Manufacturer of Controlled Substances, Notice of Application, Navinta, LLC, 23596-23597 [2013-09318]

Download as PDF 23596 Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices Drug Schedule Oxymorphone (9652) ................... II The company plans to manufacture the listed controlled substances as bulk controlled substance intermediates for distribution to its 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 June 18, 2013. Dated: April 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Manufacturer of Controlled Substances, Notice of Application, Rhodes Technologies Pursuant to § 1301.33(a) Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 6, 2013, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816, 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 Schedule I II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion and sale to dosage form manufacturers. 17:11 Apr 18, 2013 Jkt 229001 BILLING CODE 4410–09–P Manufacturer of Controlled Substances, Notice of Application, American Radiolabeled Chemicals, Inc. DEPARTMENT OF JUSTICE VerDate Mar<15>2010 [FR Doc. 2013–09283 Filed 4–18–13; 8:45 am] Drug Enforcement Administration BILLING CODE 4410–09–P Tetrahydrocannabinols (7370) ..... Methylphenidate (1724) ................ Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Fentanyl (9801) ............................ Dated: April 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE [FR Doc. 2013–09317 Filed 4–18–13; 8:45 am] Drug 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 June 18, 2013. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 11, 2013, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. Louis, Missouri 63146, 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 Gamma Hydroxybutyric Acid (2010). Ibogaine (7260) ............................ Lysergic acid diethylamide (7315) Tetrahydrocannabinols (7370) ..... Dimethyltryptamine (7435) ........... 1-[1-(2Thienyl)cyclohexyl]piperidine (7470). Dihydromorphine (9145) ............... Heroin (9200) ............................... Normorphine (9313) ..................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Metazocine (9240) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 I I I I I I I I I II II II II II II II II II II II II II II II Drug Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Phenazocine (9715) ..................... Carfentanil (9743) ......................... Fentanyl (9801) ............................ Schedule II II II II II II II The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. 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 June 18, 2013. Dated: April 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–09315 Filed 4–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances, Notice of Application, Navinta, LLC Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on February 13, 2013, Navinta, LLC., 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances: Drug Pentobarbital (2270) ..................... Remifentanil (9739) ...................... Schedule II II The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then to produce commercial size batches for distribution to dosage form manufacturers upon FDA approval. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, E:\FR\FM\19APN1.SGM 19APN1 Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices 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 June 18, 2013. Dated: April 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 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: April 10, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–09325 Filed 4–18–13; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2013–09318 Filed 4–18–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR DEPARTMENT OF JUSTICE Office of the Secretary Drug Enforcement Administration Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Longitudinal Survey of Youth 1997 Manufacturer of Controlled Substances, Notice of Registration, National Center for Natural Products Research—NIDA ACTION: By Notice dated November 1, 2012 and published in the Federal Register on November 9, 2012, 77 FR 67398, National Center for Natural Products Research-NIDA MProject, University of Mississippi, 135 Coy Waller Lab Complex, University, Mississippi 38677, 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 mstockstill on DSK4VPTVN1PROD with NOTICES Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... II II The company plans to cultivate marihuana for the National Institute on Drug Abuse for research approved by the Department of Health and Human Services. 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 National Center for Natural Products Research-NIDA MProject, University of Mississippi to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated National Center for Natural Products ResearchNIDA MProject, University of Mississippi 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 VerDate Mar<15>2010 17:11 Apr 18, 2013 Jkt 229001 Notice. The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, ‘‘National Longitudinal Survey of Youth 1997,’’ (NLSY97) to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before May 20, 2013. 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 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–BLS, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: 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 email at DOL_PRA_PUBLIC@dol.gov. SUMMARY: Authority: 44 U.S.C. 3507(a)(1)(D). PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 23597 The NLSY97 includes respondents born from 1980 through 1984 and lived in the United States when the survey began in 1997. The primary objective of the survey is to study the transition from full-time schooling to the establishment of careers and families. The longitudinal focus of the survey requires information to be collected about the same individuals over many years in order to trace their education, training, work experience, fertility, income, and program participation. Research based on the NLSY97 contributes to the formation of national policy in the areas of education, training, employment programs, and school-to-work transitions. 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 that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1220–0157. For additional information, see the related notice published in the Federal Register on January 24, 2013 (78 FR 5211). 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 mention OMB Control Number 1220– 0157. 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, SUPPLEMENTARY INFORMATION: E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23596-23597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09318]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances, Notice of Application, 
Navinta, LLC

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on February 13, 2013, Navinta, 
LLC., 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414, made 
application to the Drug Enforcement Administration (DEA) to be 
registered as a bulk manufacturer of the basic classes of controlled 
substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Pentobarbital (2270).......................  II
Remifentanil (9739)........................  II
------------------------------------------------------------------------

    The company plans initially to manufacture API quantities of the 
listed controlled substances for validation purposes and FDA approval, 
then to produce commercial size batches for distribution to dosage form 
manufacturers upon FDA approval.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substance,

[[Page 23597]]

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 June 18, 2013.

    Dated: April 10, 2013.
 Joseph T. Rannazzisi,
 Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-09318 Filed 4-18-13; 8:45 am]
BILLING CODE 4410-09-P
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