Bulk Manufacturer of Controlled Substances Registration, 22518-22519 [2018-10304]
Download as PDF
<![CDATA[
22518
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
PO 00000
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
22519
Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
Company
FR Docket
Patheon Pharmaceuticals, Inc ................................................................
Chattem Chemicals, Inc ..........................................................................
INSYS Manufacturing LLC ......................................................................
Siemens Healthcare Diagnostics Inc ......................................................
Cerilliant Corporation ...............................................................................
Noramco, Inc ...........................................................................................
Johnson Matthey, Inc ..............................................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants 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 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.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
Dated: May 7, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–10304 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: Xcelience
ACTION:
Notice of application.
Registered bulk importers 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 request for hearing
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
83
83
83
83
83
83
83
FR
FR
FR
FR
FR
FR
FR
5274
5274
5810
5812
5809
5808
7221
....................................
....................................
....................................
....................................
....................................
....................................
....................................
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)
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
11, 2018, Xcelience, 4901 West Grace
Street, Tampa, FL 33607 applied to be
registered as an importer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
Drug code
Amphetamine ...
1100
Schedule
II
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research
and analytical purposes.
The import of this class of controlled
substance will be granted only for
analytical testing, research and clinical
trials. This authorization does not
extend to the import of a finished FDA
approved or non-approved dosage form
for commercial sale.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Published
February
February
February
February
February
February
February
6, 2018.
6, 2018.
9, 2018.
9, 2018.
9, 2018.
9, 2018.
20, 2018.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10300 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0064]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension,
Without Change, of a Currently
Approved Collection; FBI
Expungement Form (FD–1114)
Criminal Justice Information
Services Division, Federal Bureau of
Investigation, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Criminal Justice Information
Services (CJIS) Division, will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies.
DATES: Comments are encouraged and
will be accepted for 60 days until July
16, 2018.
FOR FURTHER INFORMATION CONTACT:
If you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Gerry Lynn Brovey, Supervisory
Information Liaison Specialist, FBI,
CJIS, Resources Management Section,
Administrative Unit, Module C–2, 1000
Custer Hollow Road, Clarksburg, West
Virginia, 26306 (facsimile: 304–625–
5093) or email glbrovey@ic.fbi.gov.
Written comments and/or suggestions
can also be sent to the Office of
Management and Budget, Office of
Information and Regulatory Affairs,
Attention Department of Justice Desk
Officer, Washington, DC 20503.
SUMMARY:
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22518-22519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10304]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: 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.
[[Page 22519]]
------------------------------------------------------------------------
Company FR Docket Published
------------------------------------------------------------------------
Patheon Pharmaceuticals, Inc.... 83 FR 5274........ February 6, 2018.
Chattem Chemicals, Inc.......... 83 FR 5274........ February 6, 2018.
INSYS Manufacturing LLC......... 83 FR 5810........ February 9, 2018.
Siemens Healthcare Diagnostics 83 FR 5812........ February 9, 2018.
Inc.
Cerilliant Corporation.......... 83 FR 5809........ February 9, 2018.
Noramco, Inc.................... 83 FR 5808........ February 9, 2018.
Johnson Matthey, Inc............ 83 FR 7221........ February 20, 2018.
------------------------------------------------------------------------
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of these registrants 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 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. 823(a), and in accordance with 21
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer
to the above listed companies.
Dated: May 7, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-10304 Filed 5-14-18; 8:45 am]
BILLING CODE 4410-09-P
