82_FR_42288 82 FR 42117 - Importer of Controlled Substances Application: Akorn, Inc.

82 FR 42117 - Importer of Controlled Substances Application: Akorn, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 171 (September 6, 2017)

Page Range42117-42117
FR Document2017-18803

Federal Register, Volume 82 Issue 171 (Wednesday, September 6, 2017)
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Page 42117]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18803]


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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 on or 
before November 6, 2017. Such persons may also file a written request 
for a hearing on the application on or before October 6, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 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 
26, 2017, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 
applied to be registered as an importer of remifentanil (9739), a basic 
class of controlled substance listed in schedule II.
    The company plans to import remifentanil in dosage form for 
distribution.

    Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-18803 Filed 9-5-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                                             Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices                                                          42117

                                                    form and to aid in the enforcement of                   Representative/DRW, 8701 Morrissette                           on the application on or before October
                                                    environmental laws.                                     Drive, Springfield, Virginia 22152.                            6, 2017.
                                                      5. An estimate of the total number of                 Comments and requests for hearings on                          ADDRESSES: Written comments should
                                                    respondents and the amount of time                      applications to import narcotic raw                            be sent to: Drug Enforcement
                                                    estimated for an average respondent to                  material are not appropriate. 72 FR 3417                       Administration, Attention: DEA Federal
                                                    respond: An estimated 680 respondents                   (January 25, 2007).                                            Register Representative/DRW, 8701
                                                    will utilize the form, and it will take                 SUPPLEMENTARY INFORMATION: The                                 Morrissette Drive, Springfield, Virginia
                                                    each respondent approximately 30                        Attorney General has delegated his                             22152. All requests for hearing must be
                                                    minutes to complete the form.                           authority under the Controlled                                 sent to: Drug Enforcement
                                                      6. An estimate of the total public                    Substances Act to the Administrator of                         Administration, Attn: Administrator,
                                                    burden (in hours) associated with the                   the Drug Enforcement Administration                            8701 Morrissette Drive, Springfield,
                                                    collection: The estimated annual public                 (DEA), 28 CFR 0.100(b). Authority to                           Virginia 22152. All requests for hearing
                                                    burden associated with this collection is               exercise all necessary functions with                          should also be sent to: (1) Drug
                                                    340 hours, which is equal to 680 (the                   respect to the promulgation and                                Enforcement Administration, Attn:
                                                    total number of respondents) * .5 (30                   implementation of 21 CFR part 1301,                            Hearing Clerk/LJ, 8701 Morrissette
                                                    minutes).                                               incident to the registration of                                Drive, Springfield, Virginia 22152; and
                                                      If additional information is required                 manufacturers, distributors, dispensers,                       (2) Drug Enforcement Administration,
                                                    contact: Melody Braswell, Department                    importers, and exporters of controlled                         Attn: DEA Federal Register
                                                    Clearance Officer, United States                        substances (other than final orders in                         Representative/DRW, 8701 Morrissette
                                                    Department of Justice, Justice                          connection with suspension, denial, or                         Drive, Springfield, Virginia 22152.
                                                    Management Division, Policy and                         revocation of registration) has been                           SUPPLEMENTARY INFORMATION: The
                                                    Planning Staff, Two Constitution                        redelegated to the Assistant                                   Attorney General has delegated his
                                                    Square, 145 N Street NE., 3E.405A,                      Administrator of the DEA Diversion                             authority under the Controlled
                                                    Washington, DC 20530.                                   Control Division (‘‘Assistant                                  Substances Act to the Administrator of
                                                    Melody Braswell,                                        Administrator’’) pursuant to section 7 of                      the Drug Enforcement Administration
                                                    Department Clearance Officer for PRA, U.S.              28 CFR part 0, appendix to subpart R.                          (DEA), 28 CFR 0.100(b). Authority to
                                                    Department of Justice.                                     In accordance with 21 CFR                                   exercise all necessary functions with
                                                                                                            1301.34(a), this is notice that on                             respect to the promulgation and
                                                    [FR Doc. 2017–18841 Filed 9–5–17; 8:45 am]
                                                                                                            November 23, 2016, Siegfried USA,                              implementation of 21 CFR part 1301,
                                                    BILLING CODE 4410–FY–P
                                                                                                            LLC, 33 Industrial Park Road,                                  incident to the registration of
                                                                                                            Pennsville, New Jersey 08070 applied to                        manufacturers, distributors, dispensers,
                                                    DEPARTMENT OF JUSTICE                                   be registered as an importer of the                            importers, and exporters of controlled
                                                                                                            following basic classes of controlled                          substances (other than final orders in
                                                    Drug Enforcement Administration                         substances:                                                    connection with suspension, denial, or
                                                                                                                                                                           revocation of registration) has been
                                                    [Docket No. DEA–392]                                                                               Drug                redelegated to the Assistant
                                                                                                                  Controlled substance                          Schedule
                                                                                                                                                       code
                                                                                                                                                                           Administrator of the DEA Diversion
                                                    Importer of Controlled Substances
                                                                                                            Opium, raw .............................   9600    II          Control Division (‘‘Assistant
                                                    Application: Siegfried USA, LLC
                                                                                                            Poppy Straw Concentrate .......            9670    II          Administrator’’) pursuant to section 7 of
                                                    ACTION:   Notice of application.                                                                                       28 CFR part 0, appendix to subpart R.
                                                                                                               The company plans to import the                                 In accordance with 21 CFR
                                                    DATES:  Registered bulk manufacturers of                listed controlled substances to                                1301.34(a), this is notice that on May 26,
                                                    the affected basic classes, and                         manufacture bulk active                                        2017, Akorn, Inc., 1222 W. Grand
                                                    applicants therefore, may file written                  pharmaceuticals ingredients (API) for                          Avenue, Decatur, Illinois 62522 applied
                                                    comments on or objections to the                        distribution to its customers.                                 to be registered as an importer of
                                                    issuance of the proposed registration in                  Dated: August 28, 2017.                                      remifentanil (9739), a basic class of
                                                    accordance with 21 CFR 1301.34(a) on                    Demetra Ashley,
                                                                                                                                                                           controlled substance listed in schedule
                                                    or before October 6, 2017. Such persons                                                                                II.
                                                                                                            Acting Assistant Administrator.                                    The company plans to import
                                                    may also file a written request for a                   [FR Doc. 2017–18802 Filed 9–5–17; 8:45 am]
                                                    hearing on the application pursuant to                                                                                 remifentanil in dosage form for
                                                    21 CFR 1301.43 on or before October 6,
                                                                                                            BILLING CODE 4410–09–P                                         distribution.
                                                    2017.                                                                                                                    Dated: August 28, 2017.
                                                    ADDRESSES: Written comments should                      DEPARTMENT OF JUSTICE                                          Demetra Ashley,
                                                    be sent to: Drug Enforcement                                                                                           Acting Assistant Administrator.
                                                    Administration, Attention: DEA Federal                  Drug Enforcement Administration                                [FR Doc. 2017–18803 Filed 9–5–17; 8:45 am]
                                                    Register Representative/DRW, 8701                       [Docket No. DEA–392]                                           BILLING CODE 4410–09–P
                                                    Morrissette Drive, Springfield, Virginia
                                                    22152. All requests for hearing must be                 Importer of Controlled Substances
                                                    sent to: Drug Enforcement                               Application: Akorn, Inc.                                       DEPARTMENT OF JUSTICE
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                                                    Administration, Attn: Administrator,
                                                    8701 Morrissette Drive, Springfield,                    ACTION:      Notice of application.                            Drug Enforcement Administration
                                                    Virginia 22152. All requests for hearing
                                                                                                                                                                           Marcus W. Anderson, M.D.; Decision
                                                    should also be sent to: (1) Drug                        DATES:  Registered bulk manufacturers of
                                                                                                                                                                           and Order
                                                    Enforcement Administration, Attn:                       the affected basic classes, and
                                                    Hearing Clerk/LJ, 8701 Morrissette                      applicants therefore, may file written                           On May 12, 2017, the Assistant
                                                    Drive, Springfield, Virginia 22152; and                 comments on or objections on or before                         Administrator, Diversion Control
                                                    (2) Drug Enforcement Administration,                    November 6, 2017. Such persons may                             Division, Drug Enforcement
                                                    Attn: DEA Federal Register                              also file a written request for a hearing                      Administration (DEA), issued an Order


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Document Created: 2017-09-06 00:56:29
Document Modified: 2017-09-06 00:56:29
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 on or before November 6, 2017. Such persons may also file a written request for a hearing on the application on or before October 6, 2017.
FR Citation82 FR 42117 

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