83_FR_54823 83 FR 54613 - Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research

83 FR 54613 - Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 210 (October 30, 2018)

Page Range54613-54613
FR Document2018-23695

Federal Register, Volume 83 Issue 210 (Tuesday, October 30, 2018)
[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Page 54613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23695]



[[Page 54613]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Sigma 
Aldrich Research

ACTION: Notice of application.

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

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 on or before December 31, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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 delegated 
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 1301.33(a), this is notice that on June 
14, 2018, Sigma Aldrich Research, 1-3 Strathmore Road, Natick, 
Massachusetts 01760-2447 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Cathinone..........................            1235  I
Mephedrone (4-Methyl-N-                        1248  I
 methylcathinone).
Lysergic acid diethylamide.........            7315  I
3,4-Methylenedioxymethamphetamine..            7405  I
Dimethyltryptamine.................            7435  I
5-Methoxy-N,N-diisopropyltryptamine            7439  I
MDPV (3,4-                                     7535  I
 Methylenedioxypyrovalerone).
Heroin.............................            9200  I
Normorphine........................            9313  I
Norlevorphanol.....................            9634  I
Amphetamine........................            1100  II
Nabilone...........................            7379  II
Cocaine............................            9041  II
Codeine............................            9050  II
Ecgonine...........................            9180  II
Levorphanol........................            9220  II
Meperidine.........................            9230  II
Methadone..........................            9250  II
Morphine...........................            9300  II
Thebaine...........................            9333  II
Levo-alphacetylmethadol............            9648  II
Remifentanil.......................            9739  II
Sufentanil.........................            9740  II
Carfentanil........................            9743  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to manufacture reference standards.

    Dated: October 11, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23695 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                       Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices                                                                                         54613

                                               DEPARTMENT OF JUSTICE                                                        ADDRESSES:   Written comments should                                         manufacturers, distributors, dispensers,
                                                                                                                            be sent to: Drug Enforcement                                                 importers, and exporters of controlled
                                               Drug Enforcement Administration                                              Administration, Attention: DEA Federal                                       substances (other than final orders in
                                                                                                                            Register Representative/DPW, 8701                                            connection with suspension, denial, or
                                               [Docket No. DEA–392]
                                                                                                                            Morrissette Drive, Springfield, Virginia                                     revocation of registration) has been
                                               Bulk Manufacturer of Controlled                                              22152.                                                                       delegated to the Assistant Administrator
                                               Substances Application: Sigma Aldrich                                                                                                                     of the DEA Diversion Control Division
                                               Research                                                                     SUPPLEMENTARY INFORMATION:      The                                          (‘‘Assistant Administrator’’) pursuant to
                                                                                                                            Attorney General has delegated his                                           section 7 of 28 CFR part 0, appendix to
                                               ACTION:       Notice of application.                                         authority under the Controlled                                               subpart R.
                                                                                                                            Substances Act to the Administrator of                                          In accordance with 21 CFR
                                               DATES:  Registered bulk manufacturers of                                     the Drug Enforcement Administration                                          1301.33(a), this is notice that on June
                                               the affected basic classes, and                                              (DEA), 28 CFR 0.100(b). Authority to                                         14, 2018, Sigma Aldrich Research, 1–3
                                               applicants therefore, may file written                                       exercise all necessary functions with                                        Strathmore Road, Natick, Massachusetts
                                               comments on or objections to the                                             respect to the promulgation and                                              01760–2447 applied to be registered as
                                               issuance of the proposed registration on                                     implementation of 21 CFR part 1301,                                          a bulk manufacturer of the following
                                               or before December 31, 2018.                                                 incident to the registration of                                              basic classes of controlled substances:

                                                                                                                        Controlled substance                                                                                           Drug code    Schedule

                                               Cathinone ........................................................................................................................................................................            1235   I
                                               Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................                                  1248   I
                                               Lysergic acid diethylamide ..............................................................................................................................................                     7315   I
                                               3,4-Methylenedioxymethamphetamine ............................................................................................................................                                7405   I
                                               Dimethyltryptamine ..........................................................................................................................................................                 7435   I
                                               5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................                             7439   I
                                               MDPV (3,4-Methylenedioxypyrovalerone) .......................................................................................................................                                 7535   I
                                               Heroin ..............................................................................................................................................................................         9200   I
                                               Normorphine ....................................................................................................................................................................              9313   I
                                               Norlevorphanol ................................................................................................................................................................               9634   I
                                               Amphetamine ...................................................................................................................................................................               1100   II
                                               Nabilone ...........................................................................................................................................................................          7379   II
                                               Cocaine ............................................................................................................................................................................          9041   II
                                               Codeine ...........................................................................................................................................................................           9050   II
                                               Ecgonine ..........................................................................................................................................................................           9180   II
                                               Levorphanol .....................................................................................................................................................................             9220   II
                                               Meperidine .......................................................................................................................................................................            9230   II
                                               Methadone .......................................................................................................................................................................             9250   II
                                               Morphine ..........................................................................................................................................................................           9300   II
                                               Thebaine ..........................................................................................................................................................................           9333   II
                                               Levo-alphacetylmethadol .................................................................................................................................................                     9648   II
                                               Remifentanil .....................................................................................................................................................................            9739   II
                                               Sufentanil .........................................................................................................................................................................          9740   II
                                               Carfentanil .......................................................................................................................................................................           9743   II
                                               Fentanyl ...........................................................................................................................................................................          9801   II



                                                 The company plans to manufacture                                           issuance of the proposed registration on                                     SUPPLEMENTARY INFORMATION:
                                               reference standards.                                                         or before November 29, 2018. Such                                              The Attorney General has delegated
                                                 Dated: October 11, 2018.                                                   persons may also file a written request                                      his authority under the Controlled
                                                                                                                            for a hearing on the application on or                                       Substances Act to the Administrator of
                                               John J. Martin,
                                                                                                                            before November 29, 2018.                                                    the Drug Enforcement Administration
                                               Assistant Administrator.                                                                                                                                  (DEA), 28 CFR 0.100(b). Authority to
                                               [FR Doc. 2018–23695 Filed 10–29–18; 8:45 am]                                 ADDRESSES:   Written comments should                                         exercise all necessary functions with
                                               BILLING CODE 4410–09–P                                                       be sent to: Drug Enforcement                                                 respect to the promulgation and
                                                                                                                            Administration, Attention: DEA Federal                                       implementation of 21 CFR part 1301,
                                                                                                                            Register Representative/DPW, 8701                                            incident to the registration of
                                               DEPARTMENT OF JUSTICE                                                        Morrissette Drive, Springfield, Virginia                                     manufacturers, distributors, dispensers,
                                                                                                                            22152. All requests for hearing must be                                      importers, and exporters of controlled
                                               Drug Enforcement Administration                                              sent to: Drug Enforcement                                                    substances (other than final orders in
                                                                                                                            Administration, Attn: Administrator,                                         connection with suspension, denial, or
                                               [Docket No. DEA–392]
                                                                                                                            8701 Morrissette Drive, Springfield,                                         revocation of registration) has been
                                               Importer of Controlled Substances                                            Virginia 22152. All requests for hearing                                     redelegated to the Assistant
                                                                                                                            should also be sent to: (1) Drug
khammond on DSK30JT082PROD with NOTICES




                                               Application: Catalent CTS, LLC                                                                                                                            Administrator of the DEA Diversion
                                                                                                                            Enforcement Administration, Attn:                                            Control Division (‘‘Assistant
                                               ACTION:       Notice of application.                                         Hearing Clerk/OALJ, 8701 Morrissette                                         Administrator’’) pursuant to section 7 of
                                                                                                                            Drive, Springfield, Virginia 22152; and                                      28 CFR part 0, appendix to subpart R.
                                               DATES:  Registered bulk manufacturers of                                     (2) Drug Enforcement Administration,                                           In accordance with 21 CFR
                                               the affected basic classes, and                                              Attn: DEA Federal Register                                                   1301.34(a), this is notice that on July 17,
                                               applicants therefore, may file written                                       Representative/DPW, 8701 Morrissette                                         2018, Catalent CTS, LLC, 10245
                                               comments on or objections to the                                             Drive, Springfield, Virginia 22152.                                          Hickman Mills Drive, Kansas City,


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Document Created: 2018-10-30 00:43:18
Document Modified: 2018-10-30 00:43:18
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 on or before December 31, 2018.
FR Citation83 FR 54613 

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