81_FR_32057 81 FR 31959 - Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC

81 FR 31959 - Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 98 (May 20, 2016)

Page Range31959-31960
FR Document2016-11940

Federal Register, Volume 81 Issue 98 (Friday, May 20, 2016) 
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31959-31960]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 
1301.33(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

Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31959 representative consumer organizations DEPARTMENT OF JUSTICE Dated: May 16, 2016. have the right to appear as parties in Louis J. Milione, Commission antidumping and Drug Enforcement Administration Deputy Assistant Administrator. countervailing duty investigations. The [FR Doc. 2016–11939 Filed 5–19–16; 8:45 am] [Docket No. DEA–392] Secretary will prepare a public service BILLING CODE 4410–09–P list containing the names and addresses Manufacturer of Controlled of all persons, or their representatives, Substances Registration: Pharmacore, who are parties to the investigations. Inc. DEPARTMENT OF JUSTICE Background ACTION: Notice of registration. Drug Enforcement Administration On March 31, 2016, Compass Chemical International LLC, Smyrna, SUMMARY: Pharmacore, Inc. applied to [Docket No. DEA–392] Georgia, filed a petition with the be registered as a manufacturer of Commission and Commerce, alleging certain basic classes of controlled Bulk Manufacturer of Controlled that an industry in the United States is substances. The Drug Enforcement Substances Application: Mallinckrodt, materially injured or threatened with Administration (DEA) grants LLC material injury by reason of LTFV and Pharmacore, Inc. registration as a subsidized imports of 1- manufacturer of those controlled ACTION: Notice of application. hydroxyethylidene-1, 1-diphosphonic substances. acid from China. Accordingly, effective SUPPLEMENTARY INFORMATION: By notice DATES: Registered bulk manufacturers of March 31, 2016, the Commission, dated January 27, 2016, and published the affected basic classes, and pursuant to sections 703(a) and 733(a) of in the Federal Register on February 4, applicants therefore, may file written the Tariff Act of 1930 (19 U.S.C. 2016, 81 FR 6044, Pharmacore, Inc., comments on or objections to the 1671b(a) and 1673b(a)), instituted countervailing duty investigation No. 4180 Mendenhall Oaks Parkway, High issuance of the proposed registration in 701–TA–558 and antidumping duty Point, North Carolina 27265 applied to accordance with 21 CFR 1301.33(a) on investigation No. 731–TA–1316 be registered as a manufacturer of or before July 19, 2016. (Preliminary). certain basic classes of controlled substances. No comments or objections ADDRESSES: Written comments should Notice of the institution of the be sent to: Drug Enforcement Commission’s investigations and of a were submitted for this notice. The DEA has considered the factors in Administration, Attention: DEA Federal public conference to be held in Register Representative/ODW, 8701 connection therewith was given by 21 U.S.C. 823(a) and determined that the registration of Pharmacore, Inc. to Morrissette Drive, Springfield, Virginia posting copies of the notice in the Office 22152. of the Secretary, U.S. International manufacture the basic classes of Trade Commission, Washington, DC, controlled substances is consistent with SUPPLEMENTARY INFORMATION: The and by publishing the notice in the the public interest and with United Attorney General has delegated her Federal Register of April 7, 2016 (81 FR States obligations under international authority under the Controlled 20416). The conference was held in treaties, conventions, or protocols in Substances Act to the Administrator of Washington, DC, on April 21, 2016, and effect on May 1, 1971. The DEA the Drug Enforcement Administration all persons who requested the investigated the company’s maintenance (DEA), 28 CFR 0.100(b). Authority to opportunity were permitted to appear in of effective controls against diversion by exercise all necessary functions with person or by counsel. inspecting and testing the company’s respect to the promulgation and The Commission made these physical security systems, verifying the implementation of 21 CFR part 1301, determinations pursuant to sections company’s compliance with state and incident to the registration of 703(a) and 733(a) of the Tariff Act of local laws, and reviewing the company’s manufacturers, distributors, dispensers, 1930 (19 U.S.C. 1671b(a) and 1673b(a)). background and history. importers, and exporters of controlled It completed and filed its Therefore, pursuant to 21 U.S.C. substances (other than final orders in determinations in these investigations 823(a), and in accordance with 21 CFR connection with suspension, denial, or on May 16, 2016. The views of the 1301.33, the above-named company is revocation of registration) has been Commission are contained in USITC granted registration as a bulk redelegated to the Deputy Assistant Publication 4612 (May 2016), entitled 1- manufacturer of the following basic Administrator of the DEA Office of Hydroxyethylidene-1, 1-Diphosphonic classes of controlled substances: Diversion Control (‘‘Deputy Assistant Acid from China: Investigation Nos. Administrator’’) pursuant to section 7 of 701–TA–558 and 731–TA–1316 Controlled substance Schedule 28 CFR part 0, appendix to subpart R. (Preliminary). Oxymorphone (9652) .................... II In accordance with 21 CFR By order of the Commission. Noroxymorphone (9668) ............... II 1301.33(a), this is notice that on Issued: May 16, 2016. February 19, 2016, Mallinckrodt, LLC, Lisa R. Barton, The company plans to manufacture 3600 North Second Street, Saint Louis, Secretary to the Commission. the listed controlled substances as Missouri 63147 applied to be registered [FR Doc. 2016–11891 Filed 5–19–16; 8:45 am] active pharmaceutical ingredients (APIs) as a bulk manufacturer of the following BILLING CODE 7020–02–P for clinical trials. basic classes of controlled substances: mstockstill on DSK3G9T082PROD with NOTICES Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... I Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I Codeine-N-oxide (9053) .............................................................................................................................................................................. I Dihydromorphine (9145) .............................................................................................................................................................................. I Difenoxin (9168) .......................................................................................................................................................................................... I 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

31960 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Controlled substance Schedule Morphine-N-oxide (9307) ............................................................................................................................................................................. I Normorphine (9313) .................................................................................................................................................................................... I Norlevorphanol (9634) ................................................................................................................................................................................. I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) ............................................................................................... I Amphetamine (1100) ................................................................................................................................................................................... II Methamphetamine (1105) ........................................................................................................................................................................... II Lisdexamfetamine (1205) ............................................................................................................................................................................ II Methylphenidate (1724) ............................................................................................................................................................................... II Nabilone (7379) ........................................................................................................................................................................................... II 4-Anilino-N-phenethyl-4-piperidine (ANPP) (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 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 Tapentadol (9780) ....................................................................................................................................................................................... II Fentanyl (9801) ........................................................................................................................................................................................... II The company plans to manufacturer DATES: Registered bulk manufacturers of respect to the promulgation and bulk active pharmaceutical ingredients the affected basic classes, and implementation of 21 CFR part 1301, (APIs) for distribution to its customers. applicants therefore, may file written incident to the registration of Dated: May 16, 2016. comments on or objections to the manufacturers, distributors, dispensers, Louis J. Milione, issuance of the proposed registration in importers, and exporters of controlled accordance with 21 CFR 1301.33(a) on substances (other than final orders in Deputy Assistant Administrator. or before July 19, 2016. connection with suspension, denial, or [FR Doc. 2016–11940 Filed 5–19–16; 8:45 am] ADDRESSES: Written comments should revocation of registration) has been BILLING CODE 4410–09–P be sent to: Drug Enforcement redelegated to the Deputy Assistant Administration, Attention: DEA Federal Administrator of the DEA Office of DEPARTMENT OF JUSTICE Register Representative/ODW, 8701 Diversion Control (‘‘Deputy Assistant Morrissette Drive, Springfield, Virginia Administrator’’) pursuant to section 7 of Drug Enforcement Administration 22152. 28 CFR part 0, appendix to subpart R. [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The In accordance with 21 CFR Attorney General has delegated her 1301.33(a), this is notice that on March Bulk Manufacturer of Controlled authority under the Controlled 3, 2016, American Radiolabeled Substances Application: American Substances Act to the Administrator of Chemicals, 101 Arc Drive, Saint Louis, Radiolabeled Chemicals the Drug Enforcement Administration Missouri 63146 applied to be registered (DEA), 28 CFR 0.100(b). Authority to as a bulk manufacturer of the following ACTION: Notice of application. exercise all necessary functions with basic classes of controlled substances: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... I Ibogaine (7260) ........................................................................................................................................................................................... I Lysergic Acid Diethylamide (7315) .............................................................................................................................................................. I mstockstill on DSK3G9T082PROD with NOTICES Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I Dimethyltryptamine (7435) .......................................................................................................................................................................... I 1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ............................................................................................................................................... I Dihydromorphine (9145) .............................................................................................................................................................................. I Heroin (9200) ............................................................................................................................................................................................... I Normorphine (9313) .................................................................................................................................................................................... I Amphetamine (1100) ................................................................................................................................................................................... II Methamphetamine (1105) ........................................................................................................................................................................... II VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1


Document Created: 2016-05-20 02:00:06
Document Modified: 2016-05-20 02:00:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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.
FR Citation81 FR 31959 
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