Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Indian Flower LLC, 24666-24667 [2021-09662]
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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810.
SUPPLEMENTARY INFORMATION: On March
6, 2019, the Commission instituted this
investigation under section 337 of the
Tariff Act of 1930, as amended, 19
U.S.C. 1337 (‘‘section 337’’), based on a
complaint filed by Medytox Inc. of
Seoul, South Korea (‘‘Medytox’’);
Allergan plc of Dublin, Ireland; and
Allergan, Inc. of Irvine, California
(collectively, ‘‘Allergan’’) (all
collectively, ‘‘Complainants’’). See 84
FR 8112–13 (March 6, 2019). The
complaint, as supplemented, alleges a
violation of section 337 based upon the
importation into the United States, the
sale for importation, and the sale within
the United States after importation of
certain botulinum toxin products,
processes for manufacturing or relating
to same and certain products containing
same by reason of misappropriation of
trade secrets, the threat or effect of
which is to destroy or substantially
injure a domestic industry in the United
States. See id. The notice of
investigation names as respondents
Daewoong Pharmaceuticals Co., Ltd.
(‘‘Daewoong’’) of Seoul, South Korea
and Evolus, Inc. (‘‘Evolus’’) of Irvine,
California (collectively, ‘‘Respondents’’).
See id. The Office of Unfair Import
Investigations (‘‘OUII’’) was also a party
to the investigation. See id.
On July 6, 2020, the Administrative
Law Judge issued a final initial
determination (‘‘FID’’) finding a
violation of section 337 based on the
misappropriation of Complainants’
asserted trade secrets (including the
Medytox bacterial strain and Medytox
manufacturing processes), the threat or
effect of which is to destroy or
substantially injure an industry in the
United States. On September 21, 2020,
the Commission issued a notice
determining to review the FID in part.
See 85 FR 60489–90 (September 25,
2020).
On December 16, 2020, the
Commission found a violation of section
337 based on the misappropriation of
Complainants’ trade secrets (including
the Medytox manufacturing processes
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19:55 May 06, 2021
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but not the Medytox bacterial strain).
See 85 FR 83610–11 (Dec. 22, 2020).
The Commission issued a limited
exclusion order (‘‘LEO’’) against certain
botulinum neurotoxin products that are
imported and/or sold by Respondents
Daewoong and Evolus and a cease and
desist order (‘‘CDO’’) against Evolus. Id.
The Commission also set a bond during
the period of Presidential review in an
amount of $441 per 100U vial of
Respondents’ accused products. Id
On February 12, 2021, Complainants
filed an appeal from the Commission’s
final determination with the Federal
Circuit. On the same day, Respondents
also filed an appeal from the
Commission’s final determination of a
violation of section 337. On February
18, 2021, Complainants and Evolus
(collectively, ‘‘the Settling Parties’’)
announced that they had reached a
settlement agreement to resolve all
pending issues between them.
On March 3, 2021, the Settling Parties
filed a joint petition to rescind the LEO
and CDO (collectively, ‘‘the remedial
orders’’) based on the settlement
agreement. On the same day, the
Settling Parties also filed a joint motion
to limit service of the settlement
agreement. On March 16, 2021,
Daewoong filed a notice of nonopposition to the joint motion to limit
service. On April 1, 2021, the Settling
Parties further filed a joint motion to
terminate the investigation without
prejudice pursuant to 19 CFR 210.21(b).
On April 5, 2021, Daewoong filed a
response to the Settling Parties’ petition
to rescind the remedial orders stating
that it does not oppose the Settling
Parties’ petition for recission.
Daewoong’s response also included a
motion for vacatur of the Commission’s
final determination. On April 8, 2021,
OUII filed a response in support of the
Settling Parties’ petition to rescind and
their joint motion to limit service. On
April 12, 2021, Daewoong filed a
response to the Settling Parties’ motion
to terminate the investigation, arguing
that the motion to terminate should be
denied as moot and opposing
termination without prejudice. On April
15, 2021, Medytox filed a response in
opposition to Daewoong’s motion to
vacate the final determination. On April
23, 2021, Daewoong filed a motion for
leave to file a reply in support of its
motion to vacate and on April 29, 2021,
Medytox filed a response in opposition
to the motion for leave to file a reply;
the Commission accepts both of these
filings and Daewoong’s motion for leave
to file a reply is granted.
Having reviewed the parties’
submissions relating to (and in response
to) the Settling Parties’ petition to
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Sfmt 4703
rescind, their joint motion to limit
service, their joint motion to terminate,
and Daewoong’s motion to vacate, and
for the reasons discussed in the
Commission Opinion issued
concurrently herewith, the Commission
has determined to grant the joint
petition to rescind the remedial orders
and the joint motion to limit service,
and to deny as moot the joint motion to
terminate the investigation. The
Commission has further determined
that, if the Federal Circuit dismisses the
pending appeals as moot, the
Commission will vacate its final
determination. Commissioner Karpel
concurs in the determination to grant
the Settling Parties’ motion to rescind
the remedial orders and their motion to
limit service; and to deny as moot their
motion to terminate the investigation.
However, Commissioner Karpel would
deny Daewoong’s motion to vacate the
Commission’s final determination as
procedurally improper. She would also
deny Daewoong’s motion for leave to
file a reply. Further, Commissioner
Karpel would decline to issue an
indicative ruling as to whether
Daewoong has established equitable
entitlement to the extraordinary remedy
of vacatur on the basis of the record
before the Commission.
The rescission proceeding is
terminated.
The Commission’s vote on this
determination took place on May 3,
2021.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: May 3, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–09652 Filed 5–6–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–814]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Indian
Flower LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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24667
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
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 July 6, 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–814 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
(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
SUMMARY:
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19:55 May 06, 2021
Jkt 253001
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 March 2, 2021, Indian Flower LLC.,
1104 North 105th East Avenue, Tulsa,
Oklahoma 74116–1527, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Drug
code
Controlled substance
Marihuana .......................
Schedule
I 7360 II
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–09662 Filed 5–6–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–832]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Green
Rush Organic Farms Inc.
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 July 6, 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–832 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 9990
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 March 31, 2021, Green Rush Organic
Farms Inc., 1318 South Kilbourn
Avenue, Chicago, Illinois 60623,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
7350
7360
7370
I
I
I
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–09663 Filed 5–6–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Notices]
[Pages 24666-24667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09662]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-814]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Indian Flower LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
[[Page 24667]]
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 July 6, 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-814 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 (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.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on March 2, 2021, Indian Flower LLC., 1104 North 105th East Avenue,
Tulsa, Oklahoma 74116-1527, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
------------------------------------------------------------------------
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-09662 Filed 5-6-21; 8:45 am]
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