Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 16498 [2022-06167]
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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices
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 January 17, 2022,
Siemens Healthcare Diagnostics Inc.,
100 GBC Drive, Mailstop 514, Newark,
Delaware 19702–2461, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Ecgonine .........................
Drug
code
Schedule
9180
II
The company plans to produce the
listed controlled substance in bulk to be
used in the manufacture of DEA exempt
products. No other activities for these
drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
Controlled substance
Psilocybin .....................
Psilocin .........................
Drug
code
7437
7438
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DEPARTMENT OF JUSTICE
[FR Doc. 2022–06166 Filed 3–22–22; 8:45 am]
[Docket No. DEA–986]
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Bulk Manufacturer of Controlled
Substances Application: Usona
Institute, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[Docket No. DEA–987]
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.
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 23, 2022. Such persons
VerDate Sep<11>2014
20:07 Mar 22, 2022
Jkt 256001
I
I
Matthew J. Strait,
Deputy Assistant Administrator.
Drug Enforcement Administration
SUMMARY:
Schedule
The company plans to bulk
manufacture the listed controlled
substances for use in chemical process
development as well as pre-clinical and
clinical research.
[FR Doc. 2022–06162 Filed 3–22–22; 8:45 am]
jspears on DSK121TN23PROD with NOTICES1
may also file a written request for a
hearing on the application on or before
May 23, 2022.
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 16, 2022,
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):
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon API Manufacturing,
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:
PO 00000
Frm 00046
Fmt 4703
Sfmt 9990
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 23, 2022. Such persons
may also file a written request for a
hearing on the application on or before
May 23, 2022.
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 March 2, 2022, Patheon
API Manufacturing, Inc., 309 Delaware
Street, Greenville, South Carolina
29605–5420, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
DATES:
Controlled substance
Gamma Hydroxybutyric
Acid.
Tetrahydrocannabinols
5-Methoxy-N-NDimethyltryptamine.
Alpha-Methyltryptamine
Dimethyltryptamine .......
Psilocybin .....................
Psilocyn ........................
Thebaine .......................
Oxymorphone ...............
Noroxymorphone ..........
Drug
code
Schedule
2010
I
7370
7431
I
I
7432
7435
7437
7438
9333
9652
9668
I
I
I
I
II
II
II
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for distribution to its
customers. In reference to dug code
7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this
drug as synthetic. No other activities for
these drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–06167 Filed 3–22–22; 8:45 am]
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E:\FR\FM\23MRN1.SGM
23MRN1
]]>Agencies
[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Page 16498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06167]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-987]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Patheon API Manufacturing, 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.
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 23, 2022. Such persons may also file a written request for a
hearing on the application on or before May 23, 2022.
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 March 2, 2022, Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South Carolina 29605-5420, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Tetrahydrocannabinols.................. 7370 I
5-Methoxy-N-N-Dimethyltryptamine....... 7431 I
Alpha-Methyltryptamine................. 7432 I
Dimethyltryptamine..................... 7435 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
Thebaine............................... 9333 II
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances as an Active Pharmaceutical Ingredient (API) for
distribution to its customers. In reference to dug code 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture this
drug as synthetic. No other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-06167 Filed 3-22-22; 8:45 am]
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