81_FR_71968 81 FR 71767 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.

81 FR 71767 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

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

Page Range71767-71767
FR Document2016-25133

Federal Register, Volume 81 Issue 201 (Tuesday, October 18, 2016)
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Notices]
[Page 71767]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25133]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Johnson 
Matthey Inc.

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 in accordance with 21 CFR 
1301.33(a) on or before December 19, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 Assistant Administrator of the DEA Office of Diversion Control 
(``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 
September 5, 2016, Johnson Matthey Inc., Custom Pharmaceuticals 
Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742 
applied to be registered as a bulk manufacturer the following basic 
classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled Substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............     2010  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Dihydromorphine........................     9145  I
Difenoxin..............................     9168  I
Propiram...............................     9649  I
Amphetamine............................     1100  II
Methamphetamine........................     1105  II
Lisdexamfetamine.......................     1205  II
Methylphenidate........................     1724  II
Nabilone...............................     7379  II
Cocaine................................     9041  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Diphenoxylate..........................     9170  II
Ecgonine...............................     9180  II
Hydrocodone............................     9193  II
Meperidine.............................     9230  II
Methadone..............................     9250  II
Methadone intermediate.................     9254  II
Morphine...............................     9300  II
Thebaine...............................     9333  II
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Alfentanil.............................     9737  II
Remifentanil...........................     9739  II
Sufentanil.............................     9740  II
Tapentadol.............................     9780  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers.
    In reference to drug codes 7360 (marihuana) and 7370 (THC), the 
company plans to bulk manufacture these drugs as synthetics. No other 
activities for these drug codes are authorized for this registration.

    Dated: October 11, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-25133 Filed 10-17-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                 Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Notices                                                   71767

                                             exercise all necessary functions with                      Administration, Attention: DEA Federal                          The company plans to manufacture
                                             respect to the promulgation and                            Register Representative/DRW, 8701                             the listed controlled substances in bulk
                                             implementation of 21 CFR part 1301,                        Morrissette Drive, Springfield, Virginia                      for sale to its customers.
                                             incident to the registration of                            22152.                                                          In reference to drug codes 7360
                                             manufacturers, distributors, dispensers,                                                                                 (marihuana) and 7370 (THC), the
                                             importers, and exporters of controlled                     SUPPLEMENTARY INFORMATION:      The                           company plans to bulk manufacture
                                             substances (other than final orders in                     Attorney General has delegated her                            these drugs as synthetics. No other
                                             connection with suspension, denial, or                     authority under the Controlled                                activities for these drug codes are
                                             revocation of registration) has been                       Substances Act to the Administrator of                        authorized for this registration.
                                             redelegated to the Assistant                               the Drug Enforcement Administration
                                                                                                                                                                        Dated: October 11, 2016.
                                             Administrator of the DEA Office of                         (DEA), 28 CFR 0.100(b). Authority to
                                                                                                        exercise all necessary functions with                         Louis J. Milione,
                                             Diversion Control (‘‘Assistant
                                                                                                        respect to the promulgation and                               Assistant Administrator.
                                             Administrator’’) pursuant to section 7 of
                                             28 CFR part 0, appendix to subpart R.                      implementation of 21 CFR part 1301,                           [FR Doc. 2016–25133 Filed 10–17–16; 8:45 am]
                                               In accordance with 21 CFR                                incident to the registration of                               BILLING CODE 4410–09–P

                                             1301.34(a), this is notice that on                         manufacturers, distributors, dispensers,
                                             September 5, 2016, Johnson Matthey                         importers, and exporters of controlled
                                             Inc., Pharmaceutical Materials, 2003                       substances (other than final orders in                        DEPARTMENT OF LABOR
                                             Nolte Drive, West Deptford, New Jersey                     connection with suspension, denial, or
                                             08066–1742, applied to be registered as                    revocation of registration) has been                          Wage and Hour Division
                                             an importer of the following basic                         redelegated to the Assistant
                                                                                                        Administrator of the DEA Office of                            Agency Information Collection
                                             classes of controlled substances:                                                                                        Activities; Comment Request;
                                                                                                        Diversion Control (‘‘Assistant
                                                                                                        Administrator’’) pursuant to section 7 of                     Information Collections: Report of
                                                                                  Drug
                                               Controlled substance                       Schedule                                                                    Construction Contractor’s Wage Rates
                                                                                  code                  28 CFR part 0, appendix to subpart R.
                                             Coca Leaves ................          9040   II              In accordance with 21 CFR                                   AGENCY: Wage and Hour Division,
                                             Thebaine .......................      9333   II            1301.33(a), this is notice that on                            Department of Labor.
                                             Opium, raw ...................        9600   II            September 5, 2016, Johnson Matthey                            ACTION: Notice.
                                             Noroxymorphone ..........             9668   II            Inc., Custom Pharmaceuticals
                                             Poppy Straw Con-                      9670   II            Department, 2003 Nolte Drive, West                            SUMMARY:    The Department of Labor
                                               centrate.                                                Deptford, New Jersey 08066–1742                               (DOL) is soliciting comments
                                             Fentanyl ........................     9801   II            applied to be registered as a bulk                            concerning a proposed extension of the
                                                                                                        manufacturer the following basic classes                      information collection request (ICR)
                                                The company plans to import                             of controlled substances:                                     titled, ‘‘Report of Construction
                                             Thebaine derivatives and Fentanyl as                                                                                     Contractor’s Wage Rates.’’ This
                                             reference standards. The company plans                                                             Drug                  comment request is part of continuing
                                             to import the remaining listed                               Controlled Substance                             Schedule
                                                                                                                                                code                  Departmental efforts to reduce
                                             controlled substances as raw materials,                                                                                  paperwork and respondent burden in
                                             to be used in the manufacture of bulk                      Gamma Hydroxybutyric                      2010    I           accordance with the Paperwork
                                             controlled substances, for distribution to                   Acid.                                                       Reduction Act of 1995 (PRA), 44 U.S.C.
                                             its customers.                                             Marihuana .....................           7360    I
                                                                                                                                                                      3501 et seq.
                                                                                                        Tetrahydrocannabinols                     7370    I
                                               Dated: October 11, 2016.                                 Dihydromorphine ..........                9145    I
                                                                                                                                                                         This program helps to ensure that
                                             Louis J. Milione,                                          Difenoxin .......................         9168    I           requested data can be provided in the
                                             Assistant Administrator.                                   Propiram .......................          9649    I           desired format, reporting burden (time
                                                                                                        Amphetamine ...............               1100    II          and financial resources) is minimized,
                                             [FR Doc. 2016–25126 Filed 10–17–16; 8:45 am]
                                                                                                        Methamphetamine ........                  1105    II          collection instruments are clearly
                                             BILLING CODE 4410–09–P
                                                                                                        Lisdexamfetamine ........                 1205    II          understood, and the impact of collection
                                                                                                        Methylphenidate ...........               1724    II          requirements on respondents can be
                                             DEPARTMENT OF JUSTICE                                      Nabilone .......................          7379    II          properly assessed. A copy of the
                                                                                                        Cocaine ........................          9041    II          proposed information request can be
                                             Drug Enforcement Administration                            Codeine ........................          9050    II          obtained by contacting the office listed
                                                                                                        Dihydrocodeine .............              9120    II          below in the FOR FURTHER INFORMATION
                                             [Docket No. DEA–392]                                       Oxycodone ...................             9143    II          CONTACT section of this Notice.
                                                                                                        Hydromorphone ............                9150    II
                                             Bulk Manufacturer of Controlled                                                                                          DATES: Written comments must be
                                                                                                        Diphenoxylate ...............             9170    II
                                             Substances Application: Johnson                            Ecgonine .......................          9180    II
                                                                                                                                                                      submitted to the office listed in the
                                             Matthey Inc.                                               Hydrocodone ................              9193    II          ADDRESSES section below on or before
                                                                                                        Meperidine ....................           9230    II          December 19, 2016.
                                             ACTION:     Notice of application.                         Methadone ....................            9250    II          ADDRESSES: You may submit comments
                                                                                                        Methadone intermediate                    9254    II          identified by Control Number 1235–
                                             DATES:  Registered bulk manufacturers of                   Morphine .......................          9300    II          0015, by either one of the following
                                             the affected basic classes, and                            Thebaine .......................          9333    II          methods: Email: WHDPRAComments@
                                             applicants therefore, may file written                     Oxymorphone ...............               9652    II
Lhorne on DSK30JT082PROD with NOTICES




                                                                                                                                                                      dol.gov; Mail, Hand Delivery, Courier:
                                             comments on or objections to the                           Noroxymorphone ..........                 9668    II          Division of Regulations, Legislation, and
                                             issuance of the proposed registration in                   Alfentanil .......................        9737    II          Interpretation, Wage and Hour, U.S.
                                             accordance with 21 CFR 1301.33(a) on                       Remifentanil ..................           9739    II          Department of Labor, Room S–3502, 200
                                             or before December 19, 2016.                               Sufentanil ......................         9740    II
                                                                                                                                                                      Constitution Avenue NW., Washington,
                                                                                                        Tapentadol ....................           9780    II
                                             ADDRESSES: Written comments should                                                                                       DC 20210. Instructions: Please submit
                                                                                                        Fentanyl ........................         9801    II
                                             be sent to: Drug Enforcement                                                                                             one copy of your comments by only one


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Document Created: 2016-10-17 23:52:23
Document Modified: 2016-10-17 23:52:23
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 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 December 19, 2016.
FR Citation81 FR 71767 

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