Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc., 15567-15568 [2016-06532]

Download as PDF 15567 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 December 22, 2015, Mallinckrodt LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II [FR Doc. 2016–06543 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P jstallworth on DSK7TPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC ACTION: Notice of application. VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DEPARTMENT OF JUSTICE ADDRESSES: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 November 12, 2015, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. 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 1301.33(a) on or before May 23, 2016. DATES: Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Hydromorphinol (9301) ................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Oxymorphone (9652) ................... Schedule I I I II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 [FR Doc. 2016–06537 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc. ACTION: Notice of registration. Halo Pharmaceutical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63838, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Halo Pharmaceutical, Inc. to manufacture the basic classes of 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 and testing 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: SUMMARY: Controlled substance Dihydromorphine (9145) ............... Hydromorphone (9150) ................ Schedule I II The company plans to manufacture Hydromorphone HCl for sale to other manufacturers and to manufacture other controlled substances for distribution to E:\FR\FM\23MRN1.SGM 23MRN1 15568 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: its customers. Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–06532 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Cambrex Charles City ACTION: Notice of registration. Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63835, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a manufacturer of certain basic classes of controlled substances. No other comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cambrex Charles City to manufacture the basic classes of 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 and testing the company’s physical security systems, verifying the SUMMARY: Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Fentanyl (9801) ............................ Schedule II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers, for dosage form development, for clinical trials, and for use in stability qualification studies. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–06536 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Cerilliant Corporation applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cerilliant Corporation registration as an importer of those controlled substances. SUMMARY: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63836, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665–2402 applied to be registered as an importer of certain basic classes of controlled substances. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Cerilliant Corporation to import the basic classes of 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 and testing 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 above-named company is granted registration as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: [Docket No. DEA–392] Importer of Controlled Substances Registration: Cerilliant Corporation ACTION: Notice of registration. jstallworth on DSK7TPTVN1PROD with NOTICES Controlled substance Schedule 3-Fluoro-N-methylcathinone (3–FMC) (1233) ............................................................................................................................................. Cathinone (1235) ......................................................................................................................................................................................... Methcathinone (1237) .................................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4–FMC) (1238) ............................................................................................................................................. Pentedrone (a-methylaminovalerophenone) (1246) .................................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... 4-Methyl-N-ethylcathinone (4–MEC) (1249) ................................................................................................................................................ Naphyrone (1258) ........................................................................................................................................................................................ N-Ethylamphetamine (1475) ........................................................................................................................................................................ N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. Fenethylline (1503) ...................................................................................................................................................................................... Methaqualone (2565) .................................................................................................................................................................................. JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) (6250) ................................................................................................................... SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) (7008) ................................................................. VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1 I I I I I I I I I I I I I I

Agencies

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15567-15568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06532]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Halo 
Pharmaceutical, Inc.

ACTION: Notice of registration.

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SUMMARY: Halo Pharmaceutical, Inc. applied to be registered as a 
manufacturer of certain basic classes of controlled substances. The 
Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc. 
registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and 
published in the Federal Register on October 21, 2015, 80 FR 63838, 
Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New 
Jersey 07981 applied to be registered as a manufacturer of certain 
basic classes of controlled substances. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Halo Pharmaceutical, Inc. to 
manufacture the basic classes of 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 and testing 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. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Dihydromorphine (9145).....................  I
Hydromorphone (9150).......................  II
------------------------------------------------------------------------

    The company plans to manufacture Hydromorphone HCl for sale to 
other manufacturers and to manufacture other controlled substances for 
distribution to

[[Page 15568]]

its customers. Dihydromorphine is an intermediate in the manufacture of 
Hydromorphone and is not for commercial distribution.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06532 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P