Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals Inc., 11998-11999 [2025-04044]
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11998
Federal Register / Vol. 90, No. 48 / Thursday, March 13, 2025 / Notices
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 29, 2025,
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):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Marihuana ............................................................................................................................................................................
Tetrahydrocannabinols ........................................................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .....................................................................................................................................
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 nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–04046 Filed 3–12–25; 8:45 am]
BILLING CODE P
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 December 23, 2024,
Sigma Aldrich Research Biochemicals
Inc., 400–600 Summit Drive, Burlington,
Massachusetts 01803, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Drug Enforcement Administration
[Docket No. 1507]
Bulk Manufacturer of Controlled
Substances Application: Sigma Aldrich
Research Biochemicals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sigma Aldrich Research
Biochemicals 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 May 12, 2025. Such persons
may also file a written request for a
hearing on the application on or before
May 12, 2025.
khammond on DSK9W7S144PROD with NOTICES
Controlled substance
Drug code
Cathinone ...........................................................................................................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) .......................................................................................................................................................
Methaqualone .....................................................................................................................................................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) .................................................................................................................
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ..........................................................................................................................................
Lysergic acid diethylamide .................................................................................................................................................................................
Tetrahydrocannabinols .......................................................................................................................................................................................
Mescaline ............................................................................................................................................................................................................
2,5-Dimethoxyamphetamine ...............................................................................................................................................................................
3,4-Methylenedioxymethamphetamine ...............................................................................................................................................................
Alpha-methyltryptamine ......................................................................................................................................................................................
Dimethyltryptamine .............................................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ................................................................................................................................................................
N-Benzylpiperazine .............................................................................................................................................................................................
2C–H 2-(2,5-Dimethoxyphenyl) ethanamine) .....................................................................................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) ..........................................................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) .........................................................................................................................................
Heroin .................................................................................................................................................................................................................
Normorphine .......................................................................................................................................................................................................
Norlevorphanol ...................................................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ..................................................................................................................
Amphetamine ......................................................................................................................................................................................................
Lisdexamfetamine ...............................................................................................................................................................................................
Methylphenidate .................................................................................................................................................................................................
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ADDRESSES:
DEPARTMENT OF JUSTICE
SUMMARY:
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7396
7405
7432
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7493
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11999
Federal Register / Vol. 90, No. 48 / Thursday, March 13, 2025 / Notices
Controlled substance
Drug code
Nabilone ..............................................................................................................................................................................................................
Phencyclidine ......................................................................................................................................................................................................
Cocaine ...............................................................................................................................................................................................................
Codeine ..............................................................................................................................................................................................................
Ecgonine .............................................................................................................................................................................................................
Levorphanol ........................................................................................................................................................................................................
Meperidine ..........................................................................................................................................................................................................
Methadone ..........................................................................................................................................................................................................
Morphine .............................................................................................................................................................................................................
Thebaine .............................................................................................................................................................................................................
Levo-alphacetylmethadol ....................................................................................................................................................................................
Noroxymorphone ................................................................................................................................................................................................
Remifentanil ........................................................................................................................................................................................................
Sufentanil ............................................................................................................................................................................................................
Carfentanil ..........................................................................................................................................................................................................
Tapentadol ..........................................................................................................................................................................................................
Fentanyl ..............................................................................................................................................................................................................
The company plans to manufacture
the listed controlled substances as
reference standards. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–04044 Filed 3–12–25; 8:45 am]
BILLING CODE 4410–09–P
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Office of the Federal Register.
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AGENCY:
ACTION:
During an appropriations
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(OFR) publishes documents directly
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may publish documents related to
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would prevent or significantly damage
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FOR FURTHER INFORMATION CONTACT: Liza
Davis, Director of Legal Affairs and
Policy, or Miriam Vincent, Senior Staff
Attorney, Office of the Federal Register,
National Archives and Records
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:14 Mar 12, 2025
Jkt 265001
Administration, (202) 741–6030 or
Fedreg.legal@nara.gov.
SUPPLEMENTARY INFORMATION: Due to the
possibility of a lapse in appropriations
and in accordance with the provisions
of the Antideficiency Act, Public Law
97–258, as amended (31 U.S.C. 1341),
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During an appropriations lapse, the
OFR publishes documents directly
related to the performance of
governmental functions necessary to
address imminent threats to the safety of
human life or protection of property and
may publish documents related to
funded programs if delaying publication
until the end of the appropriations lapse
would prevent or significantly damage
the execution of funded functions at the
agency. The OFR is prohibited by law
from publishing any other agency
documents. The OFR does not make
case-by-case determinations as to
whether certain documents are directly
related to activities that qualify for an
exemption under the Antideficiency
Act. It is the responsibility of the agency
submitting a document for publication
to provide justification and certify that
the document is authorized under the
Antideficiency Act.
During an appropriations lapse
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provides justification and certifies that
publication in the Federal Register is
necessary for one of the following
reasons:
Unfunded Agencies or Programs
• To safeguard human life, protect
property, or
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• To provide other emergency
services consistent with the
performance of functions and services
exempted under the Antideficiency Act.
Funded Agencies or Programs
• Because delaying publication until
the end of the appropriations lapse
would prevent or significantly damage
the execution of funded functions at the
agency.
The OFR may be able to accept
documents transmitted for publication if
delaying publication would
significantly damage the execution of
funded functions at the agency.
Under the August 16, 1995 opinion of
the Office of Legal Counsel of the
Department of Justice (OLC),
Government Operations in the Event of
a Lapse in Appropriations, exempt
functions and services would include
activities such as those related to the
constitutional duties of the President,
food and drug inspection, air traffic
control, responses to natural or
manmade disasters, law enforcement,
and supervision of financial markets.
Documents related to normal or routine
activities of Federal agencies, even if
funded under prior year appropriations,
will not be published.
In another opinion, issued on
December 13, 1995, Effect of
Appropriations for Other Agencies and
Branches on the Authority to Continue
Department of Justice Functions During
the Lapse in the Department’s
Appropriations, the OLC found that the
necessary-implication exception
allowed unfunded agencies to provide
support to funded agencies or programs
under certain conditions. Based on OLC
interpretation of the December 13, 1995
opinion, as this applies to the OFR, if an
agency with current appropriations
submits a document for publication and
certifies that delaying publication until
the end of the appropriations lapse
would prevent or significantly damage
the execution of funded functions at the
E:\FR\FM\13MRN1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11998-11999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04044]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1507]
Bulk Manufacturer of Controlled Substances Application: Sigma
Aldrich Research Biochemicals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Sigma Aldrich Research Biochemicals 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
May 12, 2025. Such persons may also file a written request for a
hearing on the application on or before May 12, 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
is notice that on December 23, 2024, Sigma Aldrich Research
Biochemicals Inc., 400-600 Summit Drive, Burlington, Massachusetts
01803, 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
Mephedrone (4-Methyl-N- 1248 I
methylcathinone).
Methaqualone.......................... 2565 I
JWH-018 (also known as AM678) (1- 7118 I
Pentyl-3-(1-naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I
naphthoyl) indole).
Lysergic acid diethylamide............ 7315 I
Tetrahydrocannabinols................. 7370 I
Mescaline............................. 7381 I
2,5-Dimethoxyamphetamine.............. 7396 I
3,4-Methylenedioxymethamphetamine..... 7405 I
Alpha-methyltryptamine................ 7432 I
Dimethyltryptamine.................... 7435 I
5-Methoxy-N,N-diisopropyltryptamine... 7439 I
N-Benzylpiperazine.................... 7493 I
2C-H 2-(2,5-Dimethoxyphenyl) 7517 I
ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone). 7535 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Heroin................................ 9200 I
Normorphine........................... 9313 I
Norlevorphanol........................ 9634 I
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Amphetamine........................... 1100 II
Lisdexamfetamine...................... 1205 II
Methylphenidate....................... 1724 II
[[Page 11999]]
Nabilone.............................. 7379 II
Phencyclidine......................... 7471 II
Cocaine............................... 9041 II
Codeine............................... 9050 II
Ecgonine.............................. 9180 II
Levorphanol........................... 9220 II
Meperidine............................ 9230 II
Methadone............................. 9250 II
Morphine.............................. 9300 II
Thebaine.............................. 9333 II
Levo-alphacetylmethadol............... 9648 II
Noroxymorphone........................ 9668 II
Remifentanil.......................... 9739 II
Sufentanil............................ 9740 II
Carfentanil........................... 9743 II
Tapentadol............................ 9780 II
Fentanyl.............................. 9801 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
as reference standards. No other activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-04044 Filed 3-12-25; 8:45 am]
BILLING CODE 4410-09-P
