Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, LLC, 30983 [2021-12213]

Download as PDF 30983 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices import of the Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12212 Filed 6–9–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–845] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, 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. SUMMARY: 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 August 9, 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–845 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 khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 17:15 Jun 09, 2021 Jkt 253001 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). In addition to seeking to produce marihuana extract, this applicant is separately seeking to cultivate marihuana. See Notice of Application, Bulk Manufacturers of Marihuana, 84 FR 44920, 44922 (Aug. 27, 2019). DEA thus 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 May 6, 2021, Maridose, LLC., 74 Orion Street, Brunswick, Maine 04011, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Drug code Controlled substance I Marihuana Extract ........ 7350 Schedule II William T. McDermott, Assistant Administrator. [FR Doc. 2021–12213 Filed 6–9–21; 8:45 am] ACTION: Notice of application. National Center for Natural Products Research 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 file written comments on or objections to the issuance of the proposed registration on or before July 12, 2021. Such persons may also file a written request for a hearing on the application on or before July 12, 2021. DATES: 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 request 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on April 14, 2021, National Center for Natural Products Research, 806 Hathorn Road, 135 Coy Waller Lab, University, Mississippi 38677–1848, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Marihuana Extract .......... Marihuana ....................... Tetrahydrocannabinols ... Drug code Schedule 7350 7360 7370 I I I BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–843] Importer of Controlled Substances Application: National Center for Natural Products Research Drug Enforcement Administration, Justice. AGENCY: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 The company plans to acquire new genetic materials with improved Cannabinoids for research and manufacturing purposes. No other activity for these drug codes 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 FDA-approved or non- E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12213]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-845]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Maridose, 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 August 9, 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-845 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). In addition to seeking to produce 
marihuana extract, this applicant is separately seeking to cultivate 
marihuana. See Notice of Application, Bulk Manufacturers of Marihuana, 
84 FR 44920, 44922 (Aug. 27, 2019). DEA thus 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 May 6, 2021, Maridose, LLC., 74 Orion Street, Brunswick, Maine 
04011, applied to be registered as a bulk manufacturer of the following 
basic class(es) of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana Extract......................     7350  I
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William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12213 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P