Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC, 31959-31960 [2016-11940]

Download as PDF 31959 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices representative consumer organizations have the right to appear as parties in Commission antidumping and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigations. Background On March 31, 2016, Compass Chemical International LLC, Smyrna, Georgia, filed a petition with the Commission and Commerce, alleging that an industry in the United States is materially injured or threatened with material injury by reason of LTFV and subsidized imports of 1hydroxyethylidene-1, 1-diphosphonic acid from China. Accordingly, effective March 31, 2016, the Commission, pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation No. 701–TA–558 and antidumping duty investigation No. 731–TA–1316 (Preliminary). Notice of the institution of the Commission’s investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of April 7, 2016 (81 FR 20416). The conference was held in Washington, DC, on April 21, 2016, and all persons who requested the opportunity were permitted to appear in person or by counsel. The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on May 16, 2016. The views of the Commission are contained in USITC Publication 4612 (May 2016), entitled 1Hydroxyethylidene-1, 1-Diphosphonic Acid from China: Investigation Nos. 701–TA–558 and 731–TA–1316 (Preliminary). By order of the Commission. Issued: May 16, 2016. Lisa R. Barton, Secretary to the Commission. mstockstill on DSK3G9T082PROD with NOTICES [FR Doc. 2016–11891 Filed 5–19–16; 8:45 am] BILLING CODE 7020–02–P Drug Enforcement Administration Dated: May 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [Docket No. DEA–392] [FR Doc. 2016–11939 Filed 5–19–16; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P Manufacturer of Controlled Substances Registration: Pharmacore, Inc. ACTION: Drug Enforcement Administration Notice of registration. Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer of those controlled substances. SUMMARY: By notice dated January 27, 2016, and published in the Federal Register on February 4, 2016, 81 FR 6044, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 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 Pharmacore, 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: SUPPLEMENTARY INFORMATION: Controlled substance Oxymorphone (9652) .................... Noroxymorphone (9668) ............... DEPARTMENT OF JUSTICE Schedule II II The company plans to manufacture the listed controlled substances as active pharmaceutical ingredients (APIs) for clinical trials. [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC 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 1301.33(a) on or before July 19, 2016. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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 February 19, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... Tetrahydrocannabinols (7370) ..................................................................................................................................................................... Codeine-N-oxide (9053) .............................................................................................................................................................................. Dihydromorphine (9145) .............................................................................................................................................................................. Difenoxin (9168) .......................................................................................................................................................................................... VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1 I I I I I 31960 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Controlled substance Schedule Morphine-N-oxide (9307) ............................................................................................................................................................................. Normorphine (9313) .................................................................................................................................................................................... Norlevorphanol (9634) ................................................................................................................................................................................. Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) ............................................................................................... Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Lisdexamfetamine (1205) ............................................................................................................................................................................ Methylphenidate (1724) ............................................................................................................................................................................... Nabilone (7379) ........................................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) ..................................................................................................................................... Codeine (9050) ............................................................................................................................................................................................ Dihydrocodeine (9120) ................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Hydromorphone (9150) ............................................................................................................................................................................... Diphenoxylate (9170) .................................................................................................................................................................................. Ecgonine (9180) .......................................................................................................................................................................................... Hydrocodone (9193) .................................................................................................................................................................................... Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Methadone intermediate (9254) .................................................................................................................................................................. 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) ......................................................................................................................................................................................... Tapentadol (9780) ....................................................................................................................................................................................... Fentanyl (9801) ........................................................................................................................................................................................... The company plans to manufacturer bulk active pharmaceutical ingredients (APIs) for distribution to its customers. Drug Enforcement Administration 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 July 19, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: Dated: May 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–11940 Filed 5–19–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals ACTION: Notice of application. DATES: 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 March 3, 2016, American Radiolabeled Chemicals, 101 Arc Drive, Saint Louis, Missouri 63146 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: mstockstill on DSK3G9T082PROD with NOTICES Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... Ibogaine (7260) ........................................................................................................................................................................................... Lysergic Acid Diethylamide (7315) .............................................................................................................................................................. Tetrahydrocannabinols (7370) ..................................................................................................................................................................... Dimethyltryptamine (7435) .......................................................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... Dihydromorphine (9145) .............................................................................................................................................................................. Heroin (9200) ............................................................................................................................................................................................... Normorphine (9313) .................................................................................................................................................................................... Amphetamine (1100) ................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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 II II II E:\FR\FM\20MYN1.SGM 20MYN1 I I I I I I I I I II II

Agencies

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31959-31960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11940]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: 
Mallinckrodt, LLC

ACTION: Notice of application.

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

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 
1301.33(a) on or before July 19, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

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 1301.33(a), this is notice that on 
February 19, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint 
Louis, Missouri 63147 applied to be registered as a bulk manufacturer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)............  I
Tetrahydrocannabinols (7370)................  I
Codeine-N-oxide (9053)......................  I
Dihydromorphine (9145)......................  I
Difenoxin (9168)............................  I

[[Page 31960]]

 
Morphine-N-oxide (9307).....................  I
Normorphine (9313)..........................  I
Norlevorphanol (9634).......................  I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-   I
 yl)-N-phenylacetamide) (9821).
Amphetamine (1100)..........................  II
Methamphetamine (1105)......................  II
Lisdexamfetamine (1205).....................  II
Methylphenidate (1724)......................  II
Nabilone (7379).............................  II
4-Anilino-N-phenethyl-4-piperidine (ANPP)     II
 (8333).
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
Dextropropoxyphene, bulk (non-dosage forms)   II
 (9273).
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
Tapentadol (9780)...........................  II
Fentanyl (9801).............................  II
------------------------------------------------------------------------

    The company plans to manufacturer bulk active pharmaceutical 
ingredients (APIs) for distribution to its customers.

    Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-11940 Filed 5-19-16; 8:45 am]
 BILLING CODE 4410-09-P
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