Importer of Controlled Substances; Notice of Registration, 30969-30970 [2011-13195]

Download as PDF 30969 Federal Register / Vol. 76, No. 103 / Friday, May 27, 2011 / Notices Dated: May 13, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 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. 2011–13207 Filed 5–26–11; 8:45 am] BILLING CODE 4410–09–P Dated: May 13, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration is granted registration as an importer of the basic classes of controlled substances listed. Dated: May 12, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–13193 Filed 5–26–11; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2011–13208 Filed 5–26–11; 8:45 am] jdjones on DSK8KYBLC1PROD with NOTICES Importer of Controlled Substances; Notice of Application BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 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 March 8, 2010, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import Remifentanil in bulk for use in dosageform manufacturing. 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 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 June 27, 2011. 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), 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 DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration VerDate Mar<15>2010 15:25 May 26, 2011 Jkt 223001 Importer of Controlled Substances; Notice of Registration By Notice dated March 8, 2011, and published in the Federal Register on March 17, 2011, 76 FR 14688, Aptuit, 10245 Hickman Mills Drive, Kansas City, Missouri 64137, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug I II The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form for packaging for a clinical trial study. In addition, the company also 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 for clinical trials. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a), and determined that the registration of Aptuit 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. DEA has investigated Aptuit 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 Frm 00068 Fmt 4703 Drug Schedule Marihuana (7360) ......................... Poppy Straw Concentrate (9670) PO 00000 By Notice dated January 18, 2011, and published in the Federal Register on February 2, 2011, 76 FR 5827, Mallinckrodt Inc., 3600 North Second Street, St. Louis, Missouri 63147, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Sfmt 4703 Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Schedule II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk 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 § 952(a), and determined that the registration of Mallinckrodt 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. DEA has investigated Mallinckrodt Inc. 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 classes of controlled substances listed. E:\FR\FM\27MYN1.SGM 27MYN1 30970 Federal Register / Vol. 76, No. 103 / Friday, May 27, 2011 / Notices Dated: May 13, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. the basic classes of controlled substances listed. Dated: May 13, 2011. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2011–13195 Filed 5–26–11; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2011–13204 Filed 5–26–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF LABOR Manufacturer of Controlled Substances; Notice of Registration Office of the Secretary By Notice dated January 18, 2011, and published in the Federal Register on February 2, 2011, 76 FR 5829, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule jdjones on DSK8KYBLC1PROD with NOTICES Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Pentobarbital (2270) ..................... Meperidine (9230) ........................ Fentanyl (9801) ............................ I I 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), the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic THC (7370). No other activity for this drug code is authorized for this registration. 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 AMRI Rensselaer, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated AMRI Rensselaer, Inc. 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 VerDate Mar<15>2010 15:25 May 26, 2011 Jkt 223001 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Standard on the Control of Hazardous Energy— Lockout/Tagout ACTION: Notice. The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ‘‘Standard on the Control of Hazardous Energy—Lockout/Tagout,’’ to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (Pub. L. 104–13, 44 U.S.C. chapter 35). DATES: Submit comments on or before June 27, 2011. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site, https://www.reginfo.gov/ public/do/PRAMain, on the day following publication of this notice or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an e-mail to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202–395–6929/Fax: 202–395–6881 (these are not toll-free numbers), e-mail: OIRA_submission@omb.eop.gov. FOR FURTHER INFORMATION CONTACT: Michel Smyth by telephone at 202–693– 4129 (this is not a toll-free number) or by e-mail at DOL_PRA_PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: The Control of Hazardous Energy Standard SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 specifies several information collection requirements, including those related to energy-control procedure; protective materials and hardware; and periodic inspection, training, and communication. This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid OMB control number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under OMB Control Number 1218–0150. The current OMB approval is scheduled to expire on May 31, 2011; however, it should be noted that information collections submitted to the OMB receive a monthto-month extension while they undergo review. For additional information, see the related notice published in the Federal Register on February 15, 2011 (76 FR 8780). Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within 30 days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should reference OMB Control Number 1218– 0150. The OMB is particularly interested in comments that: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Notices]
[Pages 30969-30970]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13195]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration

    By Notice dated January 18, 2011, and published in the Federal 
Register on February 2, 2011, 76 FR 5827, Mallinckrodt Inc., 3600 North 
Second Street, St. Louis, Missouri 63147, made application by renewal 
to the Drug Enforcement Administration (DEA) to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Phenylacetone (8501).......................  II
Coca Leaves (9040).........................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
the manufacture of controlled substances in bulk 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 Sec.  952(a), and determined that 
the registration of Mallinckrodt 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. DEA has investigated Mallinckrodt 
Inc. 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 
classes of controlled substances listed.


[[Page 30970]]


    Dated: May 13, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2011-13195 Filed 5-26-11; 8:45 am]
BILLING CODE 4410-09-P

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