Sunshine Act Meeting, 19374 [2014-07912]
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19374
Federal Register / Vol. 79, No. 67 / Tuesday, April 8, 2014 / Notices
‘‘Respondent specifically testified that
he is not at his registered address when
controlled substances arrive and that
controlled substances are left unguarded
at the registered location and can be left
unsecured for up to two days due to his
absence from the clinic.’’ Gov’t
Posthearing Brief, at 24. Without
entering a specific finding on the issue,
it would be difficult to characterize this
argument as anything other than a clear
misstatement of the Respondent’s
testimony. The Respondent testified
that, because he has prohibited
employees at PCCS from opening
shipments of controlled substances, and
because he is not in the practice every
day, it is possible that a future shipment
of controlled substances could be left
unsecured, but that he is in the process
of divining a solution to the issue and
intends to contact DI McRae to seek her
counsel on the matter. Tr. 569–71, 675–
77. The Respondent also testified that
he felt that he could place an order for
controlled substances so as to avoid a
shipment from being delivered on a day
that he is absent. Tr. 689. Given this
testimony, and the specified remedial
steps outlined above, the Government’s
contention that the Respondent replied
at this hearing that he ‘‘does not have a
system in place to prevent . . . future
diversion’’ 99 is simply not what the
man said.100
Turning to the alleged post-inspection
violations, the record establishes that
the Respondent disposed of
approximately ten vials of Demerol in
May of 2011 and that, despite learning
of thefts of controlled substances which
occurred as late as February or March of
2011, the Respondent failed to notify
the Miami Field Division Office of such
thefts and to file a DEA Form 106
reporting the thefts, in violation of 21
C.F.R. § 1301.76(b).101 Under the
circumstances presented here, where
the Respondent first became aware of
the recordkeeping deficiencies in the
course of an audit that was conducted
by DI McRae, that the Respondent did
not submit a report of theft to DEA
during active enforcement proceedings,
based on the litigation theory of his
counsel that a former employee may
have perpetrated diversion, is not
99 Gov’t
Posth’g Brf. at 23.
Berger v. United States, 295 U.S. 78, 88
(1935) (a prosecutor ‘‘may strike hard blows [but is
not] at liberty to strike foul ones’’).
101 21 C.F.R. § 1301.76(b) provides, in relevant
part: ‘‘The registrant shall notify the Field Division
Office of the Administration in his area, in writing,
of the theft or significant loss of any controlled
substances within one business day of discovery of
such loss or theft. The registrant shall also
complete, and submit to the Field Division Office
in his area, DEA Form 106 regarding the loss or
theft.’’
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100 C.f.,
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evidence that persuasively militates in
favor of revocation. While postinspection violations can raise ‘‘a
serious question as to whether [the]
Respondent can be trusted to
responsibly discharge his obligations as
a registrant,’’ they do not compel
revocation on their own, Battershell,
N.P., 76 Fed. Reg. at 44368–69
(declining to revoke registration despite
post-inspection violations), and clearly
do not do so in this case.
In whole, the Respondent has
expressed contrition for his negligence
and has corrected every violation
represented to him, but for the
unlicensed disposal, which was brought
to the attention of the DEA by the
Respondent himself, and the failure to
report thefts, which were brought to the
Government’s attention during this
proceeding as a potential defense
investigated and tendered by
Respondent through counsel. While the
post-inspection violations are relevant
considerations, on this record, they are
not dispositive to the public interest
inquiry. Battershell, N.P., 76 Fed. Reg. at
44368–69. Rather, the record has a
whole shows that the Respondent has
transgressed profoundly in his failure to
understand and execute his obligations
as a registrant, acknowledged his
failings without discernible reservation,
made a committed and sustained effort
to come into compliance with the
requirements of the CSA, DEA, and state
law, and has outlined a reasonable
approach to maintaining that
compliance. Thus, the Respondent has
successfully demonstrated, that he can
be entrusted with continued
registration. Jeri Hassman, M.D., 75 Fed.
Reg. at 8236. These proceedings are
non-punitive,102 and current Agency
precedent requires no more to lodge
successful rebuttal to the Government’s
prima facie case.
Accordingly, the Respondent,
consistent with the direction set forth in
the OSC issued in this matter, has
successfully shown cause why his
Certificate of Registration should not be
revoked, and thus, the Government’s
petition to revoke the Respondent’s
Registration should be DENIED.
However, the record in this matter
justifies the IMPOSITION OF
SPECIFIED CONDITIONS ON THE
RESPONDENT’S REGISTRATION, to
wit: (1) the Respondent must comply
with all regulatory obligations relative
to the prescribing, dispensing, storage,
and handling of controlled substances
under his COR; (2) the Respondent, at
his own expense, shall submit regular
reports at sixty-day intervals (or such
other interval as directed by DEA) to a
designated DEA official, from an
independent pharmacy contractor, preapproved by a designated DEA official,
reflecting monthly regulatory
compliance inspections; and (3) within
thirty days of the issuance a final
Agency order in this case, the
Respondent will execute a document
memorializing an irrevocable consent
for any and all agents of DEA to inspect
any and all records related to the
handling and prescribing of controlled
substances for a period of one year. The
Respondent is placed on notice that the
failure on his part to timely and
correctly submit all documentation
required by these conditions, and to
comply scrupulously with all
requirements set forth in these
enumerated conditions, will constitute
an independent basis for administrative
enforcement proceedings.
Dated: March 1, 2012.
John J. Mulrooney, II,
Chief Administrative Law Judge.
[FR Doc. 2014–07806 Filed 4–7–14; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Parole Commission
Sunshine Act Meeting
TIME AND DATE:
U.S. Parole Commission, 90 K
Street NE., 3rd Floor, Washington, DC
PLACE:
STATUS:
Open.
Approval of
January 14, 2014 minutes; reports from
the Chairman, the Commissioners, and
senior staff; Short Intervention For
Success Program; Proposed Rulemaking
Revising Conditions of Release update.
MATTERS TO BE CONSIDERED:
CONTACT PERSON FOR MORE INFORMATION:
Jacqueline Graham, Staff Assistant to
the Chairman, U.S. Parole Commission,
90 K Street NE., 3rd Floor, Washington,
DC 20530, (202) 346–7001.
Dated: April 3, 2014.
J. Patricia W. Smoot,
Acting General Counsel, U.S. Parole
Commission.
[FR Doc. 2014–07912 Filed 4–4–14; 11:15 am]
BILLING CODE 4410–31–P
102 See Jackson, 72 Fed. Reg. at 23853; Leo R.
Miller, M.D., 53 Fed. Reg. 21931, 21932 (1988).
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[Federal Register Volume 79, Number 67 (Tuesday, April 8, 2014)]
[Notices]
[Page 19374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07912]
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DEPARTMENT OF JUSTICE
Parole Commission
Sunshine Act Meeting
TIME AND DATE: 10:00 a.m., Thursday, April 17, 2014.
PLACE: U.S. Parole Commission, 90 K Street NE., 3rd Floor, Washington,
DC
STATUS: Open.
MATTERS TO BE CONSIDERED: Approval of January 14, 2014 minutes; reports
from the Chairman, the Commissioners, and senior staff; Short
Intervention For Success Program; Proposed Rulemaking Revising
Conditions of Release update.
CONTACT PERSON FOR MORE INFORMATION: Jacqueline Graham, Staff Assistant
to the Chairman, U.S. Parole Commission, 90 K Street NE., 3rd Floor,
Washington, DC 20530, (202) 346-7001.
Dated: April 3, 2014.
J. Patricia W. Smoot,
Acting General Counsel, U.S. Parole Commission.
[FR Doc. 2014-07912 Filed 4-4-14; 11:15 am]
BILLING CODE 4410-31-P
