Importer of Controlled Substances Application: Mallinckrodt LLC, 15566-15567 [2016-06543]

Download as PDF 15566 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices used in the manufacture of DEA exempt products. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–06540 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: R & D Systems, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before April 22, 2016. Such persons may also file a written request for a DATES: hearing on the application pursuant to 21 CFR 1301.43 on or before April 22, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on February 25, 2015, R & D Systems, Inc., 614 McKinley Place NE., Minneapolis, Minnesota 55413 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule jstallworth on DSK7TPTVN1PROD with NOTICES Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) (7118) .............................................................................................. CP–47,497 (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) .......................................................................................................................................................................... Psilocyn (7438) ............................................................................................................................................................................................ Amphetamine (1100) ................................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................... Cocaine (9041) ............................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... 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 these drug codes 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 Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. I I I I I I I I I II II II II II II II II II DEPARTMENT OF JUSTICE comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before April 22, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 22, 2016. Drug Enforcement Administration ADDRESSES: [FR Doc. 2016–06542 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–392] Importer of Controlled Substances Application: Mallinckrodt LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug E:\FR\FM\23MRN1.SGM 23MRN1 15567 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on December 22, 2015, Mallinckrodt LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II [FR Doc. 2016–06543 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P jstallworth on DSK7TPTVN1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC ACTION: Notice of application. VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DEPARTMENT OF JUSTICE ADDRESSES: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on November 12, 2015, Siegfried USA, LLC, 33 Industrial Park Road, Pennsville, New Jersey 08070 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before May 23, 2016. DATES: Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Hydromorphinol (9301) ................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium tincture (9630) .................. Oxymorphone (9652) ................... Schedule I I I II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 [FR Doc. 2016–06537 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Halo Pharmaceutical, Inc. ACTION: Notice of registration. Halo Pharmaceutical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Halo Pharmaceutical, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63838, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Halo Pharmaceutical, Inc. to manufacture 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. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing 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 following basic classes of controlled substances: SUMMARY: Controlled substance Dihydromorphine (9145) ............... Hydromorphone (9150) ................ Schedule I II The company plans to manufacture Hydromorphone HCl for sale to other manufacturers and to manufacture other controlled substances for distribution to E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15566-15567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06543]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mallinckrodt LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before April 22, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 22, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All request for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug

[[Page 15567]]

Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette 
Drive, Springfield, Virginia 22152; and (2) Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/ODW, 8701 
Morrissette Drive, Springfield, Virginia 22152. Comments and requests 
for hearing on applications to import narcotic raw material are not 
appropriate. 72 FR 3417 (January 25, 2007).

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
December 22, 2015, Mallinckrodt LLC, 3600 North Second Street, Saint 
Louis, Missouri 63147 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       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 to 
bulk manufacture into Active Pharmaceutical Ingredients for 
distribution to its customers.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06543 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P