Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 22122 [2016-08569]
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Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Stepan
Company registration as a manufacturer
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22555, Stepan Company, Natural
Products Department, 100 W. Hunter
Avenue, Maywood, New Jersey 07607
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Stepan Company to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Cocaine (9041) .............................
Ecgonine (9180) ...........................
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before June 13, 2016.
DEPARTMENT OF JUSTICE
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[Docket No. 16–7]
ADDRESSES:
The
Attorney General has delegated her
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy 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 January
13, 2016, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
II
II
Controlled substance
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Dated: April 4, 2016
Louis J. Milione,
Deputy Assistant Administrator.
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Noroxymorphone (9668) ..............
Schedule
I
I
II
[Docket No. DEA–392]
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredients
(API) for clinical trials.
In reference to drug codes 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Dated: March 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–08576 Filed 4–13–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
[FR Doc. 2016–08569 Filed 4–13–16; 8:45 am]
ACTION:
Notice of application.
BILLING CODE 4410–09–P
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
DATES:
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17:56 Apr 13, 2016
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Drug Enforcement Administration
Rezik A. Saqer, M.D.; Decision and
Order
On October 1, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Rezik A. Saqer, M.D.,
(Respondent). The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificates of
Registration BS4072637 and FS1975359,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V, as a practitioner,
at the respective registered locations of
11037 FM 1960 West, Suite B1,
Houston, Texas, and 3074 College Park
Drive, Conroe, Texas. Show Cause
Order, at 1. The Show Cause Order
further proposed the denial of any
applications to renew or modify either
registration, as well as the denial of any
other application for a DEA registration.
Id.
More specifically, the Show Cause
Order alleged that ‘‘[e]ffective
September 28, 2015, the Texas Medical
Board issued an Order of Temporary
Suspension . . . which suspended
[Respondent’s] medical license,’’ and
therefore, he is currently ‘‘without
authority to handle controlled
substances in Texas, the State in which
[he is] registered with’’ DEA. Id. at 2.
The Show Cause Order thus advised
Respondent that ‘‘DEA must revoke [his]
registrations based upon [his] lack of
authority to handle controlled
substances in the State of Texas.’’ Id.
(citing 21 U.S.C. 802(21), 823(f), and
824(a)(3)).
On October 2, 2015, a Diversion
Investigator served the Show Cause
Order by travelling to Respondent’s
registered location in Houston, and
leaving it with a medical assistant, who
provided a signed receipt for the Order.
Affidavit of DI, at 1. On November 5,
2015, Respondent, through his counsel,
requested a hearing on the allegations of
the Show Cause Order.1 The matter was
then placed on the docket of the Office
of Administrative Law Judges, and
1 While Respondent’s request was untimely,
Respondent’s counsel subsequently filed a motion
which established that his secretary had attempted
to file the hearing request by UPS overnight
delivery, but had provided an incorrect address.
DEA has previously held that this type of
inadvertence may establish ‘‘good cause’’ to excuse
an untimely hearing request, at least when the party
promptly moves to rectify the omission. Tony Bui,
75 FR 49979, 49980 (2010).
E:\FR\FM\14APN1.SGM
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[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Page 22122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08569]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, 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 in accordance with 21 CFR
1301.33(a) on or before June 13, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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 Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy 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
January 13, 2016, Patheon API Manufacturing, Inc., 309 Delaware Street,
Building 1106, Greenville, South Carolina 29605 applied to be
registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Noroxymorphone (9668)...................... II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as Active Pharmaceutical Ingredients (API) for clinical
trials.
In reference to drug codes 7360 (marihuana), and 7370 (THC), the
company plans to bulk manufacture these drugs as synthetics. No other
activities for these drug codes are authorized for this registration.
Dated: March 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-08569 Filed 4-13-16; 8:45 am]
BILLING CODE 4410-09-P
