Importer of Controlled Substances Application: Spex Certiprep Group, LLC, 42120 [2017-18788]
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42120
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / 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
1301.34(a), this is notice that on July 18,
2016, KVK–Tech, Inc., 110 Terry Drive,
Newtown, Pennsylvania 18940 applied
to be registered as an importer of
Lisdexamfetamine (1205), a basic class
of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research,
and analytical purposes. 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: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18787 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
(2) Drug Enforcement Administration,
Attn: 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 of subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
31, 2016, Spex Certiprep Group, LLC,
203 Norcross Avenue, Metuchen, New
Jersey 08840 applied to be registered as
an importer of the following basic
classes of controlled substances:
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Marihuana ...............................
Tetrahydrocannabinols ...........
7360
7370
Schedule
I
I
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Spex Certiprep Group,
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
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before October 6, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
2017.
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
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to import a synthetic
cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18788 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
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
DATES:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before October 6, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
2017.
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
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
December 9, 2016, Mylan
Pharmaceuticals, Inc., 781 Chestnut
Ridge Road, Morgantown, West Virginia
26505 applied to be registered as an
importer of the following basic classes
of controlled substances:
Amphetamine ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
Drug
code
1100
1724
9143
9150
9250
9300
9801
Schedule
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
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Page 42120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18788]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Spex Certiprep
Group, 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 in accordance with 21 CFR
1301.34(a) on or before October 6, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 6, 2017.
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 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
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 of subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
October 31, 2016, Spex Certiprep Group, LLC, 203 Norcross Avenue,
Metuchen, New Jersey 08840 applied to be registered as an importer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
sale to research facilities for drug testing and analysis.
In reference to drug codes 7360 (marihuana) and 7370 (THC), the
company plans to import a synthetic cannabidiol and a synthetic
tetrahydrocannabinol. No other activity for these drug codes is
authorized for this registration.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-18788 Filed 9-5-17; 8:45 am]
BILLING CODE 4410-09-P
