81_FR_63397 81 FR 63219 - Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation

81 FR 63219 - Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 178 (September 14, 2016)

Page Range63219-63219
FR Document2016-22100

Federal Register, Volume 81 Issue 178 (Wednesday, September 14, 2016)
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63219]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22100]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Alcami 
Wisconsin Corporation

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 November 14, 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 
November 18, 2015, Alcami Wisconsin Corporation, W130 N10497 Washington 
Drive, Germantown, Wisconsin 53022 applied to be registered as a bulk 
manufacturer of alfentanil (9737), a basic class of controlled 
substance listed in schedule II.
    The company plans to manufacture reference standards for 
distribution to their research and forensic customers.

    Dated: September 7, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22100 Filed 9-13-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                    Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices                                                                                     63219

                                                    to which the United States is a party                                    compliance, and to punish violations of    Substances Act to the Administrator of
                                                    (including grand jury proceedings), or                                   its provisions.                            the Drug Enforcement Administration
                                                    for the purpose of securing compliance                                                                              (DEA), 28 CFR 0.100(b). Authority to
                                                                                                                             XIII. Expiration of Final Judgment
                                                    with this Final Judgment, or as                                                                                     exercise all necessary functions with
                                                    otherwise required by law.                                                  Unless this Court grants an extension, respect to the promulgation and
                                                       D. If at the time information or                                      this Final Judgment shall expire ten       implementation of 21 CFR part 1301,
                                                    documents are furnished by Defendants                                    years from the date of its entry.          incident to the registration of
                                                    to the United States, Defendants                                         XIV. Public Interest Determination         manufacturers, distributors, dispensers,
                                                    represent and identify in writing the                                                                               importers, and exporters of controlled
                                                    material in any such information or                                         Entry of this Final Judgment is in the  substances (other than final orders in
                                                    documents to which a claim of                                            public interest. The parties have          connection with suspension, denial, or
                                                    protection may be asserted under Rule                                    complied with the requirements of the      revocation of registration) has been
                                                    26(c)(1)(G) of the Federal Rules of Civil                                Antitrust Procedures and Penalties Act,    redelegated to the Deputy Assistant
                                                    Procedure, and Defendants mark each                                      15 U.S.C § 16, including making copies     Administrator of the DEA Office of
                                                    pertinent page of such material,                                         available to the public of this Final      Diversion Control (‘‘Deputy Assistant
                                                    ‘‘Subject to claim of protection under                                   Judgment, the Competitive Impact           Administrator’’) pursuant to section 7 of
                                                    Rule 26(c)(1)(G) of the Federal Rules of                                 Statement, and any comments thereon,       28 CFR part 0, appendix to subpart R.
                                                    Civil Procedure,’’ then the United States                                and the United States’ responses to          In accordance with 21 CFR
                                                    shall give Defendants ten (10) calendar                                  comments. Based upon the record            1301.33(a), this is notice that on
                                                    days notice prior to divulging such                                      before the Court, which includes the       November 18, 2015, Alcami Wisconsin
                                                    material in any legal proceeding (other                                  Competitive Impact Statement and any       Corporation, W130 N10497 Washington
                                                    than a grand jury proceeding).                                           comments and response to comments          Drive, Germantown, Wisconsin 53022
                                                                                                                             filed with the Court, entry of this Final  applied to be registered as a bulk
                                                    XI. No Reacquisition and Other                                           Judgment is in the public interest.
                                                    Prohibited Activities                                                                                               manufacturer of alfentanil (9737), a
                                                                                                                             Date: llllllllllllllllll basic class of controlled substance listed
                                                       Defendants may not (1) reacquire any
                                                                                                                             Court approval subject to procedures of    in schedule II.
                                                    part of the Divestiture Assets, (2)                                      Antitrust Procedures and Penalties Act, 15   The company plans to manufacture
                                                    acquire any option to reacquire any part                                 U.S.C. § 16
                                                    of the Divestiture Assets or to assign the                                                                          reference standards for distribution to
                                                                                                                             lllllllllllllllllllll their research and forensic customers.
                                                    Divestiture Assets to any other person,
                                                                                                                             United States District Judge.                                            Dated: September 7, 2016.
                                                    (3) enter into any local marketing
                                                    agreement, joint sales agreement, other                                  [FR Doc. 2016–22086 Filed 9–13–16; 8:45 am]                            Louis J. Milione,
                                                    cooperative selling arrangement, or                                      BILLING CODE P                                                         Deputy Assistant Administrator.
                                                    shared services agreement, or conduct                                                                                                           [FR Doc. 2016–22100 Filed 9–13–16; 8:45 am]
                                                    other business negotiations jointly with                                                                                                        BILLING CODE 4410–09–P
                                                    the Acquirers with respect to the                                        DEPARTMENT OF JUSTICE
                                                    Divestiture Assets, or (4) provide
                                                    financing or guarantees of financing                                     Drug Enforcement Administration
                                                                                                                                                                                                    DEPARTMENT OF JUSTICE
                                                    with respect to the Divestiture Assets,                                  [Docket No. DEA–392]
                                                    during the term of this Final Judgment.                                                                                                         Drug Enforcement Administration
                                                    The shared services prohibition does                                     Bulk Manufacturer of Controlled
                                                    not preclude Defendants from                                             Substances Application: Alcami                                         [Docket No. DEA–392]
                                                    continuing or entering into agreements                                   Wisconsin Corporation
                                                    in a form customarily used in the                                                                                                               Bulk Manufacturer of Controlled
                                                                                                                             ACTION:      Notice of application.
                                                    industry to (1) share news helicopters or                                                                                                       Substances Registration
                                                    (2) pool generic video footage that does                                 DATES:  Registered bulk manufacturers of
                                                    not include recording a reporter or other                                                                                                       ACTION:       Notice of registration.
                                                                                                                             the affected basic classes, and
                                                    on-air talent, and does not preclude                                     applicants therefore, may file written
                                                    Defendants from entering into any non-                                                                                                          SUMMARY:   Registrants listed below have
                                                                                                                             comments on or objections to the                                       applied for and been granted
                                                    sales-related shared services agreement                                  issuance of the proposed registration in
                                                    or transition services agreement that is                                                                                                        registration by the Drug Enforcement
                                                                                                                             accordance with 21 CFR 1301.33(a) on                                   Administration (DEA) as bulk
                                                    approved in advance by the United                                        or before November 14, 2016.
                                                    States in its sole discretion.                                                                                                                  manufacturers of various classes of
                                                                                                                             ADDRESSES: Written comments should                                     controlled substances.
                                                    XII. Retention of Jurisdiction                                           be sent to: Drug Enforcement                                           SUPPLEMENTARY INFORMATION: The
                                                      This Court retains jurisdiction to                                     Administration, Attention: DEA Federal                                 companies listed below applied to be
                                                    enable any party to this Final Judgment                                  Register Representative/ODW, 8701                                      registered as manufacturers of various
                                                    to apply to this Court at any time for                                   Morrissette Drive, Springfield, Virginia                               basic classes of controlled substances.
                                                    further orders and directions as may be                                  22152.                                                                 Information on previously published
                                                    necessary or appropriate to carry out or                                 SUPPLEMENTARY INFORMATION: The                                         notices is listed in the table below. No
                                                    construe this Final Judgment, to modify                                  Attorney General has delegated her                                     comments or objections were submitted
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    any of its provisions, to enforce                                        authority under the Controlled                                         for these notices.

                                                                                                                Company                                                                                     FR Docket                           Published

                                                    Johnson Matthey, Inc ..............................................................................................................       81   FR   3475 ............................   January 21, 2016.
                                                    Mallinckrodt, LLC .....................................................................................................................   81   FR   31959 ..........................    May 20, 2016.
                                                    American Radiolabeled Chemicals ..........................................................................................                81   FR   31960 ..........................    May 20, 2016.
                                                    Rhodes Technologies ..............................................................................................................        81   FR   34371 ..........................    May 31, 2016.



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Document Created: 2016-09-14 02:27:24
Document Modified: 2016-09-14 02:27:24
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 November 14, 2016.
FR Citation81 FR 63219 

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