Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Notices 49579

as a bulk manufacturer of the following Dated: September 20, 2018. SUMMARY: Registrants listed below have basic classes of controlled substances: John J. Martin, applied for and been granted Assistant Administrator. registration by the Drug Enforcement Drug [FR Doc. 2018–21348 Filed 10–1–18; 8:45 am] Administration (DEA) as bulk Controlled substance code Schedule BILLING CODE 4410–09–P manufacturers of various classes of Methylphenidate ...... 1724 II schedule I and II controlled substances. Levomethorphan ...... 9210 II DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: The Levorphanol ...... 9220 II companies listed below applied to be Thebaine ...... 9333 II Drug Enforcement Administration registered as bulk manufacturers of Remifentanil ...... 9739 II various basic classes of controlled [Docket No. DEA–392] Tapentadol ...... 9780 II substances. Information on previously Bulk Manufacturer of Controlled published notices is listed in the table The company plans to manufacture Substances Registration below. No comments or objections were the listed controlled substances in bulk submitted for these notices. for distribution to its customers. ACTION: Notice of registration.

Company FR docket Published

American Radiolabeled Chem ...... 83 FR 28664 June 20, 2018. Cerilliant Corporation ...... 83 FR 28664 June 20, 2018.

The DEA has considered the factors in issuance of the proposed registration on Controlled substance Drug code Schedule 21 U.S.C. 823(a) and determined that or before December 3, 2018. Codeine ...... 9050 II the registration of these registrants to ADDRESSES: Written comments should Oxycodone ...... 9143 II manufacture the applicable basic classes be sent to: Drug Enforcement Hydromorphone ...... 9150 II of controlled substances is consistent Administration, Attention: DEA Federal Hydrocodone ...... 9193 II with the public interest and with United Register Representative/DPW, 8701 Morphine ...... 9300 II Oripavine ...... 9330 II States obligations under international Morrissette Drive, Springfield, Virginia Thebaine ...... 9333 II treaties, conventions, or protocols in 22152. Opium extracts ...... 9610 II effect on May 1, 1971. The DEA Opium fluid extract ...... 9620 II SUPPLEMENTARY INFORMATION: The investigated each of the company’s Opium tincture ...... 9630 II Attorney General has delegated his maintenance of effective controls Opium, powdered ...... 9639 II authority under the Controlled Oxymorphone ...... 9652 II against diversion by inspecting and Substances Act to the Administrator of Noroxymorphone ...... 9668 II testing each company’s physical Fentanyl ...... 9801 II the Drug Enforcement Administration security systems, verifying each (DEA), 28 CFR 0.100(b). Authority to company’s compliance with state and The company plans to manufacture exercise all necessary functions with local laws, and reviewing each the listed controlled substances in bulk respect to the promulgation and company’s background and history. for conversion to other controlled implementation of 21 CFR part 1301, Therefore, pursuant to 21 U.S.C. substances and sale to its customers, for incident to the registration of 823(a), and in accordance with 21 CFR dosage form development, for clinical manufacturers, distributors, dispensers, 1301.33, the DEA has granted a trials, and for use in stability importers, and exporters of controlled registration as a bulk manufacturer to qualification studies. substances (other than final orders in the above listed companies. connection with suspension, denial, or Dated: September 20, 2018. Dated: September 20, 2018. revocation of registration) has been John J. Martin, John J. Martin, redelegated to the Assistant Assistant Administrator. Assistant Administrator. Administrator of the DEA Diversion [FR Doc. 2018–21351 Filed 10–1–18; 8:45 am] [FR Doc. 2018–21353 Filed 10–1–18; 8:45 am] Control Division (‘‘Assistant BILLING CODE 4410–09–P BILLING CODE 4410–09–P Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE 1301.33(a), this is notice that on June 8, 2018, Cambrex Charles City, 1205 11th Drug Enforcement Administration Drug Enforcement Administration Street, Charles City, Iowa 50616 applied to be registered as a bulk manufacturer [Docket No. DEA–392] [Docket No. DEA–392] of the basic classes of controlled substances: Importer of Controlled Substances Bulk Manufacturer of Controlled Registration Substances Application: Cambrex Controlled substance Drug code Schedule ACTION: Charles City Gamma Hydroxybutyric 2010 I Notice of registration. Acid. ACTION: Notice of application. Amphetamine ...... 1100 II SUMMARY: Registrants listed below have Lisdexamfetamine ...... 1205 II applied for and been granted DATES: Registered bulk manufacturers of Methylphenidate ...... 1724 II registration by the Drug Enforcement 4-Anilino-N-phenethyl-4- 8333 II the affected basic classes, and piperidine (ANPP). Administration (DEA) as importers of applicants therefore, may file written Phenylacetone ...... 8501 II various classes of schedule I or II comments on or objections to the Cocaine ...... 9041 II controlled substances.

VerDate Sep<11>2014 18:39 Oct 01, 2018 Jkt 247001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1 amozie on DSK3GDR082PROD with NOTICES1