83 FR 2215 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

Page Range		2215-2215
FR Document		2018-00507

Federal Register, Volume 83 Issue 10 (Tuesday, January 16, 2018)

[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Page 2215]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00507]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

ACTION: Notice of application.

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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 February 15, 2018. 
Such persons may also file a written request for a hearing on the 
application February 15, 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 
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 
October 13, 2017, Catalent Pharma Solutions, LLC, 1100 Enterprise 
Drive, Winchester, KY 40391 applied to be registered as an importer for 
Gamma Hydroxybutyric Acid (2010) the basic class of controlled 
substances.
    The company plans to import the listed controlled substance in 
finished dosage form for analytical purposes only. 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 to 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: January 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-00507 Filed 1-12-18; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices 2215

Administrator’’) pursuant to section 7 of Register Representative/DRW, 8701 DEPARTMENT OF JUSTICE
28 CFR part 0, appendix to subpart R. Morrissette Drive, Springfield, Virginia
In accordance with 21 CFR 22152. All requests for hearing must be Drug Enforcement Administration
1301.34(a), this is notice that on sent to: Drug Enforcement [Docket No. DEA–392]
September 19, 2017, Janssen Administration, Attn: Administrator,
Pharmaceuticals Inc., 1400 Olympic 8701 Morrissette Drive, Springfield, Bulk Manufacturer of Controlled
Drive, BLDGS 1–5 & 7–14, Athens, Virginia 22152. All requests for hearing Substances Application: Johnson
Georgia 30601 applied to be registered should also be sent to: (1) Drug Matthey Inc.
as an importer of the following basic Enforcement Administration, Attn:
classes of controlled substances: ACTION: Notice of application.
Hearing Clerk/LJ, 8701 Morrissette
Drug
Drive, Springfield, Virginia 22152; and DATES: Registered bulk manufacturers of
Controlled substance Schedule (2) Drug Enforcement Administration,
code the affected basic classes, and
Attn: DEA Federal Register applicants therefore, may file written
Tapentadol .................... 9780 II Representative/DRW, 8701 Morrissette comments on or objections to the
Thebaine ....................... 9333 II Drive, Springfield, Virginia 22152. issuance of the proposed registration on
Concentrated Poppy 9670 II
or before March 19, 2018.
Straw. SUPPLEMENTARY INFORMATION: The
ADDRESSES: Written comments should
Attorney General has delegated his
The company plans to import an be sent to: Drug Enforcement
authority under the Controlled
intermediate form of tapentadol (9780) Administration, Attention: DEA Federal
Substances Act to the Administrator of
to bulk manufacture tapentadol for Register Representative/DRW, 8701
the Drug Enforcement Administration Morrissette Drive, Springfield, Virginia
distribution to its customers. The (DEA), 28 CFR 0.100(b). Authority to
company plans to import thebaine 22152.
exercise all necessary functions with
derivatives (9333) as reference respect to the promulgation and SUPPLEMENTARY INFORMATION: The
standards. The company plans to import Attorney General has delegated his
implementation of 21 CFR part 1301,
concentrated poppy straw to authority under the Controlled
incident to the registration of
manufacture other controlled Substances Act to the Administrator of
manufacturers, distributors, dispensers, the Drug Enforcement Administration
substances. No other activity for these
drug codes is authorized for this importers, and exporters of controlled (DEA), 28 CFR 0.100(b). Authority to
registration. Approval of permit substances (other than final orders in exercise all necessary functions with
applications will occur only when the connection with suspension, denial, or respect to the promulgation and
registrant’s business activity is revocation of registration) has been implementation of 21 CFR 1301,
consistent with what is authorized redelegated to the Assistant incident to the registration of
under 21 U.S.C. 952(a)(2). Administrator of the DEA Diversion manufacturers, distributors, dispensers,
Authorization will not extend to the Control Division (‘‘Assistant importers, and exporters of controlled
import of FDA approved or non- Administrator’’) pursuant to section 7 of substances (other than final orders in
approved finished dosage forms for 28 CFR part 0, appendix to subpart R. connection with suspension, denial, or
commercial sale. In accordance with 21 CFR revocation of registration) has been
Dated: January 4, 2018. 1301.34(a), this is notice that on October redelegated to the Assistant
Susan A. Gibson, 13, 2017, Catalent Pharma Solutions, Administrator of the DEA Diversion
LLC, 1100 Enterprise Drive, Winchester, Control Division (‘‘Assistant
Deputy Assistant Administrator.
Administrator’’) pursuant to section 7 of
[FR Doc. 2018–00508 Filed 1–12–18; 8:45 am] KY 40391 applied to be registered as an
28 CFR 0, appendix to subpart R.
BILLING CODE 4410–09–P importer for Gamma Hydroxybutyric In accordance with 21 CFR
Acid (2010) the basic class of controlled 1301.33(a), this is notice that on
substances. November 10, 2017, Johnson Matthey
DEPARTMENT OF JUSTICE The company plans to import the Inc., Pharmaceuticals Materials, 900
Drug Enforcement Administration listed controlled substance in finished River Road, Conshohocken,
dosage form for analytical purposes Pennsylvania 19428 applied to be
[Docket No. DEA–392] only. No other activity for these drug registered as a bulk manufacturer of the
codes is authorized for this registration. following basic classes of controlled
Importer of Controlled Substances substances:
Approval of permit applications will
Application: Catalent Pharma
Solutions, LLC occur only when the registrant’s
Drug
business activity is consistent with what Controlled substance code Schedule
ACTION: Notice of application. is authorized under to 21 U.S.C.
952(a)(2). Authorization will not extend Gamma Hydroxybutyric 2010 I
DATES: Registered bulk manufacturers of to the import of FDA approved or non- Acid.
the affected basic classes, and approved finished dosage forms for Amphetamine ............... 1100 II
applicants therefore, may file written Methylphenidate ........... 1724 II
commercial sale. Codeine ........................ 9050 II
comments on or objections to the
Dated: January 4, 2018. Oxycodone ................... 9143 II
issuance of the proposed registration on Diphenoxylate ............... 9170 II
daltland on DSKBBV9HB2PROD with NOTICES

or before February 15, 2018. Such Susan A. Gibson,
Hydrocodone ................ 9193 II
persons may also file a written request Deputy Assistant Administrator. Meperidine .................... 9230 II
for a hearing on the application [FR Doc. 2018–00507 Filed 1–12–18; 8:45 am] Methadone .................... 9250 II
February 15, 2018. BILLING CODE 4410–09–P Methadone intermediate 9254 II
ADDRESSES: Written comments should Morphine ....................... 9300 II
Thebaine ....................... 9333 II
be sent to: Drug Enforcement Opium tincture .............. 9630 II
Administration, Attention: DEA Federal

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Document Created: 2018-01-13 02:02:44
Document Modified: 2018-01-13 02:02:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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 February 15, 2018. Such persons may also file a written request for a hearing on the application February 15, 2018.
FR Citation		83 FR 2215

83 FR 2215 - Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 10 (January 16, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration