Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 13521 [2018-06325]
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13521
Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sharp Clinical Services,
INC.
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 April
30, 2018. Such persons may also file a
written request for a hearing on the
application on or before April 30, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
DATES:
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
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
February 2, 2018, Sharp Clinical
Services INC., 300 Kimberton Rd.,
Phoenixville, PA 19460 applied to be
registered as an importer of the
following basic classes of controlled
substances:
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Marihuana ........................................................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
Psilocybin .........................................................................................................................................................................
The company plans to import the
listed controlled substances for
analytical research, testing, and clinical
trials. 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: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06319 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
sradovich on DSK3GMQ082PROD with NOTICES
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration on or before May
29, 2018.
DATES:
VerDate Sep<11>2014
19:09 Mar 28, 2018
Jkt 244001
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
1301.33(a), this is notice that on
September 13, 2017, Navinta LLC, 1499
Lower Ferry Rd. Ewing, NJ 08618
applied to be registered as a bulk
manufacturer for the basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Controlled substance
2010
7360
7405
7437
Drug code
Pentobarbital ....
4-Anilino-Nphenethyl-4piperidine
(ANPP).
Levorphanol ......
Remifentanil ......
Fentanyl ............
Schedule
I
I
I
I
Schedule
2270
8333
II
II
9220
9739
9801
II
II
II
The company plans to initially
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–06325 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
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
DATES:
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06325]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before May 29, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
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 1301.33(a), this is notice that on
September 13, 2017, Navinta LLC, 1499 Lower Ferry Rd. Ewing, NJ 08618
applied to be registered as a bulk manufacturer for the basic classes
of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Pentobarbital...................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Levorphanol........................ 9220 II
Remifentanil....................... 9739 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to initially manufacture API quantities of the
listed controlled substances for validation purposes and FDA approval.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06325 Filed 3-28-18; 8:45 am]
BILLING CODE 4410-09-P
