Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC, 15814-15815 [2020-05748]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
15814
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
Through his testimony, the Respondent
made clear that he has not accepted
responsibility for the prescriptions he
wrote in Texas without having a DEA
COR for a place of business in Texas.
In this case, the Government has
established that the Respondent
unlawfully wrote prescriptions for
controlled substances to three
undercover investigators on five
separate occasions beginning in March
2012 and ending in April 2013. After
the Respondent was arrested, the
Government filed a motion to revoke his
bail because he continued writing
prescriptions. GE–16, at 4; GE–19, at
1170, 1173. Then, as a result of these
unlawful prescriptions, in May 2015 the
Respondent was convicted in the
Superior Court of the State of California,
County of Los Angeles, of seven counts
concerning issuing unlawful
prescriptions for Adderall,
hydrocodone, and alprazolam. That
court imposed a sentence in March
2016. Then in June 2016, the MBC
suspended the Respondent’s medical
license, a suspension which remained
in effect until January 2017. In February
2017, the Acting Administrator of the
DEA issued an Order restricting the
Respondent’s COR, and remanded the
Respondent’s case to the Office of
Administrative Law Judges for further
proceedings. Then in March and April
of 2017, the Respondent wrote three
prescriptions for Lyrica, a Schedule V
controlled substance, in Texas, without
having the authority to write such
prescriptions from the DEA.
At his hearing the Respondent
accepted some responsibility for his
actions. I find, however, that the
Respondent’s limited acceptance of
responsibility is outweighed by his
prescribing transgressions detailed
above, particularly considering the
timeline and the fact that the
Respondent’s acceptance of
responsibility is equivocal. *[See Alra
Labs, Inc. v. Drug Enf’t Admin., 54 F. 3d
450, 452 (7th Cir. 1995) (‘‘The DEA had
to decide whether to believe
[registrant’s] protestation that its
problems are behind it. It did not have
to accept that assertion.’’ (citations
omitted).] *U
When considering whether the
Respondent’s continued registration is
consistent with the public interest, an
ALJ must consider both the
egregiousness of the registrant’s
violations and the DEA’s interest in
deterring future misconduct by both the
registrant as well as other registrants.
Ruben, 78 FR at 38364. *[Omitted
additional citations].
*U Replaced citation.
VerDate Sep<11>2014
17:05 Mar 18, 2020
Jkt 250001
In this case, the Respondent’s
numerous transgressions are sufficiently
egregious to warrant revocation.19 See
Dewey C. MacKay, M.D., 75 FR 49956,
49974 n.35 (2010) (‘‘[U]nder the public
interest standard, DEA has authority to
consider those prescribing practices of a
physician, which, while not rising to the
level of intentional or knowing
misconduct, nonetheless create a
substantial risk of diversion.’’). I find
the Respondent’s transgressions
egregious for several reasons. First, the
Respondent issued prescriptions for
controlled substances to UC1 even
though he knew that UC1 was obtaining
controlled substances on the street, and
he reissued that prescription to UC1
even knowing that none of the
controlled substances the Respondent
prescribed to UC1 were detected in his
urine test. Second, almost a year later,
the Respondent again prescribed
oxycodone, this time to UC3, knowing
that UC3 had been obtaining oxycodone
on the street. Finally, after being caught,
convicted and sentenced for writing
illegal prescriptions; after having had
his medical license suspended by the
MBC for writing illegal prescriptions;
after taking courses on writing
prescriptions through PACE; and then
less than three months after he had his
medical license reinstated; he wrote
illegal prescriptions in Texas. This
misconduct, particularly on this
timeline, engenders absolutely no
confidence that the Respondent can be
entrusted with a DEA certificate of
registration.
Recommendation
The Government established that the
Respondent’s continued registration is
inconsistent with the public interest
because of his improper prescribing,
and his state conviction relating to his
unlawful prescribing of controlled
substances. While the Respondent
admitted to many of the Government’s
19 I acknowledge that the Respondent has taken
some remedial steps to reduce the likelihood that
his actions would result in future violations of the
CSA and/or its implementing regulations. See, e.g.,
ALJ–38, at 8–9. Nevertheless, a registrant does not
accept responsibility for its actions simply by taking
remedial measures. Holiday CVS, L.L.C., d/b/a CVS/
Pharmacy Nos. 219 & 5195, 77 FR 62,316, 62,346
(2012). Further, where a registrant has not accepted
responsibility it is not necessary to consider
evidence of the registrant’s remedial measures.
Jones Total Health Care Pharmacy, L.L.C. & SND
Health Care, L.L.C., 81 FR 79,188, 79,202–03 (2016).
*[In this case, Respondent has taken responsibility
for most of the allegations related to his conduct
related to his criminal conviction; however, through
his vacillations, and as a result of his conduct in
Texas, I have reason to doubt the sincerity of his
words. Therefore, I agree with the ALJ that the
egregiousness of his conduct even in the stipulated
facts must be considered in determining whether
sanction is appropriate.]
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
factual allegations, he failed to fully
accept responsibility for his actions.
Furthermore, even had the Respondent
accepted full responsibility, the
egregiousness of his violations may *T
have outweighed his acceptance of
responsibility and the remedial
measures he has taken. Accordingly, I
recommend that the Respondent’s DEA
COR be revoked and that any
application for renewal or modification
of his registration be denied.
Dated: August 28, 2017.
Charles Wm. Dorman,
U.S. Administrative Law Judge.
[FR Doc. 2020–05751 Filed 3–18–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Ainistration
[Docket No. DEA–591]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 18, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on November 6, 2019,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070–
3244 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
Controlled
substance
Gamma Hydroxybutyric
Acid.
Dihydromorphine ..........
Hydromorphinol ............
Methylphenidate ...........
Amobarbital ..................
Pentobarbital ................
Secobarbital ..................
Codeine ........................
Oxycodone ...................
Drug
code
Schedule
2010
I
9145
9301
1724
2125
2270
2315
9050
9143
I
I
II
II
II
II
II
II
*T I changed the word ‘‘would’’ to ‘‘may,’’ because
I decline to foreclose definitively the ability of the
Respondent to have convinced me that he could
have been entrusted with a registration. Most
importantly, in this case he did not
E:\FR\FM\19MRN1.SGM
19MRN1
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
Controlled
substance
Drug
code
Hydromorphone ............
Hydrocodone ................
Methadone ....................
Methadone intermediate
Morphine .......................
Oripavine ......................
Thebaine .......................
Opium tincture ..............
Oxymorphone ...............
Schedule
9150
9193
9250
9254
9300
9330
9333
9630
9652
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
Dated: February 10, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–05748 Filed 3–18–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
jbell on DSKJLSW7X2PROD with NOTICES
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act, the Oil Pollution Act of 1990, and
the Pipeline Safety Laws
On March 13, 2020, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the Central District of
California (‘‘Court’’) in the matter of
United States and the People of the
State of California vs. Plains All
American Pipeline, L.P. et al., Civil
Action No. 2:20–cv–02415 (C.D. Cal.).
The United States filed a Complaint
against Plains All American Pipeline,
L.P. and Plains Pipeline, L.P. (jointly,
‘‘Plains’’) arising out of Plains’
violations of pipeline safety laws and
liability for the May 19, 2015, discharge
of approximately 2,934 barrels of crude
oil from Plains’ Line 901, located near
Refugio State Beach and Santa Barbara,
California. The Complaint seeks
penalties, injunctive relief, and natural
resource damages and assessment costs
for the United States, on behalf of the
United States Department of
Transportation, Pipeline and Hazardous
Materials Safety Administration; the
United States Environmental Protection
Agency; the United States Department
of the Interior; the United States
Department of Commerce, National
Oceanic and Atmospheric
Administration; and the United States
Coast Guard. The United States’ claims
are brought, as applicable, under the
Pipeline Safety Laws, 49 U.S.C. 60101 et
seq.; the Clean Water Act, 33 U.S.C.
1251 et seq.; and the Oil Pollution Act
of 1990, 33 U.S.C. 2701 et seq. The State
of California is a co-plaintiff signatory to
the Complaint under applicable State of
California laws, and a signatory to the
VerDate Sep<11>2014
18:04 Mar 18, 2020
Jkt 250001
proposed Consent Decree, which also
resolves certain State of California
claims.
The proposed Consent Decree
requires Plains to: (1) Pay $24 million in
penalties; 2) implement injunctive relief
to improve Plains’ nationwide pipeline
system, in addition to modifying
operations relating to the May 19, 2015,
oil discharge from Plains’ Line 901; and
3) pay $22.325 million in natural
resource damages. Plains previously
reimbursed the United States and the
State of California approximately $10
million for natural resource damage
assessment costs, and the United States
approximately $4.26 million for removal
or clean-up costs.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States and the People of
the State of California vs. Plains
Pipeline, L.P. et al., D.J. Ref. No. 90–5–
1–1–11340. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .........
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington,
DC 20044–7611.
By mail ...........
During the public comment period,
the lodged proposed Consent Decree
may be examined and downloaded at
this Justice Department website: https://
www.usdoj.gov/enrd/consent-decrees.
We will provide a paper copy of the
Consent Decree upon written request
and payment of reproduction costs.
Please mail your request and payment
to: Consent Decree Library, U.S. DOJ—
ENRD, P.O. Box 7611, Washington, DC
20044–7611.
Please enclose a check or money order
for $25.50 (25 cents per page
reproduction cost) payable to the United
States Treasury, for a paper copy of the
proposed Consent Decree.
Susan M. Akers,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2020–05772 Filed 3–18–20; 8:45 am]
BILLING CODE 4410–CW–P
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
15815
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act; Comprehensive Environmental
Response, Compensation, and Liability
Act; and Emergency Planning and
Community Right-to-Know Act
On March 13, 2020, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the Eastern District of Virginia
in the lawsuit entitled United States and
Commonwealth of Virginia v. Virginia
Electric and Power Company (d/b/a
Dominion Energy Virginia), Civil Action
No. 3:20–cv–00177.
The United States and the
Commonwealth of Virginia filed this
lawsuit for injunctive relief and civil
penalties against Virginia Electric and
Power Company (d/b/a Dominion
Energy Virginia). The United States and
the Commonwealth allege claims under
the Clean Water Act and the Virginia
State Water Control Law for violations
of NPDES permits at certain facilities in
Virginia and West Virginia. In addition,
the United States alleges violations of
the Emergency Planning and
Community Right-to-Know Act and the
Comprehensive Environmental
Response, Compensation, and Liability
Act at the Bellemeade Power Station in
Richmond, Virginia, and the Mt. Storm
Power Station in Grant County, West
Virginia. Finally, the Commonwealth
alleges violations of the Virginia State
Water Control Law relating to certain
unpermitted discharges from the
Chesterfield Power Station in
Chesterfield County, Virginia.
Under the proposed Consent Decree,
Defendant will perform injunctive relief
designed to prevent future violations,
including auditing and implementation
of an environmental management
system, a third party environmental
audit, internal environmental audits,
and training. In addition, Defendant will
pay a total civil penalty of $1.4 million.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States and
Commonwealth of Virginia v. Virginia
Electric and Power Company (d/b/a
Dominion Energy Virginia), D.J. Ref. No.
90–5–1–1–11859. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
- Department of Justice
- Drug Enforcement Ainistration
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15814-15815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05748]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Ainistration
[Docket No. DEA-591]
Bulk Manufacturer of Controlled Substances Application: Siegfried
USA, LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before May 18, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on November 6, 2019, Siegfried USA, LLC, 33 Industrial
Park Road, Pennsville, New Jersey 08070-3244 applied to be registered
as a bulk manufacturer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Dihydromorphine........................ 9145 I
Hydromorphinol......................... 9301 I
Methylphenidate........................ 1724 II
Amobarbital............................ 2125 II
Pentobarbital.......................... 2270 II
Secobarbital........................... 2315 II
Codeine................................ 9050 II
Oxycodone.............................. 9143 II
[[Page 15815]]
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Methadone.............................. 9250 II
Methadone intermediate................. 9254 II
Morphine............................... 9300 II
Oripavine.............................. 9330 II
Thebaine............................... 9333 II
Opium tincture......................... 9630 II
Oxymorphone............................ 9652 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers.
Dated: February 10, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-05748 Filed 3-18-20; 8:45 am]
BILLING CODE 4410-09-P
