Bulk Manufacturer of Controlled Substances Application: S&B Pharma LLC, 13747-13748 [2024-03719]
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<![CDATA[
13747
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices
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 March 25, 2024. Such
persons may also file a written request
for a hearing on the application on or
before March 25, 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
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 24, 2024,
Pfizer, Inc. 45 Eastern Point Road,
Groton, Connecticut 06340–5157,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
DATES:
Drug
code
Controlled substance
ddrumheller on DSK120RN23PROD with NOTICES1
Pentobarbital .................
I
2270
Schedule
I
II
The company plans to import the
listed controlled substances as finished
dosage to support internal research
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).
VerDate Sep<11>2014
17:19 Feb 22, 2024
Jkt 262001
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03709 Filed 2–22–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 7, 2023,
Janssen Pharmaceuticals Inc., 1440
Olympic Drive, Buildings 1–5 & 7–14,
Athens, Georgia 30601–1645, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1321]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen 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.
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 March 25, 2024. Such
persons may also file a written request
for a hearing on the application on or
before March 25, 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
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
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Methylphenidate ..............
Tapentadol ......................
I
Drug
code
Schedule
1724
9780
II
II
I
The company plans to import
intermediates classified under
Tapentadol (9780) for further
manufacturing to the controlled
substance Tapentadol respectively, prior
to distribution to customers. No other
activity 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03689 Filed 2–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1327]
Bulk Manufacturer of Controlled
Substances Application: S&B Pharma
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
S&B Pharma 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 April 23, 2024. Such
persons may also file a written request
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
13748
Federal Register / Vol. 89, No. 37 / Friday, February 23, 2024 / Notices
for a hearing on the application on or
before April 23, 2024.
DEPARTMENT OF JUSTICE
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 February 6, 2024, S&B
Pharma LLC, 405 South Motor Avenue,
Azusa, California 91702, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
ddrumheller on DSK120RN23PROD with NOTICES1
Marihuana ......................
Tetrahydrocannabinols ..
Amphetamine ................
Methamphetamine .........
Lisdexamfetamine .........
Methylphenidate ............
Pentobarbital .................
4-Anilino-N-Phenethyl-4Piperidine (ANPP).
Tapentadol .....................
Fentanyl .........................
Drug
code
Schedule
7360
7370
1100
1105
1205
1724
2270
8333
I
I
II
II
II
II
II
II
9780
9801
II
II
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates for formulation and
analytical development purposes or for
sale to its customers. In reference to dug
codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03719 Filed 2–22–24; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
17:19 Feb 22, 2024
Jkt 262001
Controlled substance
Drug
code
Schedule
7435
7437
7438
1100
9250
I
I
I
II
II
Drug Enforcement Administration
[Docket No. DEA–1320]
Importer of Controlled Substances
Application: Patheon API Services, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon API Services, 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.
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 March 25, 2024. Such
persons may also file a written request
for a hearing on the application on or
before March 25, 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
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 21, 2023,
Patheon API Services, Inc., 101
Technology Place, Florence, South
Carolina 29501 applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Amphetamine ..................
Methadone ......................
The company plans to import the
listed controlled substances as reference
standards for research and development
as part of API Manufacturing. 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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–03688 Filed 2–22–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF LABOR
Office of Federal Contract Compliance
Programs
Proposed Reinstatement With Change
of Information Collection
Requirements; Comment Request
ACTION:
Notice.
The Department of Labor
(DOL), as part of its continuing effort to
reduce paperwork and respondent
burden, conducts a pre-clearance
consultation program to provide the
general public and Federal agencies
with an opportunity to comment on
proposed and/or continuing collections
of information in accordance with the
Paperwork Reduction Act of 1995. The
program helps ensure that requested
data can be provided in the desired
format, reporting burden (time and
financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements on respondents can be
properly assessed. The Office of Federal
Contract Compliance Programs (OFCCP)
is soliciting comments concerning its
proposal to obtain approval from the
Office of Management and Budget
(OMB) for a reinstatement with change
of the Monthly Employment Utilization
Report (CC–257). A copy of the
proposed information collection request
can be obtained by contacting the office
listed below in the FOR FURTHER
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 89, Number 37 (Friday, February 23, 2024)]
[Notices]
[Pages 13747-13748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03719]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1327]
Bulk Manufacturer of Controlled Substances Application: S&B
Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: S&B Pharma 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
April 23, 2024. Such persons may also file a written request
[[Page 13748]]
for a hearing on the application on or before April 23, 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 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 February 6, 2024, S&B Pharma LLC, 405 South Motor
Avenue, Azusa, California 91702, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Amphetamine............................ 1100 II
Methamphetamine........................ 1105 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
Pentobarbital.......................... 2270 II
4-Anilino-N-Phenethyl-4-Piperidine 8333 II
(ANPP).
Tapentadol............................. 9780 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates for formulation and
analytical development purposes or for sale to its customers. In
reference to dug codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-03719 Filed 2-22-24; 8:45 am]
BILLING CODE 4410-09-P
