82 FR 43569 - Importer of Controlled Substances Application: Catalent Centers, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 179 (September 18, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 179 (September 18, 2017)
| Page Range | 43569-43570 | |
| FR Document | 2017-19833 |
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)] [Notices] [Pages 43569-43570] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 43569
Register pursuant to Section 6(b) of the DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
Act on June 28, 2017 (82 FR 29328).
Drug Enforcement Administration Drug Enforcement Administration
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
[Docket No. DEA–392] [Docket No. DEA–392]
Division.
[FR Doc. 2017–19791 Filed 9–15–17; 8:45 am] Importer of Controlled Substances
Bulk Manufacturer of Controlled
BILLING CODE P
Substances Application: AMPAC Fine Application: Catalent Centers, LLC
Chemicals LLC
ACTION: Notice of application.
DEPARTMENT OF JUSTICE
ACTION: Notice of application.
Antitrust Division DATES: Registered bulk manufacturers of
the affected basic classes, and
DATES: Registered bulk manufacturers of
Notice Pursuant to the National applicants therefore, may file written
the affected basic classes, and
Cooperative Research and Production comments on or objections to the
applicants therefore, may file written
Act of 1993—fd.Io Project, Inc. issuance of the proposed registration in
comments on or objections to the
accordance with 21 CFR 1301.34(a) on
issuance of the proposed registration in
Notice is hereby given that, on August or before October 18, 2017. Such
accordance with 21 CFR 1301.33(a) on persons may also file a written request
24, 2017, pursuant to Section 6(a) of the
or before November 17, 2017. for a hearing on the application
National Cooperative Research and
Production Act of 1993, 15 U.S.C. 4301 ADDRESSES: Written comments should pursuant to 21 CFR 1301.43 on or before
et seq. (‘‘the Act’’), fd.io Project, Inc. be sent to: Drug Enforcement October 18, 2017.
(‘‘fd.io’’) has filed written notifications Administration, Attention: DEA Federal ADDRESSES: Written comments should
simultaneously with the Attorney Register Representative/DRW, 8701 be sent to: Drug Enforcement
General and the Federal Trade Morrissette Drive, Springfield, Virginia Administration, Attention: DEA Federal
Commission disclosing changes in its 22152. Register Representative/DRW, 8701
membership. The notifications were Morrissette Drive, Springfield, Virginia
filed for the purpose of extending the SUPPLEMENTARY INFORMATION: The
22152. All requests for hearing must be
Act’s provisions limiting the recovery of Attorney General has delegated his
sent to: Drug Enforcement
antitrust plaintiffs to actual damages authority under the Controlled
Administration, Attn: Administrator,
under specified circumstances. Substances Act to the Administrator of
8701 Morrissette Drive, Springfield,
Specifically, ARM Ltd., Cambridge, the Drug Enforcement Administration Virginia 22152. All requests for hearing
UNITED KINGDOM; Linaro Limited, (DEA), 28 CFR 0.100(b). Authority to should also be sent to: (1) Drug
Cambridge, UNITED KINGDOM; exercise all necessary functions with Enforcement Administration, Attn:
Rubicon Communications LLC dba respect to the promulgation and Hearing Clerk/LJ, 8701 Morrissette
Netgate, Austin, TX; and CENGN implementation of 21 CFR part 1301, Drive, Springfield, Virginia 22152; and
(Centre of Excellence in Next incident to the registration of (2) Drug Enforcement Administration,
Generation Networks), Ottawa, manufacturers, distributors, dispensers, Attn: DEA Federal Register
CANADA, have been added as parties to importers, and exporters of controlled Representative/DRW, 8701 Morrissette
this venture. substances (other than final orders in Drive, Springfield, Virginia 22152.
Also, Brocade Communications connection with suspension, denial, or
revocation of registration) has been SUPPLEMENTARY INFORMATION: The
Systems, Inc., San Jose, CA, has
redelegated to the Assistant Attorney General has delegated his
withdrawn as a party to this venture.
Administrator of the DEA Diversion authority under the Controlled
No other changes have been made in Substances Act to the Administrator of
either the membership or planned Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
activity of the group research project. (DEA), 28 CFR 0.100(b). Authority to
Membership in this group research 28 CFR part 0, appendix to subpart R.
exercise all necessary functions with
project remains open, and fd.io intends In accordance with 21 CFR respect to the promulgation and
to file additional written notifications 1301.33(a), this is notice that on August implementation of 21 CFR part 1301,
disclosing all changes in membership. 16, 2017, AMPAC Fine Chemicals LLC, incident to the registration of
On May 4, 2016, fd.io filed its original Highway 50 and Hazel Avenue, manufacturers, distributors, dispensers,
notification pursuant to Section 6(a) of Building 05001, Rancho Cordova, importers, and exporters of controlled
the Act. The Department of Justice California 95670 applied to be registered substances (other than final orders in
published a notice in the Federal as a bulk manufacturer of connection with suspension, denial, or
Register pursuant to Section 6(b) of the levomethorphan (9210), a basic class of revocation of registration) has been
Act on June 9, 2016 (81 FR 37211). controlled substance in schedule II. redelegated to the Assistant
The company plans to manufacture Administrator of the DEA Diversion
The last notification was filed with
the listed controlled substance as an Control Division (‘‘Assistant
the Department on May 30, 2017. A
intermediate in the bulk manufacture of Administrator’’) pursuant to section 7 of
notice was published in the Federal
other controlled substances for 28 CFR part 0, appendix to subpart R.
sradovich on DSKBBY8HB2PROD with NOTICES
Register pursuant to Section 6(b) of the
Act on June 28, 2017 (82 FR 29329). distribution to its customers. In accordance with 21 CFR
Dated: September 11, 2017. 1301.34(a), this is notice that on July 25,
Patricia A. Brink, 2017, Catalent Centers, LLC, 10245
Director of Civil Enforcement, Antitrust Demetra Ashley,
Hickman Mills Drive, Kansas City,
Division. Acting Assistant Administrator. Missouri 64137 applied to be registered
[FR Doc. 2017–19789 Filed 9–15–17; 8:45 am] [FR Doc. 2017–19831 Filed 9–15–17; 8:45 am] as an importer of the following basic
BILLING CODE 4410–11–P BILLING CODE 4410–09–P classes of controlled substances:
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![43570 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
Controlled substance Drug Schedule DEPARTMENT OF JUSTICE the Drug Enforcement Administration
code (DEA), 28 CFR 0.100(b). Authority to
Gamma Hydroxybutyric Acid ... 2010 I
Drug Enforcement Administration exercise all necessary functions with
Marihuana Extract .................... 7350 I [Docket No. DEA–392] respect to the promulgation and
Marihuana ................................ 7360 I implementation of 21 CFR part 1301,
Bulk Manufacturer of Controlled incident to the registration of
The company plans to import finished Substances Application: Specgx LLC
dosage unit products containing gamma- manufacturers, distributors, dispensers,
hydroxybutryic acid and cannabis importers, and exporters of controlled
ACTION: Notice of application.
extracts for clinical trial studies. substances (other than final orders in
These cannabis extracts compounds DATES: Registered bulk manufacturers of connection with suspension, denial, or
are listed under drug code 7350. No the affected basic classes, and revocation of registration) has been
other activity for these drug codes is applicants therefore, may file written redelegated to the Assistant
authorized for this registration. comments on or objections to the Administrator of the DEA Diversion
Approval of permit applications will issuance of the proposed registration in Control Division (‘‘Assistant
occur only when the registrant’s accordance with 21 CFR 1301.33(a) on Administrator’’) pursuant to section 7 of
business activity is consistent with what or before November 17, 2017. 28 CFR part 0, appendix to subpart R.
is authorized under 21 U.S.C. 952(a)(2). ADDRESSES: Written comments should In accordance with 21 CFR
Authorization will not extend to the be sent to: Drug Enforcement 1301.33(a), this is notice that on August
import of FDA approved or non- Administration, Attention: DEA Federal
approved finished dosage forms for 9, 2017, Specgx LLC, 3600 North
Register Representative/DRW, 8701 Second Street, Saint Louis, Missouri
commercial sale. Morrissette Drive, Springfield, Virginia 63147 applied to be registered as a bulk
Dated: September 11, 2017. 22152. manufacturer of the following basic
Demetra Ashley, SUPPLEMENTARY INFORMATION: The classes of controlled substances:
Acting Assistant Administrator. Attorney General has delegated his
[FR Doc. 2017–19833 Filed 9–15–17; 8:45 am] authority under the Controlled
BILLING CODE 4410–09–P Substances Act to the Administrator of
Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
Codeine-N-oxide .............................................................................................................................................................. 9053 I
Dihydromorphine ............................................................................................................................................................. 9145 I
Difenoxin .......................................................................................................................................................................... 9168 I
Morphine-N-oxide ............................................................................................................................................................ 9307 I
Normorphine .................................................................................................................................................................... 9313 I
Norlevorphanol ................................................................................................................................................................ 9634 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... 9821 I
Butyryl Fentanyl ............................................................................................................................................................... 9822 I
Amphetamine ................................................................................................................................................................... 1100 II
Methamphetamine ........................................................................................................................................................... 1105 II
Lisdexamfetamine ............................................................................................................................................................ 1205 II
Methylphenidate .............................................................................................................................................................. 1724 II
Nabilone ........................................................................................................................................................................... 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Codeine ........................................................................................................................................................................... 9050 II
Dihydrocodeine ................................................................................................................................................................ 9120 II
Oxycodone ....................................................................................................................................................................... 9143 II
Hydromorphone ............................................................................................................................................................... 9150 II
Diphenoxylate .................................................................................................................................................................. 9170 II
Ecgonine .......................................................................................................................................................................... 9180 II
Hydrocodone ................................................................................................................................................................... 9193 II
Levorphanol ..................................................................................................................................................................... 9220 II
Meperidine ....................................................................................................................................................................... 9230 II
Methadone ....................................................................................................................................................................... 9250 II
Methadone intermediate .................................................................................................................................................. 9254 II
Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. 9273 II
Morphine .......................................................................................................................................................................... 9300 II
Oripavine ......................................................................................................................................................................... 9330 II
Thebaine .......................................................................................................................................................................... 9333 II
Opium tincture ................................................................................................................................................................. 9630 II
Opium, powdered ............................................................................................................................................................ 9639 II
sradovich on DSKBBY8HB2PROD with NOTICES
Oxymorphone .................................................................................................................................................................. 9652 II
Noroxymorphone ............................................................................................................................................................. 9668 II
Alfentanil .......................................................................................................................................................................... 9737 II
Remifentanil ..................................................................................................................................................................... 9739 II
Sufentanil ......................................................................................................................................................................... 9740 II
Tapentadol ....................................................................................................................................................................... 9780 II
Fentanyl ........................................................................................................................................................................... 9801 II
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Document Created: 2017-09-16 00:51:41
Document Modified: 2017-09-16 00:51:41
| 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 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. | |
| FR Citation | 82 FR 43569 |
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