Manufacturer of Controlled Substances; Notice of Registration; Mallinckrodt LLC, 31391-31392 [2012-12817]

Download as PDF 31391 Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices Drug Schedule 5–Methoxy-N,N-diisopropyltryptamine (7439) ............................................................................................................................................. 1-[1-(2–Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... N–Benzylpiperazine (7493) ......................................................................................................................................................................... Heroin (9200) ............................................................................................................................................................................................... Normorphine (9313) .................................................................................................................................................................................... Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Nabilone (7379) ........................................................................................................................................................................................... 1–Phenylcyclohexylamine (7460) ................................................................................................................................................................ Phencyclidine (7471) ................................................................................................................................................................................... Cocaine (9041) ............................................................................................................................................................................................ Codeine (9050) ............................................................................................................................................................................................ Diprenorphine (9058) ................................................................................................................................................................................... Ecgonine (9180) .......................................................................................................................................................................................... Levomethorphan (9210) .............................................................................................................................................................................. Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Metazocine (9240) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Levo-alphacetylmethadol (9648) ................................................................................................................................................................. Remifentanil (9739) ..................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... Carfentanil (9743) ........................................................................................................................................................................................ Fentanyl (9801) ........................................................................................................................................................................................... The company plans to manufacture reference standards. 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 Sigma Aldrich Research Biochemicals, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Sigma Aldrich Research Biochemicals, 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 the basic classes of controlled substances listed. Dated: May 15, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12821 Filed 5–24–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Mallinckrodt LLC By Notice dated January 23, 2012, and published in the Federal Register on January 31, 2012, 77 FR 4828, Mallinckrodt Inc., 3600 North Second Street, St. Louis, Missouri 63147, 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: mstockstill on DSK4VPTVN1PROD with NOTICES Drug Schedule Tetrahydrocannabinols (7370) ..................................................................................................................................................................... Codeine-N-oxide (9053) .............................................................................................................................................................................. Dihydromorphine (9145) .............................................................................................................................................................................. Difenoxin (9168) .......................................................................................................................................................................................... Morphine-N-oxide (9307) ............................................................................................................................................................................. Normorphine (9313) .................................................................................................................................................................................... Norlevorphanol (9634) ................................................................................................................................................................................. Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................... Nabilone (7379) ........................................................................................................................................................................................... 4–Anilino-N-phenethyl-4-piperidine (8333) .................................................................................................................................................. Codeine (9050) ............................................................................................................................................................................................ Dihydrocodeine (9120) ................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Hydromorphone (9150) ............................................................................................................................................................................... Diphenoxylate (9170) .................................................................................................................................................................................. Ecgonine (9180) .......................................................................................................................................................................................... Hydrocodone (9193) .................................................................................................................................................................................... Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Methadone intermediate (9254) .................................................................................................................................................................. VerDate Mar<15>2010 17:55 May 24, 2012 Jkt 226001 PO 00000 Frm 00102 Fmt 4703 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 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1 I I I I I I I II II II II II II II II II II II II II II II II 31392 Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices Drug Schedule Metopon (9260) ........................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms)(9273) ............................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Oripavine (9330) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Opium tincture (9630) .................................................................................................................................................................................. Opium, powdered (9639) ............................................................................................................................................................................. Oxymorphone (9652) ................................................................................................................................................................................... Noroxymorphone (9668) .............................................................................................................................................................................. Alfentanil (9737) .......................................................................................................................................................................................... Remifentanil (9739) ..................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... Fentanyl (9801) ........................................................................................................................................................................................... The firm plans to manufacture the listed controlled substances for internal use and for sale to other companies. 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 Mallinckrodt, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Mallinckrodt, 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, 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: May 15, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Record on Objection to Commission’s Proposed Decision in Claim No. LIB–II– 083. Status: Open. All meetings are held at the Foreign Claims Settlement Commission, 600 E Street, NW., Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Judith H. Lock, Executive Officer, Foreign Claims Settlement Commission, 600 E Street NW., Suite 6002, Washington, DC 20579. Telephone: (202) 616–6975. Jaleh F. Barrett, Chief Counsel. [FR Doc. 2012–12873 Filed 5–23–12; 11:15 am] BILLING CODE 4410–BA–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Settlement Agreements Between a Plan and Party in Interest ACTION: Notice. [FR Doc. 2012–12817 Filed 5–24–12; 8:45 am] DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission [F.C.S.C. Meeting and Hearing Notice No. 05–12] mstockstill on DSK4VPTVN1PROD with NOTICES Sunshine Act Meeting The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows: Tuesday, June 5, 2012: 1 p.m.— Issuance of Proposed Decisions in claims against Libya; Hearing on the VerDate Mar<15>2010 17:55 May 24, 2012 The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ‘‘Settlement Agreements Between a Plan and Party in Interest,’’ 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 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before June 25, 2012. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov SUMMARY: BILLING CODE 4410–09–P Jkt 226001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 II II II II II II II II II II II II II 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 email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–EBSA, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503, Telephone: 202–395–6929/Fax: 202–395–6881 (these are not toll-free numbers), email: OIRA_submission@omb.eop.gov. FOR FURTHER INFORMATION CONTACT: Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at DOL_PRA_PUBLIC@dol.gov. SUPPLEMENTARY INFORMATION: Prohibited Transaction Exemption (PTE) 94–71 exempts from certain restrictions of the Employee Retirement Income Security Act of 1974 (ERISA) and section 4975(c)(2) of the Internal Revenue Code of 1986 (Code) a settlement agreement entered into between a plan and a party in interest resulting from an investigation of an employee benefit plan by the Department. PTE 03–39 similarly exempts from certain restrictions of the ERISA and certain taxes of the Code, settlement agreements entered into between a plan and a party in interest in avoidance of litigation. 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 E:\FR\FM\25MYN1.SGM 25MYN1

Agencies

[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31391-31392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12817]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Mallinckrodt LLC

    By Notice dated January 23, 2012, and published in the Federal 
Register on January 31, 2012, 77 FR 4828, Mallinckrodt Inc., 3600 North 
Second Street, St. Louis, Missouri 63147, 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
------------------------------------------------------------------------
Tetrahydrocannabinols (7370).....................  I
Codeine-N-oxide (9053)...........................  I
Dihydromorphine (9145)...........................  I
Difenoxin (9168).................................  I
Morphine-N-oxide (9307)..........................  I
Normorphine (9313)...............................  I
Norlevorphanol (9634)............................  I
Amphetamine (1100)...............................  II
Methamphetamine (1105)...........................  II
Methylphenidate (1724)...........................  II
Nabilone (7379)..................................  II
4-Anilino-N-phenethyl-4-piperidine (8333)........  II
Codeine (9050)...................................  II
Dihydrocodeine (9120)............................  II
Oxycodone (9143).................................  II
Hydromorphone (9150).............................  II
Diphenoxylate (9170).............................  II
Ecgonine (9180)..................................  II
Hydrocodone (9193)...............................  II
Levorphanol (9220)...............................  II
Meperidine (9230)................................  II
Methadone (9250).................................  II
Methadone intermediate (9254)....................  II

[[Page 31392]]

 
Metopon (9260)...................................  II
Dextropropoxyphene, bulk (non-dosage forms)(9273)  II
Morphine (9300)..................................  II
Oripavine (9330).................................  II
Thebaine (9333)..................................  II
Opium tincture (9630)............................  II
Opium, powdered (9639)...........................  II
Oxymorphone (9652)...............................  II
Noroxymorphone (9668)............................  II
Alfentanil (9737)................................  II
Remifentanil (9739)..............................  II
Sufentanil (9740)................................  II
Fentanyl (9801)..................................  II
------------------------------------------------------------------------

    The firm plans to manufacture the listed controlled substances for 
internal use and for sale to other companies.
    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 
Mallinckrodt, LLC., to manufacture the listed basic classes of 
controlled substances is consistent with the public interest at this 
time. DEA has investigated Mallinckrodt, 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, 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: May 15, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-12817 Filed 5-24-12; 8:45 am]
BILLING CODE 4410-09-P
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