Importer of Controlled Substances Application: Curia Wisconsin, Inc., 61366-61367 [2022-21935]

Download as PDF 61366 Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices 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 26, 2022, Cambrex High Point, Inc, 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265–8017, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Oxymorphone ............... Noroxymorphone .......... I 9652 9668 Schedule II I II The company plans to manufacture the above listed controlled substances in bulk for use as internal intermediates and distribution to its customers. No other activities for these drug codes are authorized for this registration. Kristi O’Malley, Assistant Administrator. [FR Doc. 2022–21933 Filed 10–7–22; 8:45 am] 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 August 11, 2022, Curia Missouri, Inc., 2460 West Bennett Street, Springfield, Missouri 65807– 1229, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Gamma Hydroxybutyric Acid. Amphetamine ................ Lisdexamfetamine ......... Methylphenidate ............ Phenylacetone ............... Tapentadol ..................... Schedule 2010 I 1100 1205 1724 8501 9780 II II II II II BILLING CODE 4410–09–P The company plans to bulk manufacture the listed controlled substances for internal use intermediates or for sale to its customers. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1079] Kristi O’Malley, Assistant Administrator. Bulk Manufacturer of Controlled Substances Application: Curia Missouri, Inc. [FR Doc. 2022–21931 Filed 10–7–22; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Curia Missouri, 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 SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF JUSTICE VerDate Sep<11>2014 17:37 Oct 07, 2022 Jkt 259001 Drug Enforcement Administration [Docket No. DEA–1078] 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. 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 July 25, 2022, Curia Wisconsin, Inc., 870 Badger Circle, Grafton, Wisconsin 53024–9436, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Schedule AGENCY: Gamma Hydroxybutyric Acid. Marihuana Extract ........ Marihuana ..................... Dimethyltryptamine ....... Curia Wisconsin, 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 The company plans to import Dimethyltryptamine and a derivative of Gamma Hydroxybutyric Acid to support post procurement reprocessing. The cannabidiol from Marihuana and Marihuana Extract is intended for analytical purposes with Tetramethylpyrazine (TMP). No other activities for these drug codes are authorized for this registration. Importer of Controlled Substances Application: Curia Wisconsin, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. SUMMARY: PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1 2010 I 7350 7360 7435 I I I 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]
[Pages 61366-61367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21935]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1078]


Importer of Controlled Substances Application: Curia Wisconsin, 
Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Curia Wisconsin, 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 
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 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 July 25, 2022, Curia Wisconsin, Inc., 870 Badger 
Circle, Grafton, Wisconsin 53024-9436, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............     2010  I
Marihuana Extract......................     7350  I
Marihuana..............................     7360  I
Dimethyltryptamine.....................     7435  I
------------------------------------------------------------------------

    The company plans to import Dimethyltryptamine and a derivative of 
Gamma Hydroxybutyric Acid to support post procurement reprocessing. The 
cannabidiol from Marihuana and Marihuana Extract is intended for 
analytical purposes with Tetramethylpyrazine (TMP). No other activities 
for these drug codes are authorized for this registration.

[[Page 61367]]

    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.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21935 Filed 10-7-22; 8:45 am]
BILLING CODE 4410-09-P
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