Bulk Manufacturer of Controlled Substances Application: Veranova, L.P., 48690-48691 [2024-12576]

Download as PDF 48690 Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices Controlled substance Drug code Morphine .............................................................................................................................................................................. Oripavine ............................................................................................................................................................................. Thebaine .............................................................................................................................................................................. Oxymorphone ...................................................................................................................................................................... Phenazocine ........................................................................................................................................................................ Carfentanil ........................................................................................................................................................................... Fentanyl ............................................................................................................................................................................... Drug Enforcement Administration 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. [Docket No. DEA–1383] SUPPLEMENTARY INFORMATION: The company plans to bulk manufacture the listed controlled substances for internal use as intermediates or for sale to its customers. The company plans to manufacture small quantities of the above listed controlled substances as radiolabeled compounds for biochemical research. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–12567 Filed 6–6–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Importer of Controlled Substances Application: Usona Institute Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Usona Institute 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: 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 July 8, 2024. Such persons may also file a written request for a hearing on the application on or before July 8, 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 ddrumheller on DSK120RN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 18:54 Jun 06, 2024 Jkt 262001 In accordance with 21 CFR 1301.34(a), this is notice that on May 13, 2024, Usona Institute, 2780 Woods Hollow Road, Room 2412, Fitchburg, Wisconsin 53711–5370, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance 5-Methoxy-N-Ndimethyltryptamine. Dimethyltryptamine .......... Psilocybin ........................ Psilocyn ........................... Drug code Schedule 7431 I 7435 7437 7438 I I I The company plans to import the listed controlled substances for research and analytical purposes. The materials will not be used for clinical trials or human consumption. 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- PO 00000 Frm 00141 Fmt 4703 Sfmt 4703 9300 9330 9333 9652 9715 9743 9801 Schedule II II II II II II II approved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–12575 Filed 6–6–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1384] Bulk Manufacturer of Controlled Substances Application: Veranova, L.P. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Veranova, L.P., 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 August 6, 2024. Such persons may also file a written request for a hearing on the application on or before August 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. SUMMARY: E:\FR\FM\07JNN1.SGM 07JNN1 48691 Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices In accordance with 21 CFR 1301.33(a), this is notice that on May 9, 2024, Veranova, SUPPLEMENTARY INFORMATION: L.P., 25 Patton Road, Pharmaceutical Service, Devens, Massachusetts 01434– 3803, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Amphetamine ................................................................................................................................................................. Methylphenidate ............................................................................................................................................................. Nabilone ......................................................................................................................................................................... Hydrocodone .................................................................................................................................................................. Levorphanol ................................................................................................................................................................... Thebaine ........................................................................................................................................................................ Alfentanil ........................................................................................................................................................................ Remifentanil ................................................................................................................................................................... Sufentanil ....................................................................................................................................................................... The company plans to bulk manufacture the listed controlled substances in order to support the manufacturing and analytical testing activities at its other Drug Enforcement Administration-registered manufacturing facility. No other activities for these drug codes are authorized for this registration. Matthew J. Strait, Acting Deputy Assistant Administrator. [FR Doc. 2024–12576 Filed 6–6–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1372] Importer of Controlled Substances Application: Unither Manufacturing LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Unither Manufacturing 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 July 8, 2024. Such persons may also file a written request for a hearing on the application on or before July 8, 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:23 Jun 06, 2024 Jkt 262001 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 April 8, 2024, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623–3226, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Methylphenidate ............. Schedule I 1724 III The company plans to import the listed controlled substances solely for updated analytical testing purposes to meet European Union requirements for their finished dosage form product. This analysis is required to allow the company to export domestically manufactured finished dosage forms to foreign markets. 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). PO 00000 Frm 00142 Fmt 4703 Sfmt 4703 1100 1724 7379 9193 9220 9333 9737 9739 9740 Schedule II II II II II II II II II Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–12562 Filed 6–6–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA–2012–0017] Reports of Injuries to Employees Operating Mechanical Power Presses; Extension of the Office of Management and Budget’s (OMB) Approval of Information Collection (Paperwork) Requirements Occupational Safety and Health Administration (OSHA), Labor. ACTION: Request for public comments. AGENCY: OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget’s (OMB) approval of the information collection requirements specified in the Reports of Injuries to Employees Operating Mechanical Power Presses. DATES: Comments must be submitted (postmarked, sent, or received) by August 6, 2024. ADDRESSES: Electronically: You may submit comments and attachments electronically at https:// www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for submitting comments. Docket: To read or download comments or other material in the docket, go to https:// www.regulations.gov. Documents in the SUMMARY: E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48690-48691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12576]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1384]


Bulk Manufacturer of Controlled Substances Application: Veranova, 
L.P.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Veranova, L.P., 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 
August 6, 2024. Such persons may also file a written request for a 
hearing on the application on or before August 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.

[[Page 48691]]


SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on May 9, 2024, Veranova, L.P., 25 Patton Road, 
Pharmaceutical Service, Devens, Massachusetts 01434-3803, applied to be 
registered as a bulk manufacturer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
        Controlled substance             Drug code         Schedule
------------------------------------------------------------------------
Amphetamine.........................            1100  II
Methylphenidate.....................            1724  II
Nabilone............................            7379  II
Hydrocodone.........................            9193  II
Levorphanol.........................            9220  II
Thebaine............................            9333  II
Alfentanil..........................            9737  II
Remifentanil........................            9739  II
Sufentanil..........................            9740  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances in order to support the manufacturing and analytical testing 
activities at its other Drug Enforcement Administration-registered 
manufacturing facility. No other activities for these drug codes are 
authorized for this registration.

Matthew J. Strait,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-12576 Filed 6-6-24; 8:45 am]
BILLING CODE 4410-09-P
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