Bulk Manufacturer of Controlled Substances Application: Usona Institute, 64364 [2018-27132]

Download as PDF 64364 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Notices (statement of Sen. Tunney). Rather, the procedure for the public interest determination is left to the discretion of the court, with the recognition that the court’s ‘‘scope of review remains sharply proscribed by precedent and the nature of Tunney Act proceedings.’’ SBC Commc’ns, 489 F. Supp. 2d at 11. A court can make its public interest determination based on the competitive impact statement and response to public comments alone. U.S. Airways, 38 F. Supp. 3d at 76. See also United States v. Enova Corp., 107 F. Supp. 2d 10, 17 (D.D.C. 2000) (noting that the ‘‘Tunney Act expressly allows the court to make its public interest determination on the basis of the competitive impact statement and response to comments alone’’); S. Rep. No. 93–298 93d Cong., 1st Sess., at 6 (1973) (‘‘Where the public interest can be meaningfully evaluated simply on the basis of briefs and oral arguments, that is the approach that should be utilized.’’). VIII. DETERMINATIVE DOCUMENTS There are no determinative materials or documents within the meaning of the APPA that were considered by the United States in formulating the proposed Final Judgment. Date: December 6, 2018 Respectfully submitted, _____ Kenneth A. Libby Special Attorney U.S. Department of Justice Antitrust Division c/o Federal Trade Commission 600 Pennsylvania Avenue, NW Washington, DC 20580 Phone: (202) 326–2694 Email: klibby@ftc.gov [FR Doc. 2018–27055 Filed 12–13–18; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Usona Institute ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before February 12, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal DATES: Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on October 31, 2018, Usona Institute, 2800 Woods Hollow Road, Madison, Wisconsin 53711 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. Dimethyltryptamine .......................................................................................................................................................... The institute plans to manufacture the listed controlled substances synthetically in bulk for use in institutesponsored research. Dated: December 4, 2018. John J. Martin, Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] amozie on DSK3GDR082PROD with NOTICES1 Importer of Controlled Substances Application: Arizona Department of Corrections Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration or the proposed authorization to import on or before DATES: VerDate Sep<11>2014 16:57 Dec 13, 2018 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 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. ADDRESSES: [FR Doc. 2018–27132 Filed 12–13–18; 8:45 am] ACTION: January 14, 2019. Such persons may also file a written request for a hearing on the application for registration and for authorization to import on or before January 14, 2019. Jkt 247001 Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the SUPPLEMENTARY INFORMATION: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 7431 7435 Schedule I I importation of a controlled substance in schedule I or II, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Additionally, pursuant to 21 CFR 1301.34(a), the Administrator of the Drug Enforcement Administration (DEA) shall, upon the filing of an application for registration to import a controlled substance in schedule I or II under 21 U.S.C. 952(a)(2)(B), provide notice and the opportunity to request a hearing to manufacturers holding registrations for the bulk manufacture of the substance and to applicants for such registrations. The Attorney General has delegated his authority under the Controlled Substances Act,1 including the provisions codified at 21 U.S.C. 952 and 1 The provisions of federal law relating to the import and export of controlled substances—those found in 21 U.S.C. 951 through 971—are more precisely referred to as the Controlled Substances Import and Export Act. However, federal courts and DEA often use the term ‘‘Controlled Substances Act’’ to refer collectively to all provisions from 21 U.S.C. 801 through 971 and, for ease of exposition, this document will do likewise. E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Notices]
[Page 64364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27132]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Usona 
Institute

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before February 12, 2019.

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

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
October 31, 2018, Usona Institute, 2800 Woods Hollow Road, Madison, 
Wisconsin 53711 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
5-Methoxy-N-N-dimethyltryptamine.........            7431  I
Dimethyltryptamine.......................            7435  I
------------------------------------------------------------------------

    The institute plans to manufacture the listed controlled substances 
synthetically in bulk for use in institute-sponsored research.

    Dated: December 4, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27132 Filed 12-13-18; 8:45 am]
 BILLING CODE 4410-09-P