Medicare
program, the scope of covered services,
and the conditions for Medicare
payment for ASCs.
Generally, to enter into an agreement,
an ASC must first be certified by a State
survey agency as complying with the
conditions or requirements set forth in
part 416 of our Medicare regulations.
Thereafter, the ASC is subject to regular
surveys by a State survey agency to
determine whether it continues to meet
these requirements.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by a Centers for
Medicare & Medicaid Services (CMS)
approved national accrediting
organization (NAO) that all applicable
Medicare conditions are met or
exceeded, we may deem those provider
entities as having met the requirements.
Accreditation by an NAO is voluntary
and is not required for Medicare
participation.
If an NAO is recognized by the
Secretary of the Department of Health
and Human Services as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program may be deemed to meet the
Medicare conditions. A NAO applying
for approval of its accreditation program
under part 488, subpart A, must provide
CMS with reasonable assurance that the
NAO requires the accredited provider
entities to meet requirements that are at
least as stringent as the Medicare
conditions. Our regulations concerning
the approval of NAOs are set forth at
§ 488.5.
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a NAO’s requirements
consider, among other factors, the
applying NAO’s requirements for
accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
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We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of the Institute
for Medical Quality (IMQ’s) request for
initial CMS-approval of its ASC
accreditation program. This notice also
solicits public comment on whether
IMQ’s requirements meet or exceed the
Medicare conditions for coverage (CfCs)
for ASCs.
III. Evaluation of a NAO’s
Accreditation Program
IMQ submitted all the necessary
materials to enable us to make a
determination concerning its request for
initial CMS-approval of its ASC
accreditation program. This application
was determined to be complete on
October 8, 2015. Under Section
1865(a)(2) of the Act and our regulations
at § 488.5, our review and evaluation of
IMQ will be conducted in accordance
with, but not necessarily limited to, the
following factors:
• The equivalency of IMQ’s standards
for ASCs as compared with Medicare’s
CfCsf or ASCs.
• IMQ’s survey process to determine
the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of IMQ’s
processes to those of State agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ IMQ’s processes and procedures
for monitoring an ASC found out of
compliance with IMQ’s program
requirements. These monitoring
procedures are used only when IMQ
identifies noncompliance. If
noncompliance is identified through
validation reviews or complaint
surveys, the State survey agency
monitors corrections as specified at
§ 488.9(c)(1).
++ IMQ’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ IMQ’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of IMQ’s staff and
other resources, and its financial
viability.
++ IMQ’s capacity to adequately fund
required surveys.
++ IMQ’s policies with respect to
whether surveys are announced or
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75867
unannounced, to assure that surveys are
unannounced.
++ IMQ’s agreement to provide CMS
with a copy of the most current
accreditation survey together with any
other information related to the survey
as CMS may require (including
corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
Dated: November 18, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–30316 Filed 12–3–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–4399]
Determination That OPHTHAINE
(proparacaine hydrochloride) Solution
and Other Drug Products Were 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 the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
SUMMARY:
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04DEN1
75868
Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Notices
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
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 approved
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is 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
Application No.
Drug
NDA 008883 ......
OPHTHAINE (proparacaine hydrochloride) Solution/Drops;
Ophthalmic, 0.5%.
PURINETHOL (mercaptopurine) Tablet; Oral, 50 milligrams
(mg).
DIDREX (benzphetamine hydrochloride) Tablet; Oral, 50 mg
OPHTHETIC (proparacaine hydrochloride) Solution/Drops;
Ophthalmic, 0.5%.
OVCON–35 (ethinyl estradiol; norethindrone) Tablet; Oral-28,
0.035 mg; 0.4 mg.
NORDETTE–28 (ethinyl estradiol; levonorgestrel) Tablet;
Oral-28, 0.03 mg; 0.15 mg.
QUIXIN (levofloxacin) Solution/Drops; Ophthalmic, 0.5% .......
SANCTURA (trospium chloride) Tablet; Oral, 20 mg ..............
BROMDAY (bromfenac sodium) Solution/Drops; Ophthalmic,
EQ 0.09% acid.
SANCTURA XR (trospium chloride) Extended-Release Capsule; Oral, 60 mg.
MYCOSTATIN (nystatin) Ointment; Topical, 100,000 units/
gram (g).
MYCOSTATIN (nystatin) Cream; Topical, 100,000 units/g .....
MYCOSTATIN (nystatin) Powder; Topical 100,000 units/g .....
TOBRAMYCIN SULFATE (PHARMACY BULK) (tobramycin
sulfate) Injectable; Injection, EQ 40 mg base/milliliter.
NDA 009053 ......
NDA 012427 ......
NDA 012583 ......
NDA 017716 ......
NDA 018782 ......
NDA 021199 ......
NDA 021595 ......
NDA 021664 ......
NDA 022103 ......
ANDA 060571 ....
ANDA 060575 ....
ANDA 060578 ....
ANDA 063116 ....
asabaliauskas on DSK5VPTVN1PROD with NOTICES
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
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18:41 Dec 03, 2015
Jkt 238001
Applicant
Apothecon, Inc.
Teva Pharmaceuticals USA.
Pharmacia & Upjohn Co.
Allergan Pharmaceutical.
Warner Chilcott LLC.
Teva Branded Pharmaceutical Products R and D, Inc.
Santen, Inc.
Allergan, Inc.
Bausch & Lomb, Inc.
Allergan, Inc.
Delcor Asset Corp.
Do.
Do.
Hospira, Inc.
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–30628 Filed 12–3–15; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75867-75868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4399]
Determination That OPHTHAINE (proparacaine hydrochloride)
Solution and Other Drug Products Were 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 the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means
[[Page 75868]]
that FDA will not begin procedures to withdraw approval of abbreviated
new drug applications (ANDAs) that refer to these drug products, and it
will allow FDA to continue to approve ANDAs that refer to the products
as long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
Stacy.Kane@fda.hhs.gov.
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 approved 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 generally known as the ``Orange
Book.'' Under FDA regulations, a drug is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 008883............. OPHTHAINE (proparacaine Apothecon, Inc.
hydrochloride)
Solution/Drops;
Ophthalmic, 0.5%.
NDA 009053............. PURINETHOL Teva Pharmaceuticals
(mercaptopurine) USA.
Tablet; Oral, 50
milligrams (mg).
NDA 012427............. DIDREX (benzphetamine Pharmacia & Upjohn Co.
hydrochloride) Tablet;
Oral, 50 mg.
NDA 012583............. OPHTHETIC (proparacaine Allergan
hydrochloride) Pharmaceutical.
Solution/Drops;
Ophthalmic, 0.5%.
NDA 017716............. OVCON-35 (ethinyl Warner Chilcott LLC.
estradiol;
norethindrone) Tablet;
Oral-28, 0.035 mg; 0.4
mg.
NDA 018782............. NORDETTE-28 (ethinyl Teva Branded
estradiol; Pharmaceutical
levonorgestrel) Products R and D,
Tablet; Oral-28, 0.03 Inc.
mg; 0.15 mg.
NDA 021199............. QUIXIN (levofloxacin) Santen, Inc.
Solution/Drops;
Ophthalmic, 0.5%.
NDA 021595............. SANCTURA (trospium Allergan, Inc.
chloride) Tablet;
Oral, 20 mg.
NDA 021664............. BROMDAY (bromfenac Bausch & Lomb, Inc.
sodium) Solution/
Drops; Ophthalmic, EQ
0.09% acid.
NDA 022103............. SANCTURA XR (trospium Allergan, Inc.
chloride) Extended-
Release Capsule; Oral,
60 mg.
ANDA 060571............ MYCOSTATIN (nystatin) Delcor Asset Corp.
Ointment; Topical,
100,000 units/gram (g).
ANDA 060575............ MYCOSTATIN (nystatin) Do.
Cream; Topical,
100,000 units/g.
ANDA 060578............ MYCOSTATIN (nystatin) Do.
Powder; Topical
100,000 units/g.
ANDA 063116............ TOBRAMYCIN SULFATE Hospira, Inc.
(PHARMACY BULK)
(tobramycin sulfate)
Injectable; Injection,
EQ 40 mg base/
milliliter.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: November 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30628 Filed 12-3-15; 8:45 am]
BILLING CODE 4164-01-P
