Importer of Controlled Substances Application: AndersonBrecon Inc. dba PCI Pharma Services, 16029-16030 [2024-04753]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices consider will help the Commission in understanding your views. You should file a prehearing brief particularly if you plan to testify at the hearing on behalf of an industry group, company, or other organization, and wish to provide detailed views or information that will support or supplement your testimony. (2) Oral hearing statements (testimony) refers to the actual oral statement that you intend to present at the hearing. Do not include any confidential business information (CBI) in that statement. If you plan to testify, you must file a copy of your oral statement by the date specified in this notice. This statement will allow Commissioners to understand your position in advance of the hearing and will also assist the court reporter in preparing an accurate transcript of the hearing (e.g., names spelled correctly). (3) Posthearing briefs refers to submissions filed after the hearing by persons who appeared at the hearing. Such briefs: (a) should be limited to matters that arose during the hearing; (b) should respond to any Commissioner and staff questions addressed to you at the hearing; (c) should clarify, amplify, or correct any statements you made at the hearing; and (d) may, at your option, address or rebut statements made by other participants in the hearing. (4) Other written submissions refers to any other written submissions that interested persons wish to make, regardless of whether they appeared at the hearing, and may include new information or updates of information previously provided. In accordance with the provisions of section 201.8 of the Commission’s Rules of Practice and Procedure (19 CFR 201.8) the document must identify on its cover (1) the investigation number and title and the type of document filed (i.e., prehearing brief, oral statement of (name), posthearing brief, or written submission), (2) the name and signature of the person filing it, (3) the name of the organization that the submission is filed on behalf of, and (4) whether it contains CBI. If it contains CBI, it must comply with the marking and other requirements set out below in this notice relating to CBI. Submitters of written documents (other than oral hearing statements) are encouraged to include a short summary of their position or interest at the beginning of the document, and a table of contents when the document addresses multiple issues. Confidential business information: Any submissions that contain CBI must also conform to the requirements of section 201.6 of the Commission’s Rules of Practice and Procedure (19 CFR VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 201.6). Section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the ‘‘confidential’’ or ‘‘nonconfidential’’ version, and that the CBI is clearly identified by means of brackets. All written submissions, except for CBI, will be made available for inspection by interested persons. As requested by the Committee, the Commission will not include any CBI in its report. However, all information, including CBI, submitted in this investigation may be disclosed to and used by: (i) 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) U.S. Government employees and contract personnel for cybersecurity purposes. The Commission will not otherwise disclose any CBI in a way that would reveal the operations of the firm supplying the information. Summaries of written submissions: Persons wishing to have a summary of their position included in the report should include a summary with their written submission on or before July 12, 2024, and should mark the summary as having been provided for that purpose. The summary should be clearly marked as ‘‘summary for inclusion in the report’’ at the top of the page. The summary may not exceed 500 words and should not include any CBI. The summary will be published as provided if it meets these requirements and is germane to the subject matter of the investigation. The Commission will list the name of the organization furnishing the summary and will include a link where the written submission can be found. By order of the Commission. Issued: February 29, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–04649 Filed 3–5–24; 8:45 am] BILLING CODE 7020–02–P PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 16029 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1324] Importer of Controlled Substances Application: AndersonBrecon Inc. dba PCI Pharma Services Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: AndersonBrecon Inc. dba PCI Pharma Services 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 April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 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 September 29, 2023, AndersonBrecon Inc. dba PCI Pharma Services, 5775 Logistics Parkway, Rockford, Illinois 61109–3608, applied DATES: E:\FR\FM\06MRN1.SGM 06MRN1 16030 Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Dimethyltryptamine .......... Cocaine ........................... Methadone ...................... I Drug code Schedule 7435 9041 9250 I II II I The company plans to import the listed controlled substances for clinical trials. 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. Marsha L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–04753 Filed 3–5–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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. In accordance with 21 CFR 1301.34(a), this is notice that on February 7, 2024, Sigma Aldrich Company LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118–4103, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance [Docket No. DEA–1332] Importer of Controlled Substances Application: Sigma Aldrich Company LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sigma Aldrich Company 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 April 5, 2024. Such persons may also file a written request for a hearing on the application on or before April 5, 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:57 Mar 05, 2024 Jkt 262001 Cathinone ........................ Methcathinone ................. Mephedrone (4-Methyl-Nmethylcathinone). Gamma Hydroxybutyric Acid. Tetrahydrocannabinols .... 4-Bromo-2,5dimethoxyamphetamine. 4-Bromo-2,5dimethoxyphenethylamine. 2,5Dimethoxyamphetamine. 3,4Methylenedioxyamphetamine. 3,4-Methylenedioxy-Nethylamphetamine. 3,4Methylenedioxymethamphetamine. 4-Methoxyamphetamine .. Dimethyltryptamine .......... N-Benzylpiperazine ......... Heroin .............................. Normorphine .................... Amobarbital ..................... Secobarbital ..................... Nabilone .......................... Phencyclidine .................. Ecgonine .......................... Ethylmorphine .................. Levorphanol ..................... Meperidine ....................... Thebaine .......................... Opium, powdered ............ PO 00000 Frm 00062 Fmt 4703 Drug code Schedule 1235 1237 1248 I I I 2010 I 7370 7391 I I 7392 I 7396 I 7400 I 7404 I 7405 I 7411 7435 7493 9200 9313 2125 2315 7379 7471 9180 9190 9220 9230 9333 9639 I I I I I II II II II II II II II II II Sfmt 4703 Controlled substance Levo-alphacetylmethadol Drug code Schedule I 9648 III The company plans to import the listed controlled substances for sale to research facilities for drug testing and analysis. In reference to drug code 7370 (Tetrahydrocannabinols) the company plans to import synthetic Tetrahydrocannabinols. No other activities for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Marsha Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–04756 Filed 3–5–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1328] Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sterling Pharma USA 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 May 6, 2024. Such persons may also file a written request for a hearing on the application on or before May 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 SUMMARY: E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16029-16030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04753]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1324]


Importer of Controlled Substances Application: AndersonBrecon 
Inc. dba PCI Pharma Services

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: AndersonBrecon Inc. dba PCI Pharma Services 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 
April 5, 2024. Such persons may also file a written request for a 
hearing on the application on or before April 5, 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 September 29, 2023, AndersonBrecon Inc. dba PCI 
Pharma Services, 5775 Logistics Parkway, Rockford, Illinois 61109-3608, 
applied

[[Page 16030]]

to be registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Dimethyltryptamine......................    7435  I
Cocaine.................................    9041  II
Methadone...............................    9250  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
clinical trials. 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.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-04753 Filed 3-5-24; 8:45 am]
BILLING CODE P
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