83 FR 64364 - Bulk Manufacturer of Controlled Substances Application: Usona Institute
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 240 (December 14, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 240 (December 14, 2018)
| Page Range | 64364-64364 | |
| FR Document | 2018-27132 |
[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)] [Notices] [Page 64364] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-27132] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Usona Institute ACTION: Notice of application. ----------------------------------------------------------------------- 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
![64364 Federal Register / Vol. 83, No. 240 / Friday, December 14, 2018 / Notices
(statement of Sen. Tunney). Rather, the _____ Register Representative/DPW, 8701
procedure for the public interest Kenneth A. Libby Morrissette Drive, Springfield, Virginia
determination is left to the discretion of Special Attorney 22152.
the court, with the recognition that the U.S. Department of Justice
court’s ‘‘scope of review remains Antitrust Division SUPPLEMENTARY INFORMATION: The
sharply proscribed by precedent and the c/o Federal Trade Commission Attorney General has delegated his
nature of Tunney Act proceedings.’’ 600 Pennsylvania Avenue, NW authority under the Controlled
SBC Commc’ns, 489 F. Supp. 2d at 11. Washington, DC 20580 Substances Act to the Administrator of
A court can make its public interest Phone: (202) 326–2694 the Drug Enforcement Administration
determination based on the competitive Email: klibby@ftc.gov
(DEA), 28 CFR 0.100(b). Authority to
impact statement and response to public [FR Doc. 2018–27055 Filed 12–13–18; 8:45 am] exercise all necessary functions with
comments alone. U.S. Airways, 38 F. BILLING CODE 6750–01–P respect to the promulgation and
Supp. 3d at 76. See also United States implementation of 21 CFR part 1301,
v. Enova Corp., 107 F. Supp. 2d 10, 17 incident to the registration of
(D.D.C. 2000) (noting that the ‘‘Tunney DEPARTMENT OF JUSTICE
manufacturers, distributors, dispensers,
Act expressly allows the court to make importers, and exporters of controlled
its public interest determination on the Drug Enforcement Administration
substances (other than final orders in
basis of the competitive impact [Docket No. DEA–392]
connection with suspension, denial, or
statement and response to comments
Bulk Manufacturer of Controlled revocation of registration) has been
alone’’); S. Rep. No. 93–298 93d Cong.,
1st Sess., at 6 (1973) (‘‘Where the public Substances Application: Usona redelegated to the Assistant
interest can be meaningfully evaluated Institute Administrator of the DEA Diversion
simply on the basis of briefs and oral Control Division (‘‘Assistant
arguments, that is the approach that ACTION: Notice of application. Administrator’’) pursuant to section 7 of
should be utilized.’’). 28 CFR part 0, appendix to subpart R.
DATES: Registered bulk manufacturers of
VIII. DETERMINATIVE DOCUMENTS In accordance with 21 CFR
the affected basic classes, and
applicants therefore, may file written 1301.33(a), this is notice that on October
There are no determinative materials 31, 2018, Usona Institute, 2800 Woods
or documents within the meaning of the comments on or objections to the
issuance of the proposed registration on Hollow Road, Madison, Wisconsin
APPA that were considered by the
or before February 12, 2019. 53711 applied to be registered as a bulk
United States in formulating the
ADDRESSES: Written comments should
manufacturer of the following basic
proposed Final Judgment.
Date: December 6, 2018 Respectfully be sent to: Drug Enforcement classes of controlled substances:
submitted, Administration, Attention: DEA Federal
Controlled substance Drug code Schedule
5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. 7431 I
Dimethyltryptamine .......................................................................................................................................................... 7435 I
The institute plans to manufacture the January 14, 2019. Such persons may importation of a controlled substance in
listed controlled substances also file a written request for a hearing schedule I or II, provide manufacturers
synthetically in bulk for use in institute- on the application for registration and holding registrations for the bulk
sponsored research. for authorization to import on or before manufacture of the substance an
Dated: December 4, 2018. January 14, 2019. opportunity for a hearing. Additionally,
John J. Martin, pursuant to 21 CFR 1301.34(a), the
ADDRESSES: Written comments should
Administrator of the Drug Enforcement
Assistant Administrator. be sent to: Drug Enforcement
Administration (DEA) shall, upon the
[FR Doc. 2018–27132 Filed 12–13–18; 8:45 am] Administration, Attention: DEA Federal
filing of an application for registration
BILLING CODE 4410–09–P Register Representative/DPW, 8701
to import a controlled substance in
Morrissette Drive, Springfield, Virginia
schedule I or II under 21 U.S.C.
22152. All requests for hearing must be 952(a)(2)(B), provide notice and the
DEPARTMENT OF JUSTICE sent to: Drug Enforcement opportunity to request a hearing to
Administration, Attn: Administrator, manufacturers holding registrations for
Drug Enforcement Administration 8701 Morrissette Drive, Springfield, the bulk manufacture of the substance
[Docket No. DEA–392] Virginia 22152. All requests for hearing and to applicants for such registrations.
should also be sent to: (1) Drug The Attorney General has delegated
Importer of Controlled Substances Enforcement Administration, Attn: his authority under the Controlled
Application: Arizona Department of Hearing Clerk/OALJ, 8701 Morrissette Substances Act,1 including the
Corrections Drive, Springfield, Virginia 22152; and provisions codified at 21 U.S.C. 952 and
(2) Drug Enforcement Administration,
ACTION: Notice of application.
amozie on DSK3GDR082PROD with NOTICES1
Attn: DEA Federal Register 1 The provisions of federal law relating to the
Representative/DPW, 8701 Morrissette import and export of controlled substances—those
DATES: Registered bulk manufacturers of found in 21 U.S.C. 951 through 971—are more
Drive, Springfield, Virginia 22152.
the affected basic class, and applicants precisely referred to as the Controlled Substances
therefore, may file written comments on SUPPLEMENTARY INFORMATION: Pursuant Import and Export Act. However, federal courts and
DEA often use the term ‘‘Controlled Substances
or objections to the issuance of the to 21 U.S.C. 958(i), the Attorney General Act’’ to refer collectively to all provisions from 21
proposed registration or the proposed shall, prior to issuing a regulation under U.S.C. 801 through 971 and, for ease of exposition,
authorization to import on or before 21 U.S.C. 952(a)(2)(B) authorizing the this document will do likewise.
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Document Created: 2018-12-14 03:50:02
Document Modified: 2018-12-14 03:50:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| 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. | |
| FR Citation | 83 FR 64364 |
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