Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc., 61367 [2022-21934]

Download as PDF 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]


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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.

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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
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