Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Rocky Mountain Biotech, LLC, 64250-64251 [2022-23050]
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64250
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
approved finished dosage forms for
commercial sale.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23051 Filed 10–21–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1038]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Morrison
Newfound Valley Manufacturing
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 23, 2022.
ADDRESSES: 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
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
(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 February 18, 2022, Morrison
Newfound Valley Manufacturing, 262
Morrison Road, Bristol, New Hampshire
03222, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
Marihuana .....................
I
7360
Schedule
II
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23053 Filed 10–21–22; 8:45 am]
BILLING CODE P
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1087]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Rocky
Mountain Biotech, LLC
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.
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 December 23, 2022.
ADDRESSES: 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
DATES:
E:\FR\FM\24OCN1.SGM
24OCN1
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
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 September 1, 2022, Rocky Mountain
Biotech, LLC, 4740 Dillon Drive, Pueblo,
Colorado 81008–2112, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Drug code
Marihuana .........
7360
Schedule
I
Kristi O’Malley,
Assistant Administrator.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 19, 2022,
10300 128th Avenue, Pleasant Prairie,
Wisconsin 53158–7336, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1104]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Drug
code
Controlled substance
Importer of Controlled Substances
Application: Nexus Pharmaceuticals,
Inc.
Nexus Pharmaceuticals, Inc.
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:
19:12 Oct 21, 2022
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. 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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–23050 Filed 10–21–22; 8:45 am]
VerDate Sep<11>2014
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 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 23, 2022.
DATES:
Jkt 259001
Remifentanil ..................
I
9739
Schedule
I
II
The company plans to import the
listed controlled substance for research
and analytical testing purposes.
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 non-
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
64251
approved finished dosage forms for
commercial sale.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23052 Filed 10–21–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1105]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Benuvia Manufacturing Inc.
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.
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 December 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2022.
DATES:
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:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 12, 2022,
Benuvia Manufacturing Inc., 3950 North
Mays Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64250-64251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23050]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1087]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Rocky Mountain Biotech, 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 therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
December 23, 2022.
ADDRESSES: 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 64251]]
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 September 1, 2022, Rocky Mountain Biotech, LLC, 4740 Dillon Drive,
Pueblo, Colorado 81008-2112, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana.......................... 7360 I
------------------------------------------------------------------------
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23050 Filed 10-21-22; 8:45 am]
BILLING CODE 4410-09-P
