Donald Brooks Reece II, M.D.; Dismissal of Proceeding, 35054-35055 [2012-14315]
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35054
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
Respondent intends to both import and
distribute its product to end users. [FOF
22, 24]. In that regard, the Respondent
has already provided the DEA with a
customer list of its retail distributors, as
it has only one: itself. In addition, not
only has the DEA verified that customer,
it has specifically investigated that
customer to ensure that it has protocols
in place to protect against diversion.
[FOF 28, 29, 34]. Accordingly, both the
purpose behind the CMEA and DEA’s
policy are met by the disclosure that the
Respondent has made in this case, and
the Respondent’s failure to disclose its
retail customers does not otherwise
weigh against its registration. [See FOF
3 (describing purpose behind CMEA);
FOF 19 (describing purpose behind
requiring customer list)].34
However, under this factor, I find Mr.
Pierce’s reaction to the Better Bodies
shipment into the United States, and his
general credibility weigh in favor of
denial. When asked whether he still
conducted business with Better Bodies
after the customs seizure, he stated,
‘‘[w]e have no control over them buying
the product from us and shipping it
without our knowledge. [Health Canada]
. . . has been informed.’’ [FOF 73].
However, GFR does have control over to
whom it sells its product, and GFR’s
decision to continue to supply a
company that has illegally handled its
product reflects a general apathy
towards diversion. As Mr. Pierce is the
President and CEO of GFR, and the
principle owner of the Respondent, this
factor raises a concern that he would
similarly turn a blind eye to the misuse
of the Respondent’s product in the
United States.
Furthermore, Mr. Pierce’s testimony
throughout this proceeding raises
credibility concerns and consequently
concerns about whether he could be
trusted with a DEA registration.
Specifically, during the hearing Mr.
Pierce testified that he conducted no
market research on the Respondent
prior to investing in it, yet was certain
that there was a need for its product in
the United States as a bronchodilator
and that individuals would purchase it
over the internet for that purpose. [FOF
116–122]. I find the assertion that he
invested in the Respondent blindly, in
light of his extensive business
experience at GFR and other companies,
34 However,
to ensure that the Respondent doesn’t
evade the customer list disclosure laws by acting as
both a retailer and a distributor, I would
recommend that if the Respondent’s registration is
granted, it should be limited to importation and
retail sales only and the Respondent should be
precluded from selling its product to other
distributors without first coordinating such
registration modification with the DEA. [FOF 117,
118].
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22:42 Jun 11, 2012
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highly unlikely. [See FOF 47, 77, 81,
87]. In addition, I find it more likely that
he was aware of the market for
ephedrine as a dietary supplement in
the United States based on Mr.
Schiefelbein’s experience selling it as
such prior to the FDA’s ban in 2004, as
well as his own experience selling it for
that purpose in Canada. [FOF 83, 53,
54]. Such knowledge likely motivated
his investment, a fact he made efforts to
conceal during this proceeding. Such
lack of candor weighs against the
Respondent’s registration. [Net
Wholesale, 70 FR 24,626, 24,627 (DEA
2005)].
V. Conclusion and Recommendation
In light of the foregoing, I find that the
Government has proved by a
preponderance of the evidence that the
Respondent’s registration would be
inconsistent with the public interest due
to its current inability to comply with
state and FDA law, its lack of candor,
and its attitude towards diversion. Once
the Government has met its burden of
proof, the burden shifts to the
Respondent to establish that its
Registration would otherwise be
consistent with the public interest.
Here, the Respondent argues that its
registration is consistent with the public
interest because, among other reasons, it
has completed its due diligence to
ensure compliance with all applicable
laws and regulations. [See Resp. Brief at
10 (stating ‘‘4 OTC has expended a great
amount of time and resources in
ensuring that its intended activities
relating to the import and distribution of
ephedrine containing products within
the United States will be in compliance
with all pertinent federal and state
laws’’)]. However, it is clear that the
Respondent has yet to grasp those laws,
because its stated practices stand
contrary to them, and its SOPs
otherwise fail to adequately address
them.
Accordingly, it is my
recommendation that the Respondent’s
application be denied.
Dated: September 22, 2011
/s/Gail A. Randall
Administrative Law Judge
[FR Doc. 2012–14307 Filed 6–11–12; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11–13]
Donald Brooks Reece II, M.D.;
Dismissal of Proceeding
On November 19, 2010, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Donald Brooks Reece II,
M.D. (Respondent), of Morehead City,
N.C. The Order proposed the revocation
of Respondent’s DEA Certificate of
Registration as a practitioner, and the
denial of any pending application to
renew or modify the registration, on the
ground that Respondent’s registration is
inconsistent with the public interest as
that term is defined in 21 U.S.C. 823(f).
Show Cause Order at 1 (citing 21 U.S.C.
824(a)(4)).
Respondent requested a hearing on
the allegations and an Administrative
Law Judge (ALJ) conducted a hearing on
May 9–13, 2011. Thereafter, on
September 30, 2011, the ALJ issued his
decision, which concluded that
‘‘Respondent’s continued registration
would be fully inconsistent with the
public interest,’’ and recommended that
his registration be revoked and that any
pending application to renew or modify
his registration be denied. ALJ at 33.
Respondent filed Exceptions, and on
November 21, 2011, the ALJ forwarded
the record to this Office for final agency
action.1
Upon review of the record, it was
noted that Respondent’s registration was
due to expire on April 30, 2012. GX 1.
Because in the absence of a timely
renewal application, Respondent’s
registration would expire, see 5 U.S.C.
558(c), pursuant to 5 U.S.C. 556(e) and
21 CFR 1316.59(e), I have taken official
notice of Respondent’s registration
record with the Agency.2 According to
1 On February 9, 2012, the Government also filed
a pleading entitled: ‘‘Notice To The Administrator
Regarding State Authority,’’ with attachments.
Therein, the Government observed that Respondent
had entered into a Consent Order with the North
Carolina Medical Board, pursuant to which he
agreed to cease the practice of medicine or surgery
in North Carolina, the State in which he held his
DEA registration. Notice to the Administrator
Regarding State Authority, at 3. This Order was
effective on December 8, 2011. Id., Attachment 5,
at 6.
2 In accordance with the Administrative
Procedure Act (APA), an agency ‘‘may take official
notice of facts at any stage in a proceeding-even in
the final decision.’’ U.S. Dept. of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). In accordance with the APA and DEA’s
regulations, Respondent is ‘‘entitled on timely
request to an opportunity to show to the contrary.’’
5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To
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35055
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
this record, Respondent has not filed a
renewal application. I therefore find that
Respondent’s registration has expired.
Under DEA precedent, ‘‘if a registrant
has not submitted a timely renewal
application prior to the expiration date,
then the registration expires and there is
nothing to revoke.’’ Ronald J. Riegel, 63
FR 67132, 67133 (1998); see also
Thomas E. Mitchell, 76 FR 20032, 20033
(2011). Moreover, in the absence of an
application (whether timely filed or
not), there is nothing to act upon.
Accordingly, because Respondent has
allowed his registration to expire and
has not filed either a renewal or a new
application, this case is now moot and
will be dismissed.
DEPARTMENT OF JUSTICE
Order
Drug Enforcement Administration
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I hereby order that the Order
to Show Cause issued to Donald Brooks
Reece II, M.D., be, and it hereby is,
dismissed. This Order is effective
immediately.
Importer of Controlled Substances;
Notice of Registration; Lipomed, Inc.
Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–14315 Filed 6–11–12; 8:45 am]
BILLING CODE 4410–09–P
By Notice dated April 2, 2012, and
published in the Federal Register on
April 12, 2012, 77 FR 21998, Lipomed,
Inc., One Broadway, Cambridge,
Massachusetts 02142, made application
by renewal to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the following basic
classes of controlled substances:
srobinson on DSK4SPTVN1PROD with NOTICES
Drug
Schedule
Cathinone (1235) .........................................................................................................................................................................................
Methcathinone (1237) ..................................................................................................................................................................................
4-methyl-N-methylcathinone (1248) ............................................................................................................................................................
N-Ethylamphetamine (1475) ........................................................................................................................................................................
N,N-Dimethylamphetamine (1480) ..............................................................................................................................................................
Fenethylline (1503) ......................................................................................................................................................................................
Aminorex (1585) ..........................................................................................................................................................................................
4-Methylaminorex (cis isomer) (1590) .........................................................................................................................................................
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Methaqualone (2565) ..................................................................................................................................................................................
Mecloqualone (2572) ...................................................................................................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (7118) .........................................................................................................................................................
1-Butyl-3-(1-naphthoyl)indole (7173) ...........................................................................................................................................................
1-[2-(4-Morpholinyl)ethyl]-3(1-naphthoyl) indole (7200) ..............................................................................................................................
Alpha-ethyltryptamine (7249) ......................................................................................................................................................................
Ibogaine (7260) ...........................................................................................................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- ...........................................................................................................................................................
hydroxycyclohexyl]-phenol (7297) ...............................................................................................................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (7298) ........................................................................................................
Lysergic acid diethylamide (7315) ...............................................................................................................................................................
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (7348) ...............................................................................................................................
Marihuana (7360) ........................................................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
Parahexyl (7374) .........................................................................................................................................................................................
Mescaline (7381) .........................................................................................................................................................................................
3,4,5-Trimethoxyamphetamine (7390) ........................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (7391) ..............................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (7392) ..........................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................
2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (7399) ................................................................................................................................................
3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine (7401) ..................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetaimine (7402) .................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................
3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................
4-Methoxyamphetamine (7411) ...................................................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine (7431) .................................................................................................................................................
Alpha-methyltryptamine (7432) ...................................................................................................................................................................
Dimethyltryptamine (7435) ..........................................................................................................................................................................
Psilocybin (7437) .........................................................................................................................................................................................
Psilocyn (7438) ............................................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine (7439) ..............................................................................................................................................
N-Ethyl-1-phenylcyclohexylamine (7455) ....................................................................................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine (7458) ....................................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine (7473) ..............................................................................................................................................
N-Ethyl-3-piperidyl benzilate (7482) ............................................................................................................................................................
N-Methyl-3-piperidyl benzilate (7484) .........................................................................................................................................................
N-Benzylpiperazine (7493) ..........................................................................................................................................................................
3,4-methylenedioxypyrovalerone (7535) .....................................................................................................................................................
3,4-methlenedioxy.N-methylcathinone (7540) .............................................................................................................................................
allow Respondent the opportunity to refute the facts
of which I take official notice, Respondent may file
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a motion for reconsideration within fifteen calendar
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days of service of this order which shall commence
on the date this order is mailed.
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]]>Agencies
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35054-35055]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14315]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-13]
Donald Brooks Reece II, M.D.; Dismissal of Proceeding
On November 19, 2010, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Donald Brooks Reece II, M.D. (Respondent), of Morehead
City, N.C. The Order proposed the revocation of Respondent's DEA
Certificate of Registration as a practitioner, and the denial of any
pending application to renew or modify the registration, on the ground
that Respondent's registration is inconsistent with the public interest
as that term is defined in 21 U.S.C. 823(f). Show Cause Order at 1
(citing 21 U.S.C. 824(a)(4)).
Respondent requested a hearing on the allegations and an
Administrative Law Judge (ALJ) conducted a hearing on May 9-13, 2011.
Thereafter, on September 30, 2011, the ALJ issued his decision, which
concluded that ``Respondent's continued registration would be fully
inconsistent with the public interest,'' and recommended that his
registration be revoked and that any pending application to renew or
modify his registration be denied. ALJ at 33. Respondent filed
Exceptions, and on November 21, 2011, the ALJ forwarded the record to
this Office for final agency action.\1\
---------------------------------------------------------------------------
\1\ On February 9, 2012, the Government also filed a pleading
entitled: ``Notice To The Administrator Regarding State Authority,''
with attachments. Therein, the Government observed that Respondent
had entered into a Consent Order with the North Carolina Medical
Board, pursuant to which he agreed to cease the practice of medicine
or surgery in North Carolina, the State in which he held his DEA
registration. Notice to the Administrator Regarding State Authority,
at 3. This Order was effective on December 8, 2011. Id., Attachment
5, at 6.
---------------------------------------------------------------------------
Upon review of the record, it was noted that Respondent's
registration was due to expire on April 30, 2012. GX 1. Because in the
absence of a timely renewal application, Respondent's registration
would expire, see 5 U.S.C. 558(c), pursuant to 5 U.S.C. 556(e) and 21
CFR 1316.59(e), I have taken official notice of Respondent's
registration record with the Agency.\2\ According to
[[Page 35055]]
this record, Respondent has not filed a renewal application. I
therefore find that Respondent's registration has expired.
---------------------------------------------------------------------------
\2\ In accordance with the Administrative Procedure Act (APA),
an agency ``may take official notice of facts at any stage in a
proceeding-even in the final decision.'' U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act 80
(1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with
the APA and DEA's regulations, Respondent is ``entitled on timely
request to an opportunity to show to the contrary.'' 5 U.S.C.
556(e); see also 21 CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take official notice,
Respondent may file a motion for reconsideration within fifteen
calendar days of service of this order which shall commence on the
date this order is mailed.
---------------------------------------------------------------------------
Under DEA precedent, ``if a registrant has not submitted a timely
renewal application prior to the expiration date, then the registration
expires and there is nothing to revoke.'' Ronald J. Riegel, 63 FR
67132, 67133 (1998); see also Thomas E. Mitchell, 76 FR 20032, 20033
(2011). Moreover, in the absence of an application (whether timely
filed or not), there is nothing to act upon. Accordingly, because
Respondent has allowed his registration to expire and has not filed
either a renewal or a new application, this case is now moot and will
be dismissed.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well
as 28 CFR 0.100(b), I hereby order that the Order to Show Cause issued
to Donald Brooks Reece II, M.D., be, and it hereby is, dismissed. This
Order is effective immediately.
Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14315 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P
