2018-20384. Sharon C. Worosilo, M.D., Decision and Order

On February 7, 2018, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Sharon C. Worosilo, M.D. (Registrant), who is registered in Somerset and East Brunswick, New Jersey. The Show Cause Order proposed to revoke Registrant's two DEA Certificates of Registration, Nos. BW8636219 and BW4026375, pursuant to 21 U.S.C. 824(a)(3), on the ground that she does not have authority to handle controlled substances in New Jersey, the state in which she is registered with the DEA, and to deny any applications for renewal or modification and any applications for any other DEA registrations. GX 2 (Order to Show Cause), at 1.

With respect to the Agency's jurisdiction, the Show Cause Order alleged that Registrant is registered with the DEA as a practitioner authorized to handle controlled substances in schedules II through V under two DEA Certificate of Registrations: No. BW4026375 at the registered address of 49 Veronica Avenue, Somerset, New Jersey, and No. BW8636219, at the registered address of 620 Cranbury Road, Suite #115, East Brunswick, New Jersey. Id. at 2. The Order stated that both of Registrant's registrations were due to expire on May 31, 2018. Id.

Regarding the substantive grounds for the proceeding, the Show Cause Order specifically alleged that the New Jersey State Board of Medical Examiners issued an Order of Temporary Suspension “suspending [her] New Jersey medical license.” “Consequently, the DEA must revoke [her] DEA registrations based on [her] lack of authority to handle controlled substances in the State of New Jersey.” Id. at 2, citing 21 U.S.C. 824(a)(3) and 21 CFR 1301.37(b).

The Show Cause Order then notified Registrant of her right to request a hearing on the allegations, or to submit a written statement in lieu of a hearing, the procedure for doing either, and the consequence for failing to elect either option. Id. at 2, citing 21 CFR 1301.43. It also notified her of her right to submit a corrective action plan in accordance with 21 U.S.C. 824(c). Id. at 2-3.

On February 15, 2018, two DEA Diversion Investigators, accompanied by a Task Force Officer, personally served Registrant with the Order to Show Cause at her residence at 1000 Avenue at Port Imperial, Number 706, Weehawken, New Jersey. GX 4 (Declaration of Service of Order to Show Cause) at 1-2.

On April 13, 2018, the Government submitted a Request for Final Agency Action (RFAA) and the evidentiary record to my Office. The Government represented that “Registrant has not requested a hearing and has not otherwise corresponded or communicated with DEA regarding the Order served on her, including the filing of any written statement in lieu of a hearing.” RFAA, at 1-2.

Based on the Government's representation that more than 30 days have now passed since the date of service of the Show Cause Order and that Registrant has not submitted a request for a hearing or any other reply, I find that Registrant has waived her right to a hearing or to submit a written statement in lieu of a hearing. 21 CFR 1301.43(d). I therefore issue this Decision and Final Order based on relevant evidence contained in the record submitted by the Government. 21 CFR 1301.43(d) & (e). I make the following findings of fact.

Registrant is the holder of two DEA Registrations pursuant to which she is authorized to dispense controlled substances in schedules II-V as a practitioner at the registered address of 49 Veronica Avenue, Somerset, New Jersey (Registration No. BW4026375), and at the registered address of 620 Cranbury Road, Suite #115, East Brunswick, New Jersey (Registration No. BW8636219). GX 1 at 1-2.

On April 12, 2018, the Associate Chief of the DEA Registration and Program Support Section certified that both registrations were due to expire by their terms on May 31, 2018. Id. at 1-2. She further stated that “[Registrant] has no other pending or valid DEA registrations in New Jersey or in any other state.” Id. at 1-2. Pursuant to 5 U.S.C. 556(e), I take official notice of Registrant's registration record with the Agency. See also 21 CFR 1316.59(e).^[1]

A review of Agency registration records shows that Registrant has not filed any applications for renewal, nor has she filed a new application for a DEA Registration. Accordingly, I find that Registrant's registrations expired on May 31, 2018, and that there is no application to act upon.

Having reviewed the record, I hold that this proceeding is now moot. DEA has long held that “if a registrant has not submitted a timely renewal application prior to the expiration date, then the registration expires and there is nothing to revoke.” Donald Brooks Reece II, M.D., 77 FR 35054 (2012) (quoting Ronald J. Riegel, 63 FR 67132, 67133 (1998); see also Thomas E. Mitchell, 76 FR 20032, 20033 (2011), Donald Kenneth Shreves, D.V.M, 83 FR 22518 (2018). Moreover, in the absence of an application (whether timely filed or not), there is nothing to act upon. Accordingly, because Respondent has allowed her registrations to expire and has not filed either a renewal or a new application, this case is now moot and will be dismissed.

Order

Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I order that the Order to Show Cause issued to Sharon C. Worosilo, M.D., be, and it hereby is, dismissed. This Order is effective immediately.

Dated: September 12, 2018.

Uttam Dhillon,

Acting Administrator.

Footnotes

1.  Under the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA's regulations, Respondent is “entitled on timely request to an opportunity to show to the contrary.” 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within 15 calendar days of service of this order which shall commence on the date this order is mailed.