83 FR 12027 - David A. Ruben, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 53 (March 19, 2018)

Page Range		12027-12029
FR Document		2018-05471
Federal Register, Volume 83 Issue 53 (Monday, March 19, 2018)
[Federal Register Volume 83, Number 53 (Monday, March 19, 2018)]
[Notices]
[Pages 12027-12029]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05471]



[[Page 12027]]

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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-38]


David A. Ruben, M.D.; Decision and Order

    On June 12, 2017, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (DEA), issued an Order to 
Show Cause to David A. Ruben, M.D. (Respondent), of Tucson, Arizona. 
The Show Cause Order proposed the revocation of Respondent's DEA 
Certificate of Registration No. AR9258434 on the ground that he 
``do[es] not have authority to handle controlled substances in the 
State of Arizona, the [S]tate in which [he is] registered with the 
DEA.'' Order to Show Cause, at 1 (citing 21 U.S.C. 823(f) and 
824(a)(3)).
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that Respondent is the holder of Certificate of Registration 
No. AR9258434 ``as a data-waived DW/30 practitioner in schedules II 
through V,'' at the registered address of 2016 South 4th Avenue, 
Tucson, Arizona. Id. The Order also alleged that this registration does 
not expire until April 30, 2020. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleged that on April 6, 2017, Respondent's ``authority to 
prescribe and administer controlled substances in the State of Arizona 
was suspended,'' and that Arizona is ``the [S]tate in which [he is] 
registered with the DEA.'' Id. Based on his ``lack of authority to 
[dispense] controlled substances in . . . Arizona,'' the Order asserted 
that ``DEA must revoke'' his registration. Id. (citing 21 U.S.C. 
823(f)(1) and 824(a)(3)).
    The Show Cause Order notified Respondent of (1) his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing ``[w]ithin 30 days after the date of receipt of 
this Order to Show Cause,'' (2) the procedure for electing either 
option, and (3) the consequence for failing to elect either option. Id. 
at 2 (citing 21 CFR 1301.43). The Show Cause Order also notified 
Respondent of his right to submit a corrective action plan 
(hereinafter, CAP) to the Assistant Administrator, Diversion Control 
Division, and the procedure for doing so. Id. at 2-3.
    On July 18, 2017, Respondent submitted his CAP by letter from his 
counsel (dated July 12, 2017) to the Agency. In his CAP, Respondent 
explained:

    Dr. Ruben intends to continue to pursue and to prevail on the 
appeal of the underlying order issued by [t]he Arizona Medical 
[B]oard . . . . Alleged violation of that order is the basis of the 
Arizona Medical Board suspension dated April 6, 2017. The underlying 
matter is on appeal in Maricopa County Arizona Superior Court . . .
    At least part of that Order being appealed stems from an Arizona 
license restriction of Dr. Ruben as to Schedule [II] drugs which was 
imposed partly as punishment for an earlier Certificate [of] 
Suspension by the DEA,\1\ which itself was based upon the earlier 
same Arizona suspension dating from 2009 and 2010. The entire matter 
is ludicrous, and will result in the lifting of the suspension of 
concern here, as this is the fourth iteration of punishment by the 
Arizona Medical Board and the DEA cannibalizing one another's 
actions in order to inflict multiple punishments for the same acts 
from 2009 and 2010.
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    \1\ On June 18, 2013, the Agency suspended Respondent's DEA 
Certificate of Registration for one year and imposed four conditions 
on his registration for two years. David A. Ruben, M.D., 78 FR 
38363, 38387-88 (2013). The Ninth Circuit Court of Appeals denied 
his petition for review of the Agency's decision. 617 Fed. Appx. 837 
(9th Cir. 2015) (unpublished).
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    All remaining bases of the Arizona suspension will also be 
overturned as unsupported by the evidence. The DEA [Show Cause 
Order] is premature and unnecessary and any hearing should be 
continued pending the outcome of the remaining state matters on 
appeal.

CAP, at 1. On December 4, 2017, the Acting Assistant Administrator 
rejected Respondent's CAP and further ``determined there is no 
potential modification of your []CAP that could or would alter my 
decision in this regard.'' See Letter from Acting Assistant 
Administrator Demetra Ashley to Respondent (dated December 4, 2017) 
(hereinafter CAP Rejection Ltr or CAP Rejection Letter), at 1.\2\
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    \2\ Respondent's CAP was attached as Exhibit 1 to Respondent's 
counsel's letter requesting a hearing. CAP, at 1 (attached as 
``EXHIBIT 1 TO REQUEST FOR HEARING'' to Letter from Respondent's 
Counsel to Hearing Clerk (dated July 12, 2017). The letter setting 
forth Respondent's request for a hearing (hereinafter, Hearing 
Request) was addressed to the Office of Administrative Law Judges 
(OALJ) as well as to the Assistant Administrator, Diversion Control 
Division, Louis Milione. Hearing Request, at 1. As discussed more 
fully infra, the record reflects that the OALJ received this letter 
on July 18, 2018. See id. In addition, the Acting Assistant 
Administrator's CAP Rejection Letter attached a copy of Respondent's 
Hearing Request (and a copy of the CAP) date-stamped ``Jul 18, 
2017'' and a handwritten notation above it stating ``DC received.'' 
The CAP Rejection Letter stated that her office did not receive the 
CAP until September 29, 2017. CAP Rejection Ltr, at 1. The record 
does not reflect facts explaining why the CAP Rejection Letter 
states that the CAP was not received by DEA's Diversion Control 
Division until September 29, 2017.
     In the CAP Rejection Letter, the Acting Assistant Administrator 
states that she was responding to Respondent's CAP ``in connection 
with an Order to Show Cause . . . issued by the Assistant 
Administrator on June 29, 2017.'' Id. As already noted, however, the 
Show Cause Order was issued on June 12, 2017. Show Cause Order, at 
1. The CAP Rejection Letter does attach, inter alia, a copy of 
Respondent's Hearing Request and CAP in connection with the June 12, 
2017 Show Cause Order. See Attachment to CAP Rejection Ltr at 2-4. 
Thus, I find that the CAP Rejection Letter's reference to a June 29, 
2017 Show Cause Order was merely a scrivener's error and that the 
Acting Assistant Administrator intended to refer to the June 12, 
2017 Show Cause Order.
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    On July 18, 2017, Respondent also filed a letter with the Office of 
Administrative Law Judges (OALJ) pursuant to which he requested a 
hearing on the allegation of the Show Cause Order. Letter from 
Respondent's Counsel to Hearing Clerk (dated July 12, 2017) 
(hereinafter, Hearing Request). The matter was placed on the OALJ's 
docket and assigned to Administrative Law Judge Charles Wm. Dorman 
(hereinafter, ALJ). On July 21, 2017, the ALJ issued an order entitled 
``Briefing Schedule for Lack of State Authority Allegations'' in which 
the ALJ found, inter alia, that ``[t]he Respondent filed a timely 
Request for Hearing.'' Briefing Schedule for Lack of State Authority 
Allegations (hereinafter, Briefing Order), at 1.\3\
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    \3\ Although the date next to the ALJ's signature states ``June 
21, 2017,'' id. at 2, the ALJ's Docket Sheet indicates that this 
order was signed on ``July 21, 2017.'' I find that the date in the 
Briefing Order was a scrivener's error and that in fact the ALJ 
signed the order on July 21, 2017 as reflected in the ALJ's Docket 
Sheet.
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    Pursuant to 21 CFR 1301.43(a), ``any person entitled to a hearing . 
. . and desiring a hearing shall, within 30 days after the date of 
receipt of the order to show cause, . . . file with the Administrator a 
written request for a hearing.'' Accord Show Cause Order, at 2. The ALJ 
did not indicate in his Briefing Order or in his Recommended Decision--
and the rest of the administrative record does not indicate--when 
Respondent received the Show Cause Order. Without any evidence in the 
record establishing when Respondent received the Show Cause Order, the 
only way in which I could find that Respondent's Hearing Request was 
timely is if it had been filed with the Administrator within 30 days of 
the June 12, 2017 date of the Show Cause Order. However, the OALJ did 
not receive Respondent's Hearing Request until July 18, 2017.\4\ 
Hearing Request, at 1. Accordingly, I find that Respondent's Hearing 
Request was not

[[Page 12028]]

timely filed pursuant to 21 CFR 1301.43(a), and as a result, Respondent 
waived his right to a hearing.
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    \4\ Although the front of Respondent's Hearing Request is 
stamped ``Received'' by the Office of Administrative Law Judges on 
July 18, 2017, the photocopy of the envelope that purportedly 
contained Respondent's Hearing Request reveals a ``Received/Date'' 
of ``July 17, 2017.'' Compare Hearing Request, at 1, with id. at 4. 
In any event, neither date is within 30 days of the June 12, 2017 
date of the Show Cause Order.
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    In the absence of a timely hearing request, I also find that the 
ALJ consequently lacked jurisdiction to hear the case. See Brown's 
Discount Apothecary BC, Inc., and Bolling Apothecary, Inc., 80 FR 
57393, 57394 (2015) (``in the absence of a hearing request, the ALJ had 
no authority to rule on the issue of whether its registration should be 
revoked''). I therefore cancel the hearing nunc pro tunc held by the 
ALJ by summary disposition. See 21 CFR 1301.43(e). Accordingly, I will 
treat this case as a Request for Final Agency Action and issue this 
Decision and Order based on the relevant evidence forwarded to my 
office by the ALJ on September 18, 2017.\5\ See id. I make the 
following findings.
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    \5\ In his Briefing Order, the ALJ ordered the Government to 
file evidence to support its allegation that Respondent lacks state 
authority to handle controlled substances, and any motion for 
summary disposition on these grounds, on August 3, 2017. Briefing 
Order at 1. The ALJ also directed Respondent to file his response to 
any summary disposition motion on August 10, 2017. Id. On August 3, 
2017, the Government filed its Motion for Summary Disposition, and 
the Respondent filed his response on August 10, 2017. See 
Government's Motion for Summary Disposition (hereinafter Govt. 
Mot.); Response to Motion for Summary Disposition (hereinafter Resp. 
Br.). On August 15, 2017, the ALJ issued his Order granting summary 
disposition and Recommended Decision. Order Granting Summary 
Disposition and Recommended Rulings, Findings of Fact, Conclusions 
of Law, and Decision (hereinafter, Recommended Decision or R.D.). 
Neither party filed exceptions to the ALJ's Recommended Decision. 
Although the ALJ's Recommended Decision did not establish that the 
ALJ had jurisdiction in this case, I will nonetheless consider the 
administrative record that he submitted to me in its entirety.
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Findings of Fact

    Respondent is a holder of DEA Certificate of Registration No. 
AR9258434, as well as DATA-Waiver identification number XR9258434. 
Government Exhibit (GX) 1 to Govt. Mot. Pursuant to his registration, 
Respondent is authorized to dispense controlled substances in schedules 
III \6\ through V as a practitioner, and he is authorized to dispense 
or prescribe schedule III-V narcotic controlled substances which ``have 
been approved by the Food and Drug Administration . . . specifically 
for use in maintenance or detoxification treatment'' for up to 100 
patients. 21 CFR 1301.28(a) & (b)(1)(iii); see GX 1. Respondent's 
registered address is 2016 South 4th Avenue, Tucson, Arizona. GX 1. 
Respondent's registration and DATA-Waiver authority do not expire until 
April 30, 2020. Id.
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    \6\ Although the Show Cause Order alleges that Respondent's 
registration authorizes him to dispense controlled substances ``in 
Schedules II through V,'' see Show Cause Order, at 1, the record 
establishes that Respondent is not authorized to dispense any 
schedule II controlled substances. GX 1. In addition, to the extent 
that the Show Cause Order's statement that Respondent's status ``as 
a data-waived DW/30 practitioner in Schedules II-V'' suggests that 
this status authorized Respondent to dispense schedule II controlled 
substances, that suggestion is incorrect as a matter of law. 21 
U.S.C. 823(g)(2)(a) (limiting authority to dispense to ``narcotic 
drugs in schedule III, IV, or V''); 21 CFR 1301.28(a) (same).
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    On April 6, 2017, the Arizona Medical Board issued an Order stating 
the Respondent's ``license to practice allopathic medicine in the State 
of Arizona . . . is summarily suspended.'' GX 2, at 7. The Board also 
prohibited Respondent ``from practicing medicine in the State of 
Arizona'' and ``from prescribing any form of treatment including 
prescription medications or injections of any kind.'' Id. Finally, the 
Board stated that ``Respondent is entitled to a formal hearing to 
defend these charges within 60 days after the issuance of this order.'' 
Id. Based on the above, I find that Respondent does not currently have 
authority under the laws of Arizona to dispense controlled substances.

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 . . . suspended [or] revoked . . . by competent State authority 
and is no longer authorized by State law to engage in the . . . 
dispensing of controlled substances.'' Also, DEA has 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, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see 
also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization 
to dispense or otherwise handle controlled substances is a prerequisite 
to the issuance and maintenance of a Federal controlled substances 
registration.'').
    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, 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 engages in professional practice. 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); Blanton, 43 FR at 
27616.
    Moreover, because ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a 
practitioner's registration ``is currently authorized to handle 
controlled substances in the [S]tate,'' Hooper, 76 FR at 71371 (quoting 
Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long 
held that revocation is warranted even where a practitioner has lost 
his state authority by virtue of the State's use of summary process and 
the State has yet to provide a hearing to challenge the suspension. 
Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 
27070, 27071 (1987). Thus, it is of no consequence that the Arizona 
Medical Board summarily suspended Respondent's state medical license. 
What is consequential is the undisputed fact that Respondent is no 
longer currently authorized to dispense controlled substances in 
Arizona, the State in which he is registered.
    As for Respondent's CAP, I conclude that there were adequate 
grounds for denying it. Specifically, Respondent's position in his CAP 
is that his DEA registration should not be revoked until the conclusion 
of his appeal of the Arizona Medical Board's decision. As already 
noted, however, revocation is warranted even where a practitioner has 
lost his state authority and the State has yet to provide a hearing to 
challenge the suspension. See Bourne Pharmacy, 72 FR at 18274; 
Wingfield Drugs, 52 FR at 27071. Thus, I agree with the Agency's denial 
of Respondent's CAP.
    I will therefore reject Respondent's CAP and order that his 
registration (and DATA-Waiver number) be revoked.\7\
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    \7\ The ALJ received and considered the Government's Motion for 
Summary Disposition and the ``Response to Motion for Summary 
Disposition'' filed by Respondent. In his responsive brief, 
Respondent argued that ``[u]nder the terms of that [Arizona Medical] 
Board Order, the suspension was for 60 days beginning on April 6, 
2017 until the matter was set for a formal hearing'' before the 
Board. Resp. Br. at 1. However, as already noted above, the Arizona 
Medical Board's Order ``summarily suspended'' Respondent ``from 
prescribing any form of treatment including prescription medications 
or injections of any kind.'' GX 2, at 7. Thus, I agree with the ALJ 
that the fact that the Board gave Respondent the right to a formal 
hearing within 60 days of its April 6, 2017 Order ``does not obviate 
the fact that the Respondent currently does not possess state 
authority to handle controlled substances in Arizona,'' the State in 
which he is registered. R.D. at 5. Accordingly, if the ALJ had the 
authority to issue his conclusion rejecting Respondent's argument, I 
would have adopted it, and I would have done so for the same reason.

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[[Page 12029]]

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 No. AR9258434 and DATA-Waiver Identification Number 
XR9258434, issued to David A. Ruben, M.D., be, and they hereby are, 
revoked. I further order that any pending application of David A. Ruben 
to renew or modify the above registration, or any pending application 
of David A. Ruben for any other registration, be, and it hereby is, 
denied. This Order is effective immediately.\8\
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    \8\ For the same reasons which led the Arizona Medical Board to 
revoke Respondent's medical license, I conclude that the public 
interest necessitates that this Order be effective immediately. 21 
CFR 1316.67.

    Dated: March 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-05471 Filed 3-16-18; 8:45 am]
BILLING CODE 4410-09-P
Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices 12027

DEPARTMENT OF JUSTICE Dr. Ruben intends to continue to pursue On July 18, 2017, Respondent also
and to prevail on the appeal of the filed a letter with the Office of
Drug Enforcement Administration underlying order issued by [t]he Arizona Administrative Law Judges (OALJ)
Medical [B]oard . . . . Alleged violation of
pursuant to which he requested a
[Docket No. 17–38] that order is the basis of the Arizona Medical
Board suspension dated April 6, 2017. The hearing on the allegation of the Show
underlying matter is on appeal in Maricopa Cause Order. Letter from Respondent’s
David A. Ruben, M.D.; Decision and Counsel to Hearing Clerk (dated July 12,
County Arizona Superior Court . . .
Order At least part of that Order being appealed 2017) (hereinafter, Hearing Request).
On June 12, 2017, the Assistant stems from an Arizona license restriction of The matter was placed on the OALJ’s
Dr. Ruben as to Schedule [II] drugs which docket and assigned to Administrative
Administrator, Diversion Control
was imposed partly as punishment for an Law Judge Charles Wm. Dorman
Division, Drug Enforcement earlier Certificate [of] Suspension by the
Administration (DEA), issued an Order (hereinafter, ALJ). On July 21, 2017, the
DEA,1 which itself was based upon the
to Show Cause to David A. Ruben, M.D. ALJ issued an order entitled ‘‘Briefing
earlier same Arizona suspension dating from
(Respondent), of Tucson, Arizona. The 2009 and 2010. The entire matter is Schedule for Lack of State Authority
Show Cause Order proposed the ludicrous, and will result in the lifting of the Allegations’’ in which the ALJ found,
revocation of Respondent’s DEA suspension of concern here, as this is the inter alia, that ‘‘[t]he Respondent filed a
Certificate of Registration No. fourth iteration of punishment by the timely Request for Hearing.’’ Briefing
AR9258434 on the ground that he Arizona Medical Board and the DEA Schedule for Lack of State Authority
cannibalizing one another’s actions in order Allegations (hereinafter, Briefing Order),
‘‘do[es] not have authority to handle to inflict multiple punishments for the same
controlled substances in the State of at 1.3
acts from 2009 and 2010. Pursuant to 21 CFR 1301.43(a), ‘‘any
Arizona, the [S]tate in which [he is] All remaining bases of the Arizona person entitled to a hearing . . . and
registered with the DEA.’’ Order to suspension will also be overturned as
desiring a hearing shall, within 30 days
Show Cause, at 1 (citing 21 U.S.C. 823(f) unsupported by the evidence. The DEA
[Show Cause Order] is premature and after the date of receipt of the order to
and 824(a)(3)).
unnecessary and any hearing should be show cause, . . . file with the
With respect to the Agency’s
continued pending the outcome of the Administrator a written request for a
jurisdiction, the Show Cause Order
remaining state matters on appeal. hearing.’’ Accord Show Cause Order, at
alleged that Respondent is the holder of
CAP, at 1. On December 4, 2017, the 2. The ALJ did not indicate in his
Certificate of Registration No.
Briefing Order or in his Recommended
AR9258434 ‘‘as a data-waived DW/30 Acting Assistant Administrator rejected
Decision—and the rest of the
practitioner in schedules II through V,’’ Respondent’s CAP and further
administrative record does not
at the registered address of 2016 South ‘‘determined there is no potential
indicate—when Respondent received
4th Avenue, Tucson, Arizona. Id. The modification of your []CAP that could or
the Show Cause Order. Without any
Order also alleged that this registration would alter my decision in this regard.’’
evidence in the record establishing
does not expire until April 30, 2020. Id. See Letter from Acting Assistant
when Respondent received the Show
Regarding the substantive grounds for Administrator Demetra Ashley to
Cause Order, the only way in which I
the proceeding, the Show Cause Order Respondent (dated December 4, 2017)
could find that Respondent’s Hearing
alleged that on April 6, 2017, (hereinafter CAP Rejection Ltr or CAP
Request was timely is if it had been filed
Respondent’s ‘‘authority to prescribe Rejection Letter), at 1.2
with the Administrator within 30 days
and administer controlled substances in of the June 12, 2017 date of the Show
1 On June 18, 2013, the Agency suspended
the State of Arizona was suspended,’’ Cause Order. However, the OALJ did
Respondent’s DEA Certificate of Registration for one
and that Arizona is ‘‘the [S]tate in which year and imposed four conditions on his not receive Respondent’s Hearing
[he is] registered with the DEA.’’ Id. registration for two years. David A. Ruben, M.D., 78 Request until July 18, 2017.4 Hearing
Based on his ‘‘lack of authority to FR 38363, 38387–88 (2013). The Ninth Circuit Request, at 1. Accordingly, I find that
[dispense] controlled substances in . . . Court of Appeals denied his petition for review of
the Agency’s decision. 617 Fed. Appx. 837 (9th Cir. Respondent’s Hearing Request was not
Arizona,’’ the Order asserted that ‘‘DEA 2015) (unpublished).
must revoke’’ his registration. Id. (citing 2 Respondent’s CAP was attached as Exhibit 1 to Administrator on June 29, 2017.’’ Id. As already
21 U.S.C. 823(f)(1) and 824(a)(3)). Respondent’s counsel’s letter requesting a hearing. noted, however, the Show Cause Order was issued
The Show Cause Order notified CAP, at 1 (attached as ‘‘EXHIBIT 1 TO REQUEST on June 12, 2017. Show Cause Order, at 1. The CAP
FOR HEARING’’ to Letter from Respondent’s Rejection Letter does attach, inter alia, a copy of
Respondent of (1) his right to request a Respondent’s Hearing Request and CAP in
Counsel to Hearing Clerk (dated July 12, 2017). The
hearing on the allegations or to submit letter setting forth Respondent’s request for a connection with the June 12, 2017 Show Cause
a written statement in lieu of a hearing hearing (hereinafter, Hearing Request) was Order. See Attachment to CAP Rejection Ltr at 2–
‘‘[w]ithin 30 days after the date of addressed to the Office of Administrative Law 4. Thus, I find that the CAP Rejection Letter’s
Judges (OALJ) as well as to the Assistant reference to a June 29, 2017 Show Cause Order was
receipt of this Order to Show Cause,’’ (2) merely a scrivener’s error and that the Acting
Administrator, Diversion Control Division, Louis
the procedure for electing either option, Milione. Hearing Request, at 1. As discussed more Assistant Administrator intended to refer to the
and (3) the consequence for failing to fully infra, the record reflects that the OALJ June 12, 2017 Show Cause Order.
elect either option. Id. at 2 (citing 21 received this letter on July 18, 2018. See id. In 3 Although the date next to the ALJ’s signature

CFR 1301.43). The Show Cause Order addition, the Acting Assistant Administrator’s CAP states ‘‘June 21, 2017,’’ id. at 2, the ALJ’s Docket
Rejection Letter attached a copy of Respondent’s Sheet indicates that this order was signed on ‘‘July
also notified Respondent of his right to Hearing Request (and a copy of the CAP) date- 21, 2017.’’ I find that the date in the Briefing Order
submit a corrective action plan stamped ‘‘Jul 18, 2017’’ and a handwritten notation was a scrivener’s error and that in fact the ALJ
(hereinafter, CAP) to the Assistant above it stating ‘‘DC received.’’ The CAP Rejection signed the order on July 21, 2017 as reflected in the
Administrator, Diversion Control Letter stated that her office did not receive the CAP ALJ’s Docket Sheet.
sradovich on DSK3GMQ082PROD with NOTICES

until September 29, 2017. CAP Rejection Ltr, at 1. 4 Although the front of Respondent’s Hearing
Division, and the procedure for doing The record does not reflect facts explaining why the Request is stamped ‘‘Received’’ by the Office of
so. Id. at 2–3. CAP Rejection Letter states that the CAP was not Administrative Law Judges on July 18, 2017, the
On July 18, 2017, Respondent received by DEA’s Diversion Control Division until photocopy of the envelope that purportedly
submitted his CAP by letter from his September 29, 2017. contained Respondent’s Hearing Request reveals a
In the CAP Rejection Letter, the Acting Assistant ‘‘Received/Date’’ of ‘‘July 17, 2017.’’ Compare
counsel (dated July 12, 2017) to the Administrator states that she was responding to Hearing Request, at 1, with id. at 4. In any event,
Agency. In his CAP, Respondent Respondent’s CAP ‘‘in connection with an Order to neither date is within 30 days of the June 12, 2017
explained: Show Cause . . . issued by the Assistant date of the Show Cause Order.

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12028 Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices

timely filed pursuant to 21 CFR by the Food and Drug Administration practitioner’s registration, Congress
1301.43(a), and as a result, Respondent . . . specifically for use in maintenance directed that ‘‘[t]he Attorney General
waived his right to a hearing. or detoxification treatment’’ for up to shall register practitioners . . . if the
In the absence of a timely hearing 100 patients. 21 CFR 1301.28(a) & applicant is authorized to dispense . . .
request, I also find that the ALJ (b)(1)(iii); see GX 1. Respondent’s controlled substances under the laws of
consequently lacked jurisdiction to hear registered address is 2016 South 4th the State in which he practices.’’ 21
the case. See Brown’s Discount Avenue, Tucson, Arizona. GX 1. U.S.C. 823(f). Because Congress has
Apothecary BC, Inc., and Bolling Respondent’s registration and DATA- clearly mandated that a practitioner
Apothecary, Inc., 80 FR 57393, 57394 Waiver authority do not expire until possess state authority in order to be
(2015) (‘‘in the absence of a hearing April 30, 2020. Id. deemed a practitioner under the CSA,
request, the ALJ had no authority to rule On April 6, 2017, the Arizona Medical DEA has held repeatedly that revocation
on the issue of whether its registration Board issued an Order stating the of a practitioner’s registration is the
should be revoked’’). I therefore cancel Respondent’s ‘‘license to practice appropriate sanction whenever he is no
the hearing nunc pro tunc held by the allopathic medicine in the State of longer authorized to dispense controlled
ALJ by summary disposition. See 21 Arizona . . . is summarily suspended.’’ substances under the laws of the State
CFR 1301.43(e). Accordingly, I will treat GX 2, at 7. The Board also prohibited in which he engages in professional
this case as a Request for Final Agency Respondent ‘‘from practicing medicine practice. See, e.g., Calvin Ramsey, 76 FR
Action and issue this Decision and in the State of Arizona’’ and ‘‘from 20034, 20036 (2011); Sheran Arden
Order based on the relevant evidence prescribing any form of treatment Yeates, M.D., 71 FR 39130, 39131
forwarded to my office by the ALJ on including prescription medications or (2006); Dominick A. Ricci, 58 FR 51104,
September 18, 2017.5 See id. I make the injections of any kind.’’ Id. Finally, the 51105 (1993); Bobby Watts, 53 FR
following findings. Board stated that ‘‘Respondent is 11919, 11920 (1988); Blanton, 43 FR at
entitled to a formal hearing to defend 27616.
Findings of Fact these charges within 60 days after the Moreover, because ‘‘the controlling
Respondent is a holder of DEA issuance of this order.’’ Id. Based on the question’’ in a proceeding brought
Certificate of Registration No. above, I find that Respondent does not under 21 U.S.C. 824(a)(3) is whether the
AR9258434, as well as DATA-Waiver currently have authority under the laws holder of a practitioner’s registration ‘‘is
identification number XR9258434. of Arizona to dispense controlled currently authorized to handle
Government Exhibit (GX) 1 to Govt. substances. controlled substances in the [S]tate,’’
Mot. Pursuant to his registration, Hooper, 76 FR at 71371 (quoting Anne
Discussion
Respondent is authorized to dispense Lazar Thorn, 62 FR 12847, 12848
controlled substances in schedules III 6 Pursuant to 21 U.S.C. 824(a)(3), the (1997)), the Agency has also long held
through V as a practitioner, and he is Attorney General is authorized to that revocation is warranted even where
authorized to dispense or prescribe suspend or revoke a registration issued a practitioner has lost his state authority
schedule III–V narcotic controlled under section 823 of the CSA, ‘‘upon a by virtue of the State’s use of summary
substances which ‘‘have been approved finding that the registrant . . . has had process and the State has yet to provide
his State license . . . suspended [or] a hearing to challenge the suspension.
5 In his Briefing Order, the ALJ ordered the revoked . . . by competent State Bourne Pharmacy, 72 FR 18273, 18274
Government to file evidence to support its authority and is no longer authorized by (2007); Wingfield Drugs, 52 FR 27070,
allegation that Respondent lacks state authority to State law to engage in the . . . 27071 (1987). Thus, it is of no
handle controlled substances, and any motion for dispensing of controlled substances.’’
summary disposition on these grounds, on August consequence that the Arizona Medical
3, 2017. Briefing Order at 1. The ALJ also directed Also, DEA has long held that the Board summarily suspended
Respondent to file his response to any summary possession of authority to dispense Respondent’s state medical license.
disposition motion on August 10, 2017. Id. On controlled substances under the laws of What is consequential is the undisputed
August 3, 2017, the Government filed its Motion for the State in which a practitioner engages
Summary Disposition, and the Respondent filed his fact that Respondent is no longer
response on August 10, 2017. See Government’s
in professional practice is a currently authorized to dispense
Motion for Summary Disposition (hereinafter Govt. fundamental condition for obtaining controlled substances in Arizona, the
Mot.); Response to Motion for Summary Disposition and maintaining a practitioner’s State in which he is registered.
(hereinafter Resp. Br.). On August 15, 2017, the ALJ registration. See, e.g., James L. Hooper,
issued his Order granting summary disposition and As for Respondent’s CAP, I conclude
Recommended Decision. Order Granting Summary
76 FR 71371 (2011), pet. for rev. denied, that there were adequate grounds for
Disposition and Recommended Rulings, Findings of 481 Fed. Appx. 826 (4th Cir. 2012); see denying it. Specifically, Respondent’s
Fact, Conclusions of Law, and Decision (hereinafter, also Frederick Marsh Blanton, 43 FR position in his CAP is that his DEA
Recommended Decision or R.D.). Neither party filed 27616 (1978) (‘‘State authorization to
exceptions to the ALJ’s Recommended Decision. registration should not be revoked until
Although the ALJ’s Recommended Decision did not
dispense or otherwise handle controlled the conclusion of his appeal of the
establish that the ALJ had jurisdiction in this case, substances is a prerequisite to the Arizona Medical Board’s decision. As
I will nonetheless consider the administrative issuance and maintenance of a Federal already noted, however, revocation is
record that he submitted to me in its entirety. controlled substances registration.’’).
6 Although the Show Cause Order alleges that
warranted even where a practitioner has
This rule derives from the text of two lost his state authority and the State has
Respondent’s registration authorizes him to
dispense controlled substances ‘‘in Schedules II
provisions of the CSA. First, Congress yet to provide a hearing to challenge the
through V,’’ see Show Cause Order, at 1, the record defined ‘‘the term ‘practitioner’ [to] suspension. See Bourne Pharmacy, 72
establishes that Respondent is not authorized to mean[ ] a . . . physician . . . or other FR at 18274; Wingfield Drugs, 52 FR at
dispense any schedule II controlled substances. GX person licensed, registered or otherwise
sradovich on DSK3GMQ082PROD with NOTICES

1. In addition, to the extent that the Show Cause 27071. Thus, I agree with the Agency’s
Order’s statement that Respondent’s status ‘‘as a
permitted, by . . . the jurisdiction in denial of Respondent’s CAP.
data-waived DW/30 practitioner in Schedules II–V’’ which he practices . . . to distribute, I will therefore reject Respondent’s
suggests that this status authorized Respondent to dispense, [or] administer . . . a CAP and order that his registration (and
dispense schedule II controlled substances, that controlled substance in the course of
suggestion is incorrect as a matter of law. 21 U.S.C. DATA-Waiver number) be revoked.7
823(g)(2)(a) (limiting authority to dispense to
professional practice.’’ 21 U.S.C.
‘‘narcotic drugs in schedule III, IV, or V’’); 21 CFR 802(21). Second, in setting the 7 The ALJ received and considered the

1301.28(a) (same). requirements for obtaining a Government’s Motion for Summary Disposition and

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Federal Register / Vol. 83, No. 53 / Monday, March 19, 2018 / Notices 12029

Order DATES: The Department of Justice estimated for an average respondent to
Pursuant to the authority vested in me encourages public comment and will respond: 51, 50 minutes per response,
by 21 U.S.C. 823(f) and 824(a), as well accept input until May 18, 2018. 2,550 annual hours.
FOR FURTHER INFORMATION CONTACT: If 6. An estimate of the total public
as 28 CFR 0.100(b), I order that DEA
you have additional comments burden (in hours) associated with the
Certificate of Registration No.
especially on the estimated public collection: $5,220.53.
AR9258434 and DATA-Waiver If additional information is required
Identification Number XR9258434, burden or associated response time,
suggestions, or need a copy of the contact: Melody Braswell, Department
issued to David A. Ruben, M.D., be, and Clearance Officer, United States
they hereby are, revoked. I further order proposed information collection
instrument with instructions or Department of Justice, Justice
that any pending application of David Management Division, Policy and
A. Ruben to renew or modify the above additional information, please contact
Jean King, General Counsel, Office of Planning Staff, Two Constitution
registration, or any pending application Square, 145 N Street NE, 3E.405A,
of David A. Ruben for any other the General Counsel, 5107 Leesburg
Pike, Suite 2600, Falls Church, VA Washington, DC 20530.
registration, be, and it hereby is, denied.
This Order is effective immediately.8 22041, telephone: (703) 305–0470. Dated: March 14, 2018.
SUPPLEMENTARY INFORMATION: Written Melody Braswell,
Dated: March 7, 2018.
comments and suggestions from the Department Clearance Officer for PRA, U.S.
Robert W. Patterson, public and affected agencies concerning Department of Justice.
Acting Administrator. the proposed collection of information [FR Doc. 2018–05532 Filed 3–16–18; 8:45 am]
[FR Doc. 2018–05471 Filed 3–16–18; 8:45 am] are encouraged. Your comments should BILLING CODE 4410–30–P
BILLING CODE 4410–09–P address one or more of the following
four points:
—Evaluate whether the proposed DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE collection of information is necessary
for the proper performance of the Notice of Proposed Administrative
Executive Office for Immigration functions of the Executive Office for Settlement Agreement Under the Clean
Review Immigration Review, including Comprehensive Environmental
[OMB Number 1125–NEW] whether the information will have Response, Compensation, and Liability
practical utility; Act
Agency Information Collection —Evaluate the accuracy of the agency’s On March, 12, 2018, the Department
Activities; Proposed eCollection; estimate of the burden of the of Justice formally proposed to enter a
Comments Requested; New proposed collection of information, Settlement Agreement and Order on
including the validity of the Consent for Response Action
AGENCY: Executive Office for
methodology and assumptions used; (‘‘Settlement Agreement’’) with the
Immigration Review, Department of —Evaluate whether and if so how the
Justice. Bunker Hill Mining Corp. (‘‘BHMC’’), in
quality, utility, and clarity of the
ACTION: Notice. connection with BHMC’s purchase of
information to be collected can be
property located at the Bunker Hill
enhanced; and
SUMMARY: The Department of Justice, —Minimize the burden of the collection Mine, south of Kellogg, in the Silver
Executive Office for Immigration of information on those who are to Valley of Shoshone County, Idaho (the
Review, is submitting the following respond, including through the use of ‘‘Mine’’), which is located in and part of
information collection request to the appropriate automated, electronic, the ‘‘Non-Populated Areas Operable
Office of Management and Budget mechanical, or other technological Unit of the Bunker Hill Superfund Site.’’
(OMB) for review and approval in collection techniques or other forms As described in the Settlement
accordance with the Paperwork of information technology, e.g., Agreement, BHMC agrees to perform
Reduction Act of 1995. permitting electronic submission of response actions at or in connection
responses. with the Mine and to make payments
the ‘‘Response to Motion for Summary Disposition’’ for, and in satisfaction of the liability of
filed by Respondent. In his responsive brief, Overview of This Information Placer Mining Corp. and the Estate of
Respondent argued that ‘‘[u]nder the terms of that Collection
[Arizona Medical] Board Order, the suspension was Robert Hopper, Sr., under the
for 60 days beginning on April 6, 2017 until the 1. Type of Information Collection: Comprehensive Environmental
matter was set for a formal hearing’’ before the New Voluntary Collection. Response, Compensation, and Liability
Board. Resp. Br. at 1. However, as already noted 2. The Title of the Form/Collection: Act, 42 U.S.C. 9601–9675 (‘‘CERCLA’’).
above, the Arizona Medical Board’s Order
‘‘summarily suspended’’ Respondent ‘‘from Office of the Chief Administrative Under the proposed Settlement
prescribing any form of treatment including Hearing Officer E-Filing Portal. Agreement, BHMC has agreed, as part of
prescription medications or injections of any kind.’’ 3. The agency form number, if any, the consideration BHMC is paying to
GX 2, at 7. Thus, I agree with the ALJ that the fact and the applicable component of the purchase the Mine and in satisfaction of
that the Board gave Respondent the right to a formal
hearing within 60 days of its April 6, 2017 Order Department sponsoring the collection: the liability of Placer Mining Co. and
‘‘does not obviate the fact that the Respondent There is no agency form number for this Robert Hopper, Jr., the current owners of
currently does not possess state authority to handle collection. The applicable component the Mine, to reimburse the United States
controlled substances in Arizona,’’ the State in within the Department of Justice is the over 80 percent of its costs incurred in
which he is registered. R.D. at 5. Accordingly, if the
sradovich on DSK3GMQ082PROD with NOTICES

ALJ had the authority to issue his conclusion Office of the Chief Administrative connection with the Bunker Hill Mine
rejecting Respondent’s argument, I would have Hearing Officer (OCAHO). property and have agreed to pay for
adopted it, and I would have done so for the same 4. Affected public who will be asked treatment of acid water discharged from
reason. or required to respond, as well as a brief the Mine and to otherwise manage Mine
8 For the same reasons which led the Arizona
abstract: Individuals, Business or other water as requested by the
Medical Board to revoke Respondent’s medical
license, I conclude that the public interest for-profit, and not-for-profit institutions. Environmental Protection Agency.
necessitates that this Order be effective 5. An estimate of the total number of The publication of this notice opens
immediately. 21 CFR 1316.67. respondents and the amount of time a period for public comment on the

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Document Created: 2018-03-17 04:25:08
Document Modified: 2018-03-17 04:25:08
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 12027
83 FR 12027 - David A. Ruben, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 53 (March 19, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
