Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals, 2910-2911 [2016-00778]

Download as PDF 2910 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices Dated: January 11, 2016. Louis J. Milione, Deputy Assistant Administrator. Controlled substance [FR Doc. 2016–00789 Filed 1–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: American Radiolabeled Chemicals, Inc. ACTION: Notice of registration. American Radiolabeled Chemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants American Radiolabeled Chemicals, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated October 2, 2015, and published in the Federal Register on October 13, 2015, 80 FR 61469, American Radiolabeled Chemicals, Inc., 101 Arc Drive, Saint Louis, Missouri 63146 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 American Radiolabeled Chemicals, 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: asabaliauskas on DSK5VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Ibogaine (7260) ............................ Lysergic acid diethylamide (7315) Tetrahydrocannabinols (7370) ..... VerDate Sep<11>2014 17:50 Jan 15, 2016 I I I I Jkt 238001 Dimethyltryptamine (7435) ........... 1-[1-(2Thienyl)cyclohexyl]piperidine (7470). Dihydromorphine (9145) ............... Heroin (9200) ............................... Normorphine (9313) ..................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Metazocine (9240) ........................ Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Phenazocine (9715) ..................... Carfentanil (9743) ......................... Fentanyl (9801) ............................ Schedule 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 II II II The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. Dated: January 11, 2016. Louis J. Milione, Deputy Assistant Administrator. 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings 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 November 12, 2015, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as an importer of the following basic classes of controlled substances: [FR Doc. 2016–00779 Filed 1–15–16; 8:45 am] BILLING CODE 4410–09–P Controlled substance Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Siegfried USA, 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 in accordance with 21 CFR 1301.34(a) on or before February 18, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before February 18, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia DATES: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Schedule II II The company plans to import the listed controlled substances to manufacture bulk active pharmaceuticals ingredients (API) for distribution to its customer. Dated: January 11, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–00783 Filed 1–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals ACTION: E:\FR\FM\19JAN1.SGM Notice of registration. 19JAN1 2911 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices Apertus Pharmaceuticals applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals registration as a manufacturer of those controlled substances. DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: ACTION: SUMMARY: By notice dated October 2, 2015, and published in the Federal Register on October 13, 2015, 80 FR 61470, Apertus Pharmaceuticals, 331 Consort Drive, Ballwin, Missouri 63011 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 Apertus Pharmaceuticals 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Remifentanil (9739) ...................... I I II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company plans to bulk manufacture both as synthetic substances. No other activity for these drug codes is authorized for this registration. Dated: January 11, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–00778 Filed 1–15–16; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 17:50 Jan 15, 2016 Jkt 238001 Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Rhodes Technologies Notice of registration. Rhodes Technologies applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Rhodes Technologies registration as a manufacturer of those controlled substances. SUMMARY: By notice dated August 21, 2015, and published in the Federal Register on August 31, 2015, 80 FR 52511, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 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 Rhodes Technologies 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: SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols (7370) ..... Dihydromorphine (9145) ............... Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Levorphanol (9220) ...................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Schedule I I II II II II II II II II II II II II Controlled substance Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule II II The company plans to manufacture the listed controlled substances in bulk for conversion and sale to dosage form manufacturers. In reference to drug code 7370 the company plans to bulk manufacture synthetic tetrahydrocannabinols. No other activity for this drug code is authorized for this registration. Dated: January 11, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–00781 Filed 1–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1121–0321] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: National Institute of Justice Compliance Testing Program Office of Justice Programs, Department of Justice. ACTION: 60-day notice. AGENCY: The Department of Justice (DOJ), Office of Justice Programs, National Institute of Justice (NIJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until March 21, 2016. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact: Michael O’Shea (202) 305–7954, National Institute of Justice (NIJ), Office of Justice Programs, U.S. Department of Justice, 810 Seventh Street NW., Washington, DC 20531 or Jamie.phillips@usdoj.gov. SUMMARY: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should SUPPLEMENTARY INFORMATION: E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2910-2911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00778]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Apertus 
Pharmaceuticals

ACTION: Notice of registration.

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[[Page 2911]]

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

SUPPLEMENTARY INFORMATION: 
    By notice dated October 2, 2015, and published in the Federal 
Register on October 13, 2015, 80 FR 61470, Apertus Pharmaceuticals, 331 
Consort Drive, Ballwin, Missouri 63011 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 Apertus Pharmaceuticals 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
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Remifentanil (9739)........................  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company 
plans to bulk manufacture both as synthetic substances. No other 
activity for these drug codes is authorized for this registration.

    Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-00778 Filed 1-15-16; 8:45 am]
 BILLING CODE 4410-09-P