Importer of Controlled Substances Application: Siegfried USA, LLC, 71473-71474 [2019-27953]
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Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices
accept responsibility for [the
registrant’s] actions and demonstrate
that [registrant] will not engage in future
misconduct.’’’ Jayam Krishna-Iyer, 74
FR at 463 (quoting Medicine Shoppe, 73
FR 364, 387 (2008)); see also Jackson, 72
FR at 23,853; John H. Kennnedy, M.D.,
71 FR 35,705, 35,709 (2006); Prince
George Daniels, D.D.S., 60 FR 62,884,
62,887 (1995). The issue of trust is
necessarily a fact-dependent
determination based on the
circumstances presented by the
individual respondent; therefore, the
Agency looks at factors, such as the
acceptance of responsibility, and the
credibility of that acceptance as it
relates to the probability of repeat
violations or behavior, and the nature of
the misconduct that forms the basis for
sanction, while also considering the
Agency’s interest in deterring similar
acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
Regarding all of these matters, I agree
with the analyses and conclusions
contained in the R.D.’s
Recommendation. R.D., at 56–59.
Here, the Respondent has accepted
absolutely no responsibility for her
actions. Regarding the allegations of her
lapsed MCSR, she testified and
presented evidence that she had relied
to her detriment on a previous employer
to file on her behalf; however, she also
demonstrated that she had knowledge,
and, possibly even contrary to her
testimony, that she knew directly from
the state, that her MCSR had not been
renewed in October; and yet, she still
continued prescribing controlled
substances without obtaining a new
MCSR until February. Tr. 524–69; RX 2;
see also R.D., at 56–57 (‘‘[H]er testimony
and her reliance on the email
correspondence with [her employer]
leave no doubt that she continues to
adhere to her position that the former
bears all the blame, and she bears
none.’’)
Additionally, Respondent took no
responsibility for the allegations related
to her prescribing practices. Instead, she
provided vague theories about evidence
tampering, unfinished charts and
testified that the Government’s exhibits
were ‘‘not [her] typical notes.’’ Tr. 574–
75, 610, 616; see also R.D., at 57. She
offered no intention of instituting
remedial measures. ‘‘There was no
indication from the Respondent that she
planned to, or already had, improved
her recordkeeping practices when
issuing prescriptions for powerful
controlled substance medications.’’
R.D., at 57.
In sum, I find that the record supports
the imposition of a sanction because the
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18:44 Dec 26, 2019
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Respondent did not unequivocally
accept responsibility.
In sanction determinations, the
Agency has also historically considered
its interest in deterring similar acts, both
with respect to the respondent in a
particular case and the community of
registrants as a whole. See Joseph
Gaudio, M.D., 74 FR 10,083, 10,095
(2009); Singh, 81 FR at 8248. Here, the
interests of specific and general
deterrence ‘‘militate in favor of
revocation.’’ R.D., at 58. Respondent has
evidenced no understanding that her
controlled substance prescribing fell
short of legal requirements.
To the extent that her progress notes fail
to establish an adequate basis for prescribing
powerful controlled drugs, she chalks that up
to the risks attendant upon the practice of a
busy prescriber, and she fails to recognize
any significance of prescriptions issued
before the patient’s previous medication
supply would have been exhausted.
R.D., at 58–59. As such, it is not
reasonable to believe that Respondent’s
future prescribing will comply with
legal requirements. Further, given the
number of Respondent’s violations, a
sanction less than revocation would
send a message to the regulated
community that ‘‘so long as there is
another person available to blame for
failing to file required paperwork, and a
busy . . . practice to blame for
inadequate documentation,’’
compliance with the law is not a
condition precedent to maintaining a
registration. Id. at 59.
In evaluating the egregiousness of
Respondent’s conduct, I agree with the
Chief ALJ that although ‘‘the record did
not paint the picture of a pill mill
operator, this Respondent failed to
exercise the level of care in prescribing
and documenting her prescribing
decisions that would allow a
meaningful evaluation by those charged
with regulating controlled substances.’’
Id. Throughout the hearing, she
vehemently protested against any
acceptance of responsibility,
consistently pinning blame on everyone
and anyone else, even when entirely
implausible, and unsupported by the
evidence, and she demonstrated a
general disdain for the charges against
her and the situation in which she had
found herself. Id.
Accordingly, I find that the factors
weigh in favor of sanction and I shall
order the sanctions the Government
requested, as contained in the Order
below.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f) and 824(a), I hereby revoke DEA
PO 00000
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Certificate of Registration No.
MH0525153 issued to Lisa Hamilton,
N.P. I further hereby deny any pending
application of Lisa Hamilton, N.P. to
renew or modify this registration, as
well as any other pending application of
Lisa Hamilton, N.P. for registration in
Massachusetts. This Order is effective
January 27, 2020. ins
Dated: December 4, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–27945 Filed 12–26–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–572]
Importer 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 January 27, 2020. Such
persons may also file a written request
for a hearing on the application on or
before January 27, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on November 6, 2019,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070
applied to be registered as an importer
of the following basic classes of
controlled substances:
DATES:
Controlled substance
Opium, raw .....................
Poppy Straw Concentrate.
E:\FR\FM\27DEN1.SGM
27DEN1
Drug
code
Schedule
9600
9670
II
II
71474
Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices
The company plans to import the
listed controlled substances to
manufacture bulk active pharmaceutical
ingredients (API) for distribution to its
customers.
Dated: December 10, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–27953 Filed 12–26–19; 8:45 am]
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
ADDRESSES:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–552]
Importer of Controlled Substances
Application: Myoderm
ACTION:
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 January 27, 2020. Such
persons may also file a written request
for a hearing on the application on or
before January 27, 2020.
DATES:
Notice of application.
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 14, 2019,
Myoderm, 48 East Main Street,
Norristown, Pennsylvania 19401–4915
applied to be registered as an importer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Amphetamine ...........................................................................................................................................................
Lisdexamfetamine ....................................................................................................................................................
Methylphenidate .......................................................................................................................................................
Nabilone ...................................................................................................................................................................
Oxycodone ...............................................................................................................................................................
Hydromorphone .......................................................................................................................................................
Hydrocodone ............................................................................................................................................................
Morphine ..................................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to import the
listed controlled substances for clinical
trials, research, and analytical purposes.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[FR Doc. 2019–27952 Filed 12–26–19; 8:45 am]
ADDRESSES:
Drug Enforcement Administration
Controlled substance
BILLING CODE 4410–09–P
[Docket No. DEA–566]
jbell on DSKJLSW7X2PROD with NOTICES
Dated: December 10, 2019.
William T. McDermott,
Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2019–27954 Filed 12–26–19; 8:45 am]
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
DATES:
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18:44 Dec 26, 2019
Jkt 250001
SUPPLEMENTARY INFORMATION:
Methylphenidate .......
Hydromorphone ........
Hydrocodone ............
Oripavine ..................
Thebaine ...................
Tapentadol ................
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals Inc.
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
comments on or objections to the
issuance of the proposed registration on
or before February 25, 2020.
In
accordance with 21 CFR 1301.33(a), this
is notice that on October 9, 2019,
Janssen Pharmaceuticals Inc., Buildings
1–5 & 7–14, 1440 Olympic Drive,
Athens, Georgia 30601 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
Dated: November 13, 2019.
William T. McDermott,
Acting Assistant Administrator.
Schedule
Drug
code
1724
9150
9193
9330
9333
9780
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BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Notice To Ensure State Workforce
Agencies Are Aware of the Revised
Schedule of Remuneration for the
Unemployment Compensation for ExService Members (UCX) Program That
Reflects the Military Pay Increase
Effective January 1, 2020
Employment and Training
Administration, Labor.
ACTION: Notice.
AGENCY:
Schedule
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The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
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II
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Each year, the Department of
Defense issues a Schedule of
Remuneration used by states for UCX
purposes. States must use the schedule
to determine Federal military wages for
UCX ‘‘first claims’’ only when the
Federal Claims Control Center (FCCC)
responds to a request for information
indicating that there is no Copy 5 of the
SUMMARY:
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[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71473-71474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27953]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-572]
Importer 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 January 27, 2020.
Such persons may also file a written request for a hearing on the
application on or before January 27, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on November 6, 2019, Siegfried USA, LLC, 33 Industrial
Park Road, Pennsville, New Jersey 08070 applied to be registered as an
importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Opium, raw............................. 9600 II
Poppy Straw Concentrate................ 9670 II
------------------------------------------------------------------------
[[Page 71474]]
The company plans to import the listed controlled substances to
manufacture bulk active pharmaceutical ingredients (API) for
distribution to its customers.
Dated: December 10, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27953 Filed 12-26-19; 8:45 am]
BILLING CODE 4410-09-P
