Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications, 56086-56087 [2018-24605]
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56086
Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
CMS–R–240 Prospective Payments for
Hospital Outpatient Services
CMS–10164 Medicare EDI Enrollment
Form and EDI Registration
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
khammond on DSK30JT082PROD with NOTICES
Information Collection
1. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Prospective
Payments for Hospital Outpatient
Services; Use: Section 1833(t) of the Act,
as added by section 4523 of the
Balanced Budget Act of 1997 (the BBA)
requires the Secretary to establish a
prospective payment system (PPS) for
hospital outpatient services. Successful
implementation of an outpatient PPS
requires that CMS distinguish facilities
or organizations that function as
departments of hospitals from those that
are freestanding, so that CMS can
determine which services should be
paid under the OPPS, the clinical
laboratory fee schedule, or other
payment provisions applicable to
services furnished to hospital
outpatients. Information from the
reports required under sections
413.65(b)(3) and (c) is needed to make
these determinations. In addition,
section 1866(b)(2) of the Act authorizes
hospitals and other providers to impose
deductible and coinsurance charges for
facility services, but does not allow such
charges by facilities or organizations
which are not provider-based.
Implementation of this provision
requires that CMS have information
from the required reports, so it can
determine which facilities are providerbased. Form Number: CMS–R–240
VerDate Sep<11>2014
17:36 Nov 08, 2018
Jkt 247001
(OMB control number: 0938–0798);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 750; Total
Annual Responses: 13,649,150; Total
Annual Hours: 680,920 (For policy
questions regarding this collection
contact Emily Lipkin at 410–786–3633.)
2. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Medicare EDI
Enrollment Form and EDI Registration;
Use: The Congress, recognizing the need
to simplify the administration of health
care transactions, enacted the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–191, on August 21,
1996. Title II, Subtitle F of this
legislation directs the Secretary of the
Department of Health and Human
Services to develop unique standards
for specified electronic transactions and
code sets for those transactions. The
purpose of this Subtitle is to improve
the Medicare and Medicaid programs in
particular and the efficiency and
effectiveness of the health care industry
in general through the establishment of
standards and requirements to facilitate
the electronic transmission of certain
health information. This Subtitle also
requires that the Secretary adopt
standards for financial and
administrative transactions, and data
elements for those transactions to enable
health information to be exchanged
electronically. The Standards for
Electronic Transactions final rule, 45
CFR part 162 Subpart K § 162.1101
through Subpart R § 162.1802,
(hereinafter referred to as ‘‘Transactions
Rule’’) published August 17, 2000
adopted standards for health care
transactions and code sets. Subsequent
to the Transactions Rule, CMS–0003–P
and CMS–0005–P proposed
modifications to the adopted standards
essential to permit initial
implementation of the standards
throughout the entire healthcare
industry.
Currently, Medicare contractors have
a process in place to enroll providers for
electronic billing and other EDI
transactions. In support of the HIPAA
Transactions Rule, the purpose of this
Paperwork Reduction Act (PRA) request
is to establish a common form that is
sufficient to address all HIPAA
transactions. Form Number: CMS–10164
(OMB control number: 0938–0983);
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Frequency: Hourly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 193,268;
Number of Responses: 193,268; Total
Annual Hours: 64,423. (For policy
questions regarding this collection,
contact Matt Klischer at 410–786–7488.)
Dated: November 6, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–24592 Filed 11–8–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4099]
Tedor Pharma, Inc., et al.; Withdrawal
of Approval of 10 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
December 10, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUMMARY:
E:\FR\FM\09NON1.SGM
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Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices
Application No.
Drug
Applicant
ANDA 040747 ......................
Benzphetamine Hydrochloride (HCl) Tablets, 25 milligrams (mg) and 50 mg.
Gentamicin Sulfate Injection USP, Equivalent to (EQ)
10 mg base/milliliter (mL) and EQ 40 mg base/mL.
Isoflurane USP, 99.9% ....................................................
Tedor Pharma, Inc., 400 Highland Corporate Dr., Cumberland, RI 02864.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Fresenius Kabi USA, LLC.
ANDA 062356 ......................
ANDA 074097 ......................
ANDA 076484 ......................
ANDA 080504 ......................
ANDA 083559 ......................
ANDA 084315 ......................
ANDA 084850 ......................
ANDA 086389 ......................
ANDA 087863 ......................
Ciprofloxacin Injection USP, 200 mg/20 mL and 400
mg/40 mL.
Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL;
2% and 0.02 mg/mL; 2%.
Lidocaine HCl Injection, 2%.
Mepivacaine HCl Injection, 3% .......................................
Dexamethasone Acetate Injectable Suspension USP,
EQ 8 mg base/mL.
Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05
mg/mL.
Lidocaine HCl Viscous Oral Topical Solution USP, 2%
Choledyl SA (oxtriphylline) Extended-Release Tablets
USP, 400 mg.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 10,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on December 10,
2018 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24605 Filed 11–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–2506]
khammond on DSK30JT082PROD with NOTICES
56087
Determination That AXIRON
(Testosterone) Transdermal Metered
Solution, 30 Milligrams/1.5 Milliliter
Actuation, 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 AXIRON (testosterone)
SUMMARY:
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17:36 Nov 08, 2018
Jkt 247001
Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA
22202.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Belmora LLC.
International Medication Systems, Ltd., 1886 Santa
Anita Ave., South El Monte, CA 91733.
Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
transdermal metered solution, 30
milligrams (mg)/1.5 milliliter (mL)
actuation, 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 if 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.
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
PO 00000
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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.
AXIRON (testosterone) transdermal
metered solution, 30 mg/1.5 mL
actuation, is the subject of NDA 022504,
held by Eli Lilly and Company and
initially approved on November 23,
2010. AXIRON is indicated for
replacement therapy in males for
conditions associated with a deficiency
or absence of endogenous testosterone.
In a letter dated September 5, 2017,
Eli Lilly and Company requested
withdrawal of NDA 022504 for AXIRON
(testosterone). Eli Lilly and Company
later submitted a letter dated September
7, 2017 correcting a typographical error
in the September 5, 2017 letter. In the
Federal Register of June 21, 2018 (83 FR
28856), FDA announced that it was
withdrawing approval of NDA 022504,
effective July 23, 2018.
K&L Gates LLP submitted a citizen
petition received by FDA on June 27,
E:\FR\FM\09NON1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56086-56087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4099]
Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 10 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 10, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
[[Page 56087]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040747................. Benzphetamine Tedor Pharma, Inc.,
Hydrochloride (HCl) 400 Highland
Tablets, 25 Corporate Dr.,
milligrams (mg) and Cumberland, RI
50 mg. 02864.
ANDA 062356................. Gentamicin Sulfate Fresenius Kabi USA,
Injection USP, LLC, Three
Equivalent to (EQ) Corporate Dr., Lake
10 mg base/ Zurich, IL 60047.
milliliter (mL) and
EQ 40 mg base/mL.
ANDA 074097................. Isoflurane USP, Hospira, Inc., 275
99.9%. North Field Dr.,
Bldg. H1, Lake
Forest, IL 60045.
ANDA 076484................. Ciprofloxacin Fresenius Kabi USA,
Injection USP, 200 LLC.
mg/20 mL and 400 mg/
40 mL.
ANDA 080504................. Epinephrine and Belmora LLC, 2231
Lidocaine HCl Crystal Dr., #1000,
Injection, 0.01 mg/ Arlington, VA
mL; 2% and 0.02 mg/ 22202.
mL; 2%.
Lidocaine HCl
Injection, 2%..
ANDA 083559................. Mepivacaine HCl Do.
Injection, 3%.
ANDA 084315................. Dexamethasone Watson Laboratories,
Acetate Injectable Inc., Subsidiary of
Suspension USP, EQ Teva
8 mg base/mL. Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 084850................. Levonordefrin and Belmora LLC.
Mepivacaine HCl
Injection, 2%; 0.05
mg/mL.
ANDA 086389................. Lidocaine HCl International
Viscous Oral Medication Systems,
Topical Solution Ltd., 1886 Santa
USP, 2%. Anita Ave., South
El Monte, CA 91733.
ANDA 087863................. Choledyl SA Warner Chilcott Co.,
(oxtriphylline) LLC, Subsidiary of
Extended-Release Teva
Tablets USP, 400 mg. Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 10, 2018. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the
table that are in inventory on December 10, 2018 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24605 Filed 11-8-18; 8:45 am]
BILLING CODE 4164-01-P
