83 FR 2214 - Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 10 (January 16, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 10 (January 16, 2018)
| Page Range | 2214-2215 | |
| FR Document | 2018-00508 |
[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)] [Notices] [Pages 2214-2215] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00508] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc. 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 pursuant on or before 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 [[Page 2215]] 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 September 19, 2017, Janssen Pharmaceuticals Inc., 1400 Olympic Drive, BLDGS 1-5 & 7-14, Athens, Georgia 30601 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Tapentadol............................. 9780 II Thebaine............................... 9333 II Concentrated Poppy Straw............... 9670 II ------------------------------------------------------------------------ The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. The company plans to import thebaine derivatives (9333) as reference standards. The company plans to import concentrated poppy straw to manufacture other controlled substances. 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: January 4, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-00508 Filed 1-12-18; 8:45 am] BILLING CODE 4410-09-P
![2214 Federal Register / Vol. 83, No. 10 / Tuesday, January 16, 2018 / Notices
argument that a different standard of that after five (5) years from the date of and the United States’ responses to
proof should apply. its entry, this Final Judgment may be comments. Based upon the record
B. In any enforcement proceeding in terminated upon notice by the United before the Court, which includes the
which the Court finds that TransDigm States to the Court and TransDigm that Competitive Impact Statement and any
has violated this Final Judgment, the the divestiture has been completed and comments and response to comments
United States may apply to the Court for that the continuation of the Final filed with the Court, entry of this Final
a one-time extension of this Final Judgment no longer is necessary or in Judgment is in the public interest.
Judgment, together with such other the public interest. Date: llllllllllllllll
relief as may be appropriate. TransDigm Court approval subject to procedures
XVII. Public Interest Determination
agrees to reimburse the United States for of Antitrust Procedures and Penalties
any attorneys’ fees, experts’ fees, and Entry of this Final Judgment is in the
Act, 15 U.S.C. 16.
costs incurred in connection with any public interest. The parties have
lllllllllllllllllll
effort to enforce this Final Judgment. complied with the requirements of the
Antitrust Procedures and Penalties Act, United States District Judge.
XVI. Expiration of Final Judgment 15 U.S.C. 16, including making copies APPENDIX A: Real Property
Unless this Court grants an extension, available to the public of this Final
this Final Judgment shall expire ten (10) Judgment, the Competitive Impact (Owned and Leased)
years from the date of its entry, except Statement, and any comments thereon SCHROTH U.S. Leased Real Property
Facility name Address Type of facility
Pompano Beach ................................................. 1371 SW 8th Street, Pompano Beach, FL ...... Manufacturing Plant, Office, and Warehouse.
SCHROTH Germany Leased Real
Property
Facility name Address Type of facility
Headquarters ‘‘Im Ohl’’ ....................................... Im Ohl 14, 59757, Arnsberg, Germany ........... Manufacturing Plant and Office (Head-
quarters).
Parking Area ‘‘Im Ohl’’ ........................................ Im Ohl 14, 59757, Arnsberg, Germany ........... Parking Area.
SCHROTH Germany Owned Real
Property
Facility name Address Type of facility
Warehouse ‘‘Im Ohl’’ .......................................... Im Ohl 14, 59757, Arnsberg, Germany; Land Warehouse.
Register of Neheim-Husten of the local
court of Arnsberg; Page 13024; Plot 5, Par-
cel 390.
Warehouse ‘‘Im Ohl’’ .......................................... Im Ohl 14, 59757, Arnsberg, Germany; Land Warehouse.
Register of Neheim-Husten of the local
court of Arnsberg; Page 9777; Plot 5, Par-
cel 88.
[FR Doc. 2018–00544 Filed 1–12–18; 8:45 am] persons may also file a written request Representative/DRW, 8701 Morrissette
BILLING CODE 4410–11–P for a hearing on the application Drive, Springfield, Virginia 22152.
pursuant on or before February 15,
SUPPLEMENTARY INFORMATION: The
2018.
DEPARTMENT OF JUSTICE Attorney General has delegated his
ADDRESSES: Written comments should authority under the Controlled
Drug Enforcement Administration be sent to: Drug Enforcement Substances Act to the Administrator of
Administration, Attention: DEA Federal the Drug Enforcement Administration
[Docket No. DEA–392] Register Representative/DRW, 8701 (DEA), 28 CFR 0.100(b). Authority to
Importer of Controlled Substances Morrissette Drive, Springfield, Virginia exercise all necessary functions with
Application: Janssen Pharmaceuticals, 22152. All requests for hearing must be respect to the promulgation and
Inc. sent to: Drug Enforcement implementation of 21 CFR part 1301,
Administration, Attn: Administrator, incident to the registration of
ACTION: Notice of application. 8701 Morrissette Drive, Springfield, manufacturers, distributors, dispensers,
daltland on DSKBBV9HB2PROD with NOTICES
Virginia 22152. All requests for hearing importers, and exporters of controlled
DATES: Registered bulk manufacturers of should also be sent to: (1) Drug substances (other than final orders in
the affected basic classes, and Enforcement Administration, Attn: connection with suspension, denial, or
applicants therefore, may file written Hearing Clerk/LJ, 8701 Morrissette revocation of registration) has been
comments on or objections to the Drive, Springfield, Virginia 22152; and redelegated to the Assistant
issuance of the proposed registration on (2) Drug Enforcement Administration, Administrator of the DEA Diversion
or before February 15, 2018. Such Attn: DEA Federal Register Control Division (‘‘Assistant
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![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 02:02:51
Document Modified: 2018-01-13 02:02:51
| 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 pursuant on or before February 15, 2018. | |
| FR Citation | 83 FR 2214 |
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