Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 76312 [2015-30812]

Download as PDF 76312 Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices By notice dated August 10, 2015, and published in the Federal Register on August 18, 2015, 80 FR 50032, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321 applied to be registered as an importer of certain basic classes of controlled substances. Comments and requests for hearings 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 Cody Laboratories, Inc. 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: Controlled substance Schedule Phenylacetone (8501) .................. Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ II II II Lhorne on DSK9F6TC42PROD with NOTICES The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with the DEA as a manufacturer of several controlled substances that are manufactured from poppy straw concentrate. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacturer tapentadol for distribution to its customers. Dated: November 30, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30814 Filed 12–7–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 14:17 Dec 07, 2015 Jkt 238001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc. 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 1301.33(a) on or before February 8, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/OD/D, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearing should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. 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 1301.33(a), this is notice that on October 2, 2015, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: DATES: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333). Meperidine (9230) ........................ Fentanyl (9801) ............................ PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Schedule I I II II II II II II II The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. In reference to drug code 7360 (marihuana), and 7370 (THC), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Dated: November 30, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30812 Filed 12–7–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under CERCLA On November 20, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Oklahoma, in the lawsuit entitled United States v. The Doe Run Resources Childress Royalty Corporation and NL Industries Inc., Case No. 4:15–cv– 00663–CVE–TLW. Defendants leased property where mining operations took place at the Tar Creek Site. The proposed settlement resolves the United States’ claims and the claims of the State of Oklahoma on behalf of the Oklahoma Department of Environmental Quality against The Doe Run Resources Corporation (‘‘Doe Run’’) and NL Industries Inc. (‘‘NL’’) under Section 107 of CERCLA for recovery of response costs incurred and to be incurred at the Site. Under the proposed Consent Decree, Doe Run will pay $3,433,137 and NL will pay $6,603,590 to resolve the United States’ claims. Doe Run and NL will pay $62,000 and $225,000 respectively to resolve the claims of the State. In addition, the Settling Federal Agency (the Department of the Interior) is resolving its CERCLA liability at the Site by paying $5.0 million. The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States of America v. The Doe Run Resources Childress Royalty Corporation and NL Industries Inc., Case No. 4:15–cv–00663–CVE–TLW, D.J. Ref. No. 90–11–2–330/10. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Page 76312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30812]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: AMRI 
Rensselaer, Inc.

ACTION: Notice of application.

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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 in accordance with 21 CFR 
1301.33(a) on or before February 8, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/OD/D, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearing should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.

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 1301.33(a), this is notice that on 
October 2, 2015, AMRI Rensselaer, Inc., 33 Riverside Avenue, 
Rensselaer, New York 12144 applied to be registered as a bulk 
manufacturer of the following basic classes controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)    II
 (8333).
Meperidine (9230)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacture bulk controlled substances for use 
in product development and for distribution to its customers.
    In reference to drug code 7360 (marihuana), and 7370 (THC), the 
company plans to bulk manufacture these drugs as synthetic. No other 
activities for these drug codes are authorized for this registration.

    Dated: November 30, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30812 Filed 12-7-15; 8:45 am]
 BILLING CODE 4410-09-P

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