Stephen R. Kovacs, D.O.; Decision and Order, 66747-66750 [2018-28072]

Download as PDF khammond on DSK30JT082PROD with NOTICES Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices Shenzhen Yibo Technology Co., Ltd., E District 4F, 5 Building, Wen Ge Industrial Zone, Heshuikou, Gongming St., Guangming New District, Shenzhen City, Guangdong Province, China 518106. Twist Vapor Franchising, LLC, 14937 Bruce B Downs Boulevard, Tampa, FL 33613. United Wholesale LLC, 73 Linden Street, Glastonbury, CT 06033. Vape4U LLC, 8926 Benson Ave. Ste E, Montclair, CA 91763. Vaperz LLC, 19818 S Harlem Ave., Frankfort, IL 60423. Vaportronix, LLC, 2941 NE 185th Street, Aventura, FL 33180. Vapor 4 Life Holdings, Inc., 4080 Commercial Ave., Suite A, Northbrook, IL 60062. The ZFO, 42 Nichols St., Suite 14, Spencerport, NY 14559. Ziip Lab Co., Ltd., E District 4F, 5 Building, Wen Ge Industrial Zone, Heshuikou, Gongming St., Guangming New District, Shenzhen City, Guangdong Province, China 518106. Ziip Lab S.A., Ave. Golero, 911 Office 27, Punta del Este—Maldonado, Uruguay, 20100. (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and (5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the VerDate Sep<11>2014 17:14 Dec 26, 2018 Jkt 247001 issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: December 20, 2018. Lisa Barton, Secretary to the Commission. 66747 Act on September 4, 2018 (83 FR 44903). Suzanne Morris, Chief, Premerger and Division Statistics Unit, Antitrust Division. [FR Doc. 2018–28041 Filed 12–26–18; 8:45 am] BILLING CODE 4410–11–P [FR Doc. 2018–28068 Filed 12–26–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 2018–48] DEPARTMENT OF JUSTICE Stephen R. Kovacs, D.O.; Decision and Order Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—DVD Copy Control Association Notice is hereby given that, on December 5, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (‘‘the Act’’), the DVD Copy Control Association (‘‘DVD CCA’’) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Shenzhen Soling Industrial Co., Ltd., Shenzhen City, Guangdong, PEOPLE’S REPUBLIC OF CHINA, has been added as a party to this venture. Also, Fujitsu Limited, Nakahara-ku, Kawasaki, JAPAN; and Koninklijke Philips Electronics N.V., Eindhoven, NETHERLANDS, have withdrawn as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and DVD CCA intends to file additional written notifications disclosing all changes in membership. On April 11, 2001, DVD CCA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on August 3, 2001 (66 FR 40727). The last notification was filed with the Department on August 14, 2018. A notice was published in the Federal Register pursuant to Section 6(b) of the PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 On August 2, 2018, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Stephen R. Kovacs, D.O. (hereinafter, Respondent), of Owasso and Claremore, Oklahoma. Order to Show Cause (hereinafter, OSC), at 1. The Show Cause Order proposes the revocation of Respondent’s Certificates of Registration on the ground that he has ‘‘no state authority to handle controlled substances’’ in Oklahoma, the State in which he is registered with the DEA. Id. (citing 21 U.S.C. 824(a)(3)). It also proposes the denial of ‘‘any applications for renewal or modification of such registrations and any applications for any other DEA registrations.’’ OSC, at 1 (citing 21 U.S.C. 824(a)(3)). Regarding jurisdiction, the Show Cause Order alleges that Respondent holds DEA Certificate of Registration No. BK9173840 at the registered address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 74055. OSC, at 2. This registration, the OSC alleges, authorizes Respondent to dispense controlled substances in schedules II through V as a practitioner-DW/275. Id. The Show Cause Order alleges that this registration expires on December 31, 2019. Id. The Show Cause Order further alleges that Respondent holds DEA Certificate of Registration No. BK7370492 at the registered address of 985 West Will Rogers Blvd., Claremore, OK 74017, with a mailing address of 13616 E 103rd St. N, Ste. A, Owasso, Oklahoma 74055. Id. This registration, the OSC alleges, authorizes Respondent to dispense controlled substances in schedules II through V as a practitioner. Id. The Show Cause Order alleges that this registration expires on December 31, 2018. Id. The substantive ground for the proceeding, as alleged in the Show Cause Order, is that Respondent is E:\FR\FM\27DEN1.SGM 27DEN1 66748 Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices khammond on DSK30JT082PROD with NOTICES ‘‘currently without authority to handle controlled substances in the State of Oklahoma, the state in which . . . [he is] registered with DEA.’’ Id. Specifically, the Show Cause Order alleges that, on May 31, 2018, the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control immediately suspended Respondent’s Oklahoma controlled substances registration OBN#29222, and that this registration is associated with Respondent’s practice location at 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 74055. Id. The Show Cause Order further alleges that Respondent’s Oklahoma controlled substances registration OBN#33269, associated with Respondent’s practice location at 985 West Will Rogers Blvd., Claremore, Oklahoma 74017, expired on October 31, 2017 and is listed as ‘‘INACTIVE.’’ Id. The Show Cause Order notifies Respondent of his right to request a hearing on the allegations or to submit a written statement while waiving his 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 Show Cause Order also notifies Respondent of the opportunity to submit a corrective action plan. OSC, at 3–4 (citing 21 U.S.C. 824(c)(2)(C)). By letter dated September 7, 2018, Respondent timely requested a hearing.1 Hearing Request, at 1. According to the Hearing Request, the Oklahoma Bureau of Narcotics & Dangerous Drugs Control (hereinafter, OBNDDC) immediately suspended ‘‘for imminent endangerment’’ Respondent’s State controlled substances registration based on ‘‘allegations of professional misconduct.’’ Id. Respondent contests the OBNDDC allegations. Id. The Hearing Request admits that Respondent ‘‘is currently suspended under the State order from prescribing medications.’’ Id. at 2. It states that, ‘‘upon a full and fair hearing of the facts,’’ Respondent ‘‘should not have his State or Federal Certificates of Registration revoked or modified.’’ Id. The Office of Administrative Law Judges put the matter on the docket and 1 Attached to the Government’s Motion for Summary Disposition is a DEA–12 (Receipt for Cash or Other Items) that, according to the Government’s allegations, Respondent executed when the Government served the OSC on August 8, 2018. Respondent does not challenge the Government’s service-related allegations. The Government does not contest the timeliness of Respondent’s request for a hearing. Government’s Motion for Summary Disposition dated September 19, 2018 (hereinafter ‘‘Summary Disposition Motion’’), at 2. Thus, I find that Respondent’s Hearing Request was timely since it was filed within 30 days of service of the OSC. 21 CFR 1301.43(a). VerDate Sep<11>2014 17:14 Dec 26, 2018 Jkt 247001 assigned it to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On September 10, 2018, the CALJ issued an Order directing the filing of evidence of lack of State authority and a briefing schedule. The Government filed a timely Summary Disposition Motion ‘‘based on Respondent’s lack of state authority to handle controlled substances.’’ Summary Disposition Motion, at 1. The Government attached to its Summary Disposition Motion a certified copy of the OBNDDC’s letter to Respondent notifying him of his ‘‘Immediate Suspension Due to Imminent Danger’’ dated May 31, 2018. Id. at Exh. 4. According to the Summary Disposition Motion, Respondent ‘‘is not authorized to possess a DEA registration’’ in Oklahoma ‘‘[a]bsent authority by the State of Oklahoma to dispense controlled substances.’’ Id. at 4. Citing Agency precedent, the Government argues that ‘‘even if the period of suspension is temporary or if there is the potential that Respondent’s state controlled substances privileges will be reinstated, summary disposition is warranted.’’ Id. On September 27, 2018, Respondent timely filed a Response to the Summary Disposition Motion. Attached to the Response is an email from the Deputy General Counsel of the Oklahoma Bureau of Narcotics dated September 13, 2018. The email asks Respondent’s attorney if he ‘‘[w]ould . . . be opposed to continuing . . . [Respondent’s] hearing until October 25, 2018.’’ Response, Exh. 1, at 1. Counsel for Respondent did not object to the continuance. Id. at 1. According to the Response, ‘‘Respondent’s rights have been severely prejudiced by delaying the state hearing.’’ Id. at 2. Respondent ‘‘admits that the OBNDDC filed the Notice of Immediate Suspension of Respondent’s Oklahoma controlled substances registration on May 31, 2018.’’ Id. at 1. He states, however, that he ‘‘has had no opportunity to present evidence or cross-examine witnesses, defenses to which he is absolutely entitled under Oklahoma law’’ and that ‘‘but for’’ the continuance, he ‘‘would have had that opportunity today.’’ Id. at 3. Respondent argues that the Agency precedent on which the Government relies ‘‘allowed some form of process with the state . . . before the Government’s motion for summary disposition was granted.’’ Id. at 2. He states that the ‘‘state administrative hearing will be concluded in less than one month . . . [at which] time both sides will have a much more complete understanding of the facts, and the ALJ will be able to PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 more effectively rule on the status of Respondent’s DEA registration.’’ Id. at 3. Respondent asks that the Summary Disposition Motion be denied or, in the alternative, that the deadline for his response be ‘‘extended . . . beyond the date of his state administrative hearing.’’ Id. The CALJ granted the Summary Disposition Motion and recommended that Respondent’s registration be revoked. Order Denying the Respondent’s Request for Extension, Granting the Government’s Motion for Summary Disposition, and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge dated September 28, 2018 (hereinafter, R.D.). The CALJ notes Respondent’s concession that his Oklahoma registration was suspended on May 31, 2018. Id. at 3. Citing Agency precedent about stay requests, the CALJ denied Respondent’s request for an extended response deadline. Id. After summarizing Agency precedent concerning a registrant’s loss of State authority to dispense controlled substances, the CALJ recommended that Respondent’s registration be revoked and that pending applications for renewal be denied. Id. at 4–7. By letter dated October 18, 2018, the CALJ certified and transmitted the record to me for final Agency action. In that letter, the CALJ advises that neither party filed exceptions. I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact. Findings of Fact Respondent’s DEA Registrations Respondent holds two DEA Certificates of Registration. First, Respondent holds DEA Certificate of Registration No. BK9173840, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner DW/275, at the registered address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 74055. Summary Disposition Motion, Exh. 1 (Certification of Registration Status), at 1. This registration expires on December 31, 2019. Id. Second, Respondent holds DEA Certificate of Registration No. BK7370492, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of 985 West Will Rogers Blvd., Claremore, Oklahoma 74017. Id. at Exh. 2 (Certification of Registration Status), at E:\FR\FM\27DEN1.SGM 27DEN1 Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices 1. This registration expires on December 31, 2018. Id. The Status of Respondent’s State License khammond on DSK30JT082PROD with NOTICES On May 31, 2018, the OBNDDC immediately suspended due to imminent danger Respondent’s ‘‘privileges to possess, administer, dispense, prescribe and/or distribute scheduled controlled dangerous substances.’’ Id. at Exh. 4, at 1. According to the immediate suspension, the OBNDDC found ‘‘by clear and convincing evidence . . . [that Respondent’s] continuing status as an Oklahoma Bureau of Narcotics registrant represents an imminent danger to the public health, safety and welfare of the citizens of Oklahoma.’’ Id. at Exh. 4, at 3. The OBNDDC’s action was based on information that Respondent wrote false Oxycodone (30mg) prescriptions for a patient with the intention of diverting the narcotics back to himself; that Respondent urged a patient to include a false report of stolen Oxycodone on a police report with the intention of getting another refill; that Respondent deleted messages pertaining to his illegal activity from a patient’s electronic device; that a patient witnessed Respondent snort Oxycodone between meetings with patients; and that Respondent was opioid dependent. Id. at Exh. 4, at 2–3. Respondent admits that the OBNDDC filed the Notice of Immediate Suspension on May 31, 2018. Response, at 1. There is no evidence in the record that the OBNDDC lifted this Immediate Suspension. Further, according to the online records of the State of Oklahoma, of which I take official notice, I find that this Immediate Suspension is still in effect today and that no Oklahoma controlled substances registration ever assigned to Respondent is currently active.2 OBNDDC Registration Search Lookup, https://pay.apps.ok.gov/obndd/ _app/search/index.php (last visited December 11, 2018). 2 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Respondent may dispute my finding by filing a properly supported motion for reconsideration within 15 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the Government; in the event Respondent files a motion, the Government shall have 15 calendar days to file a response. VerDate Sep<11>2014 17:14 Dec 26, 2018 Jkt 247001 Accordingly, I find that Respondent currently is without authority to dispense controlled substances in Oklahoma, the State in which he is registered. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (hereinafter, CSA), ‘‘upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ With respect to a practitioner, the DEA has long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner’s registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978). This rule derives from the text of two provisions of the CSA. First, Congress defined the term ‘‘practitioner’’ to mean ‘‘a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . ., to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.’’ 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress directed that ‘‘[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess State authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices. See, e.g., Hooper, supra, 76 FR at 71,371–72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988), Blanton, supra, 43 FR at 27,617. Under longstanding Agency precedent, DEA revokes the registration of a practitioner who lacks State authority to handle controlled PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 66749 substances even when the practitioner’s State authority was suspended summarily or pending a final decision on the merits. See, e.g., Bourne Pharmacy, Inc., 72 FR 18,273, 18,274 (2007). Similarly, as the CALJ made clear, the facts that a State immediately suspended a respondent’s registration and that the respondent may, some day, regain his State registration to dispense controlled substances do not change the salient fact—the respondent is not currently authorized to handle controlled substances in the State in which he is registered.3 Mehdi Nikparvarfard, M.D., 83 FR 14,503, 14,504 (2018). Here, Respondent admits that the OBNDDC suspended his Oklahoma controlled substances registration. Further, there is no evidence in the record that Respondent holds any active Oklahoma registration to handle controlled substances. As such, according to Oklahoma law, Respondent currently does not have authority to handle controlled substances in Oklahoma. Okla. Stat. tit. 63, § 2–302 (Westlaw, current with legislation of the Second Regular Session of the 56th Legislature (2018)) (Every person who dispenses any controlled dangerous substance within Oklahoma shall obtain a registration issued by OBNDDC.). Respondent, therefore, is not eligible for a DEA registration. Accordingly, I will order that Respondent’s DEA registrations be revoked and that any pending application for the renewal or modification of those registrations be denied. 21 U.S.C. 824(a)(3). Order Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 21 U.S.C. 824(a), I order that DEA Certificate of Registration Nos. BK9173840 and BK7370492 issued to Stephen R. Kovacs, D.O., be, and they hereby are, revoked. I further order that any pending application of Stephen R. Kovacs, D.O., to renew or modify these registration, as well as any other pending application by him for registration in the State of Oklahoma, be, and it hereby is, denied. This Order is effective immediately.4 3 The CALJ’s denial of Respondent’s request for an enlargement of time is the correct result. Also, as already discussed, Oklahoma’s online records still indicate that Respondent’s Oklahoma controlled substances registrations are inactive or inactivated. 4 For the same reasons the OBNDDC found by clear and convincing evidence that Respondent’s continuing status as an Oklahoma Bureau of Narcotics registrant represents an imminent danger to the public health, safety and welfare of the citizens of Oklahoma, I find that the public interest E:\FR\FM\27DEN1.SGM Continued 27DEN1 66750 Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices Dated: December 11, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018–28072 Filed 12–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Johnson Matthey Inc. ACTION: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007) ADDRESSES: Notice of application. 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 on or before January 28, 2019. Such persons may also file a written request for a hearing on the application on or before January 28, 2019. DATES: 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 October 15, 2018, Johnson Matthey Inc., 2003 Nolte Drive, West Deptford, New Jersey 08066 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Coca Leaves ............................................................................................................................................................ Thebaine .................................................................................................................................................................. Opium, raw .............................................................................................................................................................. Noroxymorphone ..................................................................................................................................................... Poppy Straw Concentrate ........................................................................................................................................ Fentanyl ................................................................................................................................................................... The company plans to import coca leaves (9040), raw opium (9600), and poppy straw concentrate (9670) in order to bulk manufacture active pharmaceutical ingredients (API) for distribution to its customers. The company plans to also import thebaine (9333), noroxymorophone (9668), and fentanyl (9801) to use as analytical reference standards, both internally and to be sold to their customers to support testing of Johnson Matthey Inc.’s API’s only. Dated: December 8, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–28073 Filed 12–26–18; 8:45 am] khammond on DSK30JT082PROD with NOTICES BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Company 17:14 Dec 26, 2018 Jkt 247001 II II II II II II FR docket Published 83 FR 49580. October 2, 2018. Drug Enforcement Administration R & D Systems, Inc. [Docket No. DEA–392] The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I or II 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or II controlled substances to the above listed company. Importer of Controlled Substances Registration ACTION: Notice of registration. The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of various classes of schedule I or II controlled substances. SUMMARY: The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice. SUPPLEMENTARY INFORMATION: necessitates that this Order be effective immediately. 21 CFR 1316.67. VerDate Sep<11>2014 9040 9333 9600 9668 9670 9801 Schedule PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66747-66750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28072]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 2018-48]


Stephen R. Kovacs, D.O.; Decision and Order

    On August 2, 2018, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Stephen R. Kovacs, D.O. 
(hereinafter, Respondent), of Owasso and Claremore, Oklahoma. Order to 
Show Cause (hereinafter, OSC), at 1. The Show Cause Order proposes the 
revocation of Respondent's Certificates of Registration on the ground 
that he has ``no state authority to handle controlled substances'' in 
Oklahoma, the State in which he is registered with the DEA. Id. (citing 
21 U.S.C. 824(a)(3)). It also proposes the denial of ``any applications 
for renewal or modification of such registrations and any applications 
for any other DEA registrations.'' OSC, at 1 (citing 21 U.S.C. 
824(a)(3)).
    Regarding jurisdiction, the Show Cause Order alleges that 
Respondent holds DEA Certificate of Registration No. BK9173840 at the 
registered address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 
74055. OSC, at 2. This registration, the OSC alleges, authorizes 
Respondent to dispense controlled substances in schedules II through V 
as a practitioner-DW/275. Id. The Show Cause Order alleges that this 
registration expires on December 31, 2019. Id.
    The Show Cause Order further alleges that Respondent holds DEA 
Certificate of Registration No. BK7370492 at the registered address of 
985 West Will Rogers Blvd., Claremore, OK 74017, with a mailing address 
of 13616 E 103rd St. N, Ste. A, Owasso, Oklahoma 74055. Id. This 
registration, the OSC alleges, authorizes Respondent to dispense 
controlled substances in schedules II through V as a practitioner. Id. 
The Show Cause Order alleges that this registration expires on December 
31, 2018. Id.
    The substantive ground for the proceeding, as alleged in the Show 
Cause Order, is that Respondent is

[[Page 66748]]

``currently without authority to handle controlled substances in the 
State of Oklahoma, the state in which . . . [he is] registered with 
DEA.'' Id. Specifically, the Show Cause Order alleges that, on May 31, 
2018, the Oklahoma State Bureau of Narcotics and Dangerous Drugs 
Control immediately suspended Respondent's Oklahoma controlled 
substances registration OBN#29222, and that this registration is 
associated with Respondent's practice location at 10314 N 138th E Ave., 
Suite 101, Owasso, Oklahoma 74055. Id. The Show Cause Order further 
alleges that Respondent's Oklahoma controlled substances registration 
OBN#33269, associated with Respondent's practice location at 985 West 
Will Rogers Blvd., Claremore, Oklahoma 74017, expired on October 31, 
2017 and is listed as ``INACTIVE.'' Id.
    The Show Cause Order notifies Respondent of his right to request a 
hearing on the allegations or to submit a written statement while 
waiving his 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 Show Cause Order also notifies 
Respondent of the opportunity to submit a corrective action plan. OSC, 
at 3-4 (citing 21 U.S.C. 824(c)(2)(C)).
    By letter dated September 7, 2018, Respondent timely requested a 
hearing.\1\ Hearing Request, at 1. According to the Hearing Request, 
the Oklahoma Bureau of Narcotics & Dangerous Drugs Control 
(hereinafter, OBNDDC) immediately suspended ``for imminent 
endangerment'' Respondent's State controlled substances registration 
based on ``allegations of professional misconduct.'' Id. Respondent 
contests the OBNDDC allegations. Id. The Hearing Request admits that 
Respondent ``is currently suspended under the State order from 
prescribing medications.'' Id. at 2. It states that, ``upon a full and 
fair hearing of the facts,'' Respondent ``should not have his State or 
Federal Certificates of Registration revoked or modified.'' Id.
---------------------------------------------------------------------------

    \1\ Attached to the Government's Motion for Summary Disposition 
is a DEA-12 (Receipt for Cash or Other Items) that, according to the 
Government's allegations, Respondent executed when the Government 
served the OSC on August 8, 2018. Respondent does not challenge the 
Government's service-related allegations. The Government does not 
contest the timeliness of Respondent's request for a hearing. 
Government's Motion for Summary Disposition dated September 19, 2018 
(hereinafter ``Summary Disposition Motion''), at 2. Thus, I find 
that Respondent's Hearing Request was timely since it was filed 
within 30 days of service of the OSC. 21 CFR 1301.43(a).
---------------------------------------------------------------------------

    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Chief Administrative Law Judge John J. 
Mulrooney, II (hereinafter, CALJ). On September 10, 2018, the CALJ 
issued an Order directing the filing of evidence of lack of State 
authority and a briefing schedule.
    The Government filed a timely Summary Disposition Motion ``based on 
Respondent's lack of state authority to handle controlled substances.'' 
Summary Disposition Motion, at 1. The Government attached to its 
Summary Disposition Motion a certified copy of the OBNDDC's letter to 
Respondent notifying him of his ``Immediate Suspension Due to Imminent 
Danger'' dated May 31, 2018. Id. at Exh. 4. According to the Summary 
Disposition Motion, Respondent ``is not authorized to possess a DEA 
registration'' in Oklahoma ``[a]bsent authority by the State of 
Oklahoma to dispense controlled substances.'' Id. at 4. Citing Agency 
precedent, the Government argues that ``even if the period of 
suspension is temporary or if there is the potential that Respondent's 
state controlled substances privileges will be reinstated, summary 
disposition is warranted.'' Id.
    On September 27, 2018, Respondent timely filed a Response to the 
Summary Disposition Motion. Attached to the Response is an email from 
the Deputy General Counsel of the Oklahoma Bureau of Narcotics dated 
September 13, 2018. The email asks Respondent's attorney if he 
``[w]ould . . . be opposed to continuing . . . [Respondent's] hearing 
until October 25, 2018.'' Response, Exh. 1, at 1. Counsel for 
Respondent did not object to the continuance. Id. at 1. According to 
the Response, ``Respondent's rights have been severely prejudiced by 
delaying the state hearing.'' Id. at 2.
    Respondent ``admits that the OBNDDC filed the Notice of Immediate 
Suspension of Respondent's Oklahoma controlled substances registration 
on May 31, 2018.'' Id. at 1. He states, however, that he ``has had no 
opportunity to present evidence or cross-examine witnesses, defenses to 
which he is absolutely entitled under Oklahoma law'' and that ``but 
for'' the continuance, he ``would have had that opportunity today.'' 
Id. at 3. Respondent argues that the Agency precedent on which the 
Government relies ``allowed some form of process with the state . . . 
before the Government's motion for summary disposition was granted.'' 
Id. at 2. He states that the ``state administrative hearing will be 
concluded in less than one month . . . [at which] time both sides will 
have a much more complete understanding of the facts, and the ALJ will 
be able to more effectively rule on the status of Respondent's DEA 
registration.'' Id. at 3. Respondent asks that the Summary Disposition 
Motion be denied or, in the alternative, that the deadline for his 
response be ``extended . . . beyond the date of his state 
administrative hearing.'' Id.
    The CALJ granted the Summary Disposition Motion and recommended 
that Respondent's registration be revoked. Order Denying the 
Respondent's Request for Extension, Granting the Government's Motion 
for Summary Disposition, and Recommended Rulings, Findings of Fact, 
Conclusions of Law, and Decision of the Administrative Law Judge dated 
September 28, 2018 (hereinafter, R.D.). The CALJ notes Respondent's 
concession that his Oklahoma registration was suspended on May 31, 
2018. Id. at 3. Citing Agency precedent about stay requests, the CALJ 
denied Respondent's request for an extended response deadline. Id. 
After summarizing Agency precedent concerning a registrant's loss of 
State authority to dispense controlled substances, the CALJ recommended 
that Respondent's registration be revoked and that pending applications 
for renewal be denied. Id. at 4-7.
    By letter dated October 18, 2018, the CALJ certified and 
transmitted the record to me for final Agency action. In that letter, 
the CALJ advises that neither party filed exceptions.
    I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Respondent's DEA Registrations

    Respondent holds two DEA Certificates of Registration. First, 
Respondent holds DEA Certificate of Registration No. BK9173840, 
pursuant to which he is authorized to dispense controlled substances in 
schedules II through V as a practitioner DW/275, at the registered 
address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 74055. 
Summary Disposition Motion, Exh. 1 (Certification of Registration 
Status), at 1. This registration expires on December 31, 2019. Id.
    Second, Respondent holds DEA Certificate of Registration No. 
BK7370492, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V as a practitioner, at the 
registered address of 985 West Will Rogers Blvd., Claremore, Oklahoma 
74017. Id. at Exh. 2 (Certification of Registration Status), at

[[Page 66749]]

1. This registration expires on December 31, 2018. Id.

The Status of Respondent's State License

    On May 31, 2018, the OBNDDC immediately suspended due to imminent 
danger Respondent's ``privileges to possess, administer, dispense, 
prescribe and/or distribute scheduled controlled dangerous 
substances.'' Id. at Exh. 4, at 1. According to the immediate 
suspension, the OBNDDC found ``by clear and convincing evidence . . . 
[that Respondent's] continuing status as an Oklahoma Bureau of 
Narcotics registrant represents an imminent danger to the public 
health, safety and welfare of the citizens of Oklahoma.'' Id. at Exh. 
4, at 3. The OBNDDC's action was based on information that Respondent 
wrote false Oxycodone (30mg) prescriptions for a patient with the 
intention of diverting the narcotics back to himself; that Respondent 
urged a patient to include a false report of stolen Oxycodone on a 
police report with the intention of getting another refill; that 
Respondent deleted messages pertaining to his illegal activity from a 
patient's electronic device; that a patient witnessed Respondent snort 
Oxycodone between meetings with patients; and that Respondent was 
opioid dependent. Id. at Exh. 4, at 2-3.
    Respondent admits that the OBNDDC filed the Notice of Immediate 
Suspension on May 31, 2018. Response, at 1. There is no evidence in the 
record that the OBNDDC lifted this Immediate Suspension. Further, 
according to the online records of the State of Oklahoma, of which I 
take official notice, I find that this Immediate Suspension is still in 
effect today and that no Oklahoma controlled substances registration 
ever assigned to Respondent is currently active.\2\ OBNDDC Registration 
Search Lookup, https://pay.apps.ok.gov/obndd/_app/search/index.php 
(last visited December 11, 2018).
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    \2\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Respondent may dispute my finding by filing 
a properly supported motion for reconsideration within 15 calendar 
days of the date of this Order. Any such motion shall be filed with 
the Office of the Administrator and a copy shall be served on the 
Government; in the event Respondent files a motion, the Government 
shall have 15 calendar days to file a response.
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    Accordingly, I find that Respondent currently is without authority 
to dispense controlled substances in Oklahoma, the State in which he is 
registered.

Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the 
registrant . . . has had his State license or registration suspended . 
. . [or] revoked . . . by competent State authority and is no longer 
authorized by State law to engage in the . . . dispensing of controlled 
substances.'' With respect to a practitioner, the DEA has long held 
that the possession of authority to dispense controlled substances 
under the laws of the State in which a practitioner engages in 
professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration. See, e.g., James L. Hooper, 
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 
(4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 
(1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a physician 
. . . or other person licensed, registered, or otherwise permitted, by 
. . . the jurisdiction in which he practices . . ., to distribute, 
dispense, . . . [or] administer . . . a controlled substance in the 
course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess State authority in order to be deemed a 
practitioner under the CSA, the DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction whenever 
he is no longer authorized to dispense controlled substances under the 
laws of the State in which he practices. See, e.g., Hooper, supra, 76 
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, M.D., 53 FR 11,919, 11,920 (1988), Blanton, supra, 43 FR at 
27,617.
    Under longstanding Agency precedent, DEA revokes the registration 
of a practitioner who lacks State authority to handle controlled 
substances even when the practitioner's State authority was suspended 
summarily or pending a final decision on the merits. See, e.g., Bourne 
Pharmacy, Inc., 72 FR 18,273, 18,274 (2007). Similarly, as the CALJ 
made clear, the facts that a State immediately suspended a respondent's 
registration and that the respondent may, some day, regain his State 
registration to dispense controlled substances do not change the 
salient fact--the respondent is not currently authorized to handle 
controlled substances in the State in which he is registered.\3\ Mehdi 
Nikparvarfard, M.D., 83 FR 14,503, 14,504 (2018).
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    \3\ The CALJ's denial of Respondent's request for an enlargement 
of time is the correct result. Also, as already discussed, 
Oklahoma's online records still indicate that Respondent's Oklahoma 
controlled substances registrations are inactive or inactivated.
---------------------------------------------------------------------------

    Here, Respondent admits that the OBNDDC suspended his Oklahoma 
controlled substances registration. Further, there is no evidence in 
the record that Respondent holds any active Oklahoma registration to 
handle controlled substances. As such, according to Oklahoma law, 
Respondent currently does not have authority to handle controlled 
substances in Oklahoma. Okla. Stat. tit. 63, Sec.  2-302 (Westlaw, 
current with legislation of the Second Regular Session of the 56th 
Legislature (2018)) (Every person who dispenses any controlled 
dangerous substance within Oklahoma shall obtain a registration issued 
by OBNDDC.). Respondent, therefore, is not eligible for a DEA 
registration. Accordingly, I will order that Respondent's DEA 
registrations be revoked and that any pending application for the 
renewal or modification of those registrations be denied. 21 U.S.C. 
824(a)(3).

Order

    Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 
21 U.S.C. 824(a), I order that DEA Certificate of Registration Nos. 
BK9173840 and BK7370492 issued to Stephen R. Kovacs, D.O., be, and they 
hereby are, revoked. I further order that any pending application of 
Stephen R. Kovacs, D.O., to renew or modify these registration, as well 
as any other pending application by him for registration in the State 
of Oklahoma, be, and it hereby is, denied. This Order is effective 
immediately.\4\
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    \4\ For the same reasons the OBNDDC found by clear and 
convincing evidence that Respondent's continuing status as an 
Oklahoma Bureau of Narcotics registrant represents an imminent 
danger to the public health, safety and welfare of the citizens of 
Oklahoma, I find that the public interest necessitates that this 
Order be effective immediately. 21 CFR 1316.67.


[[Page 66750]]


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    Dated: December 11, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-28072 Filed 12-26-18; 8:45 am]
BILLING CODE 4410-09-P