Manufacturer of Controlled Substances; Notice of Application; Organix, Inc., 52801-52802 [2013-20724]

Download as PDF 52801 Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices Schedule Drug Marihuana (7360) ......................... Poppy Straw Concentrate (9670) DEPARTMENT OF JUSTICE I II Drug Enforcement Administration ehiers on DSK2VPTVN1PROD with NOTICES The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for a clinical trial study. In addition, the company plans to import an ointment for the treatment of wounds which contain trace amounts of the controlled substances normally found in poppy straw concentrate for packaging and labeling to be used in clinical trials. Comments and requests for any hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417(2007). Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, VA 22152; and must be filed no later than September 25, 2013. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20717 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 17:12 Aug 23, 2013 Jkt 229001 Importer of Controlled Substances; Notice of Application; Chattem Chemicals, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on June 21, 2013, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug Schedule Methamphetamine (1105) ............ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ II II II II II II The company plans to import the listed controlled substances to manufacture bulk controlled substances for sale to its customers. The company plans to import an intermediate form of Tapentadol (9780); and then to bulk manufacture Tapentadol for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417(2007). Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances listed in schedule I or II, which fall under the authority of section 1002(a)(2)(B) of the Act [21 U.S.C. 952(a)(2)(B)] may, in the circumstances set forth in 21 U.S.C. 958(i), file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than September 25, 2013. This procedure is to be conducted simultaneously with, and independent of, the procedures described in 21 CFR § 1301.34(b), (c), (d), (e), and (f). As noted in a previous notice published in the Federal Register on September 23, PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 1975, 40 FR 43745–46, all applicants for registration to import a basic class of any controlled substance in schedule I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20720 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Organix, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 2, 2013, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Psilocybin (7437) .......................... Psilocyn (7438) ............................. Schedule I I I I The company plans to synthesize small quantities of the listed controlled substances to make reference standards which will be distributed to their customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than October 25, 2013. E:\FR\FM\26AUN1.SGM 26AUN1 52802 Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices Dated: August 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20724 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cambridge Isotope Lab Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 01, 2013, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Morphine (9300), a basic class of controlled substance listed in schedule II. The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards. Any other such applicant, and any person who is presently registered with DEA to manufacture such a substance, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR § 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than October 25, 2013. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20723 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ehiers on DSK2VPTVN1PROD with NOTICES Manufacturer of Controlled Substances; Notice of Registration; Morton Grove Pharmaceuticals By Notice dated March 12, 2013, and published in the Federal Register on March 20, 2013, 78 FR 17231, Morton Grove Pharmaceuticals, 6451 Main Street, Morton Grove, Illinois 60053– 2633, made application by renewal to the Drug Enforcement Administration VerDate Mar<15>2010 13:45 Aug 23, 2013 Jkt 229001 (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for distribution to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a), and determined that the registration of Morton Grove Pharmaceuticals to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Morton Grove Pharmaceuticals to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems; verification of the company’s compliance with state and local laws; and a review of 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 basic class of controlled substance listed. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20761 Filed 8–23–13; 8:45 am] No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Navinta, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Navinta, LLC., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 basic classes of controlled substances listed. Dated: August 15, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–20757 Filed 8–23–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Tin T. Win, M.D., Dismissal of Proceeding BILLING CODE 4410–09–P On February 27, 2013, I, the Administrator of the Drug Enforcement Administration, issued an Order to DEPARTMENT OF JUSTICE Show Cause and Immediate Suspension of Registration to Tin T. Win, M.D. Drug Enforcement Administration (hereinafter, Registrant), of Lake Havasu, Arizona. GX 10, at 1. Among various Manufacturer of Controlled charges, the Order alleged that Substances; Notice of Registration: Registrant issued numerous controlled Navinta, LLC substance prescriptions after the By Notice dated April 10, 2013, and Arizona Medical Board had prohibited published in the Federal Register on her ‘‘from prescribing controlled April 19, 2013, 78 FR 23596, Navinta, substances’’ and thus violated both the LLC., 1499 Lower Ferry Road, Ewing, Board’s order and federal law. Id. at 1– New Jersey 08618–1414, made 3 (citing Ariz. Rev. Stat. § 32– application to the Drug Enforcement 1401(27)(r); 21 U.S.C. 841). The Order Administration (DEA) to be registered as also notified Registrant of her right to a bulk manufacturer of the following either request a hearing on the basic classes of controlled substances: allegations or submit a written statement of position in lieu of a hearing Drug Schedule within thirty (30) days of her receipt of Pentobarbital (2270) ..................... II the Order, the procedure for electing Remifentanil (9739) ...................... II either option, and the consequence of failing to elect either option. The company plans initially to On March 6, 2013, the Order was manufacture API quantities of the listed personally served on Registrant by a controlled substances for validation DEA Special Agent and a Diversion purposes and FDA approval, then to Investigator. See GX 11. On May 20, produce commercial size batches for 2013, the Government filed a Request distribution to dosage form for Final Agency Action, which sought manufacturers upon FDA approval. the revocation of Registrant’s PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52801-52802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20724]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Organix, Inc.

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on July 2, 2013, Organix, Inc., 
240 Salem Street, Woburn, Massachusetts 01801, made application to the 
Drug Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Psilocybin (7437)..........................  I
Psilocyn (7438)............................  I
------------------------------------------------------------------------

    The company plans to synthesize small quantities of the listed 
controlled substances to make reference standards which will be 
distributed to their customers.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, may file comments 
or objections to the issuance of the proposed registration pursuant to 
21 CFR 1301.33(a).
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than October 25, 2013.


[[Page 52802]]


     Dated: August 20, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-20724 Filed 8-23-13; 8:45 am]
BILLING CODE 4410-09-P