Importer of Controlled Substances Registration, 5478-5479 [2019-02866]
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5478
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
Controlled substance
Drug
code
Cocaine ....................
Codeine ....................
Dihydrocodeine .........
Oxycodone ...............
Hydromorphone ........
Diphenoxylate ...........
Ecgonine ...................
Hydrocodone ............
Meperidine ................
Methadone ................
Methadone intermediate.
Morphine ...................
Thebaine ...................
Opium tincture ..........
Oxymorphone ...........
Noroxymorphone ......
Alfentanil ...................
Remifentanil ..............
Sufentanil ..................
Tapentadol ................
Fentanyl ....................
Schedule
9041
9050
9120
9143
9150
9170
9180
9193
9230
9250
9254
II
II
II
II
II
II
II
II
II
II
II
9300
9333
9630
9652
9668
9737
9739
9740
9780
9801
II
II
II
II
II
II
II
II
II
II
below. No comments or objections were
submitted for this notice.
Company
Sigma Aldrich
Research.
FR docket
Published
83 FR 54613
October 30, 2018.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
manufacture the applicable basic classes
of controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
In reference to drug codes 7360
(Marijuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetic. No other
activities for these drug codes are
authorized for this registration.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
Myoderm ......
83 FR 66751
December 27, 2018.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrant to import the applicable
basic class of schedule II controlled
substances is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule II controlled substances to the
above listed company.
Dated: February 11, 2019.
John J. Martin,
Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and has been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of controlled
substances. Information on the previous
published notice are listed in the table
Company
Jkt 247001
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
schedule I or schedule II controlled
substances.
The
companies listed below applied to be
registered as importers of various basic
classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
SUPPLEMENTARY INFORMATION:
FR docket
Janssen Pharmaceuticals, Inc ..........................................
Lipomed ............................................................................
Akorn, Inc ..........................................................................
Cambridge Isotope Laboratories ......................................
GE Healthcare ..................................................................
Fisher Clinical Services, Inc .............................................
17:08 Feb 20, 2019
[Docket No. DEA–392]
SUMMARY:
The registrant listed below
has applied for and has been granted
registration by the Drug Enforcement
Administration (DEA) as an importer of
schedule II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as an importer of a basic class
of controlled substance. Information on
the previously published notice is listed
in the table below. No comments or
objections were submitted and no
requests for hearing were submitted for
this notice.
SUMMARY:
Notice of registration.
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Published
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
VerDate Sep<11>2014
FR docket
[FR Doc. 2019–02870 Filed 2–20–19; 8:45 am]
[FR Doc. 2019–02869 Filed 2–20–19; 8:45 am]
[FR Doc. 2019–02882 Filed 2–20–19; 8:45 am]
ACTION:
Company
PO 00000
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83
83
83
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FR
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Published
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November
November
November
November
November
November
20,
20,
27,
27,
27,
27,
2018.
2018.
2018.
2018.
2018.
2018.
Federal Register / Vol. 84, No. 35 / Thursday, February 21, 2019 / Notices
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrants to import the
applicable basic classes of schedule I or
II controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or schedule II controlled
substances to the above listed
companies.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–02866 Filed 2–20–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–01]
Ajay S. Ahuja, M.D.; Decision and
Order
amozie on DSK3GDR082PROD with NOTICES1
On May 25, 2017, Administrative Law
Judge (ALJ) Charles Wm. Dorman issued
the attached Recommended Decision
(R.D.).1 Neither party filed exceptions to
the ALJ’s Recommended Decision.
Having reviewed the entire record, I
have decided to adopt the ALJ’s findings
of fact as modified,2 conclusions of law,
and recommended sanction except as
explained below.
Respondent’s Registration Status
Respondent is the holder of DEA
Certificate of Registration AA3029293,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V as a practitioner,
at the registered address of 825 High
Ridge Road, Stamford, Connecticut.
Government Exhibit (GX) 1, at 1.
Although not alleged in the Order to
Show Cause, see Administrative Law
1 All citations to the Recommended Decision are
to the slip opinion issued by the ALJ.
2 I have modified the Recommended Decision by
replacing the full name of DEA and state law
enforcement officials with their initials. I have
indicated where I have made these modifications in
the Recommended Decision with brackets.
VerDate Sep<11>2014
17:08 Feb 20, 2019
Jkt 247001
Judge Exhibit (ALJ Ex.) 1, I also find that
the administrative record in this case
and this Agency’s registration records,
of which I take official notice,3 show
that Respondent is the holder of DATAWaiver Identification Number
XA3029293. See GX 1, at 1.
Respondent’s DATA-Waiver authority
authorized him to dispense or prescribe
schedule III–V narcotic controlled
substances which ‘‘have been approved
by the Food and Drug Administration
. . . specifically for use in maintenance
or detoxification treatment’’ for up to
275 patients. 21 CFR 1301.28(a) &
(b)(1)(iii).
Respondent’s registration was due to
expire on June 30, 2017. GX 1, at 1.
Although the ALJ correctly indicated
that the record before him did ‘‘not
contain evidence that the Respondent
filed an application of renewal,’’ R.D., at
2 n.1, the Agency’s registration records
do indicate, and I take official notice,4
that Respondent submitted a renewal
application on May 9, 2017. Because
Respondent has submitted a timely
renewal application, I find that
Respondent’s registration has remained
in effect pending the issuance of this
Decision and Final Order. See 5 U.S.C.
558(c); 21 CFR 1301.36(i). Moreover,
because Respondent’s DATA-Waiver
authority is contingent on Respondent
being a practitioner with a valid DEA
registration, see 21 U.S.C. 823(g)(2)(A);
21 CFR 1301.28(a), I find that
Respondent’s DATA-Waiver authority
also remained in effect pending
issuance of this Decision and Final
Order. Thus, this case remains a live
controversy, and I have jurisdiction to
decide this matter.
Respondent’s Corrective Action Plan
After submitting a timely request for
a hearing on October 6, 2016, see ALJ
Ex. 2, Respondent submitted a
Corrective Action Plan (CAP) pursuant
to 21 U.S.C. 824(c)(2)(C) on October 25,
2016 to the Deputy Assistant
Administrator of DEA’s Office of
Diversion Control. ALJ Ex. 9. As part of
his CAP, Respondent promised that he:
3 Under 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 15 calendar days of service
of this order which shall commence on the date this
order is mailed.
4 I take official notice of this fact pursuant to the
same authority set forth supra in footnote 3.
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
5479
(1) ‘‘will not order or dispense
controlled substances;’’ (2) ‘‘will no
longer prescribe controlled substances
to his family members;’’ (3) ‘‘will retain
an independent monitor to review and
evaluate his practice;’’ (4) ‘‘will
continue to educate himself on issues
related to drug diversion and enroll in
related continuing medical education;’’
(5) ‘‘will cooperate with DEA in a
candid and truthful manner in future
communications with DEA;’’ and (6)
‘‘will authorize DEA to access all his
prescribing records for controlled
substances in the Connecticut
Prescription Monitoring and Reporting
System (‘CPMRS’).’’ Id. at 2–3.
On November 4, 2016, the Assistant
Administrator of DEA’s Diversion
Control Division rejected Respondent’s
CAP and further ‘‘determined there is
no potential modification of your [ ]CAP
that could or would alter my decision in
this regard.’’ See Exhibit A (Letter from
then-Assistant Administrator Louis J.
Millione to Respondent (dated
November 4, 2016)) to ALJ Ex. 11, at 1.
I conclude that the facts set forth in the
adopted Recommended Decision
demonstrate that the Agency had
adequate grounds to deny Respondent’s
CAP. Thus, I agree with the Agency’s
denial of Respondent’s CAP, and I too
reject it.
Pre-Hearing Identification of
Documents Used To Impeach a Witness
on Cross-Examination
In his Recommended Decision, the
ALJ criticized the Government’s use of
the Respondent’s earlier deposition
testimony 5 to impeach Respondent
during cross-examination because, inter
alia, ‘‘the Government had not
identified the deposition transcript as a
document it intended to use prior to the
hearing.’’ R.D., at 10. I do not adopt the
ALJ’s suggestion that a party is
precluded from using information or a
document to impeach a witness during
cross-examination unless it is identified
prior to the administrative hearing. The
APA states that ‘‘[a] party is entitled
. . . to conduct such cross-examination
as may be required for a full and true
disclosure of the facts.’’ 5 U.S.C. 556(d).
Likewise, Agency precedent has applied
this APA standard to hold that ALJs lack
the authority to preclude a party from
using relevant information to impeach a
witness during cross-examination. See
Trinity II, 83 FR 7304, 7322 n.43 (2018)
5 The deposition of Respondent apparently
occurred in connection with a civil case brought by
the United States Attorney’s Office for the District
of Connecticut against Respondent. See Transcript
61–62, 64, 109–10, 291; United States v. Ahuja, No.
3:14–CV–1558, 2017 WL 1807561 (D. Conn. May 5,
2017), aff’d, 736 F. App’x 20 (2d Cir. 2018).
E:\FR\FM\21FEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5478-5479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02866]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: The registrants listed below have applied for and been granted
registration by the Drug Enforcement Administration (DEA) as importers
of schedule I or schedule II controlled substances.
SUPPLEMENTARY INFORMATION: The companies listed below applied to be
registered as importers of various basic classes of controlled
substances. Information on previously published notices is listed in
the table below. No comments or objections were submitted and no
requests for hearing were submitted for these notices.
------------------------------------------------------------------------
Company FR docket Published
------------------------------------------------------------------------
Janssen Pharmaceuticals, Inc.. 83 FR 58598........... November 20,
2018.
Lipomed....................... 83 FR 58601........... November 20,
2018.
Akorn, Inc.................... 83 FR 60896........... November 27,
2018.
Cambridge Isotope Laboratories 83 FR 60897........... November 27,
2018.
GE Healthcare................. 83 FR 60899........... November 27,
2018.
Fisher Clinical Services, Inc. 83 FR 60900........... November 27,
2018.
------------------------------------------------------------------------
[[Page 5479]]
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the registration of the listed registrants
to import the applicable basic classes of schedule I or II controlled
substances is consistent with the public interest and with United
States obligations under international treaties, conventions, or
protocols in effect on May 1, 1971. The DEA investigated each of the
company's maintenance of effective controls against diversion by
inspecting and testing each company's physical security systems,
verifying each company's compliance with state and local laws, and
reviewing each company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in
accordance with 21 CFR 1301.34, the DEA has granted a registration as
an importer for schedule I or schedule II controlled substances to the
above listed companies.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-02866 Filed 2-20-19; 8:45 am]
BILLING CODE 4410-09-P
