Importer of Controlled Substances Application: United States Pharmacopeial Convention, 47177-47178 [2024-11890]

Download as PDF 47177 Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Notices legitimate scientific medical research and/or industrial purposes. 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 J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–11891 Filed 5–30–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1379] Importer of Controlled Substances Application: United States Pharmacopeial Convention Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: United States Pharmacopeial Convention 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 July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 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 SUMMARY: 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 April 5, 2024, United States Pharmacopeial Convention, 7135 English Muffin Way, Frederick, Maryland 21704, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES Controlled substance Drug code Cathinone ........................................................................................................................................................................ Methcathinone ................................................................................................................................................................. Methaqualone .................................................................................................................................................................. Lysergic acid diethylamide .............................................................................................................................................. 4-Methyl-2,5-dimethoxyamphetamine ............................................................................................................................. 3,4-Methylenedioxyamphetamine .................................................................................................................................... 4-Methoxyamphetamine .................................................................................................................................................. Codeine-N-oxide .............................................................................................................................................................. Difenoxin .......................................................................................................................................................................... Heroin .............................................................................................................................................................................. Morphine-N-oxide ............................................................................................................................................................ Norlevorphanol ................................................................................................................................................................ Methamphetamine ........................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Phenmetrazine ................................................................................................................................................................. Methylphenidate .............................................................................................................................................................. Amobarbital ...................................................................................................................................................................... Pentobarbital .................................................................................................................................................................... Secobarbital ..................................................................................................................................................................... Glutethimide ..................................................................................................................................................................... Phencyclidine ................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Phenylacetone ................................................................................................................................................................. Alphaprodine .................................................................................................................................................................... Anileridine ........................................................................................................................................................................ Cocaine ............................................................................................................................................................................ Dihydrocodeine ................................................................................................................................................................ Diphenoxylate .................................................................................................................................................................. Levomethorphan .............................................................................................................................................................. Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Thebaine .......................................................................................................................................................................... Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... VerDate Sep<11>2014 17:22 May 30, 2024 Jkt 262001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\31MYN1.SGM 31MYN1 1235 1237 2565 7315 7395 7400 7411 9053 9168 9200 9307 9634 1105 1205 1631 1724 2125 2270 2315 2550 7471 8333 8501 9010 9020 9041 9120 9170 9210 9220 9230 9273 9333 9652 9668 9737 9740 Schedule I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II 47178 Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Notices The company plans to import the above listed control substances for distribution as analytical reference standards to its customers for analytical testing of raw materials. 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 J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–11890 Filed 5–30–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE khammond on DSKJM1Z7X2PROD with NOTICES Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On May 24, 2024, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Alaska in the lawsuit entitled United States v. PSF, Inc., Peter Pan Seafood Company, LLC, and Silver Bay Seafoods-Valdez, LLC, Civil Action No. 3:24–cv–00112. In the Complaint, the United States alleges that Defendants PSF, Inc., Peter Pan Seafood Company, LLC, and Silver Bay Seafoods-Valdez, LLC violated section 301(a) of the Clean Water Act, 33 U.S.C. 1311(a), by violating the permit conditions and limitations of the National Pollutant Discharge Elimination System (NPDES) permits issued to Defendants by the U.S. Environmental Protection Agency and the Alaska Department of Environmental Conservation under section 402(a) of the Clean Water Act, 33 U.S.C. 1342(a) at their respective facilities in Valdez and King Cove, Alaska. The proposed Consent Decree resolves the claims in the Complaint with covenants not to sue, in return for injunctive relief and $750,000 in civil penalties. The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. PSF, Inc., Peter Pan Seafood Company, LLC, and Silver Bay Seafoods-Valdez, LLC, D.J. Ref. No. 90– 5–1–1–12463. All comments must be submitted no later than thirty (30) days after the publication date of this notice. VerDate Sep<11>2014 17:22 May 30, 2024 Jkt 262001 Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... Any comments submitted in writing may be filed in whole or in part on the public court docket without notice to the commenter. During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. If you require assistance accessing the Consent Decree, you may request assistance by email or by mail to the addresses provided above for submitting comments. Kathryn C. Macdonald, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2024–11975 Filed 5–30–24; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On May 21, 2024, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Eastern District of Texas in the lawsuit entitled United States of America v. TPC Group LLC, Civil Action No. 24–00187. In this action, the United States, on behalf of the U.S. Environmental Protection Agency, filed a Complaint and proposed Consent Decree against TPC Group LLC (TPC Group) for violating the chemical accident prevention provisions of the Clean Air Act (‘‘CAA’’) at TPC Group’s petrochemical manufacturing facilities in Port Neches and Houston, Texas. This case stems in part from a November 27, 2019, explosion at TPC Group’s Port Neches facility that resulted in the evacuations of thousands of residents from the City of Port Neches and surrounding areas, released more than 11 million pounds of extremely hazardous substances, caused more than $130 million in offsite property damage, and resulted in other impacts to human health and the environment. In the Complaint, the United States alleges PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 numerous violations of section 112(r) of the CAA, 42 U.S.C. 7412(r), against TPC Group at its Port Neches facility, including those related to the 2019 explosion. The complaint also alleges numerous violations of Section 112(r) of the CAA, 42 U.S.C. 7412(r), at TPC Group’s Houston facility, including failing to promptly take corrective actions for hundreds of pieces of process equipment and failing to address conditions similar to those that led to the Port Neches explosions. Under the proposed Consent Decree, TPC Group will pay $12.1 million in civil penalties to be paid through TPC Group’s bankruptcy proceedings. TPC Group will also spend approximately $80 million to improve its risk management program and improve safety at both facilities. The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States of America v. TPC Group LLC, D.J. Ref. No. 90–5–2–1– 12550. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... Any comments submitted in writing or at a public meeting may be filed in whole or in part on the public court docket without notice to the commenter. During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. If you require assistance accessing the proposed Consent Decree, you may request assistance by email or by mail to the addresses provided above for submitting comments. Thomas Carroll, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2024–11881 Filed 5–30–24; 8:45 am] BILLING CODE 4410–15–P E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Notices]
[Pages 47177-47178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11890]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1379]


Importer of Controlled Substances Application: United States 
Pharmacopeial Convention

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: United States Pharmacopeial Convention 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 
July 1, 2024. Such persons may also file a written request for a 
hearing on the application on or before July 1, 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 April 5, 2024, United States Pharmacopeial 
Convention, 7135 English Muffin Way, Frederick, Maryland 21704, applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Cathinone................................            1235  I
Methcathinone............................            1237  I
Methaqualone.............................            2565  I
Lysergic acid diethylamide...............            7315  I
4-Methyl-2,5-dimethoxyamphetamine........            7395  I
3,4-Methylenedioxyamphetamine............            7400  I
4-Methoxyamphetamine.....................            7411  I
Codeine-N-oxide..........................            9053  I
Difenoxin................................            9168  I
Heroin...................................            9200  I
Morphine-N-oxide.........................            9307  I
Norlevorphanol...........................            9634  I
Methamphetamine..........................            1105  II
Lisdexamfetamine.........................            1205  II
Phenmetrazine............................            1631  II
Methylphenidate..........................            1724  II
Amobarbital..............................            2125  II
Pentobarbital............................            2270  II
Secobarbital.............................            2315  II
Glutethimide.............................            2550  II
Phencyclidine............................            7471  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)            8333  II
Phenylacetone............................            8501  II
Alphaprodine.............................            9010  II
Anileridine..............................            9020  II
Cocaine..................................            9041  II
Dihydrocodeine...........................            9120  II
Diphenoxylate............................            9170  II
Levomethorphan...........................            9210  II
Levorphanol..............................            9220  II
Meperidine...............................            9230  II
Dextropropoxyphene, bulk (non-dosage                 9273  II
 forms).
Thebaine.................................            9333  II
Oxymorphone..............................            9652  II
Noroxymorphone...........................            9668  II
Alfentanil...............................            9737  II
Sufentanil...............................            9740  II
------------------------------------------------------------------------


[[Page 47178]]

    The company plans to import the above listed control substances for 
distribution as analytical reference standards to its customers for 
analytical testing of raw materials. 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-approved finished 
dosage forms for commercial sale.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-11890 Filed 5-30-24; 8:45 am]
BILLING CODE P
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