Importer of Controlled Substances Application: Catalent CTS, LLC, 54613-54614 [2018-23686]
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54613
Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Sigma Aldrich
Research
ACTION:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
DEPARTMENT OF JUSTICE
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 December 31, 2018.
DATES:
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
SUPPLEMENTARY INFORMATION:
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
delegated 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 June
14, 2018, Sigma Aldrich Research, 1–3
Strathmore Road, Natick, Massachusetts
01760–2447 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Drug code
Cathinone ........................................................................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) .......................................................................................................................
Heroin ..............................................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Nabilone ...........................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
issuance of the proposed registration on
or before November 29, 2018. Such
persons may also file a written request
for a hearing on the application on or
before November 29, 2018.
The company plans to manufacture
reference standards.
Dated: October 11, 2018.
John J. Martin,
Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSK30JT082PROD with NOTICES
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent CTS, 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
DATES:
VerDate Sep<11>2014
17:34 Oct 29, 2018
Jkt 247001
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
[FR Doc. 2018–23695 Filed 10–29–18; 8:45 am]
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9801
Schedule
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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 July 17,
2018, Catalent CTS, LLC, 10245
Hickman Mills Drive, Kansas City,
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Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices
[FR Doc. 2018–23686 Filed 10–29–18; 8:45 am]
dispense controlled substances in
schedules II through V as a practitioner.
Id. The OSC alleges that this registration
expires on December 31, 2018. Id.
The substantive ground for the
proceeding, as alleged in the OSC, is
that Registrant is ‘‘without authority to
handle controlled substances in New
Hampshire, the state in which [he is]
registered with the DEA.’’ Id.
Specifically, the OSC alleges that the
State of New Hampshire Board of
Medicine (hereinafter, Board) issued an
Order of Emergency License Suspension
and Notice of Hearing on September 25,
2017. Id. at 1–2. On the following day,
September 26, 2017, Registrant entered
into a written agreement ‘‘not to practice
medicine [including the writing of]
prescriptions . . . until further order of
the Board.’’ Id. at 2.
The OSC notifies Registrant of his
right to request a hearing on the
allegations or to submit a written
statement while waiving his right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. (citing 21 CFR
1301.43). The OSC also notifies
Registrant of the opportunity to submit
a corrective action plan. OSC, at 2–3
(citing 21 U.S.C. 824(c)(2)(C)).
BILLING CODE 4410–09–P
Adequacy of Service
Missouri 64137–1418 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled substance
Gamma Hydroxybutyric
Acid.
Marihuana Extract .............
Marihuana .........................
Tetrahydrocannabinols .....
Drug
code
Schedule
2010
I
7350
7360
7370
I
I
I
The company plans to import finished
dosage unit products containing gammahydroxybutryic acid and marihuana
extracts for clinical trial studies. These
marihuana extracts compounds are
listed under drug code 7350. No other
activity for these drug codes is
authorized for this registration.
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.
Dated: October 19, 2018.
John J. Martin,
Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSK30JT082PROD with NOTICES
Eric Lee Knight, M.D.; Decision and
Order
On February 6, 2018, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Eric Lee Knight, M.D.
(hereinafter, Registrant), of Derry, New
Hampshire. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposes the revocation of Registrant’s
Certificate of Registration on the ground
that he does ‘‘not have authority to
handle controlled substances in the
State of New Hampshire, the state in
which . . . [he is] registered with the
DEA.’’ Id. (citing 21 U.S.C. 823(f) and
824(a)(3)).
Regarding jurisdiction, the OSC
alleges that Registrant holds DEA
Certificate of Registration No.
BK7282940 at the registered address of
93 1⁄2 Walnut Hill Road, Derry, New
Hampshire 03038.1 OSC, at 1. This
registration authorizes Registrant to
1 The OSC erroneously lists the number of
Registrant’s address on Walnut Hill Road as 92 1⁄2.
VerDate Sep<11>2014
17:34 Oct 29, 2018
Jkt 247001
In a Declaration dated April 27, 2018,
a Diversion Investigator (hereinafter,
DI), who describes herself as being
assigned to the DEA Boston Field
Division-Manchester (New Hampshire)
District Office, states that after two
unsuccessful attempts at serving the
OSC on Registrant, she and two Task
Force Officers traveled to the residence
of Registrant on February 16, 2018, and
‘‘[a]fter displaying our credentials to Dr.
Knight, I presented the original copy of
the . . . [OSC] to Dr. Knight.’’
(Government Exhibit (hereinafter, GX) 8
at 2–3 (Declaration of DEA Diversion
Investigator).
In its Request for Final Agency Action
dated May 3, 2018, the Government
represents that ‘‘[m]ore than 30-days
have passed since Registrant received
the . . . [OSC]; however, Registrant has
not submitted to DEA a request for
hearing.’’ Request for Final Agency
Action, at 2. In its Request for Final
Agency Action—Addendum dated
September 26, 2018, the Government
represents that Registrant has not
‘‘corresponded in writing or otherwise
with regard to his position on a hearing
before DEA.’’ Request for Final Agency
Action—Addendum, at 2. The
Government requests the issuance of a
Final Order revoking Registrant’s DEA
registration. Id. at 4.
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Fmt 4703
Sfmt 4703
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government personally served the
OSC on Registrant on February 16, 2018.
I also find that more than 30 days have
now passed since the date the
Government served the OSC. Further,
based on the Government’s written
representations, I find that neither
Registrant, nor anyone purporting to
represent him, requested a hearing,
submitted a written statement while
waiving Registrant’s right to a hearing,
or submitted a corrective action plan.
Accordingly, I find that Registrant has
waived his right to a hearing and his
right to submit a written statement and
corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I,
therefore, issue this Decision and Order
based on the record submitted by the
Government, which constitutes the
entire record before me. 21 CFR
1301.43(e).
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BK7282940 at the registered address of
93 1⁄2 Walnut Hill Road, Derry, New
Hampshire 03038. GX 1 (Certification of
Registration), at 1. Pursuant to this
registration, Registrant is authorized to
dispense controlled substances in
schedules II through V as a practitioner.
Id. Registrant’s registration expires on
December 31, 2018. Id.
The Status of Registrant’s State License
In this case, the Board issued an
Order of Emergency License Suspension
and Notice of Hearing on September 25,
2017. The Board’s Order suspended
Registrant’s New Hampshire medical
license until further order of the Board.
GX 3 (Order of Emergency License
Suspension and Notice of Hearing), at
13. On October 9, 2017, the Board
accepted Registrant’s agreement ‘‘not to
practice medicine . . . [including the
writing of] prescriptions . . . until
further order of the Board.’’ GX 4
(Preliminary Agreement Not to
Practice), at 1.
According to New Hampshire’s online
records, of which I take official notice,
Registrant’s license to practice medicine
is still suspended.2 New Hampshire
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
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]]>Agencies
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54613-54614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23686]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent CTS, 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 November 29, 2018.
Such persons may also file a written request for a hearing on the
application on or before November 29, 2018.
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
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/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:
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 July
17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City,
[[Page 54614]]
Missouri 64137-1418 applied to be registered as an importer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............. 2010 I
Marihuana Extract..................... 7350 I
Marihuana............................. 7360 I
Tetrahydrocannabinols................. 7370 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing gamma-hydroxybutryic acid and marihuana extracts for
clinical trial studies. These marihuana extracts compounds are listed
under drug code 7350. No other activity for these drug codes is
authorized for this registration. 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 non-approved finished dosage
forms for commercial sale.
Dated: October 19, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23686 Filed 10-29-18; 8:45 am]
BILLING CODE 4410-09-P
