83 FR 5809 - Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5809-5809 | |
| FR Document | 2018-02638 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Page 5809] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02638] [[Page 5809]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation 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 April 10, 2018. 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 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 July 19, 2017, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1- 7010 I oxobutan-2-yl)-1-(4-fluorobenzyl)-1H- indazole-3-carboxamide). MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I fluorobenzyl)-1H-indazole-3-carboxamido)- 3,3-dimethylbutanoate). MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I oxobutan-2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide). 5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I indazole-3-carboxamido)-3- methylbutanoate). 5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I fluoropentyl)-1H-indazole-3-carboxamido)- 3,3-dimethylbutanoate). MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1- 7042 I (cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate). 5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)- 7049 I 1-(5-fluoropentyl)-1H-indazole-3- carboxamide). U-47700 (3,4-dichloro-N-[2- 9547 I (dimethylamino)cyclohexyl]-N- methylbenzamide). Acryl fentanyl (N-(1-phenethylpiperidin-4- 9811 I yl)-N-phenylacrylamide). 4-Fluoroisobutyryl fentanyl (N-(4- 9824 I fluorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide). Furanyl fentanyl (N-(1-phenethylpiperidin- 9834 I 4-yl)-N-phenylfuran-2-carboxamide). ------------------------------------------------------------------------ The company plans to manufacture small quantities of the listed controlled substances to make reference standards which will be distributed to its customers. Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-02638 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5809
DEPARTMENT OF JUSTICE ADDRESSES: Written comments should importers, and exporters of controlled
be sent to: Drug Enforcement substances (other than final orders in
Drug Enforcement Administration Administration, Attention: DEA Federal connection with suspension, denial, or
Register Representative/DRW, 8701 revocation of registration) has been
[Docket No. DEA–392] Morrissette Drive, Springfield, Virginia redelegated to the Assistant
22152. Administrator of the DEA Diversion
Bulk Manufacturer of Controlled
SUPPLEMENTARY INFORMATION: The Control Division (‘‘Assistant
Substances Application: Cerilliant
Attorney General has delegated his Administrator’’) pursuant to section 7 of
Corporation
authority under the Controlled 28 CFR part 0, appendix to subpart R.
ACTION: Notice of application. Substances Act to the Administrator of In accordance with 21 CFR
the Drug Enforcement Administration 1301.33(a), this is notice that on July 19,
DATES: Registered bulk manufacturers of (DEA), 28 CFR 0.100(b). Authority to 2017, Cerilliant Corporation, 811
the affected basic classes, and exercise all necessary functions with Paloma Drive, Suite A, Round Rock,
applicants therefore, may file written respect to the promulgation and Texas 78665–2402 applied to be
comments on or objections to the implementation of 21 CFR part 1301, registered as a bulk manufacturer of the
issuance of the proposed registration on incident to the registration of following basic classes of controlled
or before April 10, 2018. manufacturers, distributors, dispensers, substances:
Controlled substance Drug code Schedule
ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ............. 7010 I
MDMB–FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ...................... 7020 I
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ........ 7032 I
5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) .............................................. 7033 I
5F–ADB; 5F–MDMB–PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ...... 7034 I
MDMB–CHMICA, MMB–CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3- 7042 I
dimethylbutanoate).
5F–APINACA, 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) .................................. 7049 I
U–47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) .............................................................. 9547 I
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) ................................................................................. 9811 I
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ......................................... 9824 I
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) ............................................................. 9834 I
The company plans to manufacture Register Representative/DRW, 8701 In accordance with 21 CFR
small quantities of the listed controlled Morrissette Drive, Springfield, Virginia 1301.34(a), this is notice that on
substances to make reference standards 22152. All requests for hearing must be December 9, 2016, Mylan
which will be distributed to its sent to: Drug Enforcement Pharmaceuticals, Inc., 3711 Collins
customers. Administration, Attn: Administrator, Ferry Road, Morgantown, West Virginia
Dated: January 31, 2018. 8701 Morrissette Drive, Springfield, 26505 applied to be registered as an
Susan A. Gibson, Virginia 22152. All requests for hearing importer of the following basic classes
should also be sent to: (1) Drug of controlled substances:
Deputy Assistant Administrator.
Enforcement Administration, Attn:
[FR Doc. 2018–02638 Filed 2–8–18; 8:45 am]
Hearing Clerk/LJ, 8701 Morrissette Controlled substance Drug Schedule
BILLING CODE 4410–09–P code
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register Amphetamine ............... 1100 II
DEPARTMENT OF JUSTICE Methylphenidate ........... 1724 II
Representative/DRW, 8701 Morrissette
Oxycodone ................... 9143 II
Drug Enforcement Administration Drive, Springfield, Virginia 22152.
Hydromorphone ............ 9150 II
SUPPLEMENTARY INFORMATION: The
[Docket No. DEA–392] Methadone .................... 9250 II
Attorney General has delegated his Morphine ....................... 9300 II
Importer of Controlled Substances authority under the Controlled Fentanyl ........................ 9801 II
Application: Mylan Pharmaceuticals, Substances Act to the Administrator of
Inc. the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to The company plans to import the
ACTION: Notice of application. exercise all necessary functions with listed controlled substances in finished
respect to the promulgation and dosage form (FDF) from foreign sources
DATES: Registered bulk manufacturers of implementation of 21 CFR part 1301, for analytical testing and clinical trials
the affected basic classes, and incident to the registration of in which the foreign FDF will be
applicants therefore, may file written manufacturers, distributors, dispensers, compared to the company’s own
comments on or objections to the importers, and exporters of controlled domestically-manufactured FDF. This
issuance of the proposed registration on substances (other than final orders in analysis is required to allow the
sradovich on DSK3GMQ082PROD with NOTICES
or before March 12, 2018. Such persons connection with suspension, denial, or company to export domestically-
may also file a written request for a revocation of registration) has been manufactured FDF to foreign markets.
hearing on the application on or before redelegated to the Assistant Authorization will not extend to the
March 12, 2018. Administrator of the DEA Diversion import of Food and Drug
ADDRESSES: Written comments should Control Division (‘‘Assistant Administration approved or non-
be sent to: Drug Enforcement Administrator’’) pursuant to section 7 of approved finished dosage forms for
Administration, Attention: DEA Federal 28 CFR part 0, appendix to subpart R. commercial sale.
VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1](https://thefederalregister.org/doc/83_FR_5837/page/1.svg)
Document Created: 2018-02-09 00:11:58
Document Modified: 2018-02-09 00:11:58
| 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 April 10, 2018. | |
| FR Citation | 83 FR 5809 |
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