Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Mountain Trading LLC, 9537 [2021-02970]

Download as PDF 9537 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 18, 2021. Such persons may also file a written request for a hearing on the application on or before March 18, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on January 14, 2021, Noramco Coventry LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Controlled substance khammond on DSKJM1Z7X2PROD with NOTICES Tetrahydrocannabinols ......... Methylphenidate .................... Oxycodone ............................ Hydromorphone .................... Hydrocodone ......................... Morphine ............................... Opium, raw ........................... Oxymorphone ....................... Poppy Straw Concentrate ..... Drug code 7370 1724 9143 9150 9193 9300 9600 9652 9670 Schedule I II II II II II II II II The company (formerly known as Rhodes Technologies) plans to import Opium, raw (9600), and Poppy Straw Concentrate (9670) in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. The company plans to import the other listed controlled substances for internal reference standards use only. The comparisons of foreign reference standards to the company’s domestically manufactured API will allow the company to export domestically manufactured API 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 VerDate Sep<11>2014 20:13 Feb 12, 2021 Jkt 253001 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. William T. McDermott, Assistant Administrator. [FR Doc. 2021–02971 Filed 2–12–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–774] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Mountain Trading LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before April 19, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No. DEA–774 in all correspondence, including attachments. SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on November 30, 2018, Mountain Trading LLC, 6 South 89 Street West, Billings, Montana 59106, applied to be registered as a manufacturer, and on January 14, 2021, the application was changed from a manufacturer to a bulk manufacturer, of the following basic class(es) of controlled substances: Controlled substance Marihuana ..................... Tetrahydrocannabinols Drug code 7360 7370 Schedule I I William T. McDermott, Assistant Administrator. [FR Doc. 2021–02970 Filed 2–12–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–787] Importer of Controlled Substances Application: Sigma Aldrich Co., LLC. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sigma Aldrich Co. LLC. has applied to be registered as an importer SUMMARY: E:\FR\FM\16FEN1.SGM 16FEN1

Agencies

[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Page 9537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02970]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-774]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Mountain Trading LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: The Drug Enforcement Administration (DEA) is providing notice 
of an application it has received from an entity applying to be 
registered to manufacture in bulk basic class(es) of controlled 
substances listed in schedule I. DEA intends to evaluate this and other 
pending applications according to its regulations governing the program 
of growing marihuana for scientific and medical research under DEA 
registration.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefor, may file written comments on or objections to 
the issuance of the proposed registration on or before April 19, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper 
handling of comments, please reference Docket No. DEA-774 in all 
correspondence, including attachments.

SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA) 
prohibits the cultivation and distribution of marihuana except by 
persons who are registered under the CSA to do so for lawful purposes. 
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is 
providing notice that the entity identified below has applied for 
registration as a bulk manufacturer of schedule I controlled 
substances. In response, registered bulk manufacturers of the affected 
basic class(es), and applicants therefor, may file written comments on 
or objections of the requested registration, as provided in this 
notice. This notice does not constitute any evaluation or determination 
of the merits of the application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for product development and distribution to DEA-
registered researchers. If the application for registration is granted, 
the registrant would not be authorized to conduct other activity under 
this registration aside from those coincident activities specifically 
authorized by DEA regulations. DEA will evaluate the application for 
registration as a bulk manufacturer for compliance with all applicable 
laws, treaties, and regulations and to ensure adequate safeguards 
against diversion are in place.
    As this applicant has applied to become registered as a bulk 
manufacturer of marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the 
manner described in the rule published at 85 FR 82333 on December 18, 
2020, and reflected in DEA regulations at 21 CFR part 1318.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on November 30, 2018, Mountain Trading LLC, 6 South 89 Street West, 
Billings, Montana 59106, applied to be registered as a manufacturer, 
and on January 14, 2021, the application was changed from a 
manufacturer to a bulk manufacturer, of the following basic class(es) 
of controlled substances:

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


William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02970 Filed 2-12-21; 8:45 am]
BILLING CODE 4410-09-P