Importer of Controlled Substances Application: Benuvia Operations, LLC, 63622 [2023-19998]
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63622
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1266]
Importer of Controlled Substances
Application: Benuvia Operations, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Operations, LLC 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
SUMMARY:
on or before October 16, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 16, 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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on August 10, 2023,
Benuvia Operations, LLC, 3950 North
Mays Street, Round Rock, Texas 78665–
2729, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Ibogaine ...........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Mescaline .........................................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration
The company plans to import the
listed controlled substances for clinical
trial manufacturing and analytical
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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–19998 Filed 9–14–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE P
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1248]
Bulk Manufacturer of Controlled
Substances Application: PCI Synthesis
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PCI Synthesis 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.
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 November 14, 2023. Such
persons may also file a written request
for a hearing on the application on or
before November 14, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
7260
7370
7381
7400
7405
7431
7435
7437
7438
7439
7365
Schedule
I
I
I
I
I
I
I
I
I
I
II
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 30, 2023, PCI
Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950–
0195, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Amphetamine ...............
E:\FR\FM\15SEN1.SGM
15SEN1
Drug
code
1100
Schedule
II
]]>Agencies
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Page 63622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19998]
[[Page 63622]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1266]
Importer of Controlled Substances Application: Benuvia
Operations, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Benuvia Operations, LLC 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
October 16, 2023. Such persons may also file a written request for a
hearing on the application on or before October 16, 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 August 10, 2023, Benuvia Operations, LLC, 3950 North
Mays Street, Round Rock, Texas 78665-2729, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Ibogaine........................... 7260 I
Tetrahydrocannabinols.............. 7370 I
Mescaline.......................... 7381 I
3,4-Methylenedioxyamphetamine...... 7400 I
3,4-Methylenedioxymethamphetamine.. 7405 I
5-Methoxy-N,N-dimethyltryptamine... 7431 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 I
Dronabinol in an oral solution in a 7365 II
drug product approved for
marketing by the U.S. Food and
Drug Administration.
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
clinical trial manufacturing and analytical 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-19998 Filed 9-14-23; 8:45 am]
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