Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc., 61367 [2022-21934]
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61367
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21935 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
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 5, 2022, VICI
Health Sciences, LLC, 6655 Amberton
Drive, Suite N, Elkridge, Maryland
21075–6202, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Drug
code
Controlled substance
Drug Enforcement Administration
Importer of Controlled Substances
Application: VICI Health Sciences, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VICI Health Sciences, 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 November 10, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 10, 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. 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:37 Oct 07, 2022
I
Ibogaine ........................
[Docket No. DEA–1082]
Jkt 259001
7260
Schedule
II
The company plans to import the
listed controlled substances for use in
clinical trials, research and analytical
testing as well as dosage formulation
development. 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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21942 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1081]
Bulk Manufacturer of Controlled
Substances Application: Curia New
York, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Curia New York, 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 December 12, 2022. Such
persons may also file a written request
SUMMARY:
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
for a hearing on the application on or
before December 12, 2022.
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 July 18, 2022, Curia
New York, Inc., 33 Riverside Avenue,
Rensselaer, New York 12144–2951,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
Amphetamine ...............
Lisdexamfetamine ........
Pentobarbital ................
4-Anilino-N-phenethyl-4piperidine (ANPP).
Codeine ........................
Oxycodone ...................
Hydromorphone ............
Hydrocodone ................
Meperidine ....................
Morphine .......................
Fentanyl ........................
Drug
code
Schedule
7360
7370
1100
1205
2270
8333
I
I
II
II
II
II
9050
9143
9150
9193
9230
9300
9801
II
II
II
II
II
II
II
The company plans to manufacture
the above controlled substances as bulk
active pharmaceutical ingredients (API)
for use in product development and for
distribution to its customers. 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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21934 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Page 61367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21934]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1081]
Bulk Manufacturer of Controlled Substances Application: Curia New
York, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Curia New York, 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
December 12, 2022. Such persons may also file a written request for a
hearing on the application on or before December 12, 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 July 18, 2022, Curia New York, Inc., 33 Riverside
Avenue, Rensselaer, New York 12144-2951, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Pentobarbital.......................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Codeine................................ 9050 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Meperidine............................. 9230 II
Morphine............................... 9300 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above controlled substances as
bulk active pharmaceutical ingredients (API) for use in product
development and for distribution to its customers. 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.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21934 Filed 10-7-22; 8:45 am]
BILLING CODE 4410-09-P
