Amy S. Benjamin, N.P.; Decision and Order, 72408-72409 [2012-29302]
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72408
Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with
opportunity, he will violate the Act
again.’’ Koller, 71 FR at 66983.
Like the registrant in Koller, the
Respondent’s repeated and continuing
violations in the face of—and even
motivated by—his disagreement with
his obligations as a registrant,
undermine the confidence that can be
placed in him to execute his
responsibilities in compliance with the
law. See Koller, D.V.M., 71 FR at 66983
(‘‘Respondent’s repeated violations of
the CSA provide ample grounds to deny
his application.’’).
Following the guidance of Koller, it is
clear that the Government has sustained
its burden of showing that Respondent
committed acts inconsistent with the
public interest. Accordingly, the burden
shifts to the Respondent to show that he
can be entrusted with a DEA
registration. As discussed above, ‘‘to
rebut the Government’s prima facie
case, [the Respondent] is required not
only to accept responsibility for [the
established] misconduct, but also to
demonstrate what corrective measures
[have been] undertaken to prevent the
reoccurrence of similar acts.’’ Jeri
Hassman, M.D., 75 FR at 8236. The
present record does not present
transgressions on a level that could not
have been overcome by a credible and
persuasive acceptance of responsibility
coupled with a cogent plan for coming
into compliance and avoiding future
violations; but inasmuch as neither
demonstration was convincingly offered
by the Respondent, under current
Agency precedent, he cannot prevail.
Here, while Respondent has
nominally 84 acknowledged that his
conduct was wrongful, Tr. 763, 765, he
has failed to outline any steps he has
taken to prevent the reoccurrence of the
infractions. Generally, actions speak
louder than words, and the
Respondent’s actions speak volumes
about his level of responsibility
acceptance. By his own admission, the
Respondent continues to dispose of
controlled substances down his office
drains without DEA authorization, and
continues to administer drugs at his
unregistered Avon location. Tr. 764. The
Respondent has also failed to outline
any steps which he has taken (or even
intends to take) that would tend to
prevent controlled substances from
being left unsecured during mornings at
the unregistered Avon Office. Clear on
84 Though the Respondent acknowledged wrong
doing, he also testified, in essence, that ‘‘everybody
does it.’’ These ministrations echo the righteous
protests put forth in Koller; and are no more
compelling here. Accordingly, the evidence here, as
in Koller, leaves ‘‘the firm impression that, if given
the opportunity, [Respondent] will violate the
[CSA] again.’’ Koller, 71 FR at 66983.
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17:19 Dec 04, 2012
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the evidence presented here, is that far
from demonstrating acceptance and
contrition, the Respondent has violated
the law, disagrees with the law, and has
continued to violate the law even after
the Agency served him with an OSC.
Thus, in this case, the Respondent has
failed to sustain his burden of showing
that he can be entrusted with the
responsibilities incumbent upon a DEA
registrant. Koller, 71 FR at 66983; Jeri
Hassman, M.D., 75 FR at 8236.85
Where, as here, the Government has
made out a prima facie case that the
Respondent has committed acts that
render registration inconsistent with the
public interest, Agency precedent has
firmly placed acknowledgement of guilt
and acceptance of responsibility as
conditions precedent to merit the
granting or continuation of status as a
registrant. Hoxie v. DEA, 419 F.3d 477,
483 (6th Cir. 2005); Ronald Lynch, M.D.,
75 FR 78745, 78749 (Respondent’s
attempts to minimize misconduct held
to undermine acceptance of
responsibility); George Mathew, M.D.,
75 FR 66138, 66140, 66145, 66148
(2010); George C. Aycock, M.D., 74 FR
17529, 17543 (2009); Steven M.
Abbadessa, D.O., 74 FR 10077, 10078
(2009); Jayam Krishna-Iyer, M.D., 74 FR
459, 463 (2009); Medicine ShoppeJonesborough, 73 FR 364, 387 (2008). As
explained above, Respondent has not
rebutted the Government’s prima facie
case to the extent that he can avoid the
sanction of a revocation of his
registrations. Accordingly, the
Respondent’s Certificate of Registrations
should be revoked, and any pending
renewal applications should be denied.
Dated: December 21, 2011.
John J. Mulrooney II,
Chief Administrative Law Judge.
[FR Doc. 2012–29333 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Amy S. Benjamin, N.P.; Decision and
Order
On April 20, 2012, the Deputy
Assistant Administrator, Office of
85 In its Posthearing Brief the Government
contends that ‘‘the agency has recently admitted
and considered testimony with regard to
community impact [of revocation].’’ Gov’t Posth’g
Brf. at 33. However, the Agency has recently once
again re-affirmed its view that ‘‘community impact
evidence is not relevant in determining whether to
* * * revoke an existing registration under the
various authorities provided in 21 U.S.C. 824(a).’’
Cheek, M.D., 76 FR at 66972. Accordingly,
community impact has not played a role in this
recommended decision. Id.
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Frm 00090
Fmt 4703
Sfmt 4703
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Amy S. Benjamin, N.P.
(Respondent), of Wheeler, Mississippi.
The Show Cause Order proposed the
revocation of Respondent’s DEA
Certificate of Registration MB1536171,
and the denial of any pending
applications to renew or modify the
registration, on the ground that
Respondent lacks authority to handle
controlled substances in Mississippi,
the State in which she is registered with
the Agency. Show Cause Order, at 1
(citing 21 U.S.C. 824(a)(3)). Specifically,
the Show Cause Order alleged that on
June 10, 2011, the State of Mississippi
Board of Nursing issued a final order,
which suspended her nursing license, to
include her authority to handle
controlled substances in the State. Id.
The Show Cause Order notified
Registrant of her right to request a
hearing on the allegations, or in lieu of
a hearing, to submit a written statement
regarding the matters of fact and law
asserted therein; the procedures for
doing either; and the consequences for
failing to do either. Id. at 2 (citing 21
CFR 1301.43(a), (c), (d), & (e)). The
Show Cause Order was personally
served on Registrant by members of the
DEA New Orleans Field DivisionOxford Resident Office on April 23,
2012. GX 2, at 2; GX 6. Since the date
of service of the Show Cause Order,
thirty days have now passed and neither
Registrant, nor anyone purporting to
represent her, has requested a hearing or
submitted a written statement in lieu of
a hearing. I therefore find that Registrant
has waived her right to a hearing or to
submit a written statement in lieu of a
hearing. 21 CFR 1301.43(d).
I further find that Registrant’s DEA
registration was due to expire on July
31, 2012, and that Registrant has failed
to submit a renewal application. See
Gov. Notification of Registration
Expiration, at Ex. B. Therefore, I find
that Registrant’s registration expired on
July 31, 2012.
It is well settled that ‘‘[i]f 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
William W. Nucklos, 73 FR 34330
(2008). Moreover, in the absence of an
application (whether timely filed or
not), there is nothing to act upon. See
Donald Brooks Reece II, M.D., 77 FR
35054 (2012). Because Registrant’s
registration has expired and there is no
pending application to act upon, I
conclude that this case is now moot and
will be dismissed.
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Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices
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 the
Order to Show Cause issued to Amy S.
Benjamin, N.P., be, and it hereby is,
dismissed.
Dated: November 16, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–29302 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances,
Notice of Application, Mylan
Pharmaceuticals, Inc.
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on October 8, 2012, Mylan
Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia
26505, made application by renewal to
the Drug Enforcement Administration
(DEA) to be registered as an importer of
the following basic classes of controlled
substances:
Drug
Schedule
mstockstill on DSK4VPTVN1PROD with
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Methadone (9250) ........................
Morphine (9300) ...........................
Fentanyl (9801) ............................
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II
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II
17:19 Dec 04, 2012
Jkt 229001
Dated: November 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–29410 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Fisher Clinical
Services, Inc.
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule II, which
falls under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43 and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
VerDate Mar<15>2010
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 4, 2013.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic classes of
any controlled substances in schedules
I or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on October 16, 2012, Fisher Clinical
Services, Inc., 7554 Schantz Road,
Allentown, Pennsylvania 18106, made
application to the Drug Enforcement
Administration (DEA) for registration as
an importer of levorphanol (9220), a
basic class of controlled substance in
schedule II.
The company plans to import the
listed controlled substance for analytical
research and clinical trials.
The import of the above listed basic
class of controlled substance would be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of a finished
FDA approved or non-approved dosage
form for commercial distribution in the
United States.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic class of controlled substance
listed in schedules I or II, which fall
under the authority of section
1002(a)(2)(B) of the Act 21 U.S.C.
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
952(a)(2)(B) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43 and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than January 4, 2013.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedules I
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: November 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2012–29404 Filed 12–4–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application:
Siemens Healthcare Diagnostics, Inc.
Pursuant to § 1301.33(a) Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 7, 2012,
Siemens Healthcare Diagnostics, Inc.,
Attn: RA, 100 GBC Drive, Mail Stop 514,
Newark, Delaware 19702, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Drug
Tetrahydrocannabinols (7370) .....
Ecgonine (9180) ...........................
Morphine (9300) ...........................
E:\FR\FM\05DEN1.SGM
05DEN1
Schedule
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[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72408-72409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29302]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Amy S. Benjamin, N.P.; Decision and Order
On April 20, 2012, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Amy S. Benjamin, N.P. (Respondent), of Wheeler,
Mississippi. The Show Cause Order proposed the revocation of
Respondent's DEA Certificate of Registration MB1536171, and the denial
of any pending applications to renew or modify the registration, on the
ground that Respondent lacks authority to handle controlled substances
in Mississippi, the State in which she is registered with the Agency.
Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(3)). Specifically, the
Show Cause Order alleged that on June 10, 2011, the State of
Mississippi Board of Nursing issued a final order, which suspended her
nursing license, to include her authority to handle controlled
substances in the State. Id.
The Show Cause Order notified Registrant of her right to request a
hearing on the allegations, or in lieu of a hearing, to submit a
written statement regarding the matters of fact and law asserted
therein; the procedures for doing either; and the consequences for
failing to do either. Id. at 2 (citing 21 CFR 1301.43(a), (c), (d), &
(e)). The Show Cause Order was personally served on Registrant by
members of the DEA New Orleans Field Division-Oxford Resident Office on
April 23, 2012. GX 2, at 2; GX 6. Since the date of service of the Show
Cause Order, thirty days have now passed and neither Registrant, nor
anyone purporting to represent her, has requested a hearing or
submitted a written statement in lieu of a hearing. I therefore find
that Registrant has waived her right to a hearing or to submit a
written statement in lieu of a hearing. 21 CFR 1301.43(d).
I further find that Registrant's DEA registration was due to expire
on July 31, 2012, and that Registrant has failed to submit a renewal
application. See Gov. Notification of Registration Expiration, at Ex.
B. Therefore, I find that Registrant's registration expired on July 31,
2012.
It is well settled that ``[i]f 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 William W. Nucklos, 73 FR
34330 (2008). Moreover, in the absence of an application (whether
timely filed or not), there is nothing to act upon. See Donald Brooks
Reece II, M.D., 77 FR 35054 (2012). Because Registrant's registration
has expired and there is no pending application to act upon, I conclude
that this case is now moot and will be dismissed.
[[Page 72409]]
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 the Order to Show
Cause issued to Amy S. Benjamin, N.P., be, and it hereby is, dismissed.
Dated: November 16, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-29302 Filed 12-4-12; 8:45 am]
BILLING CODE 4410-09-P