80_FR_34809 80 FR 34693 - Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc.

80 FR 34693 - Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 116 (June 17, 2015)

Page Range34693-34693
FR Document2015-14912

Siemens Healthcare Diagnostics, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances.

Federal Register, Volume 80 Issue 116 (Wednesday, June 17, 2015)
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Page 34693]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14912]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Siemens 
Healthcare Diagnostics, Inc.

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Siemens Healthcare Diagnostics, Inc. applied to be registered 
as a manufacturer of certain basic classes of controlled substances. 
The Drug Enforcement Administration (DEA) grants Siemens Healthcare 
Diagnostics, Inc. registration as a manufacturer of those controlled 
substances.

SUPPLEMENTARY INFORMATION: By notice dated January 9, 2015, and 
published in the Federal Register on January 26, 2015, 80 FR 3982, 
Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 
514, Newark, Delaware 19702 applied to be registered as a manufacturer 
of certain basic classes of controlled substances. No comments or 
objections were submitted to this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of Siemens Healthcare Diagnostics, 
Inc. to manufacture the basic classes of controlled substances is 
consistent with the public interest and with United States obligations 
under international treaties, conventions, or protocols in effect on 
May 1, 1971. The DEA investigated the company's maintenance of 
effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances listed:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Ecgonine (9180)............................  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
------------------------------------------------------------------------

    The company plans to produce the listed controlled substances in 
bulk to be used in the manufacture of reagents and drug calibrator 
controls which are DEA exempt products.
    In reference to drug code 7370 the company plans to bulk 
manufacture a synthetic tetrahydrocannabinol. No other activity for 
this drug code is authorized for this registration.

    Dated: June 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-14912 Filed 6-16-15; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices                                                             34693

                                                    management strategies for Fire Island                   continuation or recurrence of material                 the Federal Register on January 26,
                                                    National Seashore for the next 15 to 20                 injury to an industry in the United                    2015, 80 FR 3982, Siemens Healthcare
                                                    years to support the protection of                      States within a reasonably foreseeable                 Diagnostics, Inc., Attn: RA, 100 GBC
                                                    important natural resources and                         time.                                                  Drive, Mailstop 514, Newark, Delaware
                                                    processes; significant recreation                                                                              19702 applied to be registered as a
                                                                                                            Background
                                                    resources; cultural resources of national,                                                                     manufacturer of certain basic classes of
                                                    state, and local significance; and                         The Commission, pursuant to section                 controlled substances. No comments or
                                                    residential communities.                                751(c) of the Tariff Act of 1930 (19                   objections were submitted to this notice.
                                                       The park is composed of two distinct                 U.S.C. 1675(c)), instituted these reviews                The DEA has considered the factors in
                                                    units—the barrier island that runs                      on April 1, 2014 (79 FR 18311) and                     21 U.S.C. 823(a) and determined that
                                                    parallel to the south shore of Long                     determined on July 7, 2014 that it would               the registration of Siemens Healthcare
                                                    Island and the 613-acre William Floyd                   conduct full reviews (79 FR 42049, July                Diagnostics, Inc. to manufacture the
                                                    Estate situated on the south shore of                   18, 2014). Notice of the scheduling of                 basic classes of controlled substances is
                                                    Long Island near the east end of Fire                   the Commission’s reviews and of a                      consistent with the public interest and
                                                    Island. To address the specific needs of                public hearing to be held in connection                with United States obligations under
                                                    these two distinct units, the Draft GMP/                therewith was given by posting copies                  international treaties, conventions, or
                                                    EIS includes two sets of alternatives.                  of the notice in the Office of the                     protocols in effect on May 1, 1971. The
                                                    One addresses park-wide alternatives                    Secretary, U.S. International Trade                    DEA investigated the company’s
                                                    for Fire Island National Seashore with a                Commission, Washington, DC, and by                     maintenance of effective controls
                                                    primary emphasis on the barrier island                  publishing the notice in the Federal                   against diversion by inspecting and
                                                    and includes a no-action alternative and                Register on November 14, 2014 (79 FR                   testing the company’s physical security
                                                    two action alternatives. The other set of               68299). The hearing was held in                        systems, verifying the company’s
                                                    alternatives focuses specifically on the                Washington, DC, on March 26, 2015,                     compliance with state and local laws,
                                                    William Floyd Estate and includes a no-                 and all persons who requested the                      and reviewing the company’s
                                                    action and a single action alternative.                 opportunity were permitted to appear in                background and history.
                                                    The Draft GMP/EIS also incorporates                     person or by counsel.                                    Therefore, pursuant to 21 U.S.C.
                                                    plans for the Otis Pike High Dunes Fire                    The Commission made these                           823(a), and in accordance with 21 CFR
                                                    Island Wilderness and includes a draft                  determinations pursuant to section                     1301.33, the above-named company is
                                                    Wilderness Stewardship Plan for public                  751(c) of the Tariff Act of 1930 (19                   granted registration as a bulk
                                                    review concurrent with the Draft GMP/                   U.S.C. 1675(c)). It completed and filed                manufacturer of the basic classes of
                                                    EIS.                                                    its determinations in these reviews on                 controlled substances listed:
                                                    FOR FURTHER INFORMATION CONTACT:                        June 11, 2015. The views of the
                                                    Ellen Carlson, NPS/Northeast Region, 15                 Commission are contained in USITC                              Controlled substance                  Schedule
                                                    State Street, Boston, MA 02019. Phone:                  Publication 4538 (June 2015), entitled
                                                                                                            Citric Acid and Certain Citrate Salts                  Tetrahydrocannabinols (7370) .....            I
                                                    (617) 223–5048. Email: Fire_Island_
                                                                                                            from Canada and China: Investigation                   Ecgonine (9180) ...........................   II
                                                    GMP@nps.gov.                                                                                                   Morphine (9300) ...........................   II
                                                                                                            Nos. 701–TA–456 and 731–TA–1151–
                                                      Dated: June 1, 2015.                                  1152 (Review).                                         Thebaine (9333) ...........................   II
                                                    Michael A. Caldwell,
                                                                                                              By order of the Commission.                             The company plans to produce the
                                                    Regional Director, Northeast Region, National
                                                    Park Service.                                             Issued: June 12, 2015.                               listed controlled substances in bulk to
                                                    [FR Doc. 2015–14927 Filed 6–16–15; 8:45 am]             Lisa R. Barton,                                        be used in the manufacture of reagents
                                                    BILLING CODE 4310–WV–P
                                                                                                            Secretary to the Commission.                           and drug calibrator controls which are
                                                                                                            [FR Doc. 2015–14863 Filed 6–16–15; 8:45 am]            DEA exempt products.
                                                                                                            BILLING CODE 7020–02–P                                    In reference to drug code 7370 the
                                                    INTERNATIONAL TRADE                                                                                            company plans to bulk manufacture a
                                                    COMMISSION                                                                                                     synthetic tetrahydrocannabinol. No
                                                                                                            DEPARTMENT OF JUSTICE                                  other activity for this drug code is
                                                    [Investigation Nos. 701–TA–456 and 731–                                                                        authorized for this registration.
                                                    TA–1151–1152 (Review)]                                  Drug Enforcement Administration                          Dated: June 11, 2015.
                                                    Citric Acid and Certain Citrate Salts                   [Docket No. DEA–392]                                   Joseph T. Rannazzisi,
                                                    From Canada and China                                                                                          Deputy Assistant Administrator.
                                                                                                            Manufacturer of Controlled                             [FR Doc. 2015–14912 Filed 6–16–15; 8:45 am]
                                                    Determination                                           Substances Registration: Siemens                       BILLING CODE 4410–09–P
                                                      On the basis of the record 1 developed                Healthcare Diagnostics, Inc.
                                                    in the subject five-year reviews, the
                                                    United States International Trade                       ACTION:   Notice of registration.
                                                                                                                                                                   DEPARTMENT OF JUSTICE
                                                    Commission (‘‘Commission’’)                             SUMMARY:   Siemens Healthcare
                                                    determines, pursuant to the Tariff Act of               Diagnostics, Inc. applied to be registered             Drug Enforcement Administration
                                                    1930, that revocation of the                            as a manufacturer of certain basic                     [Docket No. DEA–411F]
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    countervailing duty order on citric acid                classes of controlled substances. The
                                                    and certain citrate salts from China and                Drug Enforcement Administration                        Adjusted Aggregate Production
                                                    the antidumping duty orders on citric                   (DEA) grants Siemens Healthcare                        Quotas for Difenoxin, Diphenoxylate
                                                    acid and certain citrate salts from China               Diagnostics, Inc. registration as a                    (for Conversion), and Marijuana
                                                    and Canada would be likely to lead to                   manufacturer of those controlled
                                                                                                            substances.                                            AGENCY:  Drug Enforcement
                                                      1 Therecord is defined in sec. 207.2(f) of the                                                               Administration, Department of Justice.
                                                    Commission’s Rules of Practice and Procedure (19        SUPPLEMENTARY INFORMATION: By notice
                                                                                                                                                                   ACTION: Final order.
                                                    CFR 207.2(f)).                                          dated January 9, 2015, and published in


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Document Created: 2015-12-15 14:22:23
Document Modified: 2015-12-15 14:22:23
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 registration.
FR Citation80 FR 34693 

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