Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, LLC

• Published date: 10 June 2021
• Citation: 86 FR 30983
• Pages: 30983-30983
• FR Document: 2021-12213
• Section: Notices
• Issuer: Justice Department,Drug Enforcement Administration

30983

Federal Register/Vol. 86, No. 110/Thursday, June 10, 2021/Notices

import of the Food and Drug

Administration-approved or non-

approved 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

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:

Controlled substance Drug

code Schedule

Marihuana Extract........7350 I

William T. McDermott,

Assistant Administrator.

[FR Doc. 2021–12213 Filed 6–9–21; 8:45 am]

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

AGENCY

: Drug Enforcement

Administration, Justice.

ACTION

: Notice of application.

SUMMARY

: 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.

DATES

: 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.

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 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.

SUPPLEMENTARY INFORMATION

: 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):

Controlled substance Drug

code Schedule

Marihuana Extract..........7350 I

Marihuana.......................7360 I

Tetrahydrocannabinols...7370 I

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-

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