Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 22122 [2016-08569]

Download as PDF 22122 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 mstockstill on DSK4VPTVN1PROD with NOTICES 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: VerDate Sep<11>2014 17:56 Apr 13, 2016 Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 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 14APN1

Agencies

[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