Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc., 47109-47110 [2012-19197]

Download as PDF 47109 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices Drug Schedule mstockstill on DSK4VPTVN1PROD with NOTICES 5-Methoxy-N,N-diisopropyltryptamine (7439) ............................................................................................................................................ N-Benzylpiperazine (7493) ........................................................................................................................................................................ 3,4-Methylenedioxypyrovalerone (7535) ................................................................................................................................................... 3,4-Methylenedioxy-N-methylcathinone (7540) ......................................................................................................................................... Desomorphine (9055) ................................................................................................................................................................................ Etorphine (except HCl)(9056) .................................................................................................................................................................... Heroin (9200) ............................................................................................................................................................................................. Morphine-N-oxide (9307) ........................................................................................................................................................................... Normorphine (9313) ................................................................................................................................................................................... Pholcodine (9314) ...................................................................................................................................................................................... Dextromoramide (9613) ............................................................................................................................................................................. Dipipanone (9622) ..................................................................................................................................................................................... Racemoramide (9645) ............................................................................................................................................................................... Trimeperidine (9646) ................................................................................................................................................................................. 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ..................................................................................................................................... Tilidine (9750) ............................................................................................................................................................................................ Amphetamine (1100) ................................................................................................................................................................................. Methamphetamine (1105) .......................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................. Amobarbital (2125) .................................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................. Secobarbital (2315) ................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................. Phenylacetone (8501) ................................................................................................................................................................................ Cocaine (9041) .......................................................................................................................................................................................... Codeine (9050) .......................................................................................................................................................................................... Dihydrocodeine (9120) .............................................................................................................................................................................. Oxycodone (9143) ..................................................................................................................................................................................... Hydromorphone (9150) .............................................................................................................................................................................. Benzoylecgonine (9180) ............................................................................................................................................................................ Ethylmorphine (9190) ................................................................................................................................................................................ Meperidine (9230) ...................................................................................................................................................................................... Methadone (9250) ..................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) (9273) ............................................................................................................................ Morphine (9300) ........................................................................................................................................................................................ Oripavine (9330) ........................................................................................................................................................................................ Thebaine (9333) ........................................................................................................................................................................................ Levo-alphacetylmethadol (9648) ............................................................................................................................................................... Oxymorphone (9652) ................................................................................................................................................................................. Poppy Straw Concentrate (9670) .............................................................................................................................................................. Alfentanil (9737) ......................................................................................................................................................................................... Sufentanil (9740) ....................................................................................................................................................................................... Fentanyl (9801) .......................................................................................................................................................................................... The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Comments and requests for hearing 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 schedules 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 VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 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 6, 2012. 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 substances in schedules I or II are, and will continue to be, required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 I I I I I I I I I I I 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 II II II II II II 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: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–19199 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on July 3, 2012, Clinical Supplies E:\FR\FM\07AUN1.SGM 07AUN1 47110 Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices 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 Drug Schedule to 21 CFR § 1301.43, and in such form as prescribed by 21 CFR § 1316.47. Methylphenidate (1724) ................ II Any such written comments or Sufentanil (9740) .......................... II objections should be addressed, in quintuplicate, to the Drug Enforcement The company plans to import the Administration, Office of Diversion listed controlled substances for Control, Federal Register Representative packaging, labeling, and distributing to (ODL), 8701 Morrissette Drive, customers which are qualified clinical sites, conducting FDA-approved clinical Springfield, Virginia 22152; and must be filed no later than September 6, 2012 trials. This procedure is to be conducted The import of the above listed basic simultaneously with, and independent classes of controlled substances would of, the procedures described in 21 CFR be granted only for analytical testing 1301.34(b), (c), (d), (e), and (f). As noted and clinical trials. This authorization in a previous notice published in the does not extend to the import of a Federal Register on September 23, 1975, finished FDA approved or non40 FR 43745–46, all applicants for approved dosage form for commercial registration to import a basic class of distribution in the United States. Any bulk manufacturer who is any controlled substance in schedules I presently, or is applying to be, or II are, and will continue to be, registered with DEA to manufacture required to demonstrate to the Deputy such basic classes of controlled Assistant Administrator, Office of substances listed in schedules I or II, Diversion Control, Drug Enforcement Management Inc., 342 42nd Street South, Fargo, North Dakota 58103, made application by renewal to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: 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: July 30, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–19197 Filed 8–6–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; R & D Systems, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on May 4, 2012, R & D Systems, Inc., 614 McKinley Place NE., Minneapolis, Minnesota 55413, made application to the Drug Enforcement Administration (DEA) for registration as an importer of the following basic classes of controlled substances: Drug Schedule mstockstill on DSK4VPTVN1PROD with NOTICES 1-Pentyl-3-(1-naphthoyl)indole (7118) ....................................................................................................................................................... 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (7297) .................................................................................................... Marihuana (7360) ...................................................................................................................................................................................... Tetrahydrocannabinols (7370) ................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (7391) ............................................................................................................................................ 3,4-Methylenedioxymethamphetamine (7405) .......................................................................................................................................... Dimethyltryptamine (7435) ......................................................................................................................................................................... Amphetamine (1100) ................................................................................................................................................................................. Methylphenidate (1724) ............................................................................................................................................................................. Phencyclidine (7471) ................................................................................................................................................................................. Cocaine (9041) .......................................................................................................................................................................................... Oxycodone (9143) ..................................................................................................................................................................................... Thebaine (9333) ........................................................................................................................................................................................ Fentanyl (9801) .......................................................................................................................................................................................... The company plans to import the listed controlled substances in dosage form to distribute to researchers. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. The import of the above listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished FDA approved or nonapproved dosage form for commercial distribution in the United States. Any bulk manufacturer who is presently, or is applying to be, VerDate Mar<15>2010 16:52 Aug 06, 2012 Jkt 226001 registered with DEA to manufacture such basic classes of controlled substances listed in schedules 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, PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 I I I I I I I II II II II II II II Springfield, Virginia 22152; and must be filed no later than September 6, 2012. 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 substances in schedules 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 E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47109-47110]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19197]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Clinical Supplies Management Inc.

    Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this 
is notice that on July 3, 2012, Clinical Supplies

[[Page 47110]]

Management Inc., 342 42nd Street South, Fargo, North Dakota 58103, 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
------------------------------------------------------------------------
Methylphenidate (1724).......................................         II
Sufentanil (9740)............................................         II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
packaging, labeling, and distributing to customers which are qualified 
clinical sites, conducting FDA-approved clinical trials.
    The import of the above listed basic classes of controlled 
substances would be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
FDA approved or non-approved dosage form for commercial distribution in 
the United States.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances listed in schedules 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 Sec.  1301.43, and in such form as prescribed by 21 
CFR Sec.  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 6, 2012
    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 
schedules 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: July 30, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-19197 Filed 8-6-12; 8:45 am]
BILLING CODE 4410-09-P
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