85666 Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 

1Under 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, 

Registrant may dispute my finding by filing a 

properly supported motion for reconsideration 

within fifteen 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 Registrant 

files a motion, the Government shall have fifteen 

calendar days to file a response. Any such motion 

and response may be filed and served by email 

(dea.addo.attorneys@dea.usdoj.gov). 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Irene G. Gurvits, M.D.; Decision and 

Order 

On August 19, 2020, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Irene G. 

Gurvits, M.D. (hereinafter, Registrant). 

OSC, at 1. The OSC proposed the 

revocation of Registrant’s Certificate of 

Registration No. BG6075875. Id. It 

alleged that Registrant is without 

‘‘authority to handle controlled 

substances in the State of New York, the 

state in which [Registrant is] registered 

with the DEA.’’ Id. at 2 (citing 21 U.S.C. 

824(a)(3)). 

Specifically, the OSC alleged that on 

May 26, 2020, ‘‘the New York State 

Board for Professional Medical Conduct 

issued a Determination and Order 

revoking [Registrant’s] license to 

practice medicine in the State of New 

York.’’ Id. The OSC further alleged that 

because Registrant’s medical license 

was revoked, Registrant lacks the 

authority to handle controlled 

substances in the State of New York. Id. 

The OSC notified Registrant of the 

right to either request a hearing on the 

allegations or submit a written 

statement in lieu of exercising the right 

to a hearing, the procedures for electing 

each option, and the consequences for 

failing to elect either option. Id. (citing 

21 CFR 1301.43). The OSC also notified 

Registrant of the opportunity to submit 

a corrective action plan. Id. at 3 (citing 

21 U.S.C. 824(c)(2)(C)). 

A DEA Diversion Investigator 

(hereinafter, DI) personally served 

Registrant with the OSC on August 31, 

2020, at her home address, which is also 

the mail address on her registration. 

Request for Final Agency Action 

(hereinafter, RFAA) Exhibit (hereinafter, 

RFAAX) 4, at 1–2 (Declaration of DI). 

The DI stated that after the DI explained 

the purpose of the Order, Registrant 

‘‘refused to accept the Order and 

slammed the door shut.’’ Id. The DI 

slipped the envelope with the Order 

under Registrant’s door and ‘‘Registrant 

then opened the door and [the DI] again 

explained the purpose of the Order. 

Registrant took the envelope containing 

the signed Order from underneath the 

door and immediately closed the door.’’ 

Id. 

I find that more than thirty days have 

now passed since the Government 

accomplished service of the OSC. 

Further, based on the Government’s 

written representations, I find that 

neither Registrant, nor anyone 

purporting to represent Registrant, 

requested a hearing, submitted a written 

statement while waiving Registrant’s 

right to a hearing ‘‘or otherwise 

corresponded or communicated with 

DEA regarding the Order served on 

her.’’ RFAA, at 1. Accordingly, I find 

that Registrant has waived the right to 

a hearing and the right to submit a 

written statement and corrective action 

plan. 21 CFR 1301.43(d) and 21 U.S.C. 

824(c)(2)(C). I, therefore, issue this 

Decision and Order based on the record 

submitted by the Government, which 

constitutes the entire record before me. 

21 CFR 1301.46. 

I. Findings of Fact 

a. Registrant’s DEA Registration 

Registrant is the holder of DEA 

Certificate of Registration No. 

BG6075875 at the registered address of 

102 West 75 St., Suite 107, New York, 

NY 10023. RFAAX 1 (Certification of 

Registration Status). Pursuant to this 

registration, Registrant is authorized to 

dispense controlled substances in 

schedules II through V as a practitionerDW/30. Id. Registrant’s registration 

expires on September 30, 2022, and ‘‘is 

in an active pending status until the 

resolution of administrative 

proceedings.’’ Id. 

b. The Status of Registrant’s State 

License 

The State of New York Department of 

Health State Board for Professional 

Conduct (hereinafter, the Board) entered 

a Determination and Order on May 26, 

2020, revoking Registrant’s medical 

license effective upon service on 

Registrant. RFAAX 3 (Board Order), at 8. 

The State of New York’s online records, 

of which I take official notice, document 

Registrant’s license status as ‘‘license 

revoked.’’ 1 New York Office of the 

Professions, Verification Searches, 

http://www.op.nysed.gov/ 

opsearches.htm# (last visited date of 

signature of this Order). 

Accordingly, I find that Registrant 

currently is not licensed to engage in the 

practice of medicine in New York, the 

state in which Registrant is registered 

with the DEA. 

II. 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 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 also 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., 

James L. Hooper, 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); Frederick Marsh Blanton, 43 FR 

at 27,617. 


KHAMMOND on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 249 / Tuesday, December 29, 2020 / Notices 85667 

According to the New York 

Controlled Substances Act (hereinafter, 

the Act), ‘‘[i]t shall be unlawful for any 

person to manufacture, sell, prescribe, 

distribute, dispense, administer, 

possess, have under his control, 

abandon, or transport a controlled 

substance except as expressly allowed 

by this article.’’ N.Y. Pub. Health Law 

§ 3304 (West 2020). The Act defines 

‘‘practitioner,’’ as ‘‘a physician . . . or 

other person licensed, or otherwise 

permitted to dispense, administer, or 

conduct research with respect to a 

controlled substance in the course of a 

licensed professional practice. . . .’’ Id. 

at § 3302(29). Finally, New York 

regulations state that ‘‘[a] prescription 

for a controlled substance may be issued 

only by a practitioner who is . . . 

authorized to prescribe controlled 

substances pursuant to his licensed 

professional practice . . .’’ N.Y. Comp. 

Codes R. & Regs. Tit. 10, § 80.64 (West 

2020). 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to practice medicine in New 

York. As already discussed, a physician 

must be a licensed practitioner to 

dispense a controlled substance in New 

York. Thus, because Registrant lacks 

authority to practice medicine in New 

York and, therefore, is not authorized to 

handle controlled substances in New 

York, Registrant is not eligible to 

maintain a DEA registration. 

Accordingly, I will order that 

Registrant’s DEA registration be 

revoked. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a), I hereby revoke DEA Certificate 

of Registration No. BG6075875 issued to 

Irene G. Gurvits, M.D. Further, pursuant 

to 28 CFR 0.100(b) and the authority 

vested in me by 21 U.S.C. 823(f), I 

hereby deny any pending application of 

Irene G. Gurvits, M.D. to renew or 

modify this registration or for any other 

registrations in the State of New York. 

This Order is effective January 28, 2021. 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–28683 Filed 12–28–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 18–33] 

Steven M. Kotsonis, M.D.; Order 

On May 3, 2018, the Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration (hereinafter, DEA or 

Government) issued an Order to Show 

Cause (hereinafter, OSC) to Steven M. 

Kotsonis, M.D. (hereinafter, 

Respondent), which sought to revoke 

Respondent’s DEA Certificate of 

Registration FK1584336 and to deny any 

pending applications for renewals or 

modifications of such registration, based 

on its contention that his continued 

registration is inconsistent with the 

public interest. Administrative Law 

Judge Exhibit (ALJX) 1 (OSC). In 

response to the OSC, Respondent 

submitted a timely request for a hearing, 

which was held from August 14–17, 

2018. On October 23, 2018, Chief 

Administrative Law Judge John J. 

Mulrooney, II issued a Recommended 

Rulings, Findings of Fact, Conclusions 

of Law, and Decision of the 

Administrative Law Judge (hereinafter, 

Recommended Decision), which 

recommended that I revoke 

Respondent’s registration and that I 

deny any pending application for 

renewal. Respondent filed Exceptions to 

the Recommended Decision, and the 

record was forwarded to me for final 

Agency action on November 26, 2018. 

After reviewing the record, I learned 

that Respondent had surrendered his 

DEA registration on December 23, 2019. 

I issued an Order on September 25, 

2020, requiring the Government to 

produce documentation of Respondent’s 

surrender of his registration. The Order 

further instructed the parties to file a 

Request for Dismissal ‘‘if it is the intent 

of [the] party to rely on Respondent’s 

voluntary surrender of his registration to 

terminate this proceeding’’ or a brief on 

the issue ‘‘if [the] party opposes the 

dismissal of this proceeding prior to the 

issuance of my Decision on the 

Government’s allegation in the OSC.’’ 

Both parties filed timely responses. 

Respondent filed a Request for 

Dismissal on October 15, 2020. As 

grounds for the dismissal, Respondent 

stated that, ‘‘upon DEA request, he 

voluntarily surrendered his DEA 

registration on December 23, 2019.’’ 

Respondent Request for Dismissal. 

The Government submitted a 

response to my September 25 Order on 

October 23, 2020 (hereinafter, the 

Government Response). As required by 

my September 25 Order, the 

Government submitted a copy of the 

Voluntary Surrender of Controlled 

Substances Privileges form, DEA–104, 

signed by Respondent surrendering DEA 

Registration No. FK1584336. The 

Government stated that Respondent 

voluntarily surrendered his DEA 

registration following a guilty plea to 

felony criminal drug charges in a 

criminal matter concurrent to the 

instant matter. Government Response at 

2. The Government Response neither 

requested that I dismiss this matter nor 

that I file a final Decision on the 

allegations it made in the OSC. Rather, 

the Government provided legal 

arguments regarding why Respondent’s 

voluntary surrender of his registration 

did not preclude me from issuing a final 

Decision. Id. at 2–3. The Government 

then concluded its Response stating that 

I ‘‘should issue whatever order is 

appropriate in light of the 

administrative record presented.’’ Id. at 

3. 

Based upon my review of the parties’ 

submissions, the record, and public 

documents from Respondent’s criminal 

case, I am granting Respondent’s 

Request for Dismissal. 

Facts 

Respondent was registered with DEA 

as a practitioner in schedules II through 

V under Certificate of Registration No. 

FK1584336, at the registered address of 

347 Park Ave., Pewaukee, Wisconsin 

53702. OSC at 1. In its OSC, the 

Government contended that 

Respondent’s registration was 

inconsistent with the public interest and 

should be revoked because Respondent 

failed to comply with applicable federal 

law relating to controlled substances. Id. 

at 1–2. Specifically, the OSC alleged 

that Respondent issued prescriptions for 

controlled substances outside the usual 

course of professional practice and not 

for a legitimate medical purpose, in 

violation of 21 CFR 1306.04(a). Id. at 2. 

On December 23, 2019, Respondent 

voluntarily surrendered his DEA 

registration. Government Response, 

Attachment 1 (DEA Form 104 signed by 

Respondent). In his surrender form, 

Respondent affirmed that he was 

voluntarily surrendering his registration 

for cause ‘‘[i]n view of [his] alleged 

failure to comply with the Federal 

requirements pertaining to controlled 

substances.’’ Id. Respondent also 

acknowledged that submitting the form 

to DEA would result in the immediate 

termination of his registration. Id. 

The Government stated in its 

Response that Respondent surrendered 

his DEA registration ‘‘following a guilty 

plea to felony criminal drug charges in 

[a] concurrent criminal matter.’’ 


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