Importer of Controlled Substances Registration, 60898-60899 [2018-25863]

Download as PDF 60898 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices The company plans to import the listed controlled substances for analytical research, testing and clinical trials. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25869 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 SUPPLEMENTARY INFORMATION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Noramco Inc. ACTION: 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 January 28, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: Notice of application. 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 4, 2018, Noramco Inc., 1550 Olympic Dr. Athens, Georgia 30601 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: Controlled substance Drug code amozie on DSK3GDR082PROD with NOTICES1 Cathinone ................................................................................................................................................................ Gamma Hydroxybutyric Acid ................................................................................................................................... Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ Codeine-N-oxide ...................................................................................................................................................... Dihydromorphine ..................................................................................................................................................... Hydromorphinol ....................................................................................................................................................... Morphine-N-oxide .................................................................................................................................................... Amphetamine .......................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................... Methylphenidate ...................................................................................................................................................... Nabilone .................................................................................................................................................................. Codeine ................................................................................................................................................................... Dihydrocodeine ........................................................................................................................................................ Oxycodone .............................................................................................................................................................. Hydromorphone ....................................................................................................................................................... Hydrocodone ........................................................................................................................................................... Morphine .................................................................................................................................................................. Oripavine ................................................................................................................................................................. Thebaine .................................................................................................................................................................. Opium tincture ......................................................................................................................................................... Oxymorphone .......................................................................................................................................................... Noroxymorphone ..................................................................................................................................................... Alfentanil .................................................................................................................................................................. Sufentanil ................................................................................................................................................................. Carfentanil ............................................................................................................................................................... Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25874 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P Jkt 247001 The registrant listed below has applied for and has been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or II controlled substances. The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for this notice. SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] ACTION: 17:45 Nov 26, 2018 I I I I I I I I II II II II II II II II II II II II II II II II II II II II SUMMARY: Importer of Controlled Substances Registration VerDate Sep<11>2014 1235 2010 7360 7370 9053 9145 9301 9307 1100 1205 1724 7379 9050 9120 9143 9150 9193 9300 9330 9333 9630 9652 9668 9737 9740 9743 9780 9801 Schedule PO 00000 Notice of registration. Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 60899 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices Company FR Docket Alcami Carolinas Corporation ............................................. 83 FR 46758 ...................................................................... The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I controlled substances to the above listed company. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25863 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: GE Healthcare ACTION: Notice of application. 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 December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement amozie on DSK3GDR082PROD with NOTICES1 DATES: 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 September 5, 2018, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004, applied to be registered as an importer of cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of Ioflupane, in the form of three separate analogues of cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. Supplies of this particular controlled substance are not available in the form needed within the current domestic supply of the United States. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25864 Filed 11–26–18; 8:45 am] Published DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC ACTION: Notice of application. 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 January 28, 2019. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 delegated 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 October 4, 2018, Insys Manufacturing, LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: BILLING CODE 4410–09–P Controlled substance Drug code Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 September 14, 2018. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 7360 7370 Schedule I I

Agencies

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60898-60899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25863]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: The registrant listed below has applied for and has been 
granted registration by the Drug Enforcement Administration (DEA) as an 
importer of schedule I or II controlled substances.

SUPPLEMENTARY INFORMATION: The company listed below applied to be 
registered as an importer of various basic classes of controlled 
substances. Information on the previously published notice is listed in 
the table below. No comments or objections were submitted and no 
requests for a hearing were submitted for this notice.

[[Page 60899]]



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                 Company                           FR Docket                           Published
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Alcami Carolinas Corporation............  83 FR 46758................  September 14, 2018.
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    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of the listed registrant to 
import the applicable basic classes of schedule I controlled substances 
is consistent with the public interest and with United States 
obligations under international treaties, conventions, or protocols in 
effect on May 1, 1971. The DEA investigated the company's maintenance 
of effective controls against diversion by inspecting the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the DEA has granted a registration as 
an importer for schedule I controlled substances to the above listed 
company.

    Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25863 Filed 11-26-18; 8:45 am]
 BILLING CODE 4410-09-P