83 FR 47351 - Sharon C. Worosilo, M.D., Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 182 (September 19, 2018)

Page Range		47351-47352
FR Document		2018-20384

Federal Register, Volume 83 Issue 182 (Wednesday, September 19, 2018)

[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Pages 47351-47352]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20384]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


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

[[Page 47352]]

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\
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    \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.
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    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.
[FR Doc. 2018-20384 Filed 9-18-18; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices 47351

seeking review of the Commission’s On April 5, 2018, the Commission DEPARTMENT OF JUSTICE
finding of violation as to the ’577 and determined to modify the remedial
’668 patents. Arista Networks, Inc. v. orders to suspend enforcement of those Drug Enforcement Administration
Int’l Trade Comm’n, Appeal No. 17– orders with respect to the ’668 patent.
2336. On August 3, 2017, the Federal Sharon C. Worosilo, M.D., Decision
Notice (Apr. 5, 2018); Comm’n Order
Circuit consolidated the Arista and and Order
(Apr. 5, 2018).
Cisco appeals. Cisco Sys., Inc. v. Int’l On February 7, 2018, the Acting
On June 26, 2018, the Commission
Trade Comm’n, Appeal No. 17–2289, Assistant Administrator, Diversion
Dkt. No. 20. accepted the ALJ’s recommended
determination finding no infringement Control Division, Drug Enforcement
On August 25, 2017, Arista filed a Administration (DEA), issued an Order
motion with the Federal Circuit seeking with respect to the ’577 patent and
determined to modify the remedial to Show Cause to Sharon C. Worosilo,
to stay the Commission’s remedial M.D. (Registrant), who is registered in
orders pending resolution of the appeal orders to exempt Arista’s redesigned
Somerset and East Brunswick, New
on the merits. On September 22, 2017, products that were the subject of the
Jersey. The Show Cause Order proposed
the Federal Circuit denied this request modification proceeding. The
to revoke Registrant’s two DEA
‘‘subject to the condition that the Commission also determined to suspend Certificates of Registration, Nos.
product redesign on which Cisco relies the modification proceeding as to the BW8636219 and BW4026375, pursuant
to deny irreparable harm must be ’668 patent. The ’577 patent expired on to 21 U.S.C. 824(a)(3), on the ground
permitted to enter the country, without June 30, 2018. that she does not have authority to
being blocked by the Commission order On August 27, 2018, the Federal handle controlled substances in New
under review in this case, unless and Circuit granted a motion of the parties Jersey, the state in which she is
until Commission proceedings are to voluntarily dismiss the consolidated registered with the DEA, and to deny
initiated and completed to produce an appeal from the Commission’s final any applications for renewal or
enforceable determination that such a determination on violation. Cisco Sys., modification and any applications for
redesign is barred by the order here Inc., Appeal No. 17–2289, Dkt. No. 121 any other DEA registrations. GX 2
under review or by a new or amended (Order to Show Cause), at 1.
(Aug. 27, 2018).
order.’’ Cisco Sys, Inc. v. ITC; Arista With respect to the Agency’s
Networks, Inc. v. ITC, Appeal Nos. On August 27, 2018, Cisco and Arista jurisdiction, the Show Cause Order
2017–2289, –2351, Order at 3 (Fed. Cir. filed a joint motion to terminate the alleged that Registrant is registered with
Sept. 22, 2017). modification proceeding in its entirety the DEA as a practitioner authorized to
On September 27, 2017, Cisco pursuant to Commission Rule handle controlled substances in
petitioned for a modification proceeding 210.21(b)(1) (19 CFR 210.21(b)(1)) based schedules II through V under two DEA
to determine whether Arista’s on a settlement agreement between the Certificate of Registrations: No.
redesigned switches infringe the patent parties. The motion indicates that the BW4026375 at the registered address of
claims that are the subject of the LEO Agreement fully resolves the disputed 49 Veronica Avenue, Somerset, New
and CDO issued in this investigation issues in the modification proceeding, Jersey, and No. BW8636219, at the
and for modification of the remedial that there are no other agreements, registered address of 620 Cranbury
orders to specify the status of these written or oral, express or implied, Road, Suite #115, East Brunswick, New
redesigned products. between them concerning the subject Jersey. Id. at 2. The Order stated that
On November 1, 2017, the matter of this proceeding, and that the both of Registrant’s registrations were
Commission instituted the modification motion includes a public version of this due to expire on May 31, 2018. Id.
proceeding. 82 FR 50678 (Nov. 1, 2017). Motion along with an accompanying Regarding the substantive grounds for
On November 7, 2018, the Commission public version of the Agreement. The the proceeding, the Show Cause Order
issued a notice clarifying that OUII is motion also contends that termination specifically alleged that the New Jersey
not named as a party in the modification of the modification proceeding will not State Board of Medical Examiners
proceeding. 82 FR 52318 (Nov. 13, adversely affect the public interest. issued an Order of Temporary
2017). Suspension ‘‘suspending [her] New
On February 14, 2018, the Federal The Commission has determined to Jersey medical license.’’ ‘‘Consequently,
Circuit summarily affirmed the PTAB’s grant the joint motion and terminate the the DEA must revoke [her] DEA
decision finding the claims of the ’668 modification proceeding in its entirety. registrations based on [her] lack of
patent unpatentable. Cisco Systems, Inc. We note that only the ’668 patent authority to handle controlled
v. Arista Networks, Inc., Appeal No. 17– remains in the modification proceeding. substances in the State of New Jersey.’’
2384, Order (Feb. 14, 2018). The Court The authority for the Commission’s Id. at 2, citing 21 U.S.C. 824(a)(3) and
issued the mandate on March 23, 2018. determination is contained in section 21 CFR 1301.37(b).
Id., Dkt. No. 54. 337 of the Tariff Act of 1930, as The Show Cause Order then notified
On March 23, 2018, the ALJ issued a amended (19 U.S.C. 1337), and in part Registrant of her right to request a
recommended determination in the 210 of the Commission’s Rules of hearing on the allegations, or to submit
modification proceeding (‘‘MRD’’), Practice and Procedure (19 CFR part a written statement in lieu of a hearing,
finding that Arista’s redesigned 210). the procedure for doing either, and the
products infringe the relevant claims of consequence for failing to elect either
the ’668 patent but do not infringe the By order of the Commission. option. Id. at 2, citing 21 CFR 1301.43.
amozie on DSK3GDR082PROD with NOTICES1

relevant claims of the ’577 patent. MRD Issued: September 14, 2018. It also notified her of her right to submit
(Mar. 23, 2018). Also on March 23, Lisa Barton, a corrective action plan in accordance
2018, the ALJ issued an order denying Secretary to the Commission. with 21 U.S.C. 824(c). Id. at 2–3.
Arista’s motion to stay the modification [FR Doc. 2018–20363 Filed 9–18–18; 8:45 am]
On February 15, 2018, two DEA
proceedings or to stay the remedial Diversion Investigators, accompanied by
BILLING CODE 7020–02–P
orders with respect to the ’668 patent. a Task Force Officer, personally served
Order No. 20 (Mar. 23, 2018). Registrant with the Order to Show

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Document Created: 2018-09-19 02:55:20
Document Modified: 2018-09-19 02:55:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 47351

83 FR 47351 - Sharon C. Worosilo, M.D., Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 182 (September 19, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration