82_FR_34837 82 FR 34695 - Bulk Manufacturer of Controlled Substances Registration

82 FR 34695 - Bulk Manufacturer of Controlled Substances Registration

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 142 (July 26, 2017)

Page Range34695-34696
FR Document2017-15692

Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.

Federal Register, Volume 82 Issue 142 (Wednesday, July 26, 2017)
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34695-34696]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15692]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: Registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as bulk 
manufacturers of various classes of controlled substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as manufacturers of various basic classes of controlled 
substances. Information on previously published notices is listed in 
the table below. No comments or objections were submitted for these 
notices.

------------------------------------------------------------------------
            Company                 FR docket            Published
------------------------------------------------------------------------
Cedarburg Pharmaceuticals.....  82 FR 19083.....  April 25, 2017.
Siegfried USA, LLC............  82 FR 19084.....  April 25, 2017.
Sigma Aldrich Research          82 FR 19085.....  April 25, 2017.
 Biochemicals, Inc.
------------------------------------------------------------------------

    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of these registrants to manufacture 
the applicable 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 each of the company's maintenance of 
effective controls against diversion by inspecting and testing each 
company's physical security systems, verifying each company's 
compliance with state and local laws, and reviewing each company's 
background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a

[[Page 34696]]

registration as a bulk manufacturer to the above listed persons.

    Dated: July 19, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-15692 Filed 7-25-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                          Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices                                                                                           34695

                                                    Dated: July 20, 2017.                                                     applicants therefore, may file written                                       implementation of 21 CFR part 1301,
                                                  Demetra Ashley,                                                             comments on or objections to the                                             incident to the registration of
                                                  Acting Assistant Administrator.                                             issuance of the proposed registration in                                     manufacturers, distributors, dispensers,
                                                  [FR Doc. 2017–15693 Filed 7–25–17; 8:45 am]                                 accordance with 21 CFR 1301.33(a) on                                         importers, and exporters of controlled
                                                  BILLING CODE 4410–09–P                                                      or before September 25, 2017.                                                substances (other than final orders in
                                                                                                                              ADDRESSES: Written comments should                                           connection with suspension, denial, or
                                                                                                                              be sent to: Drug Enforcement                                                 revocation of registration) has been
                                                  DEPARTMENT OF JUSTICE                                                       Administration, Attention: DEA Federal                                       redelegated to the Assistant
                                                                                                                              Register Representative/DRW, 8701                                            Administrator of the DEA Diversion
                                                  Drug Enforcement Administration                                             Morrissette Drive, Springfield, Virginia                                     Control Division (‘‘Assistant
                                                  [Docket No. DEA–392]                                                        22152.                                                                       Administrator’’) pursuant to section 7 of
                                                                                                                              SUPPLEMENTARY INFORMATION:    The                                            28 CFR part 0, appendix to subpart R.
                                                  Bulk Manufacturer of Controlled
                                                                                                                              Attorney General has delegated his                                             In accordance with 21 CFR
                                                  Substances Application: AMRI
                                                                                                                              authority under the Controlled                                               1301.33(a), this is notice that on March
                                                  Rensselaer, Inc.
                                                                                                                              Substances Act to the Administrator of                                       30, 2017, AMRI Rensselaer, Inc., 33
                                                  ACTION:       Notice of application.                                        the Drug Enforcement Administration                                          Riverside Avenue, Rensselaer, New
                                                                                                                              (DEA), 28 CFR 0.100(b). Authority to                                         York 12144 applied to be registered as
                                                  DATES:  Registered bulk manufacturers of                                    exercise all necessary functions with                                        a bulk manufacturer of the following
                                                  the affected basic classes, and                                             respect to the promulgation and                                              basic classes of controlled substances:

                                                                                                                           Controlled substance                                                                                          Drug code      Schedule

                                                  Marihuana ........................................................................................................................................................................           7360     I
                                                  Tetrahydrocannabinols ....................................................................................................................................................                   7370     I
                                                  Amphetamine ...................................................................................................................................................................              1100     II
                                                  Lisdexamfetamine ............................................................................................................................................................                1205     II
                                                  Methylphenidate ..............................................................................................................................................................               1724     II
                                                  Pentobarbital ....................................................................................................................................................................           2270     II
                                                  4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................                              8333     II
                                                  Codeine ...........................................................................................................................................................................          9050     II
                                                  Oxycodone .......................................................................................................................................................................            9143     II
                                                  Hydromorphone ...............................................................................................................................................................                9150     II
                                                  Hydrocodone ...................................................................................................................................................................              9193     II
                                                  Meperidine .......................................................................................................................................................................           9230     II
                                                  Morphine ..........................................................................................................................................................................          9300     II
                                                  Fentanyl ...........................................................................................................................................................................         9801     II



                                                    The company plans to manufacture                                          DEPARTMENT OF JUSTICE                                                        SUPPLEMENTARY INFORMATION:       The
                                                  bulk controlled substances for use in                                                                                                                    companies listed below applied to be
                                                  product development and for                                                 Drug Enforcement Administration                                              registered as manufacturers of various
                                                  distribution to its customers.                                              [Docket No. DEA–392]                                                         basic classes of controlled substances.
                                                    In reference to drug codes 7360                                                                                                                        Information on previously published
                                                  (marihuana) and 7370 (THC), the                                             Bulk Manufacturer of Controlled                                              notices is listed in the table below. No
                                                  company plans to bulk manufacture                                           Substances Registration                                                      comments or objections were submitted
                                                  these drugs as synthetics. No other                                                                                                                      for these notices.
                                                  activities for these drug codes are                                         ACTION:        Notice of registration.
                                                  authorized for this registration.
                                                                                                                              SUMMARY:   Registrants listed below have
                                                    Dated: July 19, 2017.                                                     applied for and been granted
                                                  Demetra Ashley,                                                             registration by the Drug Enforcement
                                                  Acting Assistant Administrator.                                             Administration (DEA) as bulk
                                                  [FR Doc. 2017–15688 Filed 7–25–17; 8:45 am]                                 manufacturers of various classes of
                                                  BILLING CODE 4410–09–P                                                      controlled substances.

                                                                                                          Company                                                                                            FR docket                               Published

                                                  Cedarburg Pharmaceuticals ......................................................................................                   82 FR 19083 ...........................................   April 25, 2017.
                                                  Siegfried USA, LLC ...................................................................................................             82 FR 19084 ...........................................   April 25, 2017.
                                                  Sigma Aldrich Research Biochemicals, Inc ..............................................................                            82 FR 19085 ...........................................   April 25, 2017.
mstockstill on DSK30JT082PROD with NOTICES




                                                    The DEA has considered the factors in                                     treaties, conventions, or protocols in                                       company’s compliance with state and
                                                  21 U.S.C. 823(a) and determined that                                        effect on May 1, 1971. The DEA                                               local laws, and reviewing each
                                                  the registration of these registrants to                                    investigated each of the company’s                                           company’s background and history.
                                                  manufacture the applicable basic classes                                    maintenance of effective controls                                              Therefore, pursuant to 21 U.S.C.
                                                  of controlled substances is consistent                                      against diversion by inspecting and                                          823(a), and in accordance with 21 CFR
                                                  with the public interest and with United                                    testing each company’s physical                                              1301.33, the DEA has granted a
                                                  States obligations under international                                      security systems, verifying each



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                                                  34696                        Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices

                                                  registration as a bulk manufacturer to                     Dated: July 19, 2017.                               Administrator’’) pursuant to section 7 of
                                                  the above listed persons.                                Demetra Ashley,                                       28 CFR part 0, appendix to subpart R.
                                                    Dated: July 19, 2017.                                  Acting Assistant Administrator.                          In accordance with 21 CFR
                                                  Demetra Ashley,                                          [FR Doc. 2017–15690 Filed 7–25–17; 8:45 am]           1301.34(a), this is notice that on June
                                                                                                           BILLING CODE 4410–09–P
                                                                                                                                                                 27, 2016, AMRI Rensselaer, Inc., 33
                                                  Acting Assistant Administrator.
                                                                                                                                                                 Riverside Avenue, Rensselaer, New
                                                  [FR Doc. 2017–15692 Filed 7–25–17; 8:45 am]
                                                                                                                                                                 York 12144 applied to be registered as
                                                  BILLING CODE 4410–09–P                                                                                         an importer of poppy straw concentrate
                                                                                                           DEPARTMENT OF JUSTICE
                                                                                                                                                                 (9670), a basic class of controlled
                                                                                                           Drug Enforcement Administration                       substance listed in schedule II.
                                                  DEPARTMENT OF JUSTICE                                                                                             The company plans to import the
                                                                                                           [Docket No. DEA–392]
                                                  Drug Enforcement Administration                                                                                listed controlled substance to
                                                                                                           Importer of Controlled Substances                     manufacture bulk controlled substance
                                                                                                           Application: AMRI Rensselaer, Inc.                    for distribution to its customers.
                                                  [Docket No. DEA–392]
                                                                                                                                                                   Dated: July 20, 2017.
                                                  Bulk Manufacturer of Controlled                          ACTION:   Notice of application.                      Demetra Ashley,
                                                  Substances Application: Organic                                                                                Acting Assistant Administrator.
                                                                                                           DATES:  Registered bulk manufacturers of
                                                  Consultants, Inc.                                                                                              [FR Doc. 2017–15689 Filed 7–25–17; 8:45 am]
                                                                                                           the affected basic classes, and
                                                  ACTION:   Notice of application.                         applicants therefore, may file written                BILLING CODE 4410–09–P
                                                                                                           comments on or objections to the
                                                  DATES:  Registered bulk manufacturers of                 issuance of the proposed registration in
                                                                                                           accordance with 21 CFR 1301.34(a) on                  DEPARTMENT OF LABOR
                                                  the affected basic classes, and
                                                  applicants therefore, may file written                   or before August 25, 2017. Such persons
                                                                                                           may also file a written request for a                 Employment and Training
                                                  comments on or objections to the                                                                               Administration
                                                  issuance of the proposed registration in                 hearing on the application pursuant to
                                                  accordance with 21 CFR 1301.33(a) on                     21 CFR 1301.43 on or before August 25,
                                                                                                                                                                 Workforce Information Advisory
                                                  or before September 25, 2017.                            2017.
                                                                                                                                                                 Council
                                                                                                           ADDRESSES: Written comments should
                                                  ADDRESSES: Written comments should                                                                             AGENCY:  Employment and Training
                                                                                                           be sent to: Drug Enforcement
                                                  be sent to: Drug Enforcement                                                                                   Administration, Labor.
                                                                                                           Administration, Attention: DEA Federal
                                                  Administration, Attention: DEA Federal
                                                                                                           Register Representative/DRW, 8701                     ACTION: Notice of Renewal of the
                                                  Register Representative/DRW, 8701
                                                                                                           Morrissette Drive, Springfield, Virginia              Workforce Information Advisory
                                                  Morrissette Drive, Springfield, Virginia
                                                                                                           22152. All requests for hearing must be               Council.
                                                  22152.
                                                                                                           sent to: Drug Enforcement
                                                  SUPPLEMENTARY INFORMATION:      The                      Administration, Attn: Administrator,                  SUMMARY:  The Department of Labor
                                                  Attorney General has delegated his                       8701 Morrissette Drive, Springfield,                  (Department) announces the renewal of
                                                  authority under the Controlled                           Virginia 22152. All requests for hearing              the Workforce Information Advisory
                                                  Substances Act to the Administrator of                   should also be sent to: (1) Drug                      Council (WIAC) charter.
                                                  the Drug Enforcement Administration                      Enforcement Administration, Attn:                     FOR FURTHER INFORMATION CONTACT:
                                                  (DEA), 28 CFR 0.100(b). Authority to                     Hearing Clerk/LJ, 8701 Morrissette                    Steve Rietzke, Division of National
                                                  exercise all necessary functions with                    Drive, Springfield, Virginia 22152; and               Programs, Tools, and Technical
                                                  respect to the promulgation and                          (2) Drug Enforcement Administration,                  Assistance, Office of Workforce
                                                  implementation of 21 CFR part 1301,                      Attn: DEA Federal Register                            Investment, Rm. C–4510, 200
                                                  incident to the registration of                          Representative/DRW, 8701 Morrissette                  Constitution Ave. NW., Washington, DC
                                                  manufacturers, distributors, dispensers,                 Drive, Springfield, Virginia 22152.                   20212–0001; (202) 693–3912; or use
                                                  importers, and exporters of controlled                   Comments and requests for hearings on                 email address for the WIAC, WIAC@
                                                  substances (other than final orders in                   applications to import narcotic raw                   dol.gov.
                                                  connection with suspension, denial, or                   material are not appropriate. 72 FR 3417              SUPPLEMENTARY INFORMATION:
                                                  revocation of registration) has been                     (January 25, 2007).
                                                  redelegated to the Assistant                             SUPPLEMENTARY INFORMATION: The                        I. Background and Authority
                                                  Administrator of the DEA Diversion                       Attorney General has delegated his                      Section 15 of the Wagner-Peyser Act,
                                                  Control Division (‘‘Assistant                            authority under the Controlled                        29 U.S.C. 49l–2, as amended by section
                                                  Administrator’’) pursuant to section 7 of                Substances Act to the Administrator of                308 of the Workforce Innovation and
                                                  28 CFR part 0, appendix to subpart R.                    the Drug Enforcement Administration                   Opportunity Act of 2014 (WIOA), Public
                                                    In accordance with 21 CFR                              (DEA), 28 CFR 0.100(b). Authority to                  Law 113–128 requires the Secretary of
                                                  1301.33(a), this is notice that on                       exercise all necessary functions with                 Labor (Secretary) to establish and
                                                  November 2, 2016, Organic Consultants,                   respect to the promulgation and                       maintain the WIAC.
                                                  Inc., 90 North Polk Street, Suite 200,                   implementation of 21 CFR part 1301,                     The statute, as amended, requires the
                                                  Eugene, Oregon 97402 applied to be                       incident to the registration of                       Secretary, acting through the
                                                  registered as a bulk manufacturer for                    manufacturers, distributors, dispensers,              Commissioner of Labor Statistics and
mstockstill on DSK30JT082PROD with NOTICES




                                                  methadone intermediate (9254), a basic                   importers, and exporters of controlled                the Assistant Secretary for Employment
                                                  class of controlled substance listed in                  substances (other than final orders in                and Training, to formally consult at
                                                  schedule II.                                             connection with suspension, denial, or                least twice annually with the WIAC to
                                                    The company plans to manufacture                       revocation of registration) has been                  address: (1) Evaluation and
                                                  analytical reference standards for                       redelegated to the Assistant                          improvement of the nationwide
                                                  distribution to its customers for research               Administrator of the DEA Diversion                    workforce and labor market information
                                                  and analytical purposes.                                 Control Division (‘‘Assistant                         system established by the Wagner-


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Document Created: 2017-07-26 01:30:28
Document Modified: 2017-07-26 01:30:28
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 Citation82 FR 34695 

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