Determination That ONFI (Clobazam) Tablets, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 12616-12617 [2019-06381]
Download as PDF
<![CDATA[
12616
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
ECE Director or Administrator ..........
ECE Director or Administrator ..........
Recruitment Letter ............................
Web/Mail Survey ..............................
1,140
627
1
1
5/60
30/60
95
314
Total ...........................................
...........................................................
........................
........................
........................
409
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06312 Filed 4–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0803]
Advisory Committee; Technical
Electronic Product Radiation Safety
Standards Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Technical Electronic
Product Radiation Safety Standards
Committee (Committee) by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until December 24, 2020.
DATES: Authority for the Technical
Electronic Product Radiation Safety
Standards Committee would have
expired on December 24, 2018, unless
the Commissioner formally determined
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring,
MD 20993–0002, 301–796–6875,
Patricio.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Committee. The Committee is a nondiscretionary Federal advisory
SUMMARY:
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
committee established to provide advice
and consultation to the Commissioner.
The Commissioner of Food and Drugs is
charged with the administration of the
Radiation Control for Health and Safety
Act of 1968. This act creates the
Committee and requires the
Commissioner to consult with the
Committee before prescribing standards
for radiation emissions from electronic
products. This Committee provides
advice and consultation to the
Commissioner of Food and Drugs on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
The Committee shall consist of a core
of 15 voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of science
or engineering applicable to electronic
product radiation safety. Members will
be invited to serve for overlapping terms
of up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the Committee by appropriate action
prior to its expiration. The core of
voting members will include five
members selected from governmental
agencies, including State and Federal
Governments, five members from the
affected industries, and five members
from the general public, of which at
least one shall be a representative of
organized labor. A quorum shall consist
of 10 members, of which at least 3 shall
be from the general public, 3 from the
government agencies, and 3 from the
affected industries.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/TechnicalElectronic
ProductRadiationSafetyStandards
Committee/default.htm or by contacting
the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: March 27, 2019.
Lowell J. Schiller,
Commissioner of Food and Drugs.
[FR Doc. 2019–06360 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–2754]
Determination That ONFI (Clobazam)
Tablets, 5 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 or Agency) has
determined that ONFI (clobazam)
tablets, 5 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) that refer to the
drug product, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
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
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
amozie on DSK9F9SC42PROD with NOTICES
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ONFI (clobazam) tablets, 5 mg, is the
subject of NDA 202067, held by
Lundbeck Pharmaceuticals, LLC, and
initially approved on October 21, 2011.
ONFI is indicated for the adjunctive
treatment of seizures associated with
Lennox-Gastaut syndrome in patients 2
years of age or older.
In a letter dated November 2, 2012,
Lundbeck Pharmaceuticals, LLC,
notified FDA that ONFI (clobazam)
tablets, 5 mg, was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Ascend Laboratories, LLC, submitted
a citizen petition dated July 17, 2018
(Docket No. FDA–2018–P–2754), under
21 CFR 10.30, requesting that the
Agency determine whether ONFI
(clobazam) tablets, 5 mg, 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
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
§ 314.161 that ONFI (clobazam) tablets,
5 mg, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ONFI
(clobazam) tablets, 5 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ONFI
(clobazam) tablets, 5 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 drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ONFI (clobazam) tablets,
5 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 this drug product
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: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06381 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0430]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quick Turnaround Testing of
Communication Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00043
Fmt 4703
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a new collection
of information entitled ‘‘Generic
Clearance for Quick Turnaround Testing
of Communication Effectiveness.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 3, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 3, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 3, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
PO 00000
12617
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12616-12617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06381]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-2754]
Determination That ONFI (Clobazam) Tablets, 5 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 or Agency) has
determined that ONFI (clobazam) tablets, 5 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) that refer to the drug product, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.
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
[[Page 12617]]
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.
ONFI (clobazam) tablets, 5 mg, is the subject of NDA 202067, held
by Lundbeck Pharmaceuticals, LLC, and initially approved on October 21,
2011. ONFI is indicated for the adjunctive treatment of seizures
associated with Lennox-Gastaut syndrome in patients 2 years of age or
older.
In a letter dated November 2, 2012, Lundbeck Pharmaceuticals, LLC,
notified FDA that ONFI (clobazam) tablets, 5 mg, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Ascend Laboratories, LLC, submitted a citizen petition dated July
17, 2018 (Docket No. FDA-2018-P-2754), under 21 CFR 10.30, requesting
that the Agency determine whether ONFI (clobazam) tablets, 5 mg, 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 ONFI (clobazam) tablets, 5 mg, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that ONFI (clobazam)
tablets, 5 mg, was withdrawn for reasons of safety or effectiveness. We
have carefully reviewed our files for records concerning the withdrawal
of ONFI (clobazam) tablets, 5 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 drug product was not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list ONFI (clobazam)
tablets, 5 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
this drug product 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: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06381 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
