Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, LLC, 40211 [2021-15920]

Download as PDF 40211 Federal Register / Vol. 86, No. 141 / Tuesday, July 27, 2021 / Notices EARLY TERMINATION GRANTED [07/21/2021] 20211736 ........ G Green Dot Corporation; Republic Bancorp, Inc.; Republic Bank & Trust Company. Suzanne Morris, Chief, Premerger and Division Statistics, Antitrust Division, Department of Justice. Controlled substance Gamma Hydroxybutyric Acid .... Lysergic Acid Diethylamide ...... [FR Doc. 2021–15904 Filed 7–26–21; 8:45 am] Drug code Schedule 2010 7315 I I BILLING CODE 4410–11–P The company plans to import the above controlled substances as finished dosage unit products for clinical trials, research, and analytical activities. No other activity for these drug codes is 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. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–866] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 file written comments on or objections to the issuance of the proposed registration on or before August 26, 2021. Such persons may also file a written request for a hearing on the application on or before August 26, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on June 2, 2021, Catalent Pharma Solutions, LLC., 3031 Red Lion Road, Philadelphia, Pennsylvania 19114, applied to be registered as an importer of the following basic class(es) of controlled substance(s): lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:07 Jul 26, 2021 Jkt 253001 Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–15919 Filed 7–26–21; 8:45 am] BILLING CODE P In accordance with 21 CFR 1301.33(a), this is notice that on June 17, 2021, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Psilocybin .................................. Psilocyn ..................................... Drug code Schedule 7347 7348 I I The company plans to bulk manufacture the above controlled substances to produce Active Pharmaceutical Ingredient (API) and finished dosage forms for clinical trial purposes. No other activities for these drug codes are authorized for this registration. Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–15920 Filed 7–26–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–867] Notice of Lodging of Proposed Consent Decree Under the Clean Water Act Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Novitium Pharma, 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 file written comments on or objections to the issuance of the proposed registration on or before September 27, 2021. Such persons may also file a written request for a hearing on the application on or before September 27, 2021. ADDRESS: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 On July 16, 2021, the U.S. Department of Justice (DOJ) lodged a proposed Amendment to Consent Decree with the United States District Court for the Northern District of Indiana in United States and State of Indiana v. City of Elkhart, Indiana, Civil Action No. 2:11CV328. The lodging of the proposed Amendment to Consent Decree, by the United States on behalf of the U.S. Environmental Protection Agency, with the concurrence of the State of Indiana on behalf of the Indiana Department of Environmental Management, modifies the Consent Decree in this action that was entered by the Court on November 30, 2011. The 2011 Consent Decree resolved claims for civil penalties as well as injunctive relief in the form of a Long Term Control Plan (LTCP) for violations of the Clean Water Act and related State law claims in connection with the City of Elkhart’s operation of its municipal wastewater and sewer system. The proposed Amendment to Consent Decree modifies the LTCP by allowing the City to change the technology E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15920]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-867]


Bulk Manufacturer of Controlled Substances Application: Novitium 
Pharma, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Novitium Pharma, 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 file written comments on or objections to 
the issuance of the proposed registration on or before September 27, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 27, 2021.

ADDRESS: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on June 17, 2021, Novitium Pharma, LLC., 70 Lake Drive, 
East Windsor, New Jersey 08520, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin..............................    7347  I
Psilocyn................................    7348  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the above controlled 
substances to produce Active Pharmaceutical Ingredient (API) and 
finished dosage forms for clinical trial purposes. No other activities 
for these drug codes are authorized for this registration.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-15920 Filed 7-26-21; 8:45 am]
BILLING CODE 4410-09-P
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