Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 10731-10732 [2025-03061]

Download as PDF 10731 Federal Register / Vol. 90, No. 37 / Wednesday, February 26, 2025 / Notices Sharp Clinical Services, 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 28, 2025. Such persons may also file a written request for a hearing on the application on or before March 28, 2025. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, SUMMARY: 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. In accordance with 21 CFR 1301.34(a), this is notice that on January 7, 2025, Sharp Clinical Services, LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020– 8024, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... 3,4-Methylenedioxymethamphetamine ............................................................................................................................ 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. Psilocybin ......................................................................................................................................................................... The company plans to import the listed controlled substances for distribution and 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 nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2025–03060 Filed 2–25–25; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1503] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC Drug Enforcement Administration, Justice. khammond on DSK9W7S144PROD with NOTICES AGENCY: ACTION: Notice of application. Catalent Pharma Solutions, 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 28, 2025. Such persons may also file a written request for a hearing on the application on or before March 28, 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 SUMMARY: In accordance with 21 CFR 1301.34(a), this is notice that on November 19, 2024, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114–1123, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Ibogaine ........................................................................................................................................................................... VerDate Sep<11>2014 18:26 Feb 25, 2025 Jkt 265001 research, and analytical activities. No other activity for this drug code is authorized for this registration. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 I I I I 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. Controlled substance The company plans to import the listed controlled substance as finished dosage unit products for clinical trials, 2010 7405 7431 7437 Schedule 7260 Schedule I Approval of permit applications will occur only when the registrant’s business activity is consistent with what E:\FR\FM\26FEN1.SGM 26FEN1 10732 Federal Register / Vol. 90, No. 37 / Wednesday, February 26, 2025 / Notices 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. 2025–03061 Filed 2–25–25; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1501] Importer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: S&B Pharma LLC DBA Norac Pharma has applied to be registered as SUMMARY: 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 28, 2025. Such persons may also file a written request for a hearing on the application on or before March 28, 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. In accordance with 21 CFR 1301.34(a), this is notice that on December 9, 2024, S&B Pharma LLC DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Tapentadol ....................................................................................................................................................................... The company plans to import intermediate forms of Tapentadol (9780) for further manufacturing prior to distribution to its customers. The company plans to import ANPP (8333) to bulk manufacture other controlled substances for distribution to its customers. 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. khammond on DSK9W7S144PROD with NOTICES BILLING CODE 7555–01–P [Docket Nos. MC2025–1189 and K2025– 1189; MC2025–1190 and K2025–1190; MC2025–1191 and K2025–1191] BILLING CODE P New Postal Products NATIONAL SCIENCE FOUNDATION Astronomy and Astrophysics Advisory Committee; Cancellation of Meeting National Science Foundation. Notice; Cancellation of meeting AGENCY: date. 18:26 Feb 25, 2025 [FR Doc. 2025–03097 Filed 2–25–25; 8:45 am] POSTAL REGULATORY COMMISSION [FR Doc. 2025–03062 Filed 2–25–25; 8:45 am] VerDate Sep<11>2014 Dated: February 21, 2025. Crystal Robinson, Committee Management Officer, National Science Foundation. II II notice informs the public of the filing, invites public comment, and takes other administrative steps. DATES: Comments are due: February 28, 2025. ADDRESSES: Submit comments electronically via the Commission’s Filing Online system at https:// www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives. FOR FURTHER INFORMATION CONTACT: David A. Trissell, General Counsel, at 202–789–6820. SUPPLEMENTARY INFORMATION: Table of Contents Matthew Strait, Deputy Assistant Administrator. ACTION: The National Science Foundation published a notice in the Federal Register January 28, 2025, in FR Doc. 2025–01779 at 90 FR 8306, concerning a meeting of the Astronomy and Astrophysics Advisory Committee. The meeting scheduled for Tuesday, February 25, 2025, at 10 a.m. (ET) is cancelled. FOR FURTHER INFORMATION CONTACT: Please contact Crystal Robinson crrobins@nsf.gov or 703–292–8687. 8333 9780 Schedule Jkt 265001 Postal Regulatory Commission. Notice. AGENCY: ACTION: The Commission is noticing a recent Postal Service filing for the Commission’s consideration concerning a negotiated service agreement. This SUMMARY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 I. Introduction II. Public Proceeding(s) III. Summary Proceeding(s) I. Introduction Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 90, Number 37 (Wednesday, February 26, 2025)]
[Notices]
[Pages 10731-10732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-03061]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1503]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Catalent Pharma Solutions, 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 28, 2025. Such persons may also file a written request for a 
hearing on the application on or before March 28, 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 
is notice that on November 19, 2024, Catalent Pharma Solutions, LLC, 
3031 Red Lion Road, Philadelphia, Pennsylvania 19114-1123, applied to 
be registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Ibogaine...........................            7260  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substance as 
finished dosage unit products for clinical trials, research, and 
analytical activities. 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

[[Page 10732]]

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 Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-03061 Filed 2-25-25; 8:45 am]
BILLING CODE P
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