Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC, 87458-87459 [2023-27708]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 87458 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register. Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due, notwithstanding § 201.14(a) of the Commission’s Rules of Practice and Procedure. No other submissions will be accepted, unless requested by the Commission. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments. Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (‘‘Docket No. 3712’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 1). Please note the Secretary’s Office will accept only electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov.) No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary atEDIS3Help@usitc.gov. Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. VerDate Sep<11>2014 17:41 Dec 15, 2023 Jkt 262001 of this or a related proceeding, 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,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: December 13, 2023. Lisa Barton, Secretary to the Commission. [FR Doc. 2023–27767 Filed 12–15–23; 8:45 am] BILLING CODE 7020–02–P JUDICIAL CONFERENCE OF THE UNITED STATES Advisory Committee on Bankruptcy Rules; Hearing of the Judicial Conference Judicial Conference of the United States. ACTION: Advisory Committee on Bankruptcy Rules; Notice of cancellation of open hearing. AGENCY: The following public hearing on proposed amendments to the Federal Rules of Bankruptcy Procedure has been canceled: Bankruptcy Rules Hearing on January 12, 2024. The announcement for this hearing was previously published in the Federal Register on August 9, 2023. DATES: January 12, 2024. FOR FURTHER INFORMATION CONTACT: H. Thomas Byron III, Esq., Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7–300, Washington, DC 20544, Phone (202) 502–1820, RulesCommittee_Secretary@ ao.uscourts.gov. SUMMARY: (Authority: 28 U.S.C. 2073.) [FR Doc. 2023–27766 Filed 12–15–23; 8:45 am] BILLING CODE 2210–55–P 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. Frm 00074 Fmt 4703 Sfmt 4703 Drug Enforcement Administration [Docket No. DEA–1308] Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Kinetochem 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 February 16, 2024. Such persons may also file a written request for a hearing on the application on or before February 16, 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 November 28, 2023, Kinetochem LLC, 96 Market Street, Suite 102, Georgetown, Texas 78626– 3618, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUMMARY: Drug code Controlled substance Dated: December 13, 2023. Shelly L. Cox, Management Analyst, Rules Committee Staff. PO 00000 DEPARTMENT OF JUSTICE Marihuana ........................ Tetrahyrocannabinols ...... I 7360 7370 Schedule I II The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients to its customers as well as for research and clinical trials. In reference to drug codes 7360 E:\FR\FM\18DEN1.SGM 18DEN1 87459 Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices (Marihuana), and 7370 (Tetrahydrocannabinols) the company plans to bulk manufacture these drug codes as synthetic. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27708 Filed 12–15–23; 8:45 am] BILLING CODE P 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 November 28, 2023, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration Phenylacetone ................. Opium, raw ...................... Poppy Straw Concentrate [Docket No. DEA–1307] Importer of Controlled Substances Application: Siegfried USA, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Siegfried USA, 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 January 17, 2024. Such persons may also file a written request for a hearing on the application on or before January 17, 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:41 Dec 15, 2023 Jkt 262001 I Drug code Schedule 8501 9600 9670 II II II I The company plans to import the listed controlled substances to manufacture bulk Active Pharmaceuticals Ingredients for distribution to its customers. 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27705 Filed 12–15–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1306] Bulk Manufacturer of Controlled Substances Application: AJNA BioSciences Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Controlled substance Psilocybin ........................ Psilocyn ........................... I Drug code Schedule 7437 7438 I I I The company plans to bulk manufacture by cultivating research Good Manufacturing Practices whole plant mushrooms containing Psilocybin (7437) and Psilocyn (7438) to support internal research, clinical trials, and analytical purposes as well as to distribute to their customers conducting schedule I clinical research. No other activities for these drug codes are authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023–27707 Filed 12–15–23; 8:45 am] BILLING CODE P AJNA BioSciences 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 February 16, 2024. Such persons may also file a written request SUMMARY: for a hearing on the application on or before February 16, 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 September 20, 2023, AJNA BioSciences, 8022 Southpark Circle, Suite 500, Littleton, Colorado 80120–5659, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1309] Bulk Manufacturer of Controlled Substances Application: Groff Health, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87458-87459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27708]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1308]


Bulk Manufacturer of Controlled Substances Application: 
Kinetochem LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Kinetochem 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 
February 16, 2024. Such persons may also file a written request for a 
hearing on the application on or before February 16, 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 November 28, 2023, Kinetochem LLC, 96 Market Street, 
Suite 102, Georgetown, Texas 78626-3618, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
Tetrahyrocannabinols....................    7370  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances as Active Pharmaceutical Ingredients to its customers as 
well as for research and clinical trials. In reference to drug codes 
7360

[[Page 87459]]

(Marihuana), and 7370 (Tetrahydrocannabinols) the company plans to bulk 
manufacture these drug codes as synthetic. No other activities for 
these drug codes are authorized for this registration.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-27708 Filed 12-15-23; 8:45 am]
BILLING CODE P
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