Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 4021 [2023-01202]

Download as PDF 4021 Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices Controlled substance Drug code Hydromorphone ...................... Hydrocodone ........................... Methadone .............................. Methadone intermediate ......... Morphine ................................. Oripavine ................................. Thebaine ................................. Opium tincture ........................ Oxymorphone ......................... Tapentadol .............................. 9150 9193 9250 9254 9300 9330 9333 9630 9652 9780 Schedule II II II II II II II II II II The company plans to bulk manufacture the listed controlled substances in bulk for sale to its customers. No other activities for these drug codes are authorized for this registration. 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 November 30, 2022, Maridose LLC, 74 Orion Street, Brunswick, Maine 04011, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Drug code Controlled substance Marihuana Extract ........ Marihuana ..................... Tetrahydrocannabinols I 7350 7360 7370 Schedule I I I I The company plans to bulk manufacture the listed controlled substances to supply to the Drug Enforcement Administration-registered researchers for their approval studies. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–01199 Filed 1–20–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration Matthew Strait, Deputy Assistant Administrator. [Docket No. DEA–XXX] [FR Doc. 2023–01203 Filed 1–20–23; 8:45 am] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: Maridose LLC DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 16:44 Jan 20, 2023 Jkt 259001 In accordance with 21 CFR 1301.34(a), this is notice that on December 1, 2022, Janssen Pharmaceuticals Inc., 1440 Olympic Drive, Buildings 1–5 & 7–14, Athens, Georgia 30601–1645, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug Enforcement Administration Controlled substance [Docket No. DEA–1130] Maridose 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 March 24, 2023. Such persons may also file a written request for a hearing on the application on or before March 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 SUMMARY: 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. Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Janssen Pharmaceuticals 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 February 22, 2023. Such persons may also file a written request for a hearing on the application on or before February 22, 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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Methylphenidate ........... Thebaine ....................... Poppy Straw Concentrate. Tapentadol .................... Drug code Schedule 1724 9333 9670 II II II 9780 II The company plans to import intermediates classified under Tapentadol (9780) and Thebaine (9333) for further manufacturing to the controlled substances Tapentadol and Buprenorpine, respectively, prior to distribution to customers. The company plans to import Poppy Straw Concentrate (9670) to bulk manufacture other controlled substances. 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 nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–01202 Filed 1–20–23; 8:45 am] BILLING CODE P E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Page 4021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01202]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1130]


Importer of Controlled Substances Application: Janssen 
Pharmaceuticals Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Janssen Pharmaceuticals 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 
February 22, 2023. Such persons may also file a written request for a 
hearing on the application on or before February 22, 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 1, 2022, Janssen Pharmaceuticals Inc., 1440 
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645, 
applied to be registered as an importer of the following basic 
class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Methylphenidate........................     1724  II
Thebaine...............................     9333  II
Poppy Straw Concentrate................     9670  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

    The company plans to import intermediates classified under 
Tapentadol (9780) and Thebaine (9333) for further manufacturing to the 
controlled substances Tapentadol and Buprenorpine, respectively, prior 
to distribution to customers. The company plans to import Poppy Straw 
Concentrate (9670) to bulk manufacture other controlled substances. 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-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01202 Filed 1-20-23; 8:45 am]
BILLING CODE P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.