Bulk Manufacturer of Controlled Substances Application: Promega Corporation, 20700-20701 [2024-06189]
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20700
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
Controlled substance
Drug code
Gamma Hydroxybutyric Acid .................................................................................................................................................
Methaqualone ........................................................................................................................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ....................................................................................
JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ................................................................................................
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) ......................................................................
CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) ................................................
Lysergic acid diethylamide ....................................................................................................................................................
Marihuana ..............................................................................................................................................................................
Tetrahydrocannabinols ..........................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine ...................................................................................................................................
3,4-Methylenedioxyamphetamine ..........................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine .............................................................................................................................
3,4-Methylenedioxymethamphetamine ..................................................................................................................................
Bufotenine ..............................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn .................................................................................................................................................................................
Cyprenorphine .......................................................................................................................................................................
Dihydromorphine ...................................................................................................................................................................
Heroin ....................................................................................................................................................................................
Normorphine ..........................................................................................................................................................................
Beta-hydroxyfentanyl .............................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ..............................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the Drug Enforcement
Administration-exempted certified
reference materials. In-house synthesis
gives access to compounds that are
difficult to source. In reference to drug
codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06193 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1345]
Importer of Controlled Substances
Application: Halo Pharmaceutical Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Halo Pharmaceutical Inc. 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 April 24, 2024. Such
persons may also file a written request
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
for a hearing on the application on or
before April 24, 2024.
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on February 21, 2024, Halo
Pharmaceuticals Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981–
1030, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Controlled substance
Psilocybin .......................
Schedule
2010
2565
7118
7200
7297
7298
7315
7360
7370
7395
7400
7404
7405
7433
7437
7438
9054
9145
9200
9313
9830
9831
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Drug
code
Schedule
7437
I
The company plans to import the
listed controlled substance to support
formulation development and use in
clinical trials. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06190 Filed 3–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1344]
Bulk Manufacturer of Controlled
Substances Application: Promega
Corporation
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Promega Corporation has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
E:\FR\FM\25MRN1.SGM
25MRN1
20701
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
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 May 24, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 24, 2024.
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on February 5, 2024,
Promega Corporation, 3075 Sub Zero
Parkway, Fitchburg, Wisconsin 53719,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Psilocybin .......................
Psilocyn ..........................
I
Drug
code
Schedule
7437
7438
I
I
I
The company plans to bulk
manufacture the listed controlled
substances as Active Pharmaceutical
Ingredients (API) for sale to its
customers. No other activities for these
drug codes are authorized for this
registration. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06189 Filed 3–22–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1338]
Bulk Manufacturer of Controlled
Substances Application: Usona
Institute, Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 May 24, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 24, 2024.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 2, 2024,
Usona Institute, Inc, 2780 Woods
Hollow Road, Room 2413, Fitchburg,
Wisconsin 53711, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Usona Institute, Inc 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:
Controlled substance
Drug code
5-Methoxy-N-N-dimethyltryptamine .......................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn .................................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for use in chemical process
development as well as pre-clinical and
clinical research. No other activities for
these drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–06184 Filed 3–22–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1341]
Importer of Controlled Substances
Application: Sharp Clinical Services,
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sharp Clinical Services, 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
SUMMARY:
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
7431
7437
7438
Schedule
I
I
I
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 24, 2024. Such
persons may also file a written request
for a hearing on the application on or
before April 24, 2024.
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
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20700-20701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06189]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1344]
Bulk Manufacturer of Controlled Substances Application: Promega
Corporation
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Promega Corporation has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
[[Page 20701]]
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
May 24, 2024. Such persons may also file a written request for a
hearing on the application on or before May 24, 2024.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 5, 2024, Promega Corporation, 3075 Sub Zero
Parkway, Fitchburg, Wisconsin 53719, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances as Active Pharmaceutical Ingredients (API) for sale to its
customers. No other activities for these drug codes are authorized for
this registration. No other activities for these drug codes are
authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-06189 Filed 3-22-24; 8:45 am]
BILLING CODE 4410-09-P
