Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 69856-69857 [2013-27874]
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69856
Federal Register / Vol. 78, No. 225 / Thursday, November 21, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Data collection method
General Public and Special Populations ........
Screening and Recruitment ...........................
In-depth Interviews (In Person, telephone,
etc.).
Focus Groups (In Person) .............................
Focus Groups (Online) ...................................
Short Surveys .................................................
(Online, Bulletin Board, etc.) ..........................
Medium Surveys ............................................
(Online) ...........................................................
In-depth Surveys (Online) ..............................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–27928 Filed 11–20–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0573]
Determination That BANZEL
(Rufinamide) Tablet, 100 Milligrams,
Was Not Withdrawn From Sale for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) has determined
that BANZEL (rufinamide) tablet, 100
milligrams (mg), was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
rufinamide tablet, 100 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Olivia Morris, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260,
Silver Spring, MD 20993–0002, 301–
796–3601.
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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:17 Nov 20, 2013
Jkt 232001
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 (§ 314.162 (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.
BANZEL (rufinamide) tablet, 100 mg,
is the subject of NDA 21–911, held by
Eisai Inc., and initially approved on
November 14, 2008. BANZEL is
indicated for adjunctive treatment of
seizures associated with Lennox-Gastaut
syndrome in children 4 years and older
and adults.
Eisai Inc., has never marketed
BANZEL (rufinamide) tablet, 100 mg. In
previous instances (see, e.g., 72 FR
9763, 61 FR 25497), the Agency has
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
20,000
67
1
1
2/60
1
160
120
6,500
1
1
1
1.5
1
10/60
8,500
1
25/60
1,500
1
1
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Lupin Pharmaceuticals, Inc.,
submitted a citizen petition dated May
9, 2013 (Docket No. FDA–2013–P–
0573), under 21 CFR 10.30, requesting
that the Agency determine whether
BANZEL (rufinamide) tablet, 100 mg,
was withdrawn or discontinued 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 BANZEL (rufinamide)
tablet, 100 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that BANZEL
(rufinamide) tablet, 100 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of BANZEL
(rufinamide) tablet, 100 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list BANZEL (rufinamide)
tablet, 100 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 BANZEL
(rufinamide) tablet, 100 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
E:\FR\FM\21NON1.SGM
21NON1
69857
Federal Register / Vol. 78, No. 225 / Thursday, November 21, 2013 / Notices
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27874 Filed 11–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review, 30-Day
Comment Request: Certificate of
Confidentiality Electronic Application
System
Under the provisions of
Section 3507(a) (1)(D) of the Paperwork
Reduction Act of 1995, the Office of
Extramural Research (OER), National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 29, 2013,
page 2590 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The Office of
Extramural Research (OER), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
SUMMARY:
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Ann Hardy, NIH Extramural
Human Research Protections Officer and
NIH Coordinator, Certificates of
Confidentiality, 3701 Rockledge Dr.,
Rm. 3002, Bethesda, MD 20892, or call
non-toll-free number (301) 435–2690 or
Email your request, including your
address to: hardyan@od.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Certificate of
Confidentiality Electronic Application
System, 0925-New, Office of Extramural
Research (OER), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This application system will
provide one electronic form to be used
by all research organizations that wish
to request a Certificate of Confidentiality
(CoC) from NIH. As described in the
authorizing legislation (Section 301(d)
of the Public Health Service Act, 42
U.S.C. § 241(d)), CoCs are issued by the
agencies of Department of Health and
Human Services (DHHS), including
NIH, to authorize researchers
conducting sensitive research to protect
the privacy of human research subjects
by enabling them to refuse to release
names and identifying characteristics of
subjects to anyone not connected with
the research. At NIH, the issuance of
CoCs has been delegated to the
individual NIH Institutes and Centers
(ICs). The NIH ICs collectively issue
approximately 1000 new CoCs each year
for eligible research projects. However,
the process for submitting a CoC request
is not consistent across the ICs which
creates confusion for applicants. To
make the application process consistent
across the entire agency, OER is
proposing to use an electronic
application system that will be accessed
by research organizations that wish to
request a CoC from any NIH IC. Having
one system for all CoC applications to
NIH will be efficient for both applicants
and NIH staff who process these
requests. As is currently done, NIH will
use the information in the application to
determine eligibility for a CoC and to
issue the CoC to the requesting
organization.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,500.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
CoC
CoC
CoC
CoC
Applicants-Private ....................................................................................
Applicants-State/local ..............................................................................
Applicants-Small business .......................................................................
Applicants-Federal ...................................................................................
Dated: November 13, 2013.
Seleda Perryman,
Chief, Project Clearance Officer, Office of
Policy for Extramural Research
Administration, National Institutes of Health.
[FR Doc. 2013–27966 Filed 11–20–13; 8:45 am]
BILLING CODE 4140–01–P
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
respondents
400
450
50
100
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Board on Medical
Rehabilitation Research.
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17:17 Nov 20, 2013
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Sfmt 4703
Frequency of
response
1
1
1
1
Average
time per
response
90/60
90/60
90/60
90/60
Annual hour
burden
600
675
75
150
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Advisory
Board on Medical Rehabilitation Research.
Date: December 2–3, 2013.
Time: December 2, 2013, 8:30 a.m. to 5:00
p.m.
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Pages 69856-69857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27874]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0573]
Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams,
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) has determined that
BANZEL (rufinamide) tablet, 100 milligrams (mg), was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
rufinamide tablet, 100 mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Olivia Morris, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993-0002, 301-
796-3601.
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 (Sec.
314.162 (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.
BANZEL (rufinamide) tablet, 100 mg, is the subject of NDA 21-911,
held by Eisai Inc., and initially approved on November 14, 2008. BANZEL
is indicated for adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome in children 4 years and older and adults.
Eisai Inc., has never marketed BANZEL (rufinamide) tablet, 100 mg.
In previous instances (see, e.g., 72 FR 9763, 61 FR 25497), the Agency
has determined that, for purposes of Sec. Sec. 314.161 and 314.162,
never marketing an approved drug product is equivalent to withdrawing
the drug from sale.
Lupin Pharmaceuticals, Inc., submitted a citizen petition dated May
9, 2013 (Docket No. FDA-2013-P-0573), under 21 CFR 10.30, requesting
that the Agency determine whether BANZEL (rufinamide) tablet, 100 mg,
was withdrawn or discontinued 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 BANZEL (rufinamide) tablet, 100 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that BANZEL
(rufinamide) tablet, 100 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BANZEL (rufinamide) tablet, 100 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this product was not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list BANZEL (rufinamide)
tablet, 100 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 BANZEL (rufinamide) tablet, 100 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
[[Page 69857]]
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27874 Filed 11-20-13; 8:45 am]
BILLING CODE 4160-01-P
