Importer of Controlled Substances; Notice of Registration, 6061-6062 [2010-2570]

Download as PDF srobinson on DSKHWCL6B1PROD with NOTICES Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices for alleged environmental violations of the Prevention of Significant Deterioration (‘‘PSD’’) provisions of the Act, 42 U.S.C. 7470–7492; the nonattainment New Source Review (‘‘nonattainment NSR’’) provisions of the Act, 42 U.S.C. 7501–7515; and the federally-approved and enforceable state implementation plans, which incorporate and/or implement the above listed federal PSD and/or nonattainment NSR requirements. The Complaint also alleges violations of Title V of the Act, 42 U.S.C. §§ 7661–7661f, and Title V’s implementing Federal and State regulations. These violations are alleged to have occurred at one or more of each of the Lafarge Companies’ Portland cement plants located in Alpena, Michigan; Ravena, New York; Tulsa, Oklahoma; Fredonia, Kansas; Sugar Creek, Missouri; Buffalo, Iowa; Paulding, Ohio; Gand Chain, Illinois; Seattle, Washington; Whitehall, Pennsylvania; Harleyville, South Carolina; Atlanta, Georgia; and Calera, Alabama. Under the proposed settlement, the Lafarge Companies will be required to implement pollution control technologies to reduce emissions of nitrogen oxides and sulfur dioxide at designated cement kilns and to meet emission limits which are either set forth in the Consent Decree or will be set later by following procedures specified in the Decree. In addition, the Lafarge Companies must pay a total civil penalty of $5,075,000. Two-thirds of this penalty ($3,383,000) will be paid to the United States, and the remaining one-third will be shared among the participating states and agencies as set forth in the Consent Decree. The States of Alabama, Illinois, Iowa, Kansas, Michigan, Missouri, New York, Ohio and the Commonwealth of Pennsylvania Department of Environmental Protection, the South Carolina Department of Health and Environmental Control, the Washington State Department of Ecology, the Oklahoma Department of Environmental Quality, and the Puget Sound Clean Air Agency have joined in this settlement as signatories to the Consent Decree. The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either mailed to pubcomment-ees.enrd@usdoj.gov or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611, and should refer to United VerDate Nov<24>2008 16:26 Feb 04, 2010 Jkt 220001 States, et al. v. Lafarge North America, Inc., et al., D.J. Ref. 90–5–2–1–08221. The Consent Decree may be examined at the Office of the United States Attorney, Nine Executive Drive, Fairview Heights, Illinois 62208–1344 and at U.S. EPA Region 5, 77 West Jackson Blvd., Chicago, Illinois 60604– 3590. During the public comment period, the Consent Decree may also be examined on the following Department of Justice Web site, https:// www.usdoj.gov/enrd/ Consent_Decrees.html. A copy of the Consent Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044–7611 or by faxing or e-mailing a request to Tonia Fleetwood (tonia.fleetwood@usdoj.gov), fax number (202) 514–0097, phone confirmation number (202) 514–1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $38.00 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. Maureen Katz, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2010–2489 Filed 2–4–10; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration By Notice dated January 9, 2009, and published in the Federal Register on January 21, 2009, (74 FR 3641), Kenco VPI, Division of Kenco Group, Inc., 350 Corporate Place, Chattanooga, Tennessee 37419, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for distribution to its customers. One comment was received concerning this application. The comment states that DEA added Schedule II and the drug code for Nabilone (7379) to Kenco VPI’s importer registration without the benefit of the required legal process for modifying the DEA registration. The comment further states that, after Kenco VPI was properly registered as an importer of Nabilone on PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 6061 November 1, 2006, there was no further mention of Nabilone in any subsequent notices of Kenco VPI’s applications or approval of its applications published in the Federal Register by DEA until the application published on January 21, 2009. (74 FR 3641) The comment also requested clarification whether Kenco VPI imports Nabilone in finished drug product in dosage form or in bulk active pharmaceutical ingredient (API) form. Finally, the comment inquires if the aggregate national quota for Nabilone established by DEA will be affected by Kenco VPI’s application. DEA’s response to the issues raised in the comment are as follows: DEA has already admitted that Kenco VPI’s importer registration received Schedule II and the drug code for Nabilone without the benefit of the required legal process. On August 1, 2006, a Notice of Application (71 FR 43526) was published for Kenco VPI in the Federal Register. Subsequently, on November 1, 2006, a Notice of Registration (71 FR 64298) was published. These notices addressed DEA’s issuance to Kenco VPI’s importer registration of Schedule II and the drug code for Nabilone without the benefit of the required legal process. As a result of the publication of these notices, Kenco VPI’s importer registration has been legally authorized to import Nabilone, effective: November 1, 2006. DEA rejects the comment’s assertion that, between November 1, 2006 and January 21, 2009, there was no further mention of Nabilone in any subsequent notices of Kenco VPI’s applications or approval of its applications published in the Federal Register by DEA. This assertion is incorrect. Four notices were published between November 1, 2006 and January 21, 2009 as follows: (71 FR 66974, November 17, 2006), (72 FR 8792, February 27, 2007), (73 FR 14840, March 19, 2008), (73 FR 31510, June 2, 2008). Each of these notices mentions Nabilone. With regard to the comment’s request for clarification of whether Kenco VPI imports Nabilone in finished drug product in dosage form or in bulk active pharmaceutical ingredient (API) form, the company imports finished drug products in dosage form only. Kenco VPI does not import Nabilone in bulk active pharmaceutical ingredient (API) form. Since there are no domestic sources of Nabilone in finished drug product form available within the United States and since the product which Kenco VPI imports has been approved for medical use within the United States by the U.S. Food and Drug Administration, DEA finds no reason to reject Kenco VPI’s application. The E:\FR\FM\05FEN1.SGM 05FEN1 6062 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices aggregate national quota for Nabilone established by DEA will not be affected by this application of Kenco VPI since the company imports Nabilone in finished drug product form only. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Kenco VPI to import the basic class of controlled substance is consistent with the public interest, and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971, at this time. DEA has investigated Kenco VPI 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. 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 basic class of controlled substance listed. Dated: January 29, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–2570 Filed 2–4–10; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Dated: January 27, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration srobinson on DSKHWCL6B1PROD with NOTICES Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under 21 U.S.C. 952(a)(2), authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on April 3, 2009, Wildlife Laboratories, 1401 Duff Drive, Suite 400, Fort Collins, Colorado 80524, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of Etorphine Hydrochloride (9059), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for sale to its customers. VerDate Nov<24>2008 16:26 Feb 04, 2010 Jkt 220001 Any bulk manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may 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 March 8, 2010. 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. [FR Doc. 2010–2575 Filed 2–4–10; 8:45 am] BILLING CODE 4410–09–P Drug Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Cocaine (9041) ............................. Schedule I I I The Institute will manufacture small quantities of cocaine and marihuana derivatives for use by their customers in analytical kits, reagents, and reference standards as directed by the National Institute on Drug Abuse. 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 Research Triangle Institute to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Research Triangle Institute 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, 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: January 25, 2010. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2010–2578 Filed 2–4–10; 8:45 am] BILLING CODE 4410–09–P MARINE MAMMAL COMMISSION Notice of Meeting DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances Notice of Registration By Notice dated August 21, 2009, and published in the Federal Register on September 8, 2009, (74 FR 46232), Research Triangle Institute, Kenneth H. Davis Jr., Hermann Building, East Institute Drive, P.O. Box 12194, Research Triangle, North Carolina 27709, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedules I and II: PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 Time and Date: The Marine Mammal Commission will conduct a review of the potential effects of human activities, including aquaculture operations, on harbor seals in Drake’s Estero, Mann County, California, on 21–24 February 2010 from 9 a.m. to approximately 6 p.m. Place: The Red Barn, Point Reyes National Seashore, I Bear Valley Road, Point Reyes Station, CA 94956. Status: Sessions on Sunday, February 21, and Tuesday and Wednesday, February 23–24 will be open to the public. Public participation will be allowed as time permits and as determined to be desirable by the meeting chairperson. There will be no public meeting on Monday, February 22. E:\FR\FM\05FEN1.SGM 05FEN1

Agencies

[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Notices]
[Pages 6061-6062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2570]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration

    By Notice dated January 9, 2009, and published in the Federal 
Register on January 21, 2009, (74 FR 3641), Kenco VPI, Division of 
Kenco Group, Inc., 350 Corporate Place, Chattanooga, Tennessee 37419, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as an importer of Nabilone (7379), a basic class 
of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
distribution to its customers.
    One comment was received concerning this application. The comment 
states that DEA added Schedule II and the drug code for Nabilone (7379) 
to Kenco VPI's importer registration without the benefit of the 
required legal process for modifying the DEA registration. The comment 
further states that, after Kenco VPI was properly registered as an 
importer of Nabilone on November 1, 2006, there was no further mention 
of Nabilone in any subsequent notices of Kenco VPI's applications or 
approval of its applications published in the Federal Register by DEA 
until the application published on January 21, 2009. (74 FR 3641) The 
comment also requested clarification whether Kenco VPI imports Nabilone 
in finished drug product in dosage form or in bulk active 
pharmaceutical ingredient (API) form. Finally, the comment inquires if 
the aggregate national quota for Nabilone established by DEA will be 
affected by Kenco VPI's application.
    DEA's response to the issues raised in the comment are as follows: 
DEA has already admitted that Kenco VPI's importer registration 
received Schedule II and the drug code for Nabilone without the benefit 
of the required legal process. On August 1, 2006, a Notice of 
Application (71 FR 43526) was published for Kenco VPI in the Federal 
Register. Subsequently, on November 1, 2006, a Notice of Registration 
(71 FR 64298) was published. These notices addressed DEA's issuance to 
Kenco VPI's importer registration of Schedule II and the drug code for 
Nabilone without the benefit of the required legal process. As a result 
of the publication of these notices, Kenco VPI's importer registration 
has been legally authorized to import Nabilone, effective: November 1, 
2006.
    DEA rejects the comment's assertion that, between November 1, 2006 
and January 21, 2009, there was no further mention of Nabilone in any 
subsequent notices of Kenco VPI's applications or approval of its 
applications published in the Federal Register by DEA. This assertion 
is incorrect. Four notices were published between November 1, 2006 and 
January 21, 2009 as follows: (71 FR 66974, November 17, 2006), (72 FR 
8792, February 27, 2007), (73 FR 14840, March 19, 2008), (73 FR 31510, 
June 2, 2008). Each of these notices mentions Nabilone.
    With regard to the comment's request for clarification of whether 
Kenco VPI imports Nabilone in finished drug product in dosage form or 
in bulk active pharmaceutical ingredient (API) form, the company 
imports finished drug products in dosage form only. Kenco VPI does not 
import Nabilone in bulk active pharmaceutical ingredient (API) form. 
Since there are no domestic sources of Nabilone in finished drug 
product form available within the United States and since the product 
which Kenco VPI imports has been approved for medical use within the 
United States by the U.S. Food and Drug Administration, DEA finds no 
reason to reject Kenco VPI's application. The

[[Page 6062]]

aggregate national quota for Nabilone established by DEA will not be 
affected by this application of Kenco VPI since the company imports 
Nabilone in finished drug product form only.
    DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and 
determined that the registration of Kenco VPI to import the basic class 
of controlled substance is consistent with the public interest, and 
with United States obligations under international treaties, 
conventions, or protocols in effect on May 1, 1971, at this time. DEA 
has investigated Kenco VPI 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. 952(a) and Sec.  958(a), and in accordance with 21 CFR 
1301.34, the above named company is granted registration as an importer 
of the basic class of controlled substance listed.

    Dated: January 29, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2010-2570 Filed 2-4-10; 8:45 am]
BILLING CODE 4410-09-P
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