Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC, 23612 [2024-07111]

Download as PDF 23612 Federal Register / Vol. 89, No. 66 / Thursday, April 4, 2024 / Notices Drug code Controlled substance Gamma Hydroxybutyric Acid. Schedule 2010 I I I The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient that will be further synthesized into Food and Drug Administration-approved dosage forms. No other activities for this drug code are authorized for this registration. Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–07109 Filed 4–3–24; 8:45 am] BILLING CODE P (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 March 4, 2024, 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): DEPARTMENT OF JUSTICE Schedule [Docket No. DEA–1351] Psilocybin ...................... Importer of Controlled Substances Application: Lonza Tampa, LLC The company plans to import drug code 7437 (Psilocybin) as finished dosage units for clinical trials, research, and analytical 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 nonapproved finished dosage forms for commercial sale. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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. 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 6, 2024. Such persons may also file a written request for a hearing on the application on or before May 6, 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: SUMMARY: ddrumheller on DSK120RN23PROD with NOTICES1 Drug code Controlled substance Drug Enforcement Administration VerDate Sep<11>2014 17:01 Apr 03, 2024 Jkt 262001 7437 I Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–07108 Filed 4–3–24; 8:45 am] BILLING CODE 4410–09–P electronic comments on or objections to the issuance of the proposed registration on or before June 3, 2024. Such persons may also file a written request for a hearing on the application on or before June 3, 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on February 27, 2024, Benuvia Operations, LLC, 3950 North Mays Street, Round Rock, Texas 78665, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Marihuana Extract ......... I 7350 Schedule II The company plans to bulk manufacture the listed controlled substance for dosage formulation development. No other activities for these drug codes are authorized for this registration. DEPARTMENT OF JUSTICE Marsha L. Ikner, Acting Deputy Assistant Administrator. Drug Enforcement Administration [FR Doc. 2024–07111 Filed 4–3–24; 8:45 am] [Docket No. DEA–1352] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC Employee Benefits Security Administration Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Benuvia Operations, LLC 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 SUMMARY: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 DEPARTMENT OF LABOR Technical Correction to PTE 2016–11, Exemption From Certain Prohibited Transaction Restrictions: Northern Trust Corporation (Together With Its Current and Future Affiliates, Northern Trust or the Applicant) Employee Benefits Security Administration (EBSA), Labor. ACTION: Notice of Technical Correction. AGENCY: E:\FR\FM\04APN1.SGM 04APN1

Agencies

[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Notices]
[Page 23612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07111]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1352]


Bulk Manufacturer of Controlled Substances Application: Benuvia 
Operations, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Benuvia Operations, LLC 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 
June 3, 2024. Such persons may also file a written request for a 
hearing on the application on or before June 3, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on February 27, 2024, Benuvia Operations, LLC, 3950 
North Mays Street, Round Rock, Texas 78665, applied to be registered as 
a bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana Extract......................     7350  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substance for dosage formulation development. No other activities for 
these drug codes are authorized for this registration.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-07111 Filed 4-3-24; 8:45 am]
BILLING CODE P
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