83_FR_61124 83 FR 60896 - Importer of Controlled Substances Application: Akorn, Inc.

83 FR 60896 - Importer of Controlled Substances Application: Akorn, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 228 (November 27, 2018)

Page Range60896-60897
FR Document2018-25873

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60896-60897]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25873]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Akorn, Inc.

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 on or before December 27, 2018 
Such persons may also file a written request for a hearing on the 
application on or before December 27, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 May 2, 
2018, Akorn Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 applied 
to be registered as an importer of the following basic class of 
controlled substance:

[[Page 60897]]



------------------------------------------------------------------------
         Controlled substance              Drug code         Schedule
------------------------------------------------------------------------
Remifentanil..........................            9739               II
------------------------------------------------------------------------

    The company plans to import the above listed controlled substance 
for research purposes.

    Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25873 Filed 11-26-18; 8:45 am]
 BILLING CODE 4410-09-P



                                              60896                      Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices

                                              directed to the Secretary to the                        of this or a related proceeding, or (b) in                           DEPARTMENT OF JUSTICE
                                              Commission and must include a full                      internal investigations, audits, reviews,
                                              statement of the reasons why the                        and evaluations relating to the                                      Drug Enforcement Administration
                                              Commission should grant such                            programs, personnel, and operations of
                                                                                                                                                                           [Docket No. DEA–392]
                                              treatment. See 19 CFR 201.6. Documents                  the Commission including under 5
                                              for which confidential treatment by the                 U.S.C. Appendix 3; or (ii) by U.S.                                   Importer of Controlled Substances
                                              Commission is properly sought will be                   government employees and contract                                    Registration
                                              treated accordingly. All such requests                  personnel,2 solely for cybersecurity
                                              should be directed to the Secretary to                  purposes. All nonconfidential written                                ACTION:      Notice of registration.
                                              the Commission and must include a full                  submissions will be available for public
                                              statement of the reasons why the                        inspection at the Office of the Secretary                            SUMMARY:    The registrant listed below
                                              Commission should grant such                            and on EDIS.3                                                        has applied for and been granted
                                              treatment. See 19 CFR 201.6. Documents                                                                                       registration by the Drug Enforcement
                                                                                                        This action is taken under the
                                              for which confidential treatment by the                                                                                      Administration (DEA) as an importer of
                                                                                                      authority of section 337 of the Tariff Act
                                              Commission is properly sought will be                                                                                        various classes of schedule I or II
                                                                                                      of 1930, as amended (19 U.S.C. 1337),
                                              treated accordingly. All information,                                                                                        controlled substances.
                                                                                                      and of §§ 201.10 and 210.8(c) of the
                                              including confidential business                         Commission’s Rules of Practice and                                   SUPPLEMENTARY INFORMATION: The
                                              information and documents for which                     Procedure (19 CFR 201.10, 210.8(c)).                                 company listed below applied to be
                                              confidential treatment is properly                                                                                           registered as an importer of various
                                              sought, submitted to the Commission for                   By order of the Commission.                                        basic classes of controlled substances.
                                                                                                        Issued: November 20, 2018.
                                              purposes of this Investigation may be                                                                                        Information on the previously published
                                              disclosed to and used: (i) By the                       Katherine M. Hiner,                                                  notice is listed in the table below. No
                                              Commission, its employees and Offices,                  Supervisory Attorney.                                                comments or objections were submitted
                                              and contract personnel (a) for                          [FR Doc. 2018–25749 Filed 11–26–18; 8:45 am                          and no requests for hearing were
                                              developing or maintaining the records                   BILLING CODE 7020–02–P                                               submitted for this notice.

                                                                          Company                                                                          FR Docket                                                 Published

                                              Clinical Supplies Management Holdings, Inc .........................      83 FR 39127 ..........................................................................   August 08, 2018.



                                                 The DEA has considered the factors in                DEPARTMENT OF JUSTICE                                                Drive, Springfield, Virginia 22152; and
                                              21 U.S.C. 823, 952(a) and 958(a) and                                                                                         (2) Drug Enforcement Administration,
                                              determined that the registration of the                 Drug Enforcement Administration                                      Attn: DEA Federal Register
                                              listed registrant to import the applicable                                                                                   Representative/DPW, 8701 Morrissette
                                                                                                      [Docket No. DEA–392]
                                              basic class of schedule I controlled                                                                                         Drive, Springfield, Virginia 22152.
                                              substance is consistent with the public                 Importer of Controlled Substances                                    SUPPLEMENTARY INFORMATION: The
                                              interest and with United States                         Application: Akorn, Inc.                                             Attorney General has delegated his
                                              obligations under international treaties,                                                                                    authority under the Controlled
                                              conventions, or protocols in effect on                  ACTION:   Notice of application.                                     Substances Act to the Administrator of
                                              May 1, 1971. The DEA investigated the                                                                                        the Drug Enforcement Administration
                                              company’s maintenance of effective                      DATES:  Registered bulk manufacturers of                             (DEA), 28 CFR 0.100(b). Authority to
                                              controls against diversion by inspecting                the affected basic classes, and                                      exercise all necessary functions with
                                                                                                      applicants therefore, may file written                               respect to the promulgation and
                                              and testing the company’s physical
                                                                                                      comments on or objections to the                                     implementation of 21 CFR part 1301,
                                              security systems, verifying the
                                                                                                      issuance of the proposed registration on                             incident to the registration of
                                              company’s compliance with state and
                                                                                                      or before December 27, 2018 Such                                     manufacturers, distributors, dispensers,
                                              local laws, and reviewing the company’s                 persons may also file a written request
                                              background and history.                                                                                                      importers, and exporters of controlled
                                                                                                      for a hearing on the application on or                               substances (other than final orders in
                                                 Therefore, pursuant to 21 U.S.C.                     before December 27, 2018.                                            connection with suspension, denial, or
                                              952(a) and 958(a), and in accordance                    ADDRESSES: Written comments should                                   revocation of registration) has been
                                              with 21 CFR 1301.34, the DEA has                        be sent to: Drug Enforcement                                         redelegated to the Assistant
                                              granted a registration as an importer for               Administration, Attention: DEA Federal                               Administrator of the DEA Diversion
                                              schedule I controlled substances to the                 Register Representative/DPW, 8701                                    Control Division (‘‘Assistant
                                              above listed company.                                   Morrissette Drive, Springfield, Virginia                             Administrator’’) pursuant to section 7 of
                                                Dated: November 16, 2018.                             22152. All requests for hearing must be                              28 CFR part 0, appendix to subpart R.
                                                                                                      sent to: Drug Enforcement                                              In accordance with 21 CFR
                                              John J. Martin,
                                                                                                      Administration, Attn: Administrator,                                 1301.34(a), this is notice that on May 2,
                                              Assistant Administrator.                                8701 Morrissette Drive, Springfield,                                 2018, Akorn Inc., 1222 W. Grand
                                              [FR Doc. 2018–25866 Filed 11–26–18; 8:45 am]            Virginia 22152. All requests for hearing                             Avenue, Decatur, Illinois 62522 applied
                                              BILLING CODE 4410–09–P                                  should also be sent to: (1) Drug                                     to be registered as an importer of the
amozie on DSK3GDR082PROD with NOTICES1




                                                                                                      Enforcement Administration, Attn:                                    following basic class of controlled
                                                                                                      Hearing Clerk/OALJ, 8701 Morrissette                                 substance:



                                                2 All contract personnel will sign appropriate          3 Electronic Document Information System

                                              nondisclosure agreements.                               (EDIS): https://edis.usitc.gov.



                                         VerDate Sep<11>2014   17:45 Nov 26, 2018   Jkt 247001   PO 00000   Frm 00076     Fmt 4703      Sfmt 4703      E:\FR\FM\27NON1.SGM            27NON1


                                                                                   Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices                                                                                      60897

                                                                                                                   Controlled substance                                                                                     Drug code           Schedule

                                              Remifentanil .............................................................................................................................................................      9739                  II



                                                The company plans to import the                                           DEPARTMENT OF JUSTICE                                                       Administration (DEA) as bulk a
                                              above listed controlled substance for                                                                                                                   manufacturer of various classes of
                                              research purposes.                                                          Drug Enforcement Administration                                             schedule I and II controlled substances.
                                                Dated: November 16, 2018.                                                 [Docket No. DEA–392]                                                        SUPPLEMENTARY INFORMATION:     The
                                              John J. Martin,                                                                                                                                         company listed below applied to be
                                                                                                                          Bulk Manufacturer of Controlled                                             registered as bulk manufacturer of
                                              Assistant Administrator.                                                    Substances Registration
                                              [FR Doc. 2018–25873 Filed 11–26–18; 8:45 am]
                                                                                                                                                                                                      various basic classes of controlled
                                                                                                                          ACTION:       Notice of registration.                                       substances. Information on the
                                              BILLING CODE 4410–09–P
                                                                                                                                                                                                      previously published notice is listed in
                                                                                                                          SUMMARY:   The registrant listed below                                      the table below. No comments or
                                                                                                                          has applied for and been granted                                            objections were submitted for this
                                                                                                                          registration by the Drug Enforcement                                        notice.

                                                                                     Company                                                                                         FR Docket                                                Published

                                              Rhodes Technologies .............................................................               83 FR 40567 ..........................................................................    August 15, 2018.



                                                 The DEA has considered the factors in                                    DEPARTMENT OF JUSTICE                                                       Drive, Springfield, Virginia 22152; and
                                              21 U.S.C. 823(a) and determined that                                                                                                                    (2) Drug Enforcement Administration,
                                              the registration of this registrant to                                      Drug Enforcement Administration                                             Attn: DEA Federal Register
                                              manufacture the applicable basic classes                                                                                                                Representative/DPW, 8701 Morrissette
                                                                                                                          [Docket No. DEA–392]
                                              of controlled substances is consistent                                                                                                                  Drive, Springfield, Virginia 22152.
                                              with the public interest and with United                                    Importer of Controlled Substances                                           SUPPLEMENTARY INFORMATION: The
                                              States obligations under international                                      Application: Cambridge Isotope                                              Attorney General has delegated his
                                              treaties, conventions, or protocols in                                      Laboratories                                                                authority under the Controlled
                                              effect on May 1, 1971. The DEA                                                                                                                          Substances Act to the Administrator of
                                              investigated the company’s maintenance                                      ACTION:       Notice of application.                                        the Drug Enforcement Administration
                                              of effective controls against diversion by                                                                                                              (DEA), 28 CFR 0.100(b). Authority to
                                              inspecting and testing the company’s                                        DATES:  Registered bulk manufacturers of                                    exercise all necessary functions with
                                                                                                                          the affected basic classes, and                                             respect to the promulgation and
                                              physical security systems, verifying the
                                                                                                                          applicants therefore, may file written                                      implementation of 21 CFR part 1301,
                                              company’s compliance with state and
                                                                                                                          comments on or objections to the                                            incident to the registration of
                                              local laws, and reviewing the company’s
                                                                                                                          issuance of the proposed registration on                                    manufacturers, distributors, dispensers,
                                              background and history.                                                     or before December 27, 2018. Such                                           importers, and exporters of controlled
                                                 Therefore, pursuant to 21 U.S.C.                                         persons may also file a written request                                     substances (other than final orders in
                                              823(a), and in accordance with 21 CFR                                       for a hearing on the application on or                                      connection with suspension, denial, or
                                              1301.33, the DEA has granted a                                              before December 27, 2018.                                                   revocation of registration) has been
                                              registration as a bulk manufacturer to                                      ADDRESSES: Written comments should                                          redelegated to the Assistant
                                              the above listed company.                                                   be sent to: Drug Enforcement                                                Administrator of the DEA Diversion
                                                Dated: November 16, 2018.                                                 Administration, Attention: DEA Federal                                      Control Division (‘‘Assistant
                                              John J. Martin,
                                                                                                                          Register Representative/DPW, 8701                                           Administrator’’) pursuant to section 7 of
                                                                                                                          Morrissette Drive, Springfield, Virginia                                    28 CFR part 0, appendix to subpart R.
                                              Assistant Administrator.                                                    22152. All requests for hearing must be                                       In accordance with 21 CFR
                                              [FR Doc. 2018–25875 Filed 11–26–18; 8:45 am]                                sent to: Drug Enforcement                                                   1301.34(a), this is notice that on August
                                              BILLING CODE 4410–09–P                                                      Administration, Attn: Administrator,                                        30, 2018, Cambridge Isotope
                                                                                                                          8701 Morrissette Drive, Springfield,                                        Laboratories, 50 Frontage Road,
                                                                                                                          Virginia 22152. All requests for hearing                                    Andover, Massachusetts 01810 applied
                                                                                                                          should also be sent to: (1) Drug                                            to be registered as an importer of the
                                                                                                                          Enforcement Administration, Attn:                                           following basic classes of controlled
                                                                                                                          Hearing Clerk/OALJ, 8701 Morrissette                                        substances:

                                                                                                                   Controlled substance                                                                                     Drug code           Schedule

                                              Tetrahydrocannabinols ............................................................................................................................................                       7370                 I
                                              Gamma Hydroxybutyric Acid ...................................................................................................................................                            2010                 I
amozie on DSK3GDR082PROD with NOTICES1




                                              Morphine ..................................................................................................................................................................              9300                II




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Document Created: 2018-11-27 01:25:49
Document Modified: 2018-11-27 01:25:49
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 on or before December 27, 2018 Such persons may also file a written request for a hearing on the application on or before December 27, 2018.
FR Citation83 FR 60896 

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