Importer of Controlled Substances Application: Caligor Coghlan Pharma Services, 17621-17622 [2023-05938]

Download as PDF Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices In accordance with 21 CFR 1301.34(a), this is notice that on January 12, 2023, Scottsdale Research Institute, 12815 North Cave Creek Road, Phoenix, Arizona 85022, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Marihuana Extract ........... Marihuana ........................ Tetrahydrocannabinols .... Psilocybin ........................ Psilocyn ........................... Drug code Schedule 7350 7360 7370 7437 7438 I I I I I The company plans to import Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370) as flowering plants to support analytical purposes, research, and the manufacturing of dosage forms for clinical trials. This notice does not constitute an evaluation or determination of the merits of the company’s application. The company plans to import fungi material from which Psilocybin (7437) and Psilocyn (7438) will be produced for further manufacturing prior to use in research and 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05920 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug code Controlled substance Drug Enforcement Administration Psilocybin ...................... Importer of Controlled Substances Application: Lonza Tampa, LLC The company plans to import drug code 7437 (Psilocybin) as finished dosage for clinical trials, research, and analytical purposes. No other activity for this drug code is 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 non- Drug Enforcement Administration, Justice. ACTION: Notice of application. Lonza Tampa, 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. SUMMARY: VerDate Sep<11>2014 19:23 Mar 22, 2023 Jkt 259001 PO 00000 Frm 00106 Fmt 4703 7437 Schedule [Docket No. DEA–1170] AGENCY: ddrumheller on DSK120RN23PROD with NOTICES1 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, 2023. Such persons may also file a written request for a hearing on the application on or before April 24, 2023. 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 February 10, 2023, Lonza Tampa, LLC, 4901 West Grace Street, Tampa, Florida 33607–3805, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Sfmt 4703 I 17621 approved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05940 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1168] Importer of Controlled Substances Application: Caligor Coghlan Pharma Services Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Caligor Coghlan Pharma Services 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, 2023. Such persons may also file a written request for a hearing on the application on or before April 24, 2023. 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, SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1 17622 Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on February 8, 2023, Caliqor Coghlan Pharma Services, 1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Lysergic Acid Diethylamide. 5-Methoxy-N, Ndimethyltryptamine. Tapentadol ...................... Drug code Schedule 7315 I 7431 I 9780 II The company plans to import the listed controlled substances as finished dosage units for 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. Matthew Strait, Deputy Assistant Administrator. 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 1, 2023, Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, Ohio 45237, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): ADDRESSES: Controlled substance Gamma-hydroxybutyric acid. Drug code Schedule 2010 I Drug Enforcement Administration The company plans to manufacture the above-listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into Food and Drug Administrationapproved dosage forms. No other activities for this drug code are authorized for this registration. [Docket No. DEA–1166] Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05938 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [FR Doc. 2023–05944 Filed 3–22–23; 8:45 am] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc. BILLING CODE P DEPARTMENT OF JUSTICE 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 April 24, 2023. Such persons may also file a written request for a hearing on the application on or before April 24, 2023. 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 December 28, 2022, Meridian Medical Technologies, LLC, 2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Drug Enforcement Administration Controlled substance [Docket No. DEA–1154] Patheon Pharmaceuticals 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 22, 2023. Such persons may also file a written request for a hearing on the application on or before May 22, 2023. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:23 Mar 22, 2023 Jkt 259001 Importer of Controlled Substances Application: Meridian Medical Technologies, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Meridian Medical Technologies, 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. SUMMARY: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 Morphine ......................... Drug code Schedule 9300 II The company plans to import the controlled substance for analytical and research purposes. 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 non- E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17621-17622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05938]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1168]


Importer of Controlled Substances Application: Caligor Coghlan 
Pharma Services

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Caligor Coghlan Pharma Services 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, 2023. Such persons may also file a written request for a 
hearing on the application on or before April 24, 2023.

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,

[[Page 17622]]

8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on February 8, 2023, Caliqor Coghlan Pharma Services, 
1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Lysergic Acid Diethylamide.............    7315  I
5-Methoxy-N, N-dimethyltryptamine......    7431  I
Tapentadol.............................    9780  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances as 
finished dosage units for 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 non-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-05938 Filed 3-22-23; 8:45 am]
BILLING CODE P
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