Importer of Controlled Substances Application: AndersonBrecon Inc. DBA PCI of Illinois, 21811 [2019-10006]
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Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: AndersonBrecon Inc. DBA
PCI of Illinois
ACTION:
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 on or before June
14, 2019. Such persons may also file a
written request for a hearing on the
application on or before June 14, 2019.
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: 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
1301.34(a), this is notice that on March
5, 2019, AndersonBrecon Inc., DBA PCI
of Illinois, 5775 Logistics Parkway,
Rockford, Illinois 61109 applied to be
registered as an importer of the
following basic class of controlled
substance:
jbell on DSK3GLQ082PROD with NOTICES
DATES:
Controlled substance
Tetrahydrocannabinols ..
VerDate Sep<11>2014
Drug code
7370
22:43 May 14, 2019
Schedule
I
Jkt 247001
The company plans to import the
listed controlled substance for clinical
trials only. Approval of permit
application 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 FDA
approved or non-approved finished
dosage forms for commercial sale.
Dated: April 27, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–10006 Filed 5–14–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Fred J. Powell, M.D.; Decision and
Order
On January 25, 2018, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Fred J. Powell. (hereinafter,
Registrant), of St. Augustine, Florida.
Order to Show Cause (hereinafter, OSC),
at 1. The OSC proposes the revocation
of Registrant’s Certificate of Registration
(hereinafter, COR) on the ground that he
is without authority to handle
controlled substances in Florida, the
State in which he is registered with the
DEA. Id. at 2. The OSC cites the
operative statutory provisions that spell
out the requirements for registration
upon which the DEA alleges that
Registrant is deficient, and the DEA’s
authority to revoke his registration. Id.,
at 1–2 (citing 21 U.S.C. 824(a)(3)).
Jurisdiction
This Agency has jurisdiction to
decide this case based upon the OSC
allegation that Registrant holds a DEA
COR (No. AP8271138) at the registered
address of 35 Townsend Pl., St.
Augustine, FL 32092–3209. OSC, at 1.
That registration authorizes Registrant,
as a practitioner, to dispense controlled
substances in schedules II through V
and expires on March 31, 2020. Id.
Substantive Ground for Revocation of
COR Alleged in OSC
The substantive ground for the
proceeding, as alleged in the OSC, is
that Registrant agreed to a permanent
restriction prohibiting him from
prescribing and ordering Schedule I
through V controlled substances and
thus is ‘‘currently without authority to
handle controlled substances in the
State of Florida,’’ the State in which he
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
21811
is registered with the DEA under DEA
COR No. AP8271138. OSC, at 2.
The OSC notified Registrant of his
right to request a hearing on the
allegations or to submit a written
statement if he chooses to waive his
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect one of
those options. Id. (citing 21 CFR
1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan, the specific
procedures for filing a corrective action
plan, and the statutory provision that
governs such a plan. Id. at 2–3 (citing 21
U.S.C. 824(c)(2)(C)).
By letter dated March 27, 2018,
Registrant timely submitted a corrective
action plan (hereinafter, CAP). Request
for Final Agency Action dated April 10,
2018 (hereinafter, RFAA), Exhibit
(hereinafter, Exh.) 5.1 Registrant’s CAP
consists of thirteen paragraphs
containing assertions. The Assistant
Administrator of the Diversion Control
Division denied Registrant’s CAP by
letter dated April 6, 2018. Exh. 6.
In its RFAA, the Government
represents that, ‘‘At least 30 days have
passed since the time the . . . [OSC]
was served on Registrant. Registrant has
not requested a hearing.’’ RFAA, at 2.
The Government requests the issuance
of a ‘‘Final Order revoking Registrant’s
DEA registration.’’ Id. at 4.
The very existence of the CAP
evidences that service of the OSC on
Registrant was adequate. In addition,
Registrant did not dispute service.
Based on the Government’s written
representations and my review of the
record, I find that more than thirty days
have now passed since the date the
Government served the OSC. I find that
Registrant timely submitted a CAP and
that the Assistant Administrator of the
Diversion Control Division denied
Registrant’s CAP by letter dated April 6,
2018. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent him, requested a
hearing or submitted a written statement
while waiving Registrant’s right to a
hearing. Accordingly, I find that
Registrant has waived his right to a
hearing and his right to submit a written
statement. 21 CFR 1301.43(d). I,
therefore, issue this Decision and Order
based on the record submitted by the
Government, which constitutes the
entire record before me. 21 CFR
1301.43(e).
1 Also attached to the RFAA is a ‘‘Declaration’’ of
a DEA Diversion Investigator (hereinafter, DI
Declaration). Exh. 4. According to the DI
Declaration, two Diversion Investigators personally
served the OSC on Registrant on January 26, 2018.
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Page 21811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10006]
[[Page 21811]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: AndersonBrecon
Inc. DBA PCI of Illinois
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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 on or before June 14, 2019. Such
persons may also file a written request for a hearing on the
application on or before June 14, 2019.
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: 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 1301.34(a), this is notice that on March
5, 2019, AndersonBrecon Inc., DBA PCI of Illinois, 5775 Logistics
Parkway, Rockford, Illinois 61109 applied to be registered as an
importer of the following basic class of controlled substance:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................ 7370 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance for
clinical trials only. Approval of permit application 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 FDA approved or non-approved finished dosage forms for
commercial sale.
Dated: April 27, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-10006 Filed 5-14-19; 8:45 am]
BILLING CODE 4410-09-P
