81_FR_71967 81 FR 71766 - Importer of Controlled Substances Application: Anderson Brecon, Inc.

81 FR 71766 - Importer of Controlled Substances Application: Anderson Brecon, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 201 (October 18, 2016)

Page Range71766-71766
FR Document2016-25131

Federal Register, Volume 81 Issue 201 (Tuesday, October 18, 2016)
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Notices]
[Page 71766]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25131]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Anderson Brecon, 
Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before November 17, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before November 17, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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/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 1301.34(a), this is notice that on June 
10, 2016, Anderson Brecon, Inc., DBA PCI of Illinois, 4545 Assembly 
Drive, Rockford, Illinois 61109 applied to be registered as an importer 
of oxycodone (9143), a basic class of controlled substance listed in 
schedule II.
    The company plans to import the listed controlled substances in 
bulk over-encapsulated tablets for clinical trial only. Approval of 
permit applications will occur only when the registrant's business 
activity is consistent with what is authorized under 21 U.S.C. 
952(a)(2). Authorization will not extend to the import of FDA approved 
or non-approved finished dosage forms for commercial sale.

    Dated: October 11, 2016.
Louis J. Milione,
Assistant Administrator, Diversion Control Division.
[FR Doc. 2016-25131 Filed 10-17-16; 8:45 am]
BILLING CODE 4410-09-P



                                             71766                        Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices

                                             Stryker Corporation (‘‘complainant’’) of                DEPARTMENT OF JUSTICE                                    The company plans to import the
                                             Kalamazoo, Michigan. 81 FR 11590                                                                              listed controlled substances in bulk
                                             (March 4, 2016). The complaint as                       Drug Enforcement Administration                       over-encapsulated tablets for clinical
                                             supplemented alleges violations of                                                                            trial only. Approval of permit
                                             Section 337 of the Tariff Act of 1930, as               [Docket No. DEA–392]                                  applications will occur only when the
                                             amended, 19 U.S.C. 1337, in the sale for                                                                      registrant’s business activity is
                                             importation, importation, or sale within                Importer of Controlled Substances                     consistent with what is authorized
                                             the United States after importation of                  Application: Anderson Brecon, Inc.                    under 21 U.S.C. 952(a)(2). Authorization
                                             certain hospital beds, and components                                                                         will not extend to the import of FDA
                                                                                                     ACTION:   Notice of application.                      approved or non-approved finished
                                             thereof by reason of infringement of
                                             certain claims of U.S. Patent No.                                                                             dosage forms for commercial sale.
                                                                                                     DATES:  Registered bulk manufacturers of
                                             7,082,630; U.S. Patent No. 7,690,059                    the affected basic class, and applicants                Dated: October 11, 2016.
                                             (‘‘the ’059 patent’’); U.S. Patent No.                  therefore, may file written comments on               Louis J. Milione,
                                             7,784,125; and U.S. Patent No.                          or objections to the issuance of the                  Assistant Administrator, Diversion Control
                                             8,701,229 (‘‘the ’229 patent’’). The                    proposed registration in accordance                   Division.
                                             complaint further alleges that an                       with 21 CFR 1301.34(a) on or before                   [FR Doc. 2016–25131 Filed 10–17–16; 8:45 am]
                                             industry in the United States exists as                 November 17, 2016. Such persons may                   BILLING CODE 4410–09–P
                                             required by subsection (a)(2) of section                also file a written request for a hearing
                                             337. The complaint names Umano                          on the application pursuant to 21 CFR
                                             Medical Inc. of Quebec, Canada and                      1301.43 on or before November 17,                     DEPARTMENT OF JUSTICE
                                             Umano Medical World Inc. of Quebec,                     2016.
                                                                                                                                                           Drug Enforcement Administration
                                             Canada as respondents. The Office of                    ADDRESSES:   Written comments should
                                             Unfair Import Investigations is not a                   be sent to: Drug Enforcement                          [Docket No. DEA–392]
                                             party in the investigation.                             Administration, Attention: DEA Federal                Importer of Controlled Substances
                                                On September 2, 2016, the parties                    Register Representative/ODW, 8701                     Application: Johnson Matthey Inc.
                                             filed a joint motion to terminate the                   Morrissette Drive, Springfield, Virginia
                                             investigation based on settlement. The                  22152. All requests for hearing must be               ACTION:   Notice of application.
                                             parties provided confidential and non-                  sent to: Drug Enforcement
                                                                                                     Administration, Attn: Administrator,                  DATES:  Registered bulk manufacturers of
                                             confidential versions of the settlement
                                                                                                     8701 Morrissette Drive, Springfield,                  the affected basic classes, and
                                             agreement and represented that there
                                                                                                     Virginia 22152. All requests for hearing              applicants therefore, may file written
                                             are no other agreements, written or oral,
                                                                                                     should also be sent to: (1) Drug                      comments on or objections to the
                                             express or implied, between the Settling                                                                      issuance of the proposed registration in
                                                                                                     Enforcement Administration, Attn:
                                             Parties concerning the subject matter of                Hearing Clerk/LJ, 8701 Morrissette                    accordance with 21 CFR 1301.34(a) on
                                             this Investigation.                                     Drive, Springfield, Virginia 22152; and               or before November 17, 2016. Such
                                                On September 13, 2016, the ALJ                       (2) Drug Enforcement Administration,                  persons may also file a written request
                                             granted the joint motion. Order No. 10.                 Attn: DEA Federal Register                            for a hearing on the application
                                             The ALJ found that all of the                           Representative/ODW, 8701 Morrissette                  pursuant to 21 CFR 1301.43 on or before
                                             requirements of Commission Rule                         Drive, Springfield, Virginia 22152.                   November 17, 2016.
                                             210.21(a)–(b), 19 CFR 210.21(a)–(b), had                SUPPLEMENTARY INFORMATION: The                        ADDRESSES: Written comments should
                                             been met and that there were no public                  Attorney General has delegated her                    be sent to: Drug Enforcement
                                             interest concerns that would weigh                      authority under the Controlled                        Administration, Attention: DEA Federal
                                             against termination. No petitions for                   Substances Act to the Administrator of                Register Representative/DRW, 8701
                                             review were filed.                                      the Drug Enforcement Administration                   Morrissette Drive, Springfield, Virginia
                                                                                                     (DEA), 28 CFR 0.100(b). Authority to                  22152. All requests for hearing must be
                                                The Commission has determined not
                                                                                                     exercise all necessary functions with                 sent to: Drug Enforcement
                                             to review the subject ID.
                                                                                                     respect to the promulgation and                       Administration, Attn: Administrator,
                                                The authority for the Commission’s                   implementation of 21 CFR part 1301,                   8701 Morrissette Drive, Springfield,
                                             determination is contained in section                   incident to the registration of                       Virginia 22152. All requests for hearing
                                             337 of the Tariff Act of 1930, as                       manufacturers, distributors, dispensers               should also be sent to: (1) Drug
                                             amended (19 U.S.C. 1337), and in Part                   importers, and exporters of controlled                Enforcement Administration, Attn:
                                             210 of the Commission’s Rules of                        substances (other than final orders in                Hearing Clerk/LJ, 8701 Morrissette
                                             Practice and Procedure (19 CFR part                     connection with suspension, denial, or                Drive, Springfield, Virginia 22152; and
                                             210).                                                   revocation of registration) has been                  (2) Drug Enforcement Administration,
                                                                                                     redelegated to the Deputy Assistant                   Attn: DEA Federal Register
                                               By order of the Commission.
                                                                                                     Administrator of the DEA Office of                    Representative/DRW, 8701 Morrissette
                                               Issued: October 12, 2016.                                                                                   Drive, Springfield, Virginia 22152.
                                                                                                     Diversion Control (‘‘Deputy Assistant
                                             Lisa R. Barton,                                         Administrator’’) pursuant to section 7 of             Comments and request for hearings on
                                             Secretary to the Commission.                            28 CFR part 0, appendix to subpart R.                 applications to import narcotic raw
                                             [FR Doc. 2016–25094 Filed 10–17–16; 8:45 am]              In accordance with 21 CFR                           material are not appropriate. 72 FR
                                                                                                                                                           3417, (January 25, 2007).
Lhorne on DSK30JT082PROD with NOTICES




                                             BILLING CODE 7020–02–P                                  1301.34(a), this is notice that on June
                                                                                                     10, 2016, Anderson Brecon, Inc., DBA                  SUPPLEMENTARY INFORMATION: The
                                                                                                     PCI of Illinois, 4545 Assembly Drive,                 Attorney General has delegated her
                                                                                                     Rockford, Illinois 61109 applied to be                authority under the Controlled
                                                                                                     registered as an importer of oxycodone                Substances Act to the Administrator of
                                                                                                     (9143), a basic class of controlled                   the Drug Enforcement Administration
                                                                                                     substance listed in schedule II.                      (DEA), 28 CFR 0.100(b). Authority to


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Document Created: 2016-10-17 23:52:12
Document Modified: 2016-10-17 23:52:12
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 class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 17, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 17, 2016.
FR Citation81 FR 71766 

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