Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem, 48689-48690 [2024-12567]

Download as PDF 48689 Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices Procedures, Electronic Filing Procedures 1). Please note the Secretary’s Office will accept only electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov.) No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov. Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. appendix 3; or (ii) by U.S. Government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: June 4, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–12538 Filed 6–6–24; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1382] Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 August 6, 2024. Such persons may also file a written request for a hearing on the application on or before August 6, 2024. 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 May 8, 2024, American Radiolabeled Chem, 101 Arc Drive, Saint Louis, Missouri 63146–3502, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: American Radiolabeled Chem 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: ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Drug code Gamma Hydroxybutyric Acid ............................................................................................................................................... Ibogaine ............................................................................................................................................................................... Lysergic acid diethylamide .................................................................................................................................................. Tetrahydrocannabinols ........................................................................................................................................................ Dimethyltryptamine .............................................................................................................................................................. 1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................... Noroxymorphone ................................................................................................................................................................. Heroin .................................................................................................................................................................................. Normorphine ........................................................................................................................................................................ Amphetamine ....................................................................................................................................................................... Methamphetamine ............................................................................................................................................................... Amobarbital .......................................................................................................................................................................... Phencyclidine ....................................................................................................................................................................... Phenylacetone ..................................................................................................................................................................... Cocaine ................................................................................................................................................................................ Codeine ............................................................................................................................................................................... Dihydrocodeine .................................................................................................................................................................... Oxycodone ........................................................................................................................................................................... Hydromorphone ................................................................................................................................................................... Ecgonine .............................................................................................................................................................................. Hydrocodone ....................................................................................................................................................................... Meperidine ........................................................................................................................................................................... Metazocine .......................................................................................................................................................................... Methadone ........................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .................................................................................................................. 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. VerDate Sep<11>2014 17:23 Jun 06, 2024 Jkt 262001 2 All contract personnel will sign appropriate nondisclosure agreements. PO 00000 Frm 00140 Fmt 4703 Sfmt 4703 2010 7260 7315 7370 7435 7470 9145 9200 9313 1100 1105 2125 7471 8501 9041 9050 9120 9143 9150 9180 9193 9230 9240 9250 9273 Schedule 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 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. E:\FR\FM\07JNN1.SGM 07JNN1 48690 Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices Controlled substance Drug code Morphine .............................................................................................................................................................................. Oripavine ............................................................................................................................................................................. Thebaine .............................................................................................................................................................................. Oxymorphone ...................................................................................................................................................................... Phenazocine ........................................................................................................................................................................ Carfentanil ........................................................................................................................................................................... Fentanyl ............................................................................................................................................................................... Drug Enforcement Administration 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. [Docket No. DEA–1383] SUPPLEMENTARY INFORMATION: The company plans to bulk manufacture the listed controlled substances for internal use as intermediates or for sale to its customers. The company plans to manufacture small quantities of the above listed controlled substances as radiolabeled compounds for biochemical research. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–12567 Filed 6–6–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Importer of Controlled Substances Application: Usona Institute Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Usona Institute 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. 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 July 8, 2024. Such persons may also file a written request for a hearing on the application on or before July 8, 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 ddrumheller on DSK120RN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 18:54 Jun 06, 2024 Jkt 262001 In accordance with 21 CFR 1301.34(a), this is notice that on May 13, 2024, Usona Institute, 2780 Woods Hollow Road, Room 2412, Fitchburg, Wisconsin 53711–5370, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance 5-Methoxy-N-Ndimethyltryptamine. Dimethyltryptamine .......... Psilocybin ........................ Psilocyn ........................... Drug code Schedule 7431 I 7435 7437 7438 I I I The company plans to import the listed controlled substances for research and analytical purposes. The materials will not be used for clinical trials or human consumption. No other activities for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non- PO 00000 Frm 00141 Fmt 4703 Sfmt 4703 9300 9330 9333 9652 9715 9743 9801 Schedule II II II II II II II approved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2024–12575 Filed 6–6–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1384] Bulk Manufacturer of Controlled Substances Application: Veranova, L.P. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Veranova, L.P., 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 August 6, 2024. Such persons may also file a written request for a hearing on the application on or before August 6, 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. SUMMARY: E:\FR\FM\07JNN1.SGM 07JNN1

Agencies

[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48689-48690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12567]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1382]


Bulk Manufacturer of Controlled Substances Application: American 
Radiolabeled Chem

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: American Radiolabeled Chem 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 
August 6, 2024. Such persons may also file a written request for a 
hearing on the application on or before August 6, 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 May 8, 2024, American Radiolabeled Chem, 101 Arc 
Drive, Saint Louis, Missouri 63146-3502, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............         2010  I
Ibogaine.............................         7260  I
Lysergic acid diethylamide...........         7315  I
Tetrahydrocannabinols................         7370  I
Dimethyltryptamine...................         7435  I
1-[1-(2-Thienyl)cyclohexyl]piperidine         7470  I
Noroxymorphone.......................         9145  I
Heroin...............................         9200  I
Normorphine..........................         9313  I
Amphetamine..........................         1100  II
Methamphetamine......................         1105  II
Amobarbital..........................         2125  II
Phencyclidine........................         7471  II
Phenylacetone........................         8501  II
Cocaine..............................         9041  II
Codeine..............................         9050  II
Dihydrocodeine.......................         9120  II
Oxycodone............................         9143  II
Hydromorphone........................         9150  II
Ecgonine.............................         9180  II
Hydrocodone..........................         9193  II
Meperidine...........................         9230  II
Metazocine...........................         9240  II
Methadone............................         9250  II
Dextropropoxyphene, bulk (non-dosage          9273  II
 forms).

[[Page 48690]]

 
Morphine.............................         9300  II
Oripavine............................         9330  II
Thebaine.............................         9333  II
Oxymorphone..........................         9652  II
Phenazocine..........................         9715  II
Carfentanil..........................         9743  II
Fentanyl.............................         9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances for internal use as intermediates or for sale to its 
customers. The company plans to manufacture small quantities of the 
above listed controlled substances as radiolabeled compounds for 
biochemical research. In reference to drug code 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-12567 Filed 6-6-24; 8:45 am]
BILLING CODE 4410-09-P
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