83 FR 58601 - Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 224 (November 20, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 224 (November 20, 2018)
| Page Range | 58601-58601 | |
| FR Document | 2018-25229 |
[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)] [Notices] [Page 58601] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25229] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Organix, Inc. 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 January 22, 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 September 26, 2018, Organix Inc., 240 Salem Street, Woburn, Massachusetts 01801-2029, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substances Drug code Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid.............. 2010 I Lysergic acid diethylamide............. 7315 I Marihuana.............................. 7360 I Tetrahydrocannabinols.................. 7370 I Dimethyltryptamine..................... 7435 I Psilocybin............................. 7437 I Psilocyn............................... 7438 I Heroin................................. 9200 I Morphine............................... 9300 II ------------------------------------------------------------------------ The company plans to synthesize the above-listed controlled substances for distribution to its research and forensics customers. Dated: November 2, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-25229 Filed 11-19-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58601
to Applicant regarding factors three and DEPARTMENT OF JUSTICE Dated: November 2, 2018.
four of the public interest John J. Martin,
determination. Easter, 69 FR at 5581 Drug Enforcement Administration Assistant Administrator.
(finding that felony convictions related [FR Doc. 2018–25229 Filed 11–19–18; 8:45 am]
to distribution of controlled substances [Docket No. DEA–392] BILLING CODE 4410–09–P
‘‘are relevant and adverse to’’ applicant
regarding public interest factors two, Bulk Manufacturer of Controlled
three, four, and five). Specifically, I may Substances Application: Organix, Inc. DEPARTMENT OF JUSTICE
deny Applicant’s pending application
pursuant to factor three (21 U.S.C. ACTION: Notice of application. Drug Enforcement Administration
823(f)(3)) alone because he has been [Docket No. DEA–392]
convicted for unlawful distribution of DATES: Registered bulk manufacturers of
controlled substances under the CSA. the affected basic classes, and Importer of Controlled Substances
Trenton F. Horst, D.O., 80 FR 41079, applicants therefore, may file written Application: Lipomed
41090 (2015) (holding that pursuant to comments on or objections to the
ACTION: Notice of application.
21 U.S.C. 823(f)(3), DEA ‘‘may deny a issuance of the proposed registration on
pending application for a certificate of or before January 22, 2019. DATES: Registered bulk manufacturers of
registration upon a finding that the ADDRESSES: Written comments should the affected basic classes, and
applicant has been convicted of a felony be sent to: Drug Enforcement applicants therefore, may file written
related to controlled substances under Administration, Attention: DEA Federal comments on or objections to the
state or federal law’’). In the same vein, Register Representative/DPW, 8701 issuance of the proposed registration on
Applicant’s conviction for violating the Morrissette Drive, Springfield, Virginia or before December 20, 2018. Such
CSA also reflects his lack of 22152. persons may also file a written request
‘‘[c]ompliance with applicable . . . for a hearing on the application on or
Federal . . . laws relating to controlled SUPPLEMENTARY INFORMATION: The before December 20, 2018.
substances’’ under factor four. 21 U.S.C. Attorney General has delegated his ADDRESSES: Written comments should
823(f)(4). Accordingly, I find that the authority under the Controlled be sent to: Drug Enforcement
Government’s evidence of Applicant’s Substances Act to the Administrator of Administration, Attention: DEA Federal
convictions is adverse to Applicant with the Drug Enforcement Administration Register Representative/DPW, 8701
(DEA), 28 CFR 0.100(b). Authority to Morrissette Drive, Springfield, Virginia
respect to public interest factors three
exercise all necessary functions with 22152. All requests for hearing must be
and four and thus establishes that
respect to the promulgation and sent to: Drug Enforcement
granting Applicant’s application ‘‘would
implementation of 21 CFR part 1301, Administration, Attn: Administrator,
be inconsistent with the public incident to the registration of
interest.’’ 21 U.S.C. 823(f); Arvinder 8701 Morrissette Drive, Springfield,
manufacturers, distributors, dispensers, Virginia 22152. All requests for hearing
Singh, M.D., 81 FR 8247–48 & n.2 (2016) importers, and exporters of controlled
(affirming ALJ’s finding that should also be sent to: (1) Drug
substances (other than final orders in Enforcement Administration, Attn:
respondent’s felony convictions in connection with suspension, denial, or Hearing Clerk/LJ, 8701 Morrissette
violation of the CSA implicated revocation of registration) has been Drive, Springfield, Virginia 22152; and
multiple public interest factors redelegated to the Assistant (2) Drug Enforcement Administration,
(including factors three and four) and Administrator of the DEA Diversion Attn: DEA Federal Register
thus warranted denial of his application Control Division (‘‘Assistant Representative/DPW, 8701 Morrissette
as inconsistent with the public interest). Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152.
For all these reasons, and because 28 CFR part 0, appendix to subpart R. Comments and requests for hearings on
Applicant failed to respond to the Show In accordance with 21 CFR applications to import narcotic raw
Cause Order and thus has failed to offer 1301.33(a), this is notice that on material are not appropriate. 72 FR
any evidence to the contrary, I will September 26, 2018, Organix Inc., 240 3417, (January 25, 2007).
order that his application be denied. Salem Street, Woburn, Massachusetts SUPPLEMENTARY INFORMATION: The
01801–2029, applied to be registered as Attorney General has delegated his
Order a bulk manufacturer of the following authority under the Controlled
Pursuant to the authority vested in me basic classes of controlled substances: Substances Act to the Administrator of
by 21 U.S.C. 823(f), as well as 28 CFR the Drug Enforcement Administration
Drug (DEA), 28 CFR 0.100(b). Authority to
0.100(b), I order that the application of Controlled substances Schedule
code
Edward A. Ridgill, M.D., for a DEA exercise all necessary functions with
Certificate of Registration as a Gamma Hydroxybutyric Acid 2010 I respect to the promulgation and
practitioner be, and it hereby is, denied.
Lysergic acid diethylamide .. 7315 I implementation of 21 CFR part 1301,
Marihuana ............................ 7360 I incident to the registration of
This Order is effective immediately. Tetrahydrocannabinols ........ 7370 I
Dimethyltryptamine .............. 7435 I
manufacturers, distributors, dispensers,
Dated: October 31, 2018. Psilocybin ............................. 7437 I importers, and exporters of controlled
Uttam Dhillon, Psilocyn ................................ 7438 I substances (other than final orders in
Acting Administrator. Heroin .................................. 9200 I connection with suspension, denial, or
Morphine .............................. 9300 II revocation of registration) has been
[FR Doc. 2018–25224 Filed 11–19–18; 8:45 am]
redelegated to the Assistant
BILLING CODE 4410–09–P
The company plans to synthesize the Administrator of the DEA Diversion
above-listed controlled substances for Control Division (‘‘Assistant
distribution to its research and forensics Administrator’’) pursuant to section 7 of
customers. 28 CFR part 0, appendix to subpart R.
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Document Created: 2018-11-20 07:59:41
Document Modified: 2018-11-20 07:59:41
| 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 January 22, 2019. | |
| FR Citation | 83 FR 58601 |
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