[Federal Register Volume 87, Number 197 (Thursday, October 13, 2022)]
[Notices]
[Pages 62116-62117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22270]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1097]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Irvine Labs, 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 
December 12, 2022.

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: 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 does not constitute any evaluation or 
determination of the merits of the application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (API) 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.

[[Page 62117]]

    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on September 27, 2022, Irvine Labs, Inc., 7305 Murdy Circle, Huntington 
Beach, California 92647-3533, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled substances:

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                                           Drug
          Controlled substance             code          Schedule
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Marihuana Extract......................     7350  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
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    The applicant plans to manufacture bulk APIs for product 
development and distribution to DEA-registered researchers. No other 
activities for these drug codes are authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-22270 Filed 10-12-22; 8:45 am]
BILLING CODE 4410-09-P