Importer of Controlled Substances Application: Avant Biopharmaceuticals, 10382 [2023-03400]
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10382
ACTION:
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
Notice of application.
activities for these drug codes are
authorized for this registration.
Veranova, L.P. has applied to
be registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 18, 2023. Such
persons may also file a written request
for a hearing on the application on or
before April 18, 2023.
DATES:
The Drug Enforcement
Administration (DEA) requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on January 5, 2023
Veranova, L.P., 25 Patton Road, Devens,
Massachusetts 01434–3803, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
lotter on DSK11XQN23PROD with NOTICES1
Amphetamine ...............
Methylphenidate ...........
Nabilone .......................
Hydrocodone ................
Levorphanol ..................
Thebaine .......................
Alfentanil .......................
Remifentanil ..................
Sufentanil ......................
Drug
code
Schedule
1100
1724
7379
9193
9220
9333
9737
9739
9740
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture the above controlled
substances in order to support
manufacturing and analytical testing
activities at its other DEA-registered
manufacturing facility. No other
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–03410 Filed 2–16–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
In
accordance with 21 CFR 1301.34(a), this
is notice that on November 16, 2023,
Avant Biopharmaceuticals, 7220 Trade
Street, San Diego, California 92121,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1141]
Importer of Controlled Substances
Application: Avant Biopharmaceuticals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Avant Biopharmaceuticals
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before March 20, 2023. Such
persons may also file a written request
for a hearing on the application on or
before March 20, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUMMARY:
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
Psilocybin .....................
Psilocyn ........................
Drug
code
7350
7360
7370
7437
7438
Schedule
I
I
I
I
I
The company plans to import the
listed controlled substances for
analytical or scientific purposes. No
other activities for these drug codes are
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–03400 Filed 2–16–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1140]
Importer of Controlled Substances
Application: Mylan Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental Information
listed below for further drug
information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 20, 2023. Such persons
may also file a written request for a
hearing on the application on or before
March 20, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
SUMMARY:
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Page 10382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03400]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1141]
Importer of Controlled Substances Application: Avant
Biopharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Avant Biopharmaceuticals has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
March 20, 2023. Such persons may also file a written request for a
hearing on the application on or before March 20, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on November 16, 2023, Avant Biopharmaceuticals, 7220
Trade Street, San Diego, California 92121, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
analytical or scientific purposes. No other activities for these drug
codes are authorized for this registration.
Approval of permit applications will occur only when the
registrant's business activity is consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-03400 Filed 2-16-23; 8:45 am]
BILLING CODE 4410-09-P
