Importer of Controlled Substances Application: Catalent Centers, LLC, 43569-43570 [2017-19833]
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Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Register pursuant to Section 6(b) of the
Act on June 28, 2017 (82 FR 29328).
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals LLC
BILLING CODE P
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
[FR Doc. 2017–19791 Filed 9–15–17; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
Importer of Controlled Substances
Application: Catalent Centers, LLC
ACTION:
Notice of application.
sradovich on DSKBBY8HB2PROD with NOTICES
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—fd.Io Project, Inc.
Notice is hereby given that, on August
24, 2017, pursuant to Section 6(a) of the
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301
et seq. (‘‘the Act’’), fd.io Project, Inc.
(‘‘fd.io’’) has filed written notifications
simultaneously with the Attorney
General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, ARM Ltd., Cambridge,
UNITED KINGDOM; Linaro Limited,
Cambridge, UNITED KINGDOM;
Rubicon Communications LLC dba
Netgate, Austin, TX; and CENGN
(Centre of Excellence in Next
Generation Networks), Ottawa,
CANADA, have been added as parties to
this venture.
Also, Brocade Communications
Systems, Inc., San Jose, CA, has
withdrawn as a party to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and fd.io intends
to file additional written notifications
disclosing all changes in membership.
On May 4, 2016, fd.io filed its original
notification pursuant to Section 6(a) of
the Act. The Department of Justice
published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on June 9, 2016 (81 FR 37211).
The last notification was filed with
the Department on May 30, 2017. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on June 28, 2017 (82 FR 29329).
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 1301.33(a) on
or before November 17, 2017.
DATES:
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 August
16, 2017, AMPAC Fine Chemicals LLC,
Highway 50 and Hazel Avenue,
Building 05001, Rancho Cordova,
California 95670 applied to be registered
as a bulk manufacturer of
levomethorphan (9210), a basic class of
controlled substance in schedule II.
The company plans to manufacture
the listed controlled substance as an
intermediate in the bulk manufacture of
other controlled substances for
distribution to its customers.
SUPPLEMENTARY INFORMATION:
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19789 Filed 9–15–17; 8:45 am]
[FR Doc. 2017–19831 Filed 9–15–17; 8:45 am]
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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 18, 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 18, 2017.
DATES:
Antitrust Division
VerDate Sep<11>2014
43569
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.
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
1301.34(a), this is notice that on July 25,
2017, Catalent Centers, LLC, 10245
Hickman Mills Drive, Kansas City,
Missouri 64137 applied to be registered
as an importer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18SEN1.SGM
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43570
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Controlled substance
Gamma Hydroxybutyric Acid ...
Marihuana Extract ....................
Marihuana ................................
Drug
code
2010
7350
7360
Schedule
Drug Enforcement Administration
I
I
I
[Docket No. DEA–392]
The company plans to import finished
dosage unit products containing gammahydroxybutryic acid and cannabis
extracts for clinical trial studies.
These cannabis 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: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19833 Filed 9–15–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Specgx 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 1301.33(a) on
or before November 17, 2017.
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
DATES:
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 August
9, 2017, Specgx LLC, 3600 North
Second Street, Saint Louis, Missouri
63147 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
sradovich on DSKBBY8HB2PROD with NOTICES
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Difenoxin ..........................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Butyryl Fentanyl ...............................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
VerDate Sep<11>2014
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18SEN1
2010
7370
9053
9145
9168
9307
9313
9634
9821
9822
1100
1105
1205
1724
7379
8333
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9273
9300
9330
9333
9630
9639
9652
9668
9737
9739
9740
9780
9801
Schedule
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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II
]]>Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43569-43570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19833]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent Centers,
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 18, 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 18, 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 July
25, 2017, Catalent Centers, LLC, 10245 Hickman Mills Drive, Kansas
City, Missouri 64137 applied to be registered as an importer of the
following basic classes of controlled substances:
[[Page 43570]]
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing gamma-hydroxybutryic acid and cannabis extracts for clinical
trial studies.
These cannabis 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: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19833 Filed 9-15-17; 8:45 am]
BILLING CODE 4410-09-P
