Determination That CARDENE SR (Nicardipine HCl) Extended-Release Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 49840-49841 [2017-23438]
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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
collect patient experience data to inform
regulatory decision making may use.
In addition, FDA committed to meet
certain performance goals under PDUFA
VI. These goal commitments were
developed in consultation with patient
and consumer advocates, health care
professionals, and other public
stakeholders, as part of negotiations
with regulated industry. Section J.1 of
the commitment letter, ‘‘Enhancing the
Incorporation of the Patient’s Voice in
Drug Development and DecisionMaking,’’ (https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM511438.pdf) outlines work,
including the development of a series of
guidance documents and associated
public workshops to facilitate the
advancement and use of systematic
approaches to collect and utilize robust
and meaningful patient and caregiver
input that can more consistently inform
drug development, and, as appropriate,
regulatory decision making.
Prior to the issuance of each guidance,
as part of the development, FDA will
conduct a public workshop to gather
input from the wider community of
patients, patient advocates, academic
researchers, expert practitioners, drug
developers, and other stakeholders.
II. Purpose and Scope of Meeting
FDA is announcing a public
workshop to convene a discussion on
topics related to approaches to
collecting comprehensive and
representative patient and caregiver
input on burden of disease and current
therapy. The purpose of this public
workshop is to obtain feedback from
stakeholders on considerations for: (1)
Standardized nomenclature and
terminologies for patient-focused drug
development, (2) methods to collect
meaningful patient input throughout the
drug development process, and (3)
methodological considerations for data
collection, reporting, management, and
analysis of patient input. FDA is seeking
information and comments from a broad
range of stakeholders, including
patients, patient advocates, academic
and medical researchers, expert
practitioners, drug developers, and
other interested persons. FDA will
publish a discussion document
outlining the topic areas that will be
addressed in the draft guidance. This
document will be published
approximately 1 month before the
workshop date on the Web site at:
https://www.fda.gov/Drugs/NewsEvents/
ucm574725.htm. FDA is interested in
seeking information and comments on
the approaches and considerations
proposed in the discussion document,
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17:54 Oct 26, 2017
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as well as the examples provided. FDA
is also interested in seeking information
and comments on additional examples
where the approaches proposed in the
discussion document have been
successfully applied that could be
included in guidance. After this public
workshop, FDA will take into
consideration the stakeholder input
from the workshop and the public
docket, and publish a draft guidance by
the end of the third quarter of fiscal year
2018.
Registration: Interested parties are
encouraged to register early. To register
electronically, please visit: https://
pfdd.eventbrite.com. Persons without
access to the internet can call 240–402–
6525 to register. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. You will be asked to indicate
in your registration if you plan to attend
in person or via the webcast. Seating
will be limited, so early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the meeting
will be based on space availability.
If you need special accommodations
because of a disability, please contact
Meghana Chalasani (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
Request for Oral Presentations: There
will be time allotted during the
workshop for open public comment.
Sign-up for this session will be on a
first-come, first-serve basis on the day of
the workshop. Individuals and
organizations with common interests are
urged to consolidate or coordinate, and
request time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Transcripts: As soon as a transcript is
available, FDA will post it at https://
www.fda.gov/Drugs/NewsEvents/
ucm574725.htm.
Dated: October 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23437 Filed 10–26–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2660]
Determination That CARDENE SR
(Nicardipine HCl) Extended-Release
Capsules, 30 Milligrams, 45 Milligrams,
and 60 Milligrams, 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 CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 milligrams (mg), 45 mg,
and 60 mg, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
nicardipine HCl extended-release
capsules, 30 mg, 45 mg, and 60 mg, if
all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208,
Silver Spring, MD 20993–0002, 301–
796–6650.
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
SUMMARY:
E:\FR\FM\27OCN1.SGM
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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.
CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, and 60 mg, are the subject of NDA
020005, initially approved on February
21, 1992. CARDENE SR is indicated for
the treatment of hypertension.
In a letter dated September 15, 2014,
EKR Therapeutics, Inc., requested
withdrawal of NDA 020005 for
CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, and 60 mg. In the Federal Register
of October 4, 2016 (81 FR 68427), FDA
announced that it was withdrawing
approval of NDA 020005, effective
November 3, 2016.
Jubilant Generics submitted a citizen
petition dated April 27, 2017 (Docket
No. FDA–2017–P–2660), under 21 CFR
10.30, requesting that the Agency
determine whether CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were 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 CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that CARDENE
SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CARDENE
SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg 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.
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
Accordingly, the Agency will
continue to list CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg, 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. ANDAs that refer
to CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, or 60 mg, may 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.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23438 Filed 10–26–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
27, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0697. Also
include the FDA docket number found
SUMMARY:
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49841
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Generic Clearance for the Collection of
Qualitative Feedback on Agency
Service Delivery
OMB Control Number 0910–0697—
Extension
The information collection activity
will garner qualitative customer and
stakeholder feedback in an efficient,
timely manner in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This voluntary feedback will provide
insights into customer or stakeholder
perceptions, experiences and
expectations, provide an early warning
of issues with service, or focus attention
on areas where communication,
training, or changes in operations might
improve delivery of products or
services. These collections will allow
for ongoing, collaborative, and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address the
following: The target population to
which generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
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]]>Agencies
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49840-49841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23438]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-2660]
Determination That CARDENE SR (Nicardipine HCl) Extended-Release
Capsules, 30 Milligrams, 45 Milligrams, and 60 Milligrams, 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 CARDENE SR (nicardipine HCl) extended-release capsules,
30 milligrams (mg), 45 mg, and 60 mg, were not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for nicardipine
HCl extended-release capsules, 30 mg, 45 mg, and 60 mg, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Daniel Gottlieb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-6650.
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
[[Page 49841]]
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.
CARDENE SR (nicardipine HCl) extended-release capsules, 30 mg, 45
mg, and 60 mg, are the subject of NDA 020005, initially approved on
February 21, 1992. CARDENE SR is indicated for the treatment of
hypertension.
In a letter dated September 15, 2014, EKR Therapeutics, Inc.,
requested withdrawal of NDA 020005 for CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45 mg, and 60 mg. In the Federal
Register of October 4, 2016 (81 FR 68427), FDA announced that it was
withdrawing approval of NDA 020005, effective November 3, 2016.
Jubilant Generics submitted a citizen petition dated April 27, 2017
(Docket No. FDA-2017-P-2660), under 21 CFR 10.30, requesting that the
Agency determine whether CARDENE SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg, were 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 CARDENE SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that CARDENE SR (nicardipine HCl) extended-
release capsules, 30 mg, 45 mg, and 60 mg, were withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45 mg, and 60 mg 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 CARDENE SR
(nicardipine HCl) extended-release capsules, 30 mg, 45 mg, and 60 mg,
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. ANDAs that refer to CARDENE SR
(nicardipine HCl) extended-release capsules, 30 mg, 45 mg, or 60 mg,
may 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.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23438 Filed 10-26-17; 8:45 am]
BILLING CODE 4164-01-P
