Importer of Controlled Substances Application: Caligor Coghlan Pharma Services, 71934 [2024-19785]

Download as PDF 71934 Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices application and Applicant has not demonstrated that he can be entrusted with the responsibility of registration. Id. at 19. Accordingly, the Agency will order that Applicant’s application be denied. Order document upon publication in the Federal Register. Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration. [FR Doc. 2024–19731 Filed 9–3–24; 8:45 am] BILLING CODE 4410–09–P Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823, I hereby deny the pending application for a DEA Certificate of Registration, Control No. W21057811C, submitted by Samirkumar Shah, M.D., as well as any other pending application of Samirkumar Shah, M.D., for additional registration in Pennsylvania. This Order is effective October 4, 2024. Signing Authority This document of the Drug Enforcement Administration was signed on August 19, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1419] 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 October 4, 2024. Such persons may also file a written request for a hearing on the application on or before October 4, 2024. ADDRESSES: The Drug Enforcement Administration requires that all SUMMARY: 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 19, 2024, Caligor 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 Drug code ddrumheller on DSK120RN23PROD with NOTICES1 Lysergic acid diethylamide ............................................................................................................................................ 5-Methoxy-N-N-dimethyltryptamine ............................................................................................................................... Dimethyltryptamine ........................................................................................................................................................ Psilocyn .......................................................................................................................................................................... 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. Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–19785 Filed 9–3–24; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 21:26 Sep 03, 2024 Jkt 262001 Drug Enforcement Administration [Docket No. DEA–1421] Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc Notice of application. Cambrex High Point, 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 4, 2024. Such persons may also file a written request for a hearing on the application on or before November 4, 2024. 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 ADDRESSES: Drug Enforcement Administration, Justice. AGENCY: SUMMARY: I I I I DATES: DEPARTMENT OF JUSTICE ACTION: 7315 7431 7435 7438 Schedule E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19785]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1419]


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 
October 4, 2024. Such persons may also file a written request for a 
hearing on the application on or before October 4, 2024.

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 19, 2024, Caligor 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             Drug code         Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide..........            7315  I
5-Methoxy-N-N-dimethyltryptamine....            7431  I
Dimethyltryptamine..................            7435  I
Psilocyn............................            7438  I
------------------------------------------------------------------------

    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.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19785 Filed 9-3-24; 8:45 am]
BILLING CODE 4410-09-P
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