Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Irvine Labs, Inc., 62116-62117 [2022-22270]
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Federal Register / Vol. 87, No. 197 / Thursday, October 13, 2022 / Notices
implementing regulations (40 CFR
1506.6 and 43 CFR 46).
Drue DeBerry,
Acting Assistant Regional Director, Ecological
Services, Mountain-Prairie Region.
[FR Doc. 2022–22249 Filed 10–12–22; 8:45 am]
BILLING CODE 4333–15–P
INTERNATIONAL TRADE
COMMISSION
[USITC SE–22–041]
Sunshine Act Meetings
United
States International Trade Commission.
TIME AND DATE: October 13, 2022 at 11:00
a.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. No. 731–
TA–1313 (Review)(1,1,1,2Tetrafluoroethane (R–134a) from China).
The Commission is currently scheduled
to complete and file its determinations
and views of the Commission on
October 20, 2022.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
William Bishop, Supervisory Hearings
and Information Officer, 202–205–2595.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting. Earlier notification
of this meeting was not possible.
AGENCY HOLDING THE MEETING:
By order of the Commission.
Issued: October 11, 2022.
William Bishop,
Supervisory Hearings and Information
Officer.
BILLING CODE 7020–02–P
khammond on DSKJM1Z7X2PROD with NOTICES
INTERNATIONAL TRADE
COMMISSION
[USITC SE–22–042]
Sunshine Act Meetings
United
States International Trade Commission.
TIME AND DATE: October 17, 2022 at 11:00
a.m.
VerDate Sep<11>2014
17:49 Oct 12, 2022
Jkt 259001
By order of the Commission.
Issued: October 11, 2022.
William Bishop,
Supervisory Hearings and Information
Officer.
[FR Doc. 2022–22396 Filed 10–11–22; 4:15 pm]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1097]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Irvine
Labs, 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 therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 12, 2022.
SUMMARY:
[FR Doc. 2022–22397 Filed 10–11–22; 4:15 pm]
AGENCY HOLDING THE MEETING:
Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. No. 731–
TA–1586 (Final)(Sodium Nitrite from
Russia). The Commission is currently
scheduled to complete and file its
determinations and views of the
Commission on October 27, 2022.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
William Bishop, Supervisory Hearings
and Information Officer, 202–205–2595.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting. Earlier notification
of this meeting was not possible.
PLACE:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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.’’
ADDRESSES:
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13OCN1.SGM
13OCN1
62117
Federal Register / Vol. 87, No. 197 / Thursday, October 13, 2022 / Notices
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:
Drug
code
Controlled substance
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
I
7350
7360
7370
Schedule
I
I
I
I
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.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Groff NA
Hemplex LLC
khammond on DSKJM1Z7X2PROD with NOTICES
I
I
I
I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Groff NA Hemplex LLC. has
applied to be registered as a bulk
manufacturer 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 12, 2022. Such
persons may also file a written request
for a hearing on the application 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
[Docket No. DEA–1094]
Importer of Controlled Substances
Application: National Center for
Natural Products Research
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 14, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 14, 2022.
ADDRESSES: The Drug Enforcement
Administration requires that all
DATES:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 5, 2022,
National Center for Natural Products
Research, 806 Hathorn Road, 135 Coy
Waller Lab, University, Mississippi
38677, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
BILLING CODE P
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Jkt 259001
I
7350
7360
7370
[FR Doc. 2022–22266 Filed 10–12–22; 8:45 am]
AGENCY:
17:49 Oct 12, 2022
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
Schedule
Kristi O’Malley,
Assistant Administrator.
[Docket No. DEA–1092]
VerDate Sep<11>2014
Drug
code
Controlled substance
The company is federally authorized
to conduct cultivation activities in order
to bulk manufacture the listed
controlled substances for internal use
and for sale to federally registered
research investigators. No other
activities for these drug codes are
authorized for this registration.
[FR Doc. 2022–22270 Filed 10–12–22; 8:45 am]
SUMMARY:
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: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 18, 2022, Groff
NA Hemplex LLC., 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Drug
code
Controlled substance
Marihuana extract .........
Marihuana .....................
Tetrahydrocannabinols
I
7350
7360
7370
Schedule
I
I
I
I
The company plans to acquire new
genetic materials with improved
Cannabinoids for research and
manufacturing purposes. No other
activities for these drug codes are
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–22267 Filed 10–12–22; 8:45 am]
BILLING CODE P
E:\FR\FM\13OCN1.SGM
13OCN1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
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
