Bulk Manufacturer of Controlled Substances Application: Organix Inc., 32279-32280 [2021-12817]
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32279
Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Notices
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
Drug Enforcement Administration
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 July 19, 2021. Such persons
may also file a written request for a
hearing on the application on or before
July 19, 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 requests 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 April 28, 2021,
Xcelience, 4901 West Grace Street,
Tampa, Florida 33607–3805, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
[Docket No. DEA–854]
Controlled substance
Drug code
Importer of Controlled Substances
Application: Xcelience
Psilocybin ................
7437
By order of the Commission.
Issued: June 11, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–12811 Filed 6–16–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Xcelience 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.
SUMMARY:
DATES:
Schedule
I
The company plans to import drug
code 7437 (Psilocybin) as finished
dosage form for clinical trials, research,
and analytical purposes.
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 non-
approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12816 Filed 6–16–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–855]
Bulk Manufacturer of Controlled
Substances Application: Organix Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organix Inc. has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplemental
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 16, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 16, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on April 27, 2021, Organix
Inc., 240 Salem Street, Woburn,
Massachusetts 01801–2029, applied to
be registered as an bulk manufacturer of
the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
lotter on DSK11XQN23PROD with NOTICES1
Mescaline .........................................................................................................................................................................
3,4,5-trimethoxyamphetamine .........................................................................................................................................
4-bromo-2,5-dimethoxyphenethylamine ..........................................................................................................................
3,4-methylenedioxyamphetamine ....................................................................................................................................
3,4-methylenedioxymethamphetamine ............................................................................................................................
2-(2,5-dimethoxyphenyl)ethanamine ...............................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine ....................................................................................................................
2 All contract personnel will sign appropriate
nondisclosure agreements.
VerDate Sep<11>2014
18:41 Jun 16, 2021
Jkt 253001
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\17JNN1.SGM
17JNN1
7381
7390
7392
7400
7405
7517
7518
Schedule
I
I
I
I
I
I
I
32280
Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Notices
The company plans to bulk
manufacture small quantities of the
above controlled substances for use in
clinical research. No other activities for
these drug codes are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12817 Filed 6–16–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–853]
Importer of Controlled Substances
Application: Andersonbrecon Inc. DBA
PCI of Illinois
lotter on DSK11XQN23PROD with NOTICES1
18:41 Jun 16, 2021
Jkt 253001
7370
II
The company plans to import the
listed controlled substance for clinical
trial studies only. 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 the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
BILLING CODE 4410–09–P
Andersonbrecon Inc. DBA PCI
of Illinois 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 July 19, 2021. Such persons
may also file a written request for a
hearing on the application on or before
July 19, 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 May 17, 2021,
Andersonbrecon Inc. DBA PCI of
Illinois, 5775 Logistics Parkway,
Rockford, Illinois 61109–3608 applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
VerDate Sep<11>2014
I
Tetrahydrocannabinols
Schedule
[FR Doc. 2021–12819 Filed 6–16–21; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SUMMARY:
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Johnny C. Benjamin, Jr., M.D.;
Decision and Order
I. Procedural Background
On September 28, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Johnny C.
Benjamin, Jr., M.D. (hereinafter,
Registrant) of Vero Beach, Florida. OSC,
at 1. The OSC proposed the revocation
of Registrant’s Certificate of Registration
No. BB3725732. Id. It alleged that
Registrant has ‘‘been convicted of a
felony relating to controlled substances
and ha[s] no state authority to handle
controlled substances.’’ Id. (citing 21
U.S.C. 824(a)(2) & (a)(3)).
Specifically, the OSC alleged that on
April 27, 2018, Registrant was convicted
by a Federal jury of: Conspiracy to
possess with intent to distribute furanyl
fentanyl resulting in death, in violation
of 21 U.S.C. 846; distribution of furanyl
fentanyl resulting in death, in violation
of 21 U.S.C. 841(a)(1); attempt to
possess with intent to distribute acetyl
fentanyl, in violation of 21 U.S.C. 846;
possession with intent to distribute
oxycodone, in violation of 21 U.S.C.
841(a)(1); and conspiracy to possess
with intent to distribute hydrocodone
and oxycodone, in violation of 21 U.S.C.
846. Id. at 2. The OSC alleged that on
July 6, 2018, the court issued its
Judgment and sentenced Registrant to
life in prison. Id. The OSC also alleged
that, on May 3, 2018, ‘‘the State of
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Florida Department of Health
immediately suspended Registrant’s
Florida Medical License.’’ Id. The OSC
further alleged that, as a result,
Registrant is ‘‘currently without
authority to handle controlled
substances in the State of Florida, the
state in which [Registrant] is registered
with the DEA.’’ Id. (citing 21 U.S.C.
824(a)(3); 21 CFR 1301.37(b)). The OSC
concluded that ‘‘DEA must revoke . . .
[Registrant’s] DEA registration based on
[his] lack of authority to handle
controlled substances in the State of
Florida.’’ OSC, at 2.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2–3 (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. OSC, at 3–4
(citing 21 U.S.C. 824(c)(2)(C)).
II. Adequacy of Service
In a sworn Declaration, dated January
17, 2019, a DEA Diversion Investigator
assigned to the West Palm Beach
District Office of the Miami Division
(hereinafter, DI) stated that she ‘‘spoke
by telephone with United States
Penitentiary Coleman SIS Technician
[T.B.] to determine what procedures the
prison had in place for serving legal
documents on prisoners and [to] make
arrangements for service of the [OSC] on
Registrant.’’ Government’s Request for
Final Agency Action (hereinafter,
RFAA) Exhibit (hereinafter, RFAAX) 7
(DI Declaration), at 1. DI stated that T.B.
explained that T.B. ‘‘would personally
serve the [OSC] on [Registrant].’’ Id.
Accordingly, DI stated that, on October
10, 2018, she sent the OSC via FedEx
addressed to T.B. along with an
unsigned Form DEA–12, Receipt for
Cash or Other items. Id. DI further
declared that on October 18, 2018, she
‘‘received a FedEx package . . . from
[T.B.] with the Form DEA–12 which had
been signed by Registrant and witnessed
by [T.B.], dated October 16, 2018.’’ Id.;
see also RFAAX 7, Attachment (Form
DEA–12).
Additionally, on September 28, 2018,
the DEA Office of Chief Counsel
(hereinafter, CC) mailed the OSC to
Registrant at both his registered address
and his prison address. RFAAX 6 (CC
Declaration of Service). Neither letter
was returned to the Office of Chief
Counsel as undeliverable. Id.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on January 23, 2019. In its
RFAA, the Government represents that
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 86, Number 115 (Thursday, June 17, 2021)]
[Notices]
[Pages 32279-32280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12817]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-855]
Bulk Manufacturer of Controlled Substances Application: Organix
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Organix Inc. has applied to be registered as a bulk
manufacturer of basic class(es) of controlled substance(s). Refer to
Supplemental 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 16, 2021.
Such persons may also file a written request for a hearing on the
application on or before August 16, 2021.
ADDRESSES: 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 April 27, 2021, Organix Inc., 240 Salem Street,
Woburn, Massachusetts 01801-2029, applied to be registered as an bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Mescaline.......................... 7381 I
3,4,5-trimethoxyamphetamine........ 7390 I
4-bromo-2,5-dimethoxyphenethylamine 7392 I
3,4-methylenedioxyamphetamine...... 7400 I
3,4-methylenedioxymethamphetamine.. 7405 I
2-(2,5-dimethoxyphenyl)ethanamine.. 7517 I
2-(4-Iodo-2,5- 7518 I
dimethoxyphenyl)ethanamine.
------------------------------------------------------------------------
[[Page 32280]]
The company plans to bulk manufacture small quantities of the above
controlled substances for use in clinical research. No other activities
for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12817 Filed 6-16-21; 8:45 am]
BILLING CODE 4410-09-P
