[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Notices]
[Pages 69340-69341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25175]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1115]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Berkshire Roots, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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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 therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
January 17, 2023.

ADDRESSES: The DEA 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: 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 submit electronic 
comments on or objections of the requested registration, as provided in 
this notice. This notice

[[Page 69341]]

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 October 17, 2022, Berkshire Roots, Inc., 501 Dalton Avenue, 
Pittsfield, Massachusetts 01201, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled substances:

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        Controlled substance            Drug code          Schedule
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Marihuana Extract..................            7350  I
Marihuana..........................            7360  I
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Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-25175 Filed 11-17-22; 8:45 am]
BILLING CODE 4410-09-P