Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc., 71930-71931 [2024-19788]
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71930
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
Controlled substance
Drug code
Hydrocodone ..................................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Methadone .....................................................................................................................................................................
Methadone intermediate ................................................................................................................................................
Morphine ........................................................................................................................................................................
Oripavine ........................................................................................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
Tapentadol .....................................................................................................................................................................
Fentanyl .........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances in bulk for distribution and
sale to its customers. In reference to
drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic. 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
manufacturing of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19779 Filed 9–3–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4410–09–P
9193
9220
9250
9254
9300
9330
9333
9652
9668
9737
9739
9740
9780
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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: In
accordance with 21 CFR 1301.33(a), this
is notice that on July 17, 2024,
Biopharmaceutical Research Company,
11045 Commercial Parkway, Castroville,
California 95012–3209, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1418]
Bulk Manufacturer of Controlled
Substances Application:
Biopharmaceutical Research Company
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Biopharmaceutical Research
Company 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 November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
SUMMARY:
Controlled substance
Drug code
Schedule
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
7350
7360
7370
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to provided Pharmaceuticalgrade marihuana in order to facilitate
research in a manner that complies with
local, state, and federal regulations. No
other activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
AGENCY:
[FR Doc. 2024–19783 Filed 9–3–24; 8:45 am]
[Docket No. DEA–1411]
Bulk Manufacturer of Controlled
Substances Application: Cambridge
Isotope Laboratories, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Cambridge Isotope
Laboratories, Inc has applied to be
SUMMARY:
BILLING CODE P
VerDate Sep<11>2014
Drug Enforcement Administration
21:26 Sep 03, 2024
Jkt 262001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
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 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
DATES:
E:\FR\FM\04SEN1.SGM
04SEN1
71931
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
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
ADDRESSES:
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 24, 2024,
Cambridge Isotope Laboratories, Inc., 50
Frontage Road, Andover, Massachusetts
01810–5413, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Tetrahydrocannabinols ..................................................................................................................................................
The company plans to synthetically
bulk manufacture the controlled
substance Tetrahydrocannabinols to
produce analytical standards for
distribution to its customers. No other
activity for this drug code is authorized
for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19788 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
importer of basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
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 October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 2024.
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
ADDRESSES:
Drug Enforcement Administration
[Docket No. DEA–1422]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Fisher Clinical Services, Inc.
has applied to be registered as an
SUMMARY:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 10, 2024, Fisher
Clinical Services, Inc., 700A–C Nestle
Way, Breinigsville, Pennsylvania
18031–1522, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Drug code
ddrumheller on DSK120RN23PROD with NOTICES1
21:26 Sep 03, 2024
Jkt 262001
approved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19791 Filed 9–3–24; 8:45 am]
BILLING CODE P
PO 00000
I
SUPPLEMENTARY INFORMATION:
Marihuana Extract ..........................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................
Psilocybin .......................................................................................................................................................................
Methylphenidate .............................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Tapentadol .....................................................................................................................................................................
VerDate Sep<11>2014
7370
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.
Controlled substance
The company plans to import the
listed controlled substances for use in
clinical trials only. 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 non-
Schedule
Schedule
7350
7435
7437
1724
9220
9668
9780
I
I
I
II
II
II
II
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23–15]
Samirkumar Shah, M.D.; Decision and
Order
On November 28, 2022, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Samirkumar Shah, M.D.,
(Applicant) of Pittsburgh, Pennsylvania.
Frm 00054
Fmt 4703
Sfmt 4703
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]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71930-71931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19788]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1411]
Bulk Manufacturer of Controlled Substances Application: Cambridge
Isotope Laboratories, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cambridge Isotope Laboratories, 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.
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
November 4, 2024. Such persons may also file a written request for a
hearing on the application on or before November 4, 2024.
[[Page 71931]]
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: In accordance with 21 CFR 1301.33(a), this
is notice that on July 24, 2024, Cambridge Isotope Laboratories, Inc.,
50 Frontage Road, Andover, Massachusetts 01810-5413, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols............... 7370 I
------------------------------------------------------------------------
The company plans to synthetically bulk manufacture the controlled
substance Tetrahydrocannabinols to produce analytical standards for
distribution to its customers. No other activity for this drug code is
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19788 Filed 9-3-24; 8:45 am]
BILLING CODE P
