William Mikaitis, M.D.; Decision and Order, 73833-73834 [2015-29935]
Download as PDF
73833
Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
Controlled substance
Schedule
Nabilone (7379) ...........................................................................................................................................................................................
1-Phenylcyclohexylamine (7460) .................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................
Alphaprodine (9010) ....................................................................................................................................................................................
Anileridine (9020) ........................................................................................................................................................................................
Etorphine HCI (9059) ..................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Diphenoxylate (9170) ..................................................................................................................................................................................
Ecgonine (9180) ..........................................................................................................................................................................................
Ethylmorphine (9190) ..................................................................................................................................................................................
Levomethorphan (9210) ..............................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Isomethadone (9226) ..................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Meperidine intermediate-A (9232) ...............................................................................................................................................................
Meperidine intermediate-B (9233) ...............................................................................................................................................................
Meperidine intermediate-C (9234) ...............................................................................................................................................................
Metazocine (9240) .......................................................................................................................................................................................
Metopon (9260) ...........................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Dihydroetorphine (9334) ..............................................................................................................................................................................
Levo-alphacetylmethadol (9648) .................................................................................................................................................................
Noroxymorphone (9668) ..............................................................................................................................................................................
Phenazocine (9715) ....................................................................................................................................................................................
Piminodine (9730) .......................................................................................................................................................................................
Racemethorphan (9732) ..............................................................................................................................................................................
Racemorphan (9733) ...................................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Remifentanil (9739) .....................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
Carfentanil (9743) ........................................................................................................................................................................................
Tapentadol (9780) .......................................................................................................................................................................................
Bezitramide (9800) ......................................................................................................................................................................................
Moramide-intermediate (9802) ....................................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: November 19, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–29934 Filed 11–24–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
VerDate Sep<11>2014
19:15 Nov 24, 2015
Jkt 238001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
William Mikaitis, M.D.; Decision and
Order
On July 23, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to William Mikaitis,
M.D. (Registrant), of Lockport, Illinois.
The Show Cause Order proposed the
revocation of Registrant’s DEA
Certificate of Registration AM1585770,
and the denial of any applications to
renew or modify the registration as well
as any other applications for a DEA
registration, on the ground that he
‘‘do[es] not have authority to practice
medicine or handle controlled
substances in Illinois, the [S]tate in
which [he] is registered with the DEA.’’
Show Cause Order at 1 (citing 21 U.S.C.
823(f) and 824(a)(3)).
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 at the registered address of
1206 E. 9th St., Suite 210, Lockport,
PO 00000
Frm 00136
Fmt 4703
Sfmt 4703
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Illinois. Id. The Order alleged that
Registrant’s registration expires by its
terms on January 31, 2018. Id.
The Order further alleged that
‘‘[e]ffective March 5, 2015, the State of
Illinois, Department of Financial and
Professional Regulation (IDFPR),
Division of Professional Regulation,
issued an Order in which the IDFPR
temporarily suspended [his] Illinois
[P]hysician and [S]urgeon [L]icense and
[his] controlled substance licenses’’ and
that ‘‘[t]his Order remains in effect.’’ Id.
The Show Cause Order thus asserted
that ‘‘DEA must revoke [his] registration
based upon [his] lack of authority to
handle controlled substances in the
State of Illinois.’’ Id. (citing 21 U.S.C.
802(21), 823(f) and 824(a)(3)).
The Show Cause Order also notified
Registrant of his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for electing either option,
and the consequence for failing to elect
either option. Id. at 2 (citing 21 CFR
1301.43).
On July 30, 2015, a Diversion
Investigator met Registrant at the office
of his attorney and personally served
the Show Cause Order on him. See GX
5 (Affidavit of DI). The Government
E:\FR\FM\25NON1.SGM
25NON1
73834
Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Notices
represents that since the date of service,
neither Registrant, nor any person
purporting to represent him, has
requested a hearing or submitted a
written statement while waiving his
right to a hearing. See Govt. Req. for
Final Agency Action, at 3–4. Because
more than thirty (30) days have now
passed since the date of service of the
Show Cause Order and Registrant has
neither requested a hearing nor
submitted a written statement in lieu of
a hearing, I find that he has waived his
right to either request a hearing or to
submit a written statement. 21 CFR
1301.43(d). I therefore issue this
Decision and Final Order based on the
record submitted by the Government. Id.
§ 1301.43(e). I make the following
findings.
tkelley on DSK3SPTVN1PROD with NOTICES
Findings
Registrant is the holder of DEA
Certificate of Registration AM1585770,
pursuant to which he is authorized to
dispense controlled substances in
schedules II–V as a practitioner, at the
registered address of 1206 E. 9th St.,
Suite 210, Lockport, Illinois. GX 2. His
registration does not expire until
January 31, 2018. Id.
On March 5, 2015, the Illinois
Department of Financial and
Professional Regulation, Division of
Professional Regulation, ordered the
suspension of Respondent’s Illinois
Physician and Surgeon License, as well
as his state Controlled Substance
Licenses, pending proceedings before
the Department of Financial and
Professional Regulation and the Medical
Disciplinary Board of the State. GX 4 at
1. I take official notice that as of this
date, the public Web site maintained by
the Illinois Department of Financial and
Professional Regulation shows that
Registrant’s Physician and Surgeon
License as well as his Illinois Controlled
Substance Licenses remain suspended
based on the State’s allegations that he
engaged in ‘‘unprofessional conduct,
aid[ed] and abet[ed] [the] unlicensed
practice of medicine and [committed]
multiple violations of the Controlled
Substance Act.’’ 1 See https://
ilesonline.idfpr.illinois.gov/DPR/
Lookup/LicenseLookup.aspx.
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, ‘‘upon a finding that
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).
VerDate Sep<11>2014
19:15 Nov 24, 2015
Jkt 238001
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.’’
Moreover, DEA has repeatedly 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 James L. Hooper, 76 FR
71371 (2011), pet. for rev. denied, 481
Fed. App’x 826 (4th Cir. 2012).
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 . . . to
dispense . . . controlled substances
. . . 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 Act, DEA has long held that the
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
medicine. See, e.g., Calvin Ramsey, 76
FR 20034, 20036 (2011); Sheran Arden
Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988).
This is so even where a state board
has suspended a practitioner’s authority
prior to providing the practitioner with
a hearing to contest the board’s
allegations. See Gary Alfred Shearer, 78
FR 19009 (2013) (holding that
revocation is warranted even where a
state order has summarily suspended a
practitioner’s controlled substances
authority and the state agency’s order
remains subject to challenge in either
administrative or judicial proceedings);
see also Bourne Pharmacy, Inc., 72 FR
18273, 18274 (2007); Winfield Drugs,
Inc., 52 FR 27070 (1987). Accordingly,
consistent with agency precedent, the
revocation of Registrant’s registration is
warranted.
PO 00000
Frm 00137
Fmt 4703
Sfmt 4703
Because Registrant currently lacks
authority to dispense controlled
substances in Illinois, the State in which
he holds his DEA registration, I will
order that his registration be revoked
and that any pending applications be
denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 21 CFR 0.100(b), I order that DEA
Certificate of Registration AM1585770,
issued to William Mikaitis, M.D., be,
and it hereby is, revoked. I further order
that any pending application of William
Mikaitis, M.D., to renew or modify his
registration, as well as any other
pending application of William
Mikaitis, M.D., for a DEA Certificate of
Registration, be, and it hereby is,
denied. This Order is effective
immediately.2
Dated: November 17, 2015
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015–29935 Filed 11–24–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0034]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Extension
Without Change of a Previously
Approved Collection; Collection of
Laboratory Analysis Data on Drug
Samples Tested by Non-Federal (State
and Local Government) Crime
Laboratories
Drug Enforcement
Administration, Department of Justice.
ACTION: 60-day Notice.
AGENCY:
The Department of Justice
(DOJ), Drug Enforcement
Administration (DEA), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 60 days until
January 25, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have comments on the estimated
public burden or associated response
time, suggestions, or need a copy of the
proposed information collection
SUMMARY:
2 Based on the State’s finding ‘‘that Respondent’s
actions constitute an immediate danger to the
public,’’ I conclude that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
E:\FR\FM\25NON1.SGM
25NON1
Agencies
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Notices]
[Pages 73833-73834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29935]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
William Mikaitis, M.D.; Decision and Order
On July 23, 2015, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to William Mikaitis, M.D. (Registrant), of
Lockport, Illinois. The Show Cause Order proposed the revocation of
Registrant's DEA Certificate of Registration AM1585770, and the denial
of any applications to renew or modify the registration as well as any
other applications for a DEA registration, on the ground that he
``do[es] not have authority to practice medicine or handle controlled
substances in Illinois, the [S]tate in which [he] is registered with
the DEA.'' Show Cause Order at 1 (citing 21 U.S.C. 823(f) and
824(a)(3)).
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 at the registered address of 1206 E. 9th St.,
Suite 210, Lockport, Illinois. Id. The Order alleged that Registrant's
registration expires by its terms on January 31, 2018. Id.
The Order further alleged that ``[e]ffective March 5, 2015, the
State of Illinois, Department of Financial and Professional Regulation
(IDFPR), Division of Professional Regulation, issued an Order in which
the IDFPR temporarily suspended [his] Illinois [P]hysician and
[S]urgeon [L]icense and [his] controlled substance licenses'' and that
``[t]his Order remains in effect.'' Id. The Show Cause Order thus
asserted that ``DEA must revoke [his] registration based upon [his]
lack of authority to handle controlled substances in the State of
Illinois.'' Id. (citing 21 U.S.C. 802(21), 823(f) and 824(a)(3)).
The Show Cause Order also notified Registrant of his right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for electing either option, and the
consequence for failing to elect either option. Id. at 2 (citing 21 CFR
1301.43).
On July 30, 2015, a Diversion Investigator met Registrant at the
office of his attorney and personally served the Show Cause Order on
him. See GX 5 (Affidavit of DI). The Government
[[Page 73834]]
represents that since the date of service, neither Registrant, nor any
person purporting to represent him, has requested a hearing or
submitted a written statement while waiving his right to a hearing. See
Govt. Req. for Final Agency Action, at 3-4. Because more than thirty
(30) days have now passed since the date of service of the Show Cause
Order and Registrant has neither requested a hearing nor submitted a
written statement in lieu of a hearing, I find that he has waived his
right to either request a hearing or to submit a written statement. 21
CFR 1301.43(d). I therefore issue this Decision and Final Order based
on the record submitted by the Government. Id. Sec. 1301.43(e). I make
the following findings.
Findings
Registrant is the holder of DEA Certificate of Registration
AM1585770, pursuant to which he is authorized to dispense controlled
substances in schedules II-V as a practitioner, at the registered
address of 1206 E. 9th St., Suite 210, Lockport, Illinois. GX 2. His
registration does not expire until January 31, 2018. Id.
On March 5, 2015, the Illinois Department of Financial and
Professional Regulation, Division of Professional Regulation, ordered
the suspension of Respondent's Illinois Physician and Surgeon License,
as well as his state Controlled Substance Licenses, pending proceedings
before the Department of Financial and Professional Regulation and the
Medical Disciplinary Board of the State. GX 4 at 1. I take official
notice that as of this date, the public Web site maintained by the
Illinois Department of Financial and Professional Regulation shows that
Registrant's Physician and Surgeon License as well as his Illinois
Controlled Substance Licenses remain suspended based on the State's
allegations that he engaged in ``unprofessional conduct, aid[ed] and
abet[ed] [the] unlicensed practice of medicine and [committed] multiple
violations of the Controlled Substance Act.'' \1\ See https://ilesonline.idfpr.illinois.gov/DPR/Lookup/LicenseLookup.aspx.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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, ``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.'' Moreover, DEA has repeatedly
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 James L. Hooper, 76 FR
71371 (2011), pet. for rev. denied, 481 Fed. App'x 826 (4th Cir. 2012).
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 . . . to dispense . . . controlled substances . . . 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 Act, DEA has
long held that the 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
medicine. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran
Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR
51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988).
This is so even where a state board has suspended a practitioner's
authority prior to providing the practitioner with a hearing to contest
the board's allegations. See Gary Alfred Shearer, 78 FR 19009 (2013)
(holding that revocation is warranted even where a state order has
summarily suspended a practitioner's controlled substances authority
and the state agency's order remains subject to challenge in either
administrative or judicial proceedings); see also Bourne Pharmacy,
Inc., 72 FR 18273, 18274 (2007); Winfield Drugs, Inc., 52 FR 27070
(1987). Accordingly, consistent with agency precedent, the revocation
of Registrant's registration is warranted.
Because Registrant currently lacks authority to dispense controlled
substances in Illinois, the State in which he holds his DEA
registration, I will order that his registration be revoked and that
any pending applications be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 21 CFR 0.100(b), I order that DEA Certificate of
Registration AM1585770, issued to William Mikaitis, M.D., be, and it
hereby is, revoked. I further order that any pending application of
William Mikaitis, M.D., to renew or modify his registration, as well as
any other pending application of William Mikaitis, M.D., for a DEA
Certificate of Registration, be, and it hereby is, denied. This Order
is effective immediately.\2\
---------------------------------------------------------------------------
\2\ Based on the State's finding ``that Respondent's actions
constitute an immediate danger to the public,'' I conclude that the
public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
Dated: November 17, 2015
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-29935 Filed 11-24-15; 8:45 am]
BILLING CODE 4410-09-P