Importer of Controlled Substances Application: Rhodes Technologies, 22517-22518 [2018-10302]
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on April
5, 2017, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Thebaine .................................
Noroxymorphone ....................
9333
9668
II
II
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredient
(API) for supply to its customers.
Dated: May 1, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10303 Filed 5–14–18; 8:45 am]
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on April
18, 2018, Mylan Pharmaceuticals, Inc.,
3711 Collins Ferry Road, Morgantown,
West Virginia 26505 applied to be
registered as an importer of the
following basic classes of controlled
substances:
BILLING CODE 4410–09–P
Amphetamine ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
Inc.
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 June 14, 2018. Such persons
may also file a written request for a
hearing on the application on or before
June 14, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
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.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10301 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Rhodes Technologies
ACTION:
Tetrahydrocannabinols ...........
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Hydrocodone ...........................
Morphine .................................
Opium, raw .............................
Oxymorphone .........................
Poppy Straw Concentrate .......
7370
1724
9143
9150
9193
9300
9600
9652
9670
I
II
II
II
II
II
II
II
II
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 June 14, 2018. Such persons
may also file a written request for a
DATES:
PO 00000
hearing on the application on or before
June 14, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on April
6, 2018, Rhodes Technologies, 498
Washington Street, Coventry, Rhode
Island 02816 applied to be registered as
an importer of the following basic
classes of controlled substances:
Frm 00077
Fmt 4703
Sfmt 4703
The company plans to import opium,
raw (9600) and poppy straw concentrate
(9670) in order to bulk manufacture
controlled substances in Active
Pharmaceutical Ingredient (API) form.
The company distributes the
manufactured APIs in bulk to its
customers.
E:\FR\FM\15MYN1.SGM
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
On October 31, 2017, the Acting
Assistant Administrator, Diversion
Control Division, issued an Order to
Show Cause to Donald Kenneth
Shreves, D.V.M. (Respondent), of
Pottstown, Pennsylvania. The Show
Cause Order proposed the revocation of
Respondent’s Certificate of Registration
on the ground that he does ‘‘not have
authority to handle controlled
substances in the State of Pennsylvania,
the [S]tate in which [he is] registered
with the’’ Agency. Show Cause Order, at
1.
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that Respondent is registered ‘‘as
a practitioner in [s]chedules II–V under
. . . registration number BS5342934,’’ at
the location of ‘‘1361C Farmington Ave.,
Pottstown, Pennsylvania.’’ Id. The Order
further alleged that Respondent’s
registration was due to expire on
February 28, 2018. Id.
As the substantive ground for the
proceeding, the Show Cause Order
alleged that on September 28, 2017, the
Pennsylvania Board of Veterinary
Medicine ‘‘issued an Order of
Temporary Suspension’’ of his
veterinary medicine license. Id. at 1–2.
The Order alleged that as a consequence
of the Board’s action, Respondent is
currently ‘‘without to handle controlled
substances in . . . Pennsylvania, the
[S]tate in which’’ he is registered, and
therefore, his registration should be
revoked. Id. at 2.
The Show Cause Order notified
Respondent of his right to request a
hearing or to submit a written statement
while waiving his right to a hearing, the
procedure for electing either option, and
the consequence of failing to elect either
option. Id. at 2 (citing 21 CFR 1301.43).
The Order also notified Respondent of
his right to submit a corrective action
plan. Id. at 2–3 (citing 21 U.S.C.
824(c)(2)(C)).
On November 8, 2017, Respondent
was personally served with the Show
Cause Order, and on December 8, 2018,
Respondent requested a hearing. Resp.
Hrng. Req. at 1. The matter was placed
on the docket of the Office of
Administrative Law Judges and assigned
to ALJ Charles Wm. Dorman, who, on
December 11, 2017, issued an order
setting the briefing schedule. See
Briefing Schedule for Lack of State
Authority Allegations, at 1.
On January 4, 2018, the Government
submitted a Motion for Summary
Disposition; as support for its motion,
the Government attached a copy of the
Board’s Suspension Order and a
Declaration of a DEA Task Force Office
that Respondent’s Veterinary License
remained suspended as of January 2,
2017, when she queried the Board’s
website. Mot. for Summ. Disp.,
Attachments 3; 5; 6, at 2. On January 10,
2018, Respondent filed his reply and
admitted that he was currently without
authority to handle controlled
substances in Pennsylvania. Resp.’s
Reply to Govt. Mot. for Summ. Disp., at
1.
On January 11, 2018, the ALJ issued
his Recommended Decision (R.D.).
Therein, the ALJ found that there was
no dispute over the material fact that
Respondent lacks authority to dispense
controlled substances in Pennsylvania.
Id. at 5–6. The ALJ thus granted the
Government’s Motion for Summary
Disposition and recommended that
Respondent’s registration be revoked.
Id.
Neither party filed exceptions to the
Recommended Decision. On February 6,
2018, the ALJ forwarded the record to
my Office.
Having reviewed the record, I hold
that this proceeding is now moot. The
evidence in the record establishes that
Respondent’s registration was due to
expire on February 28, 2018, and
according to the Agency’s registration
record for Respondent of which I take
official notice,1 he has not submitted an
application to renew his registration.
1 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
The company plans to import the
other listed controlled substances for
internal reference standards use only.
The comparisons of foreign reference
standards to the company’s
domestically manufactured API will
allow the company to export
domestically manufactured API to
foreign markets.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10302 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[No. 18–12]
daltland on DSKBBV9HB2PROD with NOTICES
Donald Kenneth Shreves, D.V.M.;
Dismissal of Proceeding
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
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Frm 00078
Fmt 4703
Sfmt 4703
Accordingly, I find that Respondent’s
registration expired on February 28,
2018 and that there is no application to
act upon.
DEA has long held that ‘‘ ‘if a
registrant has not submitted a timely
renewal application prior to the
expiration date, then the registration
expires and there is nothing to
revoke.’ ’’ Donald Brooks Reece II, M.D.,
77 FR 35054, 35055 (2012) (quoting
Ronald J. Riegel, 63 FR 67312, 67133
(1998)); see also Thomas E. Mitchell, 76
FR 20032, 20033 (2011). ‘‘Moreover, in
the absence of an application (whether
timely filed or not), there is nothing to
act upon.’’ Reece, 77 FR at 35055.
Accordingly, because Respondent has
allowed his registration to expire and
did not file an application to renew his
registration or for any other registration
in Pennsylvania, this case is now moot
and will be dismissed.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I order that the Order to Show
Cause issued to Donald K. Shreves,
D.V.M., be, and it hereby is, dismissed.
This Order is effective immediately.
Dated: May 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–10305 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
companies listed below applied to be
registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
SUMMARY:
opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
reconsideration within fifteen calendar days of
service of this order which shall commence on the
date this order is mailed.
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22517-22518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10302]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Rhodes
Technologies
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 June 14, 2018. Such
persons may also file a written request for a hearing on the
application on or before June 14, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417, (January 25, 2007).
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been redelegated
to the Assistant Administrator of the DEA Diversion Control Division
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on April
6, 2018, Rhodes Technologies, 498 Washington Street, Coventry, Rhode
Island 02816 applied to be registered as an importer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols.................. 7370 I
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Morphine............................... 9300 II
Opium, raw............................. 9600 II
Oxymorphone............................ 9652 II
Poppy Straw Concentrate................ 9670 II
------------------------------------------------------------------------
The company plans to import opium, raw (9600) and poppy straw
concentrate (9670) in order to bulk manufacture controlled substances
in Active Pharmaceutical Ingredient (API) form. The company distributes
the manufactured APIs in bulk to its customers.
[[Page 22518]]
The company plans to import the other listed controlled substances
for internal reference standards use only. The comparisons of foreign
reference standards to the company's domestically manufactured API will
allow the company to export domestically manufactured API to foreign
markets.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10302 Filed 5-14-18; 8:45 am]
BILLING CODE 4410-09-P
