Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 9733-9735 [2025-02731]
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<![CDATA[
9733
Federal Register / Vol. 90, No. 31 / Tuesday, February 18, 2025 / Notices
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Psilocybin ......................
Psilocyn .........................
Matthew Strait,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2025–02738 Filed 2–14–25; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
DEPARTMENT OF JUSTICE
[Docket No. DEA–1496]
Patheon API 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 April 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 2025.
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 January 16, 2025,
Patheon API Inc., 6173 East Old Marion
Highway, Florence, South Carolina
29506 applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE P
Drug Enforcement Administration
Notice of application.
17:15 Feb 14, 2025
I
I
I
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–1498]
VerDate Sep<11>2014
I
7437
7438
Schedule
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.
[FR Doc. 2025–02732 Filed 2–14–25; 8:45 am]
ACTION:
Drug
code
Controlled substance
Jkt 265001
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals, Inc.
Frm 00030
Fmt 4703
Sfmt 4703
Methylphenidate ..............
Hydromorphone ...............
Tapentadol ......................
I
Drug
code
Schedule
1724
9150
9780
II
II
II
I
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates for sale to its customers.
No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02740 Filed 2–14–25; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
Janssen Pharmaceuticals, 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 April 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 2025.
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
PO 00000
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SUMMARY:
is notice that on December 4, 2024,
Janssen Pharmaceuticals, Inc., 1440
Olympic Drive, Buildings 1–5 and 7–14,
Athens, Georgia 30601–1645, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
[Docket No. DEA–1492]
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Purisys, 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 21, 2025. Such
persons may also file a written request
for a hearing on the application on or
before April 21, 2025.
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
SUMMARY:
E:\FR\FM\18FEN1.SGM
18FEN1
9734
Federal Register / Vol. 90, No. 31 / Tuesday, February 18, 2025 / Notices
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 December 10, 2024,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
SUPPLEMENTARY INFORMATION:
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
Controlled substance
Drug code
lotter on DSK11XQN23PROD with NOTICES1
Cathinone ...............................................................................................................................................................................
Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) .......................................................................................................
Gamma Hydroxybutyric Acid ..................................................................................................................................................
Ibogaine ..................................................................................................................................................................................
Lysergic acid diethylamide .....................................................................................................................................................
Marihuana Extract ..................................................................................................................................................................
Marihuana ...............................................................................................................................................................................
Tetrahydrocannabinols ...........................................................................................................................................................
Mescaline ...............................................................................................................................................................................
2,5-Dimethoxyamphetamine ...................................................................................................................................................
3,4-Methylenedioxyamphetamine ...........................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ..............................................................................................................................
3,4-Methylenedioxymethamphetamine ...................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine ........................................................................................................................................
Diethyltryptamine ....................................................................................................................................................................
Dimethyltryptamine .................................................................................................................................................................
Psilocybin ...............................................................................................................................................................................
Psilocyn ..................................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ....................................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) .............................................................................................................
Codeine-N-oxide .....................................................................................................................................................................
Dihydromorphine ....................................................................................................................................................................
Heroin .....................................................................................................................................................................................
Hydromorphinol ......................................................................................................................................................................
Morphine-N-oxide ...................................................................................................................................................................
Normorphine ...........................................................................................................................................................................
Norlevorphanol .......................................................................................................................................................................
Amphetamine .........................................................................................................................................................................
Lisdexamfetamine ..................................................................................................................................................................
Methylphenidate .....................................................................................................................................................................
Pentobarbital ..........................................................................................................................................................................
Nabilone .................................................................................................................................................................................
Cocaine ..................................................................................................................................................................................
Codeine ..................................................................................................................................................................................
Dihydrocodeine .......................................................................................................................................................................
Oxycodone .............................................................................................................................................................................
Hydromorphone ......................................................................................................................................................................
Ecgonine .................................................................................................................................................................................
Hydrocodone ..........................................................................................................................................................................
Levorphanol ............................................................................................................................................................................
Meperidine ..............................................................................................................................................................................
Meperidine intermediate-A .....................................................................................................................................................
Meperidine intermediate-B .....................................................................................................................................................
Meperidine intermediate-C .....................................................................................................................................................
Methadone ..............................................................................................................................................................................
Methadone intermediate .........................................................................................................................................................
Morphine .................................................................................................................................................................................
Oripavine ................................................................................................................................................................................
Thebaine .................................................................................................................................................................................
Opium tincture ........................................................................................................................................................................
Opium, powdered ...................................................................................................................................................................
Opium, granulated ..................................................................................................................................................................
Oxymorphone .........................................................................................................................................................................
Noroxymorphone ....................................................................................................................................................................
Alfentanil .................................................................................................................................................................................
Sufentanil ................................................................................................................................................................................
Carfentanil ..............................................................................................................................................................................
Tapentadol ..............................................................................................................................................................................
Fentanyl ..................................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the production of active
pharmaceutical ingredients (API) and
analytical reference standards for sale to
VerDate Sep<11>2014
17:15 Feb 14, 2025
Jkt 265001
its customers. The company plans to
manufacture the above listed controlled
substances as clinical trial and starting
materials to make compounds for
distribution to its customers. No other
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
1235
1727
2010
7260
7315
7350
7360
7370
7381
7396
7400
7404
7405
7431
7434
7435
7437
7438
7439
7540
9053
9145
9200
9301
9307
9313
9634
1100
1205
1724
2270
7379
9041
9050
9120
9143
9150
9180
9193
9220
9230
9232
9233
9234
9250
9254
9300
9330
9333
9630
9639
9640
9652
9668
9737
9740
9743
9780
9801
Schedule
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activities for these drug codes are
authorized for this registration.
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 90, No. 31 / Tuesday, February 18, 2025 / Notices
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02737 Filed 2–14–25; 8:45 am]
Docket: To read or download
comments or other material in the
docket, go to https://
www.regulations.gov. Documents in the
docket are listed in the https://
www.regulations.gov index; however,
some information (e.g., copyrighted
material) is not publicly available to
read or download through the website.
All submissions, including copyrighted
material, are available for inspection
through the OSHA Docket Office.
Contact the OSHA Docket Office at (202)
693–2350 (TTY (877) 889–5627) for
assistance in locating docket
submissions.
Instructions: All submissions must
include the agency name and the OSHA
docket number (OSHA–2012–0031) for
the Information Collection Request
(ICR). OSHA will place comments,
including personal information, in the
public docket, which may be available
online. Therefore, OSHA cautions
interested parties about submitting
personal information such as social
security number and date of birth.
For further information on submitting
comments, see the ‘‘Public
Participation’’ heading in the section of
this notice titled SUPPLEMENTARY
BILLING CODE P
INFORMATION
is notice that on February 4, 2025,
Lonza Tampa, LLC, 4901 West Grace
Street, Tampa, Florida 33607–3805,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
[FR Doc. 2025–02731 Filed 2–14–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Schedule
[Docket No. DEA–1497]
Psilocybin ......................
Importer of Controlled Substances
Application: Lonza Tampa, LLC
The company plans to import drug
code 7437 (Psilocybin) as bulk active
pharmaceutical ingredient and as
finished dosage units for clinical trials,
research, and analytical purposes. No
other activity for this drug code is
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.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lonza Tampa, LLC 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 20, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 20, 2025.
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
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Drug
code
Controlled substance
Drug Enforcement Administration
VerDate Sep<11>2014
17:15 Feb 14, 2025
Jkt 265001
9735
7437
I
Matthew Strait,
Deputy Assistant Administrator.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2012–0031]
Seleda Perryman, Directorate of
Standards and Guidance, OSHA, U.S.
Department of Labor, telephone (202)
693–2222.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Labor, as part of
the continuing effort to reduce
paperwork and respondent (i.e.,
employer) burden, conducts a
preclearance consultation program to
provide the public with an opportunity
AGENCY: Occupational Safety and Health to comment on proposed and
continuing information collection
Administration, Labor.
requirements in accordance with the
ACTION: Request for public comment.
Paperwork Reduction Act of 1995 (PRA)
SUMMARY: OSHA solicits public
(44 U.S.C. 3506(c)(2)(A)). This program
comments concerning the proposal to
ensures that information is in the
extend the Office of Management and
desired format, reporting burden (time
Budget’s (OMB) approval of the
and costs) is minimal, collection
information collection requirements
instruments are clearly understood, and
specified in the 4, 4′-Methylenedianiline OSHA’s estimate of the information
(MDA) in Construction Standard.
collection burden is accurate. The
DATES: Comments must be submitted
Occupational Safety and Health Act of
(postmarked, sent, or received) by April 1970 (OSH Act) (29 U.S.C. 651 et seq.)
21, 2025.
authorizes information collection by
employers as necessary or appropriate
ADDRESSES:
Electronically: You may submit
for enforcement of the OSH Act or for
comments, including attachments,
developing information regarding the
electronically at https://
causes and prevention of occupational
www.regulations.gov, which is the
injuries, illnesses, and incidents (29
Federal eRulemaking Portal. Follow the U.S.C. 657). The OSH Act also requires
instructions online for submitting
that OSHA obtain such information
comments.
with minimum burden upon employers,
4, 4′-Methylenedianiline (MDA) in
Construction Standard; Extension of
the Office of Management and
Budget’s (OMB) Approval of
Information Collection (Paperwork)
Requirements
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 90, Number 31 (Tuesday, February 18, 2025)]
[Notices]
[Pages 9733-9735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02731]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1492]
Bulk Manufacturer of Controlled Substances Application: Purisys,
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Purisys, 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 21, 2025. Such persons may also file a written request for a
hearing on the application on or before April 21, 2025.
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
[[Page 9734]]
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 December 10, 2024, Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601-1602, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone................................... 1235 I
Ethylphenidate (ethyl 2-phenyl-2-(piperidin- 1727 I
2-yl)acetate).
Gamma Hydroxybutyric Acid................... 2010 I
Ibogaine.................................... 7260 I
Lysergic acid diethylamide.................. 7315 I
Marihuana Extract........................... 7350 I
Marihuana................................... 7360 I
Tetrahydrocannabinols....................... 7370 I
Mescaline................................... 7381 I
2,5-Dimethoxyamphetamine.................... 7396 I
3,4-Methylenedioxyamphetamine............... 7400 I
3,4-Methylenedioxy-N-ethylamphetamine....... 7404 I
3,4-Methylenedioxymethamphetamine........... 7405 I
5-Methoxy-N-N-dimethyltryptamine............ 7431 I
Diethyltryptamine........................... 7434 I
Dimethyltryptamine.......................... 7435 I
Psilocybin.................................. 7437 I
Psilocyn.................................... 7438 I
5-Methoxy-N,N-diisopropyltryptamine......... 7439 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Codeine-N-oxide............................. 9053 I
Dihydromorphine............................. 9145 I
Heroin...................................... 9200 I
Hydromorphinol.............................. 9301 I
Morphine-N-oxide............................ 9307 I
Normorphine................................. 9313 I
Norlevorphanol.............................. 9634 I
Amphetamine................................. 1100 II
Lisdexamfetamine............................ 1205 II
Methylphenidate............................. 1724 II
Pentobarbital............................... 2270 II
Nabilone.................................... 7379 II
Cocaine..................................... 9041 II
Codeine..................................... 9050 II
Dihydrocodeine.............................. 9120 II
Oxycodone................................... 9143 II
Hydromorphone............................... 9150 II
Ecgonine.................................... 9180 II
Hydrocodone................................. 9193 II
Levorphanol................................. 9220 II
Meperidine.................................. 9230 II
Meperidine intermediate-A................... 9232 II
Meperidine intermediate-B................... 9233 II
Meperidine intermediate-C................... 9234 II
Methadone................................... 9250 II
Methadone intermediate...................... 9254 II
Morphine.................................... 9300 II
Oripavine................................... 9330 II
Thebaine.................................... 9333 II
Opium tincture.............................. 9630 II
Opium, powdered............................. 9639 II
Opium, granulated........................... 9640 II
Oxymorphone................................. 9652 II
Noroxymorphone.............................. 9668 II
Alfentanil.................................. 9737 II
Sufentanil.................................. 9740 II
Carfentanil................................. 9743 II
Tapentadol.................................. 9780 II
Fentanyl.................................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the production of active pharmaceutical ingredients
(API) and analytical reference standards for sale to its customers. The
company plans to manufacture the above listed controlled substances as
clinical trial and starting materials to make compounds for
distribution to its customers. No other activities for these drug codes
are authorized for this registration.
[[Page 9735]]
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-02731 Filed 2-14-25; 8:45 am]
BILLING CODE P
