Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI), 33916 [2023-11173]
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33916
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
Controlled substance
Drug code
Diphenoxylate ................................................................................................................................................................
Levomethorphan ............................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Meperidine .....................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ............................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
The company plans to import the bulk
control substances for distribution as
analytical reference standards to its
customers for analytical testing of raw
materials. 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. 2023–11166 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1198]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp. (ACSI)
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 1, 2023, Almac
Clinical Services Incorp (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Almac Clinical Services
Incorp (ACSI) 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.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
DATES:
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
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.
Psilocybin ........................
Oxycodone ......................
Hydromorphone ...............
Morphine ..........................
Tapentadol ......................
Fentanyl ...........................
Drug
code
Schedule
7437
9143
9150
9300
9780
9801
I
II
II
II
II
II
The company plans to import the
listed controlled substances as finished
dosage form units for clinical trials
purposes only. No other activities for
these drug codes are authorized for this
registration.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
9170
9210
9220
9230
9273
9333
9652
9668
9737
9740
Schedule
II
II
II
II
II
II
II
II
II
II
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. 2023–11173 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–11]
Gary Gray d/b/a Complex; Decision
and Order
On November 22, 2021, the Drug
Enforcement Administration (DEA or
the Agency) issued an Order to Show
Cause (OSC) to Gary Gray d/b/a
Complex (hereinafter, the Respondent)
seeking to deny Respondent’s
application for a DEA Certificate of
Registration to manufacture marihuana,
Control No. W14063382E. OSC, at 1.
After a hearing, the Chief
Administrative Law Judge (Chief ALJ)
issued his Recommended Rulings,
Findings of Law, and Decision of the
Administrative Law Judge
(Recommended Decision or RD), which
recommended Respondent’s application
for a manufacturing registration be
denied because ‘‘the plain language of
the controlling regulations compels the
denial of the present application as a
matter of law.’’ RD, at 2, 11. The Agency
agrees with the Chief ALJ’s
recommendation, and, for the reasons
explained below, denies Respondent’s
application as inconsistent with the
public interest under 21 U.S.C. 823(a).1
1 Effective December 2, 2022, the Medical
Marijuana and Cannabidiol Research Expansion
Act, Public Law 117–215, 136 Stat. 2257 (2022)
(Marijuana Research Amendments or MRA),
amended the Controlled Substances Act (CSA) and
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Page 33916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11173]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1198]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp. (ACSI)
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Almac Clinical Services Incorp (ACSI) 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
June 26, 2023. Such persons may also file a written request for a
hearing on the application on or before June 26, 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 May 1, 2023, Almac Clinical Services Incorp (ACSI),
25 Fretz Road, Souderton, Pennsylvania 18964, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin.............................. 7437 I
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Morphine................................ 9300 II
Tapentadol.............................. 9780 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances as
finished dosage form units for clinical trials purposes only. 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. 2023-11173 Filed 5-24-23; 8:45 am]
BILLING CODE P
