Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1 Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 51282-51283 [2017-23952]
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51282
Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
589.2001(f); request for designation ....................................
589.2001(f); response to request for review by FDA ..........
1 There
1
1
Total
annual
responses
1
1
Average
burden per
response
1
1
80
26
Total hours
80
26
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the reporting burden
for designation under § 589.2001(f) is
based on estimates in the final rule
entitled, ‘‘Substances Prohibited From
Use in Animal Food or Feed,’’
published in the Federal Register of
April 25, 2008, our experience, and the
average number of requests for
designation received in the past 3 years.
The reporting burden for § 589.2001(f) is
minimal because requests for
designation are seldom submitted. Since
2009, we have received two requests for
designation. In the last 3 years, we have
not received any new requests for
designation; therefore, we estimate that
one or fewer requests for designation
will be submitted annually. Although
we have not received any new requests
for designation in the last 3 years, we
believe these information collection
provisions should be extended to
provide for the potential future need of
a foreign government to request
designation under § 589.2001(f). Table
2, row 1 presents the expected burden
of requests for designation. Countries
designated under § 589.2001(f) are
subject to review by FDA to ensure that
their designation remains appropriate.
We assume a country’s response to a
request for review will take about one
third the time and effort of a request for
designation. Table 2, row 2 presents the
expected burden of a request for review.
The burden for this information
collection has not changed since the last
OMB approval.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23948 Filed 11–2–17; 8:45 am]
BILLING CODE 4164–01–P
ethrower on DSK3G9T082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR section
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16:18 Nov 02, 2017
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2044]
Determination That REVEX (Nalmefene
Hydrochloride Injection), 0.1 Milligram
Base/Milliliter and 1.0 Milligram Base/
Milliliter, 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 REVEX (nalmefene
hydrochloride injection), 0.1 milligram
(mg) base/milliliter (mL) and 1.0 mg
base/mL, was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for REVEX
(nalmefene hydrochloride injection), 0.1
mg base/mL and 1.0 mg base/mL, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Kelley Nduom, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–8597.
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).
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
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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,
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).
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.
REVEX (nalmefene hydrochloride
injection), 0.1 mg base/mL and 1.0 mg
base/mL, is the subject of NDA 20–459,
currently held by West-Ward
Pharmaceuticals International Limited,
and initially approved on April 17,
1995. REVEX is indicated for the
complete or partial reversal of opioid
drug effects, including respiratory
depression, induced by either natural or
synthetic opioids. REVEX is also
indicated in the management of known
or suspected opioid overdose.
In a letter dated June 5, 2009, Baxter
Healthcare Corporation, the NDA holder
at the time, notified FDA that the
manufacturing and distribution of
REVEX (nalmefene hydrochloride
injection), 0.1 mg base/mL and 1.0 mg
base/mL, had been discontinued on May
21, 2008, for business reasons. REVEX
(nalmefene hydrochloride injection), 0.1
mg base/mL and 1.0 mg base/mL, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Nirsum Pharmaceuticals, LLC,
submitted a citizen petition dated
March 31, 2017 (Docket No. FDA–2017–
E:\FR\FM\03NON1.SGM
03NON1
Federal Register / Vol. 82, No. 212 / Friday, November 3, 2017 / Notices
ethrower on DSK3G9T082PROD with NOTICES
P–2044), under 21 CFR 10.30,
requesting that the Agency determine
whether REVEX (nalmefene
hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
(and comments submitted to the docket)
and reviewing Agency records, and
based on the information we have at this
time, FDA has determined under
§ 314.161 that REVEX (nalmefene
hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that REVEX (nalmefene
hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
REVEX (nalmefene hydrochloride
injection), 0.1 mg base/mL and 1.0 mg
base/mL, 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 REVEX (nalmefene
hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, 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: October 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23952 Filed 11–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2017–0109; Control
Number: 1625–0030]
Collection of Information Under
Review by Office of Management and
Budget; OMB
Coast Guard, DHS.
Thirty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an
Information Collection Request (ICR),
abstracted below, to the Office of
Management and Budget (OMB), Office
of Information and Regulatory Affairs
(OIRA), requesting approval for
reinstatement, without change, of the
following collection of information:
1625–0030, Oil and Hazardous
Materials Transfer Procedures. Our ICR
describes the information we seek to
collect from the public. Review and
comments by OIRA ensure we only
impose paperwork burdens
commensurate with our performance of
duties.
DATES: Comments must reach the Coast
Guard and OIRA on or before December
4, 2017.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2017–0109] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
Alternatively, you may submit
comments to OIRA using one of the
following means:
(1) Email: dhsdeskofficer@
omb.eop.gov.
(2) Mail: OIRA, 725 17th Street NW.,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
A copy of the ICR is available through
the docket on the Internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–612), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE., Stop
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: Mr.
Anthony Smith, Office of Information
Management, telephone 202–475–3532,
or fax 202–372–8405, for questions on
these documents.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Public Participation and Request for
Comments
This Notice relies on the authority of
the Paperwork Reduction Act of 1995;
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16:18 Nov 02, 2017
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51283
44 U.S.C. 35, as amended. An ICR is an
application to OIRA seeking the
approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection. The Coast Guard invites
comments on whether this ICR should
be granted based on the Collection being
necessary for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology. These
comments will help OIRA determine
whether to approve the ICR referred to
in this Notice.
We encourage you to respond to this
request by submitting comments and
related materials. Comments to Coast
Guard or OIRA must contain the OMB
Control Number of the ICR. They must
also contain the docket number of this
request [USCG–2017–0109], and must
be received by December 4, 2017.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that Web site’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided. For more about privacy and
the docket, you may review a Privacy
Act notice regarding the Federal Docket
Management System in the March 24,
2005, issue of the Federal Register (70
FR 15086).
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51282-51283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23952]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-2044]
Determination That REVEX (Nalmefene Hydrochloride Injection), 0.1
Milligram Base/Milliliter and 1.0 Milligram Base/Milliliter, 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 REVEX (nalmefene hydrochloride injection), 0.1
milligram (mg) base/milliliter (mL) and 1.0 mg base/mL, was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for REVEX (nalmefene hydrochloride injection), 0.1
mg base/mL and 1.0 mg base/mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Kelley Nduom, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 301-
796-8597.
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, 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).
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.
REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0
mg base/mL, is the subject of NDA 20-459, currently held by West-Ward
Pharmaceuticals International Limited, and initially approved on April
17, 1995. REVEX is indicated for the complete or partial reversal of
opioid drug effects, including respiratory depression, induced by
either natural or synthetic opioids. REVEX is also indicated in the
management of known or suspected opioid overdose.
In a letter dated June 5, 2009, Baxter Healthcare Corporation, the
NDA holder at the time, notified FDA that the manufacturing and
distribution of REVEX (nalmefene hydrochloride injection), 0.1 mg base/
mL and 1.0 mg base/mL, had been discontinued on May 21, 2008, for
business reasons. REVEX (nalmefene hydrochloride injection), 0.1 mg
base/mL and 1.0 mg base/mL, is currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
Nirsum Pharmaceuticals, LLC, submitted a citizen petition dated
March 31, 2017 (Docket No. FDA-2017-
[[Page 51283]]
P-2044), under 21 CFR 10.30, requesting that the Agency determine
whether REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and
1.0 mg base/mL, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition (and comments submitted to
the docket) and reviewing Agency records, and based on the information
we have at this time, FDA has determined under Sec. 314.161 that REVEX
(nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg
base/mL, was withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg
base/mL, 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 REVEX (nalmefene
hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, 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: October 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23952 Filed 11-2-17; 8:45 am]
BILLING CODE 4164-01-P
