Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc., 71021-71022 [2023-22627]

Download as PDF 71021 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices All written submissions must conform with the provisions of § 201.8 of the Commission’s rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission’s rules. The Commission’s Handbook on Filing Procedures, available on the Commission’s website at https:// www.usitc.gov/documents/handbook_ on_filing_procedures.pdf, elaborates upon the Commission’s procedures with respect to filings. In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Certification.—Pursuant to § 207.3 of the Commission’s rules, any person submitting information to the Commission in connection with these investigations must certify that the information is accurate and complete to the best of the submitter’s knowledge. In making the certification, the submitter will acknowledge that any information that it submits to the Commission during these investigations may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of these or related investigations or reviews, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.12 of the Commission’s rules. By order of the Commission. Issued: October 5, 2023. Lisa Barton, Secretary to the Commission. [FR Doc. 2023–22519 Filed 10–12–23; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1280] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Chattem Chemicals, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUMMARY: 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 December 12, 2023. Such persons may also file a written request for a hearing on the application on or before December 12, 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on July 14, 2023, Chattem Chemicals, Inc. 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): lotter on DSK11XQN23PROD with NOTICES1 Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... 4-Methoxyamphetamine .................................................................................................................................................. Dihydromorphine ............................................................................................................................................................. Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Methylphenidate .............................................................................................................................................................. Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Levorphanol ..................................................................................................................................................................... Methadone ....................................................................................................................................................................... Methadone intermediate .................................................................................................................................................. Morphine .......................................................................................................................................................................... Oripavine ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... VerDate Sep<11>2014 16:55 Oct 12, 2023 Jkt 262001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1 2010 7360 7370 7411 9145 1100 1105 1205 1724 9041 9050 9120 9143 9150 9180 9193 9220 9250 9254 9300 9330 9333 9652 9668 9737 9739 9740 9780 Schedule I I I I I II II II II II II II II II II II II II II II II II II II II II II II 71022 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices Controlled substance Drug code Fentanyl ........................................................................................................................................................................... The company plans to bulk manufacture the listed controlled substances in bulk for distribution and sale to its customers. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as a synthetic. 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 manufacturing of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–22627 Filed 10–12–23; 8:45 am] BILLING CODE P [FR Doc. 2023–22623 Filed 10–12–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–1271] Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Cambridge Isotope Laboratories, 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 December 12, 2023. Such persons may also file a written request for a hearing on the application on or before December 12, 2023. SUMMARY: Drug code lotter on DSK11XQN23PROD with NOTICES1 [Docket No. DEA–1273] Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Curia New York, Inc has applied to be registered as a bulk SUMMARY: VerDate Sep<11>2014 16:55 Oct 12, 2023 Jkt 262001 manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. 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 December 12, 2023. Such persons may also file a written request for a hearing on the application on or before December 12, 2023. DATES: 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 ADDRESSES: PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 II 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 August 25, 2023, Cambridge Isotope Laboratories, Inc 50 Frontage Road, Andover, Massachusetts 01810–5413, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Tetrahydrocannabinols ............................................................................................................................................ Claude Redd, Acting Deputy Assistant Administrator. 9801 ADDRESSES: DEPARTMENT OF JUSTICE Controlled substance The company plans to synthetically bulk manufacture the controlled substance Tetrahydrocannabinols to produce analytical standards for distribution to its customers. No other activities for this drug code is authorized for this registration. Schedule 7370 Schedule I 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 August 10, 2023, Curia New York, Inc, 33 Riverside Avenue, Rensselaer, New York 12144–2951, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Schedule Marihuana ................................... Tetrahydrocannabinols ............... Amphetamine .............................. Lisdexamfetamine ....................... Methylphenidate .......................... Pentobarbital ............................... Codeine ....................................... Dihydrocodeine ........................... Oxycodone .................................. Hydromorphone .......................... Hydrocodone ............................... Meperidine .................................. Morphine ..................................... 7360 7370 1100 1205 1724 2270 8333 9050 9143 9150 9193 9230 9300 I I II II II II II II II II II II II E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 71021-71022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22627]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1280]


Bulk Manufacturer of Controlled Substances Application: Chattem 
Chemicals, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Chattem Chemicals, 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 
December 12, 2023. Such persons may also file a written request for a 
hearing on the application on or before December 12, 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on July 14, 2023, Chattem Chemicals, Inc. 3801 Saint 
Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as 
a bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
4-Methoxyamphetamine...............            7411  I
Dihydromorphine....................            9145  I
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Lisdexamfetamine...................            1205  II
Methylphenidate....................            1724  II
Cocaine............................            9041  II
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Levorphanol........................            9220  II
Methadone..........................            9250  II
Methadone intermediate.............            9254  II
Morphine...........................            9300  II
Oripavine..........................            9330  II
Thebaine...........................            9333  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
Alfentanil.........................            9737  II
Remifentanil.......................            9739  II
Sufentanil.........................            9740  II
Tapentadol.........................            9780  II

[[Page 71022]]

 
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances in bulk for distribution and sale to its customers. In 
reference to drug codes 7360 (Marihuana) and 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as a synthetic. 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 
manufacturing of Food and Drug Administration-approved or non-approved 
finished dosage forms for commercial sale.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-22627 Filed 10-12-23; 8:45 am]
BILLING CODE P
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