Drug Enforcement Administration, 64949-64951 [2016-22751]
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Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
if the applicant is authorized to
dispense . . . controlled substances
under the laws of the State in which he
practices.’’); 21 U.S.C. 802(21) (‘‘[t]he
term ‘practitioner’ means a physician
. . . 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’’).25
While the Show Cause Order did not
assert this as a ground for denial of his
application (because it occurred
subsequent to the issuance of the
Order), the Government did serve a
copy of its Addendum which presented
this development to me, on Respondent.
In response to this filing, Respondent
has raised no objection.26 In any event,
there are two other independent and
legally sufficient bases to deny his
application. Accordingly, I will deny his
application.
ORDER
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Richard
J. Settles, for a DEA Certificate of
Registration as a practitioner be, and it
hereby is, denied. This Order is effective
immediately.
Dated: September 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–22680 Filed 9–20–16; 8:45 am]
accordance with 21 CFR 1301.33(a) on
or before November 21, 2016.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated her
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on
December 18, 2015, Nanosyn, Inc.,
Nanoscale Combinatorial Synthesis,
3331–B Industrial Drive, Santa Rosa,
California 95403 applied to be registered
as a bulk manufacturer the of following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
Controlled substance
Drug
code
Oxymorphone ...........
Fentanyl ....................
9652 .......
9801 .......
Schedule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Nanosyn, Inc.
ACTION:
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 in
mstockstill on DSK3G9T082PROD with NOTICES
DATES:
25 See also Rezik A. Saqer, 81 FR 22122, 22125–
27 (2016); Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR 11919, 11920
(1988).
26 DEA has previously held that ‘‘[t]he rules
governing DEA hearings do not require the
formality of amending a show cause order to
comply with the evidence. The Government’s
failure to file an amended Show Cause Order
alleging that Respondent’s state CDS license has
expired does not render the proceeding
fundamentally unfair.’’ Roy E. Berkowitz, 74 FR
36758, 36759–60 (2009); see also Hatem M. Ataya,
81 FR 8221, 8245 (2016) (collecting cases).
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Jkt 238001
II
II
The company is a contract
manufacturer. At the request of the
company’s customers, it manufacturers
derivatives of controlled substances in
bulk form.
Dated: September 15, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–22737 Filed 9–20–16; 8:45 am]
64949
(R.D.).1 Therein, the CALJ found that it
is undisputed that Respondent is
currently without authority to handle
controlled substances in New York, the
State in which he holds DEA
Registration FL2580163. R.D. at 4. The
CALJ thus granted the Government’s
Motion for Summary Disposition and
recommended that I revoke
Respondent’s registration and deny any
pending applications.
Neither party filed exceptions to the
Recommended Decision. Having
reviewed the record, I adopt the CALJ’s
finding that Respondent lacks state
authority to handle controlled
substances in New York, the State in
which he is registered. ‘‘State
authorization to dispense or otherwise
handle controlled substances is a
prerequisite to the issuance and
maintenance of a Federal controlled
substances registration.’’ Frederick
Marsh Blanton, 43 FR 27616, 27617
(1978). See also Rezik A. Saqer, 81 FR
22122, 22124–127 (2016). Thus, once
the Government establishes that an
applicant for a practitioner’s registration
or a practitioner-registrant does not
possess state authority, there are no
further facts to be considered and
revocation is the mandatory sanction
that must be entered under the
Controlled Substances Act. Accordingly,
I will also adopt the CALJ’s
recommendation that I revoke
Respondent’s registration and deny any
pending application to renew or modify
his registration.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration FL2580163
issued to Kevin L. Lowe, M.D., be, and
it hereby is, revoked. I further order that
any pending application of Kevin L.
Lowe, M.D., to renew or modify the
above registration, be, and it hereby is,
denied. This Order is effective
immediately.2
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Kevin L. Lowe, M.D.; Decision and
Order
On May 18, 2016, Chief
Administrative Law Judge John J.
Mulrooney, II (CALJ), issued the
attached Recommended Decision
PO 00000
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Fmt 4703
Sfmt 4703
1 All citations to the Recommended Decision are
to the slip opinion issued by the CALJ.
2 Based on Respondent’s acknowledgment that he
has been convicted of conspiring to unlawfully
distribute controlled substances, see Resp.’s Hrng.
Req., at 1–2, I find that the public interest
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
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64950
Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
Dated: September 14, 2016.
Chuck Rosenberg,
Acting Administrator.
mstockstill on DSK3G9T082PROD with NOTICES
Order Granting the Government’s
Motion for Summary Disposition and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Chief Administrative Law Judge John
J. Mulrooney, II. The Deputy Assistant
Administrator, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause (OSC), dated March 28,
2016, proposing to revoke the DEA
Certificate of Registration (COR),
Number FL2580163,3 of Kevin L. Lowe,
M.D. (Respondent), pursuant to 21
U.S.C. 824(a)(3) and 21 U.S.C. 823(f). In
the OSC, the DEA avers that the
Respondent’s lack of ‘‘authority to
handle controlled substances in the
State of New York, the state in which
[the Respondent is] registered with the
DEA,’’ is a basis for revocation of the
Respondent’s COR.4
The Respondent, pro se, timely filed
a Request for Hearing dated April 3,
2016,5 wherein he conceded that he is
currently without state authority to
handle controlled substances. See Req.
for Hr’g at 1 (stating that his
‘‘imprisonment has prevented [him]
from renewing his state license’’). The
Respondent also maintained that he is
innocent of the crime for which he was
convicted and is in the process of
appealing his conviction. Id. at 1, 3.
On April 22, 2016, the Government
filed a Motion for Summary Disposition,
seeking a Recommended Decision
granting the Government’s Motion
because Respondent is currently
without authority to handle controlled
substances in New York. Gov’t Mot. at
1. Appended to its Motion, the
Government provided a Certification by
Cathy Hanczaryk, legal custodian of the
official records of the Division of
Professional Licensing Services of the
New York State Education Department,
in which Ms. Hanczaryk attests that the
Respondent ‘‘is not currently registered
to practice the profession [of medicine]
in New York’’ and has not been so
registered since October 31, 2015. Gov’t
Mot. App’x B. Ms. Hanczaryk’s
Certification further states that the
3 The Respondent’s DEA COR is current and
expires by its terms on March 31, 2017. Gov’t Mot.
App’x A.
4 The OSC also alleges that the Respondent was
convicted of one count of conspiracy to distribute
narcotics involving oxycodone in violation of 21
U.S.C. 846. OSC at 1.
5 Respondent apparently filed the Request for
Hearing with the Office of Diversion Control, and
Government counsel forwarded the request to the
Office of Administrative Law Judges on April 11,
2016.
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18:19 Sep 20, 2016
Jkt 238001
Respondent ‘‘has not filed a registration
renewal application for the period of’’
November 1, 2015 to October 31, 2017.
Id. According to a supporting
Declaration by Diversion Investigator
(DI) Chante Jones, also appended to the
Government’s Motion, DI Jones
personally obtained the Certification by
Ms. Hanczaryk after learning that the
Respondent, who had been convicted in
federal district court, did not have an
active license to practice medicine in
New York and has been without one
since October 31, 2015. Gov’t Mot.
App’x C at 1–2.
The Respondent’s reply to the
Government’s motion was due on May
11, 2016.6 Having afforded an additional
week of time in the event that the
Respondent’s reply was mailed but not
timely, the Government’s motion would
appropriately be granted as unopposed.
Even without doing so, however, the
Government’s motion must be granted
on the existing record.
In order to revoke a registrant’s DEA
registration, the DEA has the burden of
proving that the requirements for
revocation are satisfied. 21 CFR
1301.44(e). Once the DEA has made its
prima facie case for revocation of the
registrant’s DEA COR, the burden of
production then shifts to the
Respondent to show that, given the
totality of the facts and circumstances in
the record, revoking the registrant’s COR
would not be appropriate. Morall v.
DEA, 412 F.3d 165, 174 (D.C. Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661
(3d Cir. 1996); Shatz v. U.S. Dep’t of
Justice, 873 F.2d 1089, 1091 (8th Cir.
1989); Thomas E. Johnston, 45 FR
72311, 72312 (1980).
The Controlled Substances Act (CSA)
requires that, in order to maintain a
DEA registration, a practitioner must be
authorized to handle controlled
substances in the state in which he
practices. See 21 U.S.C. 823(f) (‘‘The
Attorney General shall register
practitioners . . . if the applicant is
authorized to dispense . . . controlled
substances under the laws of the State
in which he practices.’’); see also 21
U.S.C. 802(21) (the CSA defines
‘‘practitioner’’ as ‘‘a physician . . .
licensed, registered, or otherwise
permitted, . . . by the jurisdiction in
which he practices . . . to . . . dispense
[or] administer . . . a controlled
substance in the course of professional
practice’’). DEA has long held that
possession of authority under state law
to dispense controlled substances is not
6 The Government requested additional time to
file its Motion, which was granted, and the
Respondent’s original due date was likewise
extended.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
only a prerequisite to obtaining a
registration, but also an essential
condition for maintaining one. Serenity
´
Cafe, 77 FR 35027, 35028 (2012); David
W. Wang, M.D., 72 FR 54297, 54298
(2007); Sheran Arden Yeates, M.D., 71
FR 39130, 39131 (2006); Dominick A.
Ricci, M.D., 58 FR 51104, 51105 (1993);
Bobby Watts, M.D., 53 FR 11919, 11920
(1988). Because ‘‘possessing authority
under state law to handle controlled
substances is an essential condition for
holding a DEA registration,’’ this
Agency has consistently held that ‘‘the
CSA requires the revocation of a
registration issued to a practitioner who
lacks [such] authority.’’ John B. Freitas,
D.O., 74 FR 17524, 17525 (2009); see
James Alvin Chaney, M.D., 80 FR 57391,
57391 (2015); Scott Sandarg, D.M.D., 74
FR 17528, 17529 (2009); Roy Chi Lung,
M.D., 74 FR 20346, 20347 (2009); Roger
A. Rodriguez, M.D., 70 FR 33206, 33207
(2005); Stephen J. Graham, M.D., 69 FR
11661, 11662 (2004); Abraham A.
Chaplan, M.D., 57 FR 55280, 55280–81
(1992); see also Harrell E. Robinson,
M.D., 74 FR 61370, 61375 (2009)
(Agency revoked a registration based on
loss of state authority after hearing
before an ALJ, but also considered the
public interest factors in its analysis);
but see 21 U.S.C. 824(a)(3) (loss of state
authority constitutes a discretionary
basis for sanction, not a mandatory
basis). The Agency has deemed this rule
to be applicable ‘‘not only where a
registrant’s state authority has been
suspended or revoked, but also where a
practitioner with an existing DEA
registration has lost his state authority
for reasons other than through formal
disciplinary action of a State board,’’
such as ‘‘expiration of [a] state license.’’
Freitas, 74 FR at 17525 (citing William
D. Levitt, D.O., 64 FR 49822, 49823
(1999)); see Mark L. Beck, D.D.S., 64 FR
40899, 40900 (1999); Charles H. Ryan,
M.D., 58 FR 14430, 14430 (1993).
Congress does not intend for
administrative agencies to perform
meaningless tasks. See Philip E. Kirk,
M.D., 48 FR 32887 (1983), aff’d sub
nom. Kirk v. Mullen, 749 F.2d 297 (6th
Cir. 1984); see also Puerto Rico
Aqueduct & Sewer Auth. v. EPA, 35
F.3d 600, 605 (1st Cir. 1994); NLRB v.
Int’l Assoc. of Bridge, Structural &
Ornamental Ironworkers, AFL–CIO, 549
F.2d 634 (9th Cir. 1977); United States
v. Consol. Mines & Smelting Co., 455
F.2d 432, 453 (9th Cir. 1971). Thus, it
is well-settled that, where no genuine
question of fact is involved or when the
material facts are agreed upon, a
plenary, adversarial administrative
proceeding is not required. See Jesus R.
Juarez, M.D., 62 FR 14945 (1997);
E:\FR\FM\21SEN1.SGM
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Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
Dominick A. Ricci, M.D., 58 FR 51104
(1993). Here, the supplied Certification
by Ms. Hanczaryk establishes, and the
Respondent concedes,7 that the
Respondent is currently without
authorization to handle controlled
substances in New York, the jurisdiction
where the Respondent holds the DEA
COR that is the subject of this litigation.
Summary disposition of an
administrative case is warranted where,
as here, ‘‘there is no factual dispute of
substance.’’ Veg-Mix, Inc. v. U.S. Dep’t
of Agric., 832 F.2d 601, 607 (D.C. Cir.
1987) (‘‘[A]n agency may ordinarily
dispense with a hearing when no
genuine dispute exists.’’). At this
juncture, no genuine dispute exists over
the fact that the Respondent lacks state
authority to handle controlled
substances in New York. Because the
Respondent lacks such state authority,
Agency precedent dictates that he is not
entitled to maintain his DEA
registration. Simply put, there is no
contested factual matter adducible at a
hearing that would, in the Agency’s
view, provide authority to allow the
Respondent to continue to hold his
COR.8
Accordingly, I hereby Grant the
Government’s Motion for Summary
Disposition; and further Recommend
that the Respondent’s DEA registration
be Revoked forthwith, and any pending
applications for renewal be Denied.
Dated: May 18, 2016.
John J. Mulrooney, II
Chief Administrative Law Judge.
[FR Doc. 2016–22751 Filed 9–20–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[Docket No. ODAG 165]
National Commission on Forensic
Science Solicitation of Applications for
Additional Commission Membership
To Support Medicolegal Death
Investigation
Department of Justice.
Solicitation of Applications for
Additional Commission Membership for
the National Commission on Forensic
Science specifically to fill a current
forensic pathologist Commissioner
vacancy to support medicolegal death
investigation.
AGENCY:
mstockstill on DSK3G9T082PROD with NOTICES
ACTION:
7 The Respondent conceded his lack of state
authority in his Request for Hearing. Req. for Hr’g
at 1 (stating that his ‘‘imprisonment has prevented
[him] from renewing his state license’’).
8 However, should the Respondent’s state
authority be renewed, he may apply for a new DEA
COR. See Franklyn Seabrooks, M.D., 79 FR 44196,
44197 n.1 (2014).
VerDate Sep<11>2014
18:19 Sep 20, 2016
Jkt 238001
Pursuant to the Federal
Advisory Committee Act, as amended,
this notice announces the solicitation of
applications for additional Commission
membership specifically to fill a current
forensic pathologist Commissioner
vacancy to support medicolegal death
investigation.
DATES: Applications must be received
on or before October 21, 2016.
ADDRESSES: All applications should be
submitted to: Jonathan McGrath,
Designated Federal Official, 810 7th
Street NW., Washington, DC 20531, by
email at Jonathan.McGrath@usdoj.gov.
FOR FURTHER INFORMATION CONTACT:
Jonathan McGrath, Designated Federal
Official, 810 7th Street NW.,
Washington, DC 20531, by email
Jonathan.McGrath@usdoj.gov, or by
phone at (202) 514–6277.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act,
as amended (5 U.S.C. App.), this notice
announces the solicitation of
applications for additional Commission
membership on the National
Commission on Forensic Science to fill
a current vacancy. The National
Commission on Forensic Science was
chartered on April 23, 2013 and the
charter was renewed on April 23, 2015.
There is currently a forensic pathologist
Commissioner vacancy to support
medicolegal death investigation. This
notice announces the solicitation of
applications for Commission
membership to fill this vacancy.
The Commission is co-chaired by the
Department of Justice and National
Institute of Standards and Technology.
The Commission provides
recommendations and advice to the
Department of Justice concerning
national methods and strategies for:
Strengthening the validity and
reliability of the forensic sciences
(including medico-legal death
investigation); enhancing quality
assurance and quality control in
forensic science laboratories and units;
identifying and recommending
scientific guidance and protocols for
evidence seizure, testing, analysis, and
reporting by forensic science
laboratories and units; and identifying
and assessing other needs of the forensic
science communities to strengthen their
disciplines and meet the increasing
demands generated by the criminal and
civil justice systems at all levels of
government. Commission membership
includes Federal, State, and Local
forensic science service providers;
research scientists and academicians;
prosecutors, defense attorneys, and
judges; law enforcement; and other
relevant backgrounds. The Commission
SUMMARY:
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64951
reports to the Attorney General, who
through the Deputy Attorney General,
shall direct the work of the Commission
in fulfilling its mission.
The duties of the Commission
include: (a) Recommending priorities for
standards development; (b) reviewing
and recommending endorsement of
guidance identified or developed by
subject-matter experts; (c) developing
proposed guidance concerning the
intersection of forensic science and the
courtroom; (d) developing policy
recommendations, including a uniform
code of professional responsibility and
minimum requirements for training,
accreditation and/or certification; and
(e) identifying and assessing the current
and future needs of the forensic sciences
to strengthen their disciplines and meet
growing demand.
Members will be appointed by the
Attorney General in consultation with
the Director of the National Institute of
Standards and Technology and the vicechairs of the Commission. Additional
members will be selected to fill
vacancies to maintain a balance of
perspective and diversity of
experiences, including Federal, State,
and Local forensic science service
providers; research scientists and
academicians; Federal, State, Local
prosecutors, defense attorneys and
judges; law enforcement; and other
relevant stakeholders. DOJ encourages
submissions from applicants with
respect to diversity of backgrounds,
professions, ethnicities, gender, and
geography. The Commission shall
consist of approximately 30 voting
members. Members will serve without
compensation. The Commission
generally meets four times each year at
approximately three-month intervals.
Additional information regarding the
Commission can be found at: https://
www.justice.gov/ncfs.
Applications: Any qualified person
may apply to be considered for
appointment to this advisory committee.
Each application should include: (1) A
resume or curriculum vitae; (2) a
statement of interest describing the
applicant’s relevant experience; and (3)
a statement of support from the
applicant’s employer. Potential
candidates may be asked to provide
detailed information as necessary
regarding financial interests,
employment, and professional
affiliations to evaluate possible sources
of conflicts of interest. The application
period will remain open through
October 21, 2016. The applications must
be sent in one complete package, by
email, to Jonathan McGrath (contact
information above) with the subject line
of the email entitled, ‘‘NCFS
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Agencies
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64949-64951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22751]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Kevin L. Lowe, M.D.; Decision and Order
On May 18, 2016, Chief Administrative Law Judge John J. Mulrooney,
II (CALJ), issued the attached Recommended Decision (R.D.).\1\ Therein,
the CALJ found that it is undisputed that Respondent is currently
without authority to handle controlled substances in New York, the
State in which he holds DEA Registration FL2580163. R.D. at 4. The CALJ
thus granted the Government's Motion for Summary Disposition and
recommended that I revoke Respondent's registration and deny any
pending applications.
---------------------------------------------------------------------------
\1\ All citations to the Recommended Decision are to the slip
opinion issued by the CALJ.
---------------------------------------------------------------------------
Neither party filed exceptions to the Recommended Decision. Having
reviewed the record, I adopt the CALJ's finding that Respondent lacks
state authority to handle controlled substances in New York, the State
in which he is registered. ``State authorization to dispense or
otherwise handle controlled substances is a prerequisite to the
issuance and maintenance of a Federal controlled substances
registration.'' Frederick Marsh Blanton, 43 FR 27616, 27617 (1978). See
also Rezik A. Saqer, 81 FR 22122, 22124-127 (2016). Thus, once the
Government establishes that an applicant for a practitioner's
registration or a practitioner-registrant does not possess state
authority, there are no further facts to be considered and revocation
is the mandatory sanction that must be entered under the Controlled
Substances Act. Accordingly, I will also adopt the CALJ's
recommendation that I revoke Respondent's registration and deny any
pending application to renew or modify his registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration FL2580163 issued to Kevin L. Lowe, M.D., be, and it hereby
is, revoked. I further order that any pending application of Kevin L.
Lowe, M.D., to renew or modify the above registration, be, and it
hereby is, denied. This Order is effective immediately.\2\
---------------------------------------------------------------------------
\2\ Based on Respondent's acknowledgment that he has been
convicted of conspiring to unlawfully distribute controlled
substances, see Resp.'s Hrng. Req., at 1-2, I find that the public
interest necessitates that this Order be effective immediately. 21
CFR 1316.67.
[[Page 64950]]
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Dated: September 14, 2016.
Chuck Rosenberg,
Acting Administrator.
Order Granting the Government's Motion for Summary Disposition and
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Chief Administrative Law Judge John J. Mulrooney, II. The Deputy
Assistant Administrator, Drug Enforcement Administration (DEA), issued
an Order to Show Cause (OSC), dated March 28, 2016, proposing to revoke
the DEA Certificate of Registration (COR), Number FL2580163,\3\ of
Kevin L. Lowe, M.D. (Respondent), pursuant to 21 U.S.C. 824(a)(3) and
21 U.S.C. 823(f). In the OSC, the DEA avers that the Respondent's lack
of ``authority to handle controlled substances in the State of New
York, the state in which [the Respondent is] registered with the DEA,''
is a basis for revocation of the Respondent's COR.\4\
---------------------------------------------------------------------------
\3\ The Respondent's DEA COR is current and expires by its terms
on March 31, 2017. Gov't Mot. App'x A.
\4\ The OSC also alleges that the Respondent was convicted of
one count of conspiracy to distribute narcotics involving oxycodone
in violation of 21 U.S.C. 846. OSC at 1.
---------------------------------------------------------------------------
The Respondent, pro se, timely filed a Request for Hearing dated
April 3, 2016,\5\ wherein he conceded that he is currently without
state authority to handle controlled substances. See Req. for Hr'g at 1
(stating that his ``imprisonment has prevented [him] from renewing his
state license''). The Respondent also maintained that he is innocent of
the crime for which he was convicted and is in the process of appealing
his conviction. Id. at 1, 3.
---------------------------------------------------------------------------
\5\ Respondent apparently filed the Request for Hearing with the
Office of Diversion Control, and Government counsel forwarded the
request to the Office of Administrative Law Judges on April 11,
2016.
---------------------------------------------------------------------------
On April 22, 2016, the Government filed a Motion for Summary
Disposition, seeking a Recommended Decision granting the Government's
Motion because Respondent is currently without authority to handle
controlled substances in New York. Gov't Mot. at 1. Appended to its
Motion, the Government provided a Certification by Cathy Hanczaryk,
legal custodian of the official records of the Division of Professional
Licensing Services of the New York State Education Department, in which
Ms. Hanczaryk attests that the Respondent ``is not currently registered
to practice the profession [of medicine] in New York'' and has not been
so registered since October 31, 2015. Gov't Mot. App'x B. Ms.
Hanczaryk's Certification further states that the Respondent ``has not
filed a registration renewal application for the period of'' November
1, 2015 to October 31, 2017. Id. According to a supporting Declaration
by Diversion Investigator (DI) Chante Jones, also appended to the
Government's Motion, DI Jones personally obtained the Certification by
Ms. Hanczaryk after learning that the Respondent, who had been
convicted in federal district court, did not have an active license to
practice medicine in New York and has been without one since October
31, 2015. Gov't Mot. App'x C at 1-2.
The Respondent's reply to the Government's motion was due on May
11, 2016.\6\ Having afforded an additional week of time in the event
that the Respondent's reply was mailed but not timely, the Government's
motion would appropriately be granted as unopposed. Even without doing
so, however, the Government's motion must be granted on the existing
record.
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\6\ The Government requested additional time to file its Motion,
which was granted, and the Respondent's original due date was
likewise extended.
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In order to revoke a registrant's DEA registration, the DEA has the
burden of proving that the requirements for revocation are satisfied.
21 CFR 1301.44(e). Once the DEA has made its prima facie case for
revocation of the registrant's DEA COR, the burden of production then
shifts to the Respondent to show that, given the totality of the facts
and circumstances in the record, revoking the registrant's COR would
not be appropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S. Dep't
of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E. Johnston, 45
FR 72311, 72312 (1980).
The Controlled Substances Act (CSA) requires that, in order to
maintain a DEA registration, a practitioner must be authorized to
handle controlled substances in the state in which he practices. See 21
U.S.C. 823(f) (``The Attorney General shall register practitioners . .
. if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he practices.''); see
also 21 U.S.C. 802(21) (the CSA defines ``practitioner'' as ``a
physician . . . licensed, registered, or otherwise permitted, . . . by
the jurisdiction in which he practices . . . to . . . dispense [or]
administer . . . a controlled substance in the course of professional
practice''). DEA has long held that possession of authority under state
law to dispense controlled substances is not only a prerequisite to
obtaining a registration, but also an essential condition for
maintaining one. Serenity Caf[eacute], 77 FR 35027, 35028 (2012); David
W. Wang, M.D., 72 FR 54297, 54298 (2007); Sheran Arden Yeates, M.D., 71
FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105
(1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988). Because
``possessing authority under state law to handle controlled substances
is an essential condition for holding a DEA registration,'' this Agency
has consistently held that ``the CSA requires the revocation of a
registration issued to a practitioner who lacks [such] authority.''
John B. Freitas, D.O., 74 FR 17524, 17525 (2009); see James Alvin
Chaney, M.D., 80 FR 57391, 57391 (2015); Scott Sandarg, D.M.D., 74 FR
17528, 17529 (2009); Roy Chi Lung, M.D., 74 FR 20346, 20347 (2009);
Roger A. Rodriguez, M.D., 70 FR 33206, 33207 (2005); Stephen J. Graham,
M.D., 69 FR 11661, 11662 (2004); Abraham A. Chaplan, M.D., 57 FR 55280,
55280-81 (1992); see also Harrell E. Robinson, M.D., 74 FR 61370, 61375
(2009) (Agency revoked a registration based on loss of state authority
after hearing before an ALJ, but also considered the public interest
factors in its analysis); but see 21 U.S.C. 824(a)(3) (loss of state
authority constitutes a discretionary basis for sanction, not a
mandatory basis). The Agency has deemed this rule to be applicable
``not only where a registrant's state authority has been suspended or
revoked, but also where a practitioner with an existing DEA
registration has lost his state authority for reasons other than
through formal disciplinary action of a State board,'' such as
``expiration of [a] state license.'' Freitas, 74 FR at 17525 (citing
William D. Levitt, D.O., 64 FR 49822, 49823 (1999)); see Mark L. Beck,
D.D.S., 64 FR 40899, 40900 (1999); Charles H. Ryan, M.D., 58 FR 14430,
14430 (1993).
Congress does not intend for administrative agencies to perform
meaningless tasks. See Philip E. Kirk, M.D., 48 FR 32887 (1983), aff'd
sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984); see also Puerto
Rico Aqueduct & Sewer Auth. v. EPA, 35 F.3d 600, 605 (1st Cir. 1994);
NLRB v. Int'l Assoc. of Bridge, Structural & Ornamental Ironworkers,
AFL-CIO, 549 F.2d 634 (9th Cir. 1977); United States v. Consol. Mines &
Smelting Co., 455 F.2d 432, 453 (9th Cir. 1971). Thus, it is well-
settled that, where no genuine question of fact is involved or when the
material facts are agreed upon, a plenary, adversarial administrative
proceeding is not required. See Jesus R. Juarez, M.D., 62 FR 14945
(1997);
[[Page 64951]]
Dominick A. Ricci, M.D., 58 FR 51104 (1993). Here, the supplied
Certification by Ms. Hanczaryk establishes, and the Respondent
concedes,\7\ that the Respondent is currently without authorization to
handle controlled substances in New York, the jurisdiction where the
Respondent holds the DEA COR that is the subject of this litigation.
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\7\ The Respondent conceded his lack of state authority in his
Request for Hearing. Req. for Hr'g at 1 (stating that his
``imprisonment has prevented [him] from renewing his state
license'').
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Summary disposition of an administrative case is warranted where,
as here, ``there is no factual dispute of substance.'' Veg-Mix, Inc. v.
U.S. Dep't of Agric., 832 F.2d 601, 607 (D.C. Cir. 1987) (``[A]n agency
may ordinarily dispense with a hearing when no genuine dispute
exists.''). At this juncture, no genuine dispute exists over the fact
that the Respondent lacks state authority to handle controlled
substances in New York. Because the Respondent lacks such state
authority, Agency precedent dictates that he is not entitled to
maintain his DEA registration. Simply put, there is no contested
factual matter adducible at a hearing that would, in the Agency's view,
provide authority to allow the Respondent to continue to hold his
COR.\8\
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\8\ However, should the Respondent's state authority be renewed,
he may apply for a new DEA COR. See Franklyn Seabrooks, M.D., 79 FR
44196, 44197 n.1 (2014).
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Accordingly, I hereby Grant the Government's Motion for Summary
Disposition; and further Recommend that the Respondent's DEA
registration be Revoked forthwith, and any pending applications for
renewal be Denied.
Dated: May 18, 2016.
John J. Mulrooney, II
Chief Administrative Law Judge.
[FR Doc. 2016-22751 Filed 9-20-16; 8:45 am]
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