Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC, 37260-37261 [2024-09805]
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37260
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
Controlled substance
Drug code
Hydrocodone .......................................................................................................................................................................
Levorphanol .........................................................................................................................................................................
Isomethadone ......................................................................................................................................................................
Meperidine ...........................................................................................................................................................................
Meperidine-intermediate-A ..................................................................................................................................................
Meperidine intermediate-B ..................................................................................................................................................
Meperidine intermediate-C ..................................................................................................................................................
Methadone ...........................................................................................................................................................................
Methadone intermediate ......................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..................................................................................................................
Morphine ..............................................................................................................................................................................
Oripavine .............................................................................................................................................................................
Thebaine ..............................................................................................................................................................................
Opium, raw ..........................................................................................................................................................................
Opium extracts ....................................................................................................................................................................
Opium fluid extract ..............................................................................................................................................................
Opium tincture .....................................................................................................................................................................
Opium, powdered ................................................................................................................................................................
Opium, granulated ...............................................................................................................................................................
Oxymorphone ......................................................................................................................................................................
Noroxymorphone .................................................................................................................................................................
Alfentanil ..............................................................................................................................................................................
Remifentanil .........................................................................................................................................................................
Sufentanil .............................................................................................................................................................................
Carfentanil ...........................................................................................................................................................................
Tapentadol ...........................................................................................................................................................................
Bezitramide ..........................................................................................................................................................................
Fentanyl ...............................................................................................................................................................................
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic cannabidiol
and a synthetic tetrahydrocannabinol.
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.
The Drug Enforcement
Administration (DEA) published a
document in the Federal Register on
March 6, 2024, concerning an
application for an Importer of
Controlled Substances. The document
request removal of Dimethyltrytamine.
SUMMARY:
SUPPLEMENTARY INFORMATION:
In the Federal Register on March 6,
2024, in FR Doc No: 89 FR 16029, FR
No. 2024–04753, on pages 16029–16030
(2 pages), in the first column, remove
the controlled substance
Dimethltrytamine from the list to read
as follows:
Controlled substance
Drug
code
Schedule
[FR Doc. 2024–09811 Filed 5–3–24; 8:45 am]
Cocaine ........................
Methadone ....................
9041
9250
II
II
I
Marsha Ikner,
Acting Deputy Assistant Administrator.
Drug Enforcement Administration
[FR Doc. 2024–09785 Filed 5–3–24; 8:45 am]
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ddrumheller on DSK120RN23PROD with NOTICES1
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DEPARTMENT OF JUSTICE
[Docket No. 1324]
Importer of Controlled Substances
Application: AndersonBrecon dba PCI
Pharma Services; Correction
Drug Enforcement
Administration, Justice.
ACTION: Notice of correction.
AGENCY:
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
PO 00000
Frm 00101
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1357]
Bulk Manufacturer of Controlled
Substances Application: Pharmaron
Manufacturing Services (US) LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Correction
Marsha Ikner,
Acting Deputy Assistant Administrator.
BILLING CODE 4410–09–P
9193
9220
9226
9230
9232
9233
9234
9250
9254
9273
9300
9330
9333
9600
9610
9620
9630
9639
9640
9652
9668
9737
9739
9740
9743
9780
9800
9801
Schedule
Fmt 4703
Sfmt 4703
Pharmaron Manufacturing
Services (US) 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 July 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 5, 2024.
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
SUMMARY:
E:\FR\FM\06MYN1.SGM
06MYN1
37261
Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Notices
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 March 25, 2024,
SUPPLEMENTARY INFORMATION:
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Coventry,
Rhode Island 02816, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug code
Oxymorphone ......................................................................................................................................................................
Noroxymorphone .................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the purpose of producing
material for clinical trials. No other
activities for these drug codes are
authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–09805 Filed 5–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1363]
Importer of Controlled Substances
Application: AndersonBrecon dba PCI
Pharma Services
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
VerDate Sep<11>2014
18:02 May 03, 2024
Jkt 262001
In
accordance with 21 CFR 1301.34(a), this
is notice that on April 3, 2024,
AndersonBrecon dba PCI Pharma
Services, 5775 Logistics Parkway,
Rockford, Illinois 61109–3608, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
AndersonBrecon dba PCI
Pharma Services 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.
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 June 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
June 5, 2024.
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
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. 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
Drug
code
Tetrahydrocannabinols .........
Cocaine .................................
Methadone ............................
Thebaine ...............................
7370
9041
9250
9333
Schedule
I
II
II
II
The company plans to import the
listed controlled substances for clinical
trials. 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-
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
9652
9668
Schedule
II
II
approved finished dosage forms for
commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–09787 Filed 5–3–24; 8:45 am]
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DEPARTMENT OF JUSTICE
[OMB 1140–0008]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Application
and Permit for Permanent Exportation
of Firearms—ATF Form 9 (5320.9)
Bureau of Alcohol, Tobacco,
Firearms and Explosives, Department of
Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 30 days until June
5, 2024.
FOR FURTHER INFORMATION CONTACT: If
you have comments especially on the
estimated public burden or associated
response time, suggestions, or need a
copy of the proposed information
collection instrument with instructions
or additional information, please
contact: Melisa Mason, by phone at
304–616–4500, or email at
nfaombcomments@atf.gov.
SUPPLEMENTARY INFORMATION: The
proposed information collection was
previously published in the Federal
Register, volume 89 page 15614, on
Monday, March 4, 2024, allowing a 60day comment period. Written comments
and suggestions from the public and
affected agencies concerning the
proposed collection of information are
encouraged. Your comments should
SUMMARY:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37260-37261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09805]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1357]
Bulk Manufacturer of Controlled Substances Application: Pharmaron
Manufacturing Services (US) LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pharmaron Manufacturing Services (US) 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
July 5, 2024. Such persons may also file a written request for a
hearing on the application on or before July 5, 2024.
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
[[Page 37261]]
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 March 25, 2024, Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxymorphone.......................... 9652 II
Noroxymorphone....................... 9668 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the purpose of producing material for clinical trials.
No other activities for these drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09805 Filed 5-3-24; 8:45 am]
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