Manufacturer of Controlled Substances; Notice of Application, 54931 [E7-19106]

Download as PDF Federal Register / Vol. 72, No. 187 / Thursday, September 27, 2007 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to § 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on August 30, 2007, Varian, Inc., Lake Forest, 25200 Commercentre Drive, Lake Forest, California 92630–8810, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug Schedule Phencyclidine (7471) .................... 1-Piperidinocyclohexanecarboni trile (8603). Benzoylecgonine (9180) ............... II II II The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products. Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), Washington, DC 20537, or any being sent via express mail should be sent to Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 2401 Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed no later than November 26, 2007. Dated: September 21, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E7–19106 Filed 9–26–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration rwilkins on PROD1PC63 with NOTICES Kamir Garces-Mejias, M.D.; Revocation of Registration On September 6, 2005, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Kamir Garces-Mejias, VerDate Aug<31>2005 16:40 Sep 26, 2007 Jkt 211001 M.D. (Respondent), of San Juan, Puerto Rico. The Order immediately suspended Respondent’s Certificate of Registration, BG2453075, as a practitioner, on the ground that Respondent’s continued registration during the pendency of the proceeding ‘‘would constitute an imminent danger to the public health and safety,’’ because Respondent had issued numerous prescriptions for controlled substances to persons who sought the drugs through internet sites and without ‘‘establish[ing] legitimate physician-patient relationships.’’ Show Cause Order at 6. The Order also sought the revocation of Respondent’s registration and the denial of any pending applications for renewal or modification of the registration. Id. at 1. More specifically, the Show Cause Order alleged that Respondent was a participant in a scheme run by Mr. Johar Saran, the owner of Carrington Health System/Infiniti Services Group (CHS/ ISG) of Arlington, Texas. Id. at 5. According to the allegations, CHS/ISG operated several DEA-registered pharmacies, which obtained their registrations through sham-nominees and which were used to order large amounts of highly abused controlled substances from licensed distributors. Id. The Show Cause Order alleged that the controlled substances were then diverted to CHS/ISG, where they were used to fill approximately 3,000 to 4,000 orders per day which had been placed by persons through various Web sites. Id. The Show Cause Order further alleged that Respondent ‘‘participated in [this] scheme by authorizing drug orders under the guise of practicing medicine.’’ Id. The Show Cause Order alleged that Respondent ‘‘did not see [the] customers, had no prior doctor-patient relationships with the Internet customers, did not conduct physical exams,’’ and did not ‘‘create or maintain patient records.’’ Id. The Show Cause Order also alleged that between May 19 and May 27, 2005, Respondent issued 188 prescriptions to persons located in thirty-three different States, and that eighty-six percent of the prescriptions were for hydrocodone, a controlled substance. Id. at 6. On September 21, 2005, the Show Cause Order was personally served on Respondent. On October 7, 2005, Respondent, through her counsel, requested a hearing on the allegations. This letter was returned, however, by UPS as undelivered. Thereafter, on October 14, 2005, Respondent, through her counsel, against requested a hearing. Respondent also asserted that she ‘‘may be the victim of a theft identity and [that] someone may have used, without PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 54931 her authorization, one of her prescriptions.’’ Letter of Resp.’s Counsel at 1 (Oct. 14, 2005). Respondent also denied having ever ‘‘participated in any Web site related to Mr. Johar Saran’s scheme.’’ On November 16, 2005, based on Respondent’s claim that she may have been the victim of identity theft, I stayed the Immediate Suspension of her registration. In the meantime, the matter had been placed on the docket of this Agency’s Administrative Law Judges (ALJ) and assigned to Judge Gail Randall. On October 26, 2005, the ALJ ordered the parties to file their pre-hearing statements. Following my decision staying the suspension order, the Government moved to stay the filing of pre-hearing statements. On November 18, 2005, the ALJ granted the motion. In a December 4, 2006 joint status report, the parties informed the ALJ that they were unable to resolve the matter without a hearing. The Government thus requested that the matter be set for hearing. On December 13, 2006, the ALJ issued a Second Order for Pre-Hearing Statements. The Order directed that the Government file its statement on or before January 10, 2007, and that Respondent file her statement on or before January 31, 2007. On January 5, 2007, the Government filed its statement. Respondent did not, however, comply with the ALJ’s order. Accordingly, on February 15, 2007, the ALJ issued an additional order which directed Respondent to file her statement by February 28, 2007. The order also gave notice that Respondent’s failure to comply could be deemed a waiver of her right to a hearing. See Third Order for Respondent’s Prehearing Statement 1 (citing 21 CFR 1301.43(e)). Respondent also failed to comply with this order. Thereafter, on March 5, 2007, the Government moved to terminate the proceeding and requested that the ALJ find that Respondent had waived her right to a hearing. On March 7, 2007, the ALJ found that Respondent had waived her right to a hearing under 21 CFR 1301.43(e), granted the Government’s motion, and ordered that the proceeding be terminated. On March 12, 2007, Respondent’s counsel received a copy of the ALJ’s termination order and moved for reconsideration. The basis for the motion was that Respondent’s counsel ‘‘is a solo practitioner in the island of Puerto Rico with an extensive practice on civil and federal criminal cases.’’ Respondent’s Req. for Reconsideration at 2. Respondent’s counsel maintained that since January 6, 2007, he had ‘‘had an extremely busy Court calendar,’’ E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 72, Number 187 (Thursday, September 27, 2007)]
[Notices]
[Page 54931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19106]



[[Page 54931]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application

    Pursuant to Sec.  1301.33(a) of Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on August 30, 2007, Varian, 
Inc., Lake Forest, 25200 Commercentre Drive, Lake Forest, California 
92630-8810, made application by renewal to the Drug Enforcement 
Administration (DEA) to be registered as a bulk manufacturer of the 
basic classes of controlled substances listed in schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Phencyclidine (7471).......................  II
1-Piperidinocyclohexanecarboni trile (8603)  II
Benzoylecgonine (9180).....................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances for use in diagnostic products.
    Any other such applicant and any person who is presently registered 
with DEA to manufacture such a substance may file comments or 
objections to the issuance of the proposed registration pursuant to 21 
CFR 1301.33(a).
    Any such written comments or objections being sent via regular mail 
should be addressed, in quintuplicate, to the Drug Enforcement 
Administration, Office of Diversion Control, Federal Register 
Representative (ODL), Washington, DC 20537, or any being sent via 
express mail should be sent to Drug Enforcement Administration, Office 
of Diversion Control, Federal Register Representative (ODL), 2401 
Jefferson Davis Highway, Alexandria, Virginia 22301; and must be filed 
no later than November 26, 2007.

    Dated: September 21, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E7-19106 Filed 9-26-07; 8:45 am]
BILLING CODE 4410-09-P