81_FR_58096 81 FR 57932 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals

81 FR 57932 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range57932-57932
FR Document2016-20241

Federal Register, Volume 81 Issue 164 (Wednesday, August 24, 2016)
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Page 57932]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20241]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Chattem 
Chemicals

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 October 24, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated her authority under the 
Controlled Substances Act to the Administrator of the Drug Enforcement 
Administration (DEA), 28 CFR 0.100(b). Authority to exercise all 
necessary functions with respect to the promulgation and implementation 
of 21 CFR part 1301, incident to the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances (other than final orders in connection with suspension, 
denial, or revocation of registration) has been redelegated to the 
Deputy Assistant Administrator of the DEA Office of Diversion Control 
(``Deputy Assistant Administrator'') pursuant to section 7 of 28 CFR 
part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on July 
27, 2016, Chattem Chemicals, 3801 St. Elmo Avenue, Chattanooga, 
Tennessee 37409 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
4-Methoxyamphetamine (7411)................  I
Dihydromorphine (9145).....................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Pentobarbital (2270).......................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Meperidine intermediate-A (9232)...........  II
Meperidine intermediate-B (9233)...........  II
Meperidine intermediate-C (9234)...........  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium tincture (9630)......................  II
Opium, powdered (9639).....................  II
Opium, granulated (9640)...................  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 distribution and sale to its customers.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-20241 Filed 8-23-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                  57932                      Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices

                                                  investigation are or will be available for              210 of the Commission’s Rules of                               Controlled substance                   Schedule
                                                  inspection during official business                     Practice and Procedure, 19 CFR part
                                                  hours (8:45 a.m. to 5:15 p.m.) in the                   210.                                                  Dihydromorphine (9145) ...............          I
                                                  Office of the Secretary, U.S.                                                                                 Amphetamine (1100) ....................         II
                                                                                                            By order of the Commission.
                                                  International Trade Commission, 500 E                                                                         Methamphetamine (1105) ............             II
                                                                                                            Issued: August 18, 2016.                            Lisdexamfetamine (1205) .............           II
                                                  Street SW., Washington, DC 20436,                       Lisa R. Barton,                                       Methylphenidate (1724) ................         II
                                                  telephone (202) 205–2000. General                       Secretary to the Commission.                          Pentobarbital (2270) .....................      II
                                                  information concerning the Commission                                                                         Codeine (9050) .............................    II
                                                                                                          [FR Doc. 2016–20200 Filed 8–23–16; 8:45 am]
                                                  may also be obtained by accessing its                                                                         Dihydrocodeine (9120) .................         II
                                                                                                          BILLING CODE 7020–02–P
                                                  Internet server at https://www.usitc.gov.                                                                     Oxycodone (9143) ........................       II
                                                  The public record for this investigation                                                                      Hydromorphone (9150) ................           II
                                                  may be viewed on the Commission’s                                                                             Hydrocodone (9193) .....................        II
                                                  electronic docket (EDIS) at https://                    DEPARTMENT OF JUSTICE                                 Meperidine (9230) ........................      II
                                                  edis.usitc.gov. Hearing-impaired                                                                              Meperidine intermediate–A (9232)                II
                                                                                                          Drug Enforcement Administration                       Meperidine intermediate–B (9233)                II
                                                  persons are advised that information on                                                                       Meperidine intermediate–C (9234)                II
                                                  this matter can be obtained by                          [Docket No. DEA–392]                                  Methadone (9250) ........................       II
                                                  contacting the Commission’s TDD                                                                               Methadone intermediate (9254) ...               II
                                                  terminal on (202) 205–1810.                             Bulk Manufacturer of Controlled                       Morphine (9300) ...........................     II
                                                                                                          Substances Application: Chattem                       Oripavine (9330) ...........................    II
                                                  SUPPLEMENTARY INFORMATION: The
                                                                                                          Chemicals                                             Thebaine (9333) ...........................     II
                                                  Commission instituted this investigation
                                                  on June 24, 2016, based on a complaint                                                                        Opium tincture (9630) ..................        II
                                                                                                          ACTION:   Notice of application.                      Opium, powdered (9639) .............            II
                                                  filed by Intex Recreation Corp. of Long                                                                       Opium, granulated (9640) ............           II
                                                  Beach, California; and Intex Marketing                  DATES:  Registered bulk manufacturers of              Oxymorphone (9652) ...................          II
                                                  Ltd. of Tortola, British Virgin Islands                 the affected basic classes, and                       Noroxymorphone (9668) ..............            II
                                                  (together, ‘‘Intex’’). 81 FR 41346–47. The              applicants therefore, may file written                Alfentanil (9737) ...........................   II
                                                  complaint alleges that respondents                      comments on or objections to the                      Remifentanil (9739) ......................      II
                                                  Bestway (USA), Inc., of Phoenix,                        issuance of the proposed registration in              Sufentanil (9740) ..........................    II
                                                  Arizona; Bestway Global Holdings, Inc.                  accordance with 21 CFR 1301.33(a) on                  Tapentadol (9780) ........................      II
                                                  of Shanghai, China; Bestway (Hong                                                                             Fentanyl (9801) ............................    II
                                                                                                          or before October 24, 2016.
                                                  Kong) International Ltd. of Hong Kong;                  ADDRESSES: Written comments should
                                                  Bestway Inflatables & Materials                                                                                 The company plans to manufacture
                                                                                                          be sent to: Drug Enforcement                          the listed controlled substances in bulk
                                                  Corporation of Shanghai, China; and                     Administration, Attention: DEA Federal
                                                  Bestway (Nantong) Recreation Corp. of                                                                         for distribution and sale to its
                                                                                                          Register Representative/ODW, 8701                     customers.
                                                  Nantong, China (together, ‘‘Bestway’’),                 Morrissette Drive, Springfield, Virginia
                                                  are in violation of section 337 of the                  22152.                                                Louis J. Milione,
                                                  Tariff Act of 1930, as amended, 19                                                                            Deputy Assistant Administrator.
                                                  U.S.C. 1337, by reason of infringement                  SUPPLEMENTARY INFORMATION:
                                                                                                            The Attorney General has delegated                  [FR Doc. 2016–20241 Filed 8–23–16; 8:45 am]
                                                  of certain claims of U.S. Patent Nos.
                                                  8,562,773 and 9,156,203. Id. The Office                 her authority under the Controlled                    BILLING CODE 4410–09–P

                                                  of Unfair Import Investigations (‘‘OUII’’)              Substances Act to the Administrator of
                                                  is a party to the investigation. Id. at                 the Drug Enforcement Administration
                                                                                                          (DEA), 28 CFR 0.100(b). Authority to                  DEPARTMENT OF JUSTICE
                                                  41347.
                                                     On July 14, 2016, Bestway filed a                    exercise all necessary functions with                 Drug Enforcement Administration
                                                  motion to terminate the investigation                   respect to the promulgation and
                                                                                                          implementation of 21 CFR part 1301,                   [Docket No. DEA–392]
                                                  based upon a consent order stipulation
                                                  and proposed consent order. That same                   incident to the registration of
                                                                                                          manufacturers, distributors, dispensers,              Importer of Controlled Substances
                                                  day, OUII filed a response arguing that                                                                       Application: Noramco, Inc.
                                                  the motion should be granted because it                 importers, and exporters of controlled
                                                  complies with the Commission Rules for                  substances (other than final orders in                ACTION:    Notice of application.
                                                  consent orders and termination serves                   connection with suspension, denial, or
                                                  the public interest. Intex did not                      revocation of registration) has been                  DATES:  Registered bulk manufacturers of
                                                  respond to the motion.                                  redelegated to the Deputy Assistant                   the affected basic classes, and
                                                     On July 25, 2016, the ALJ granted the                Administrator of the DEA Office of                    applicants therefore, may file written
                                                  motion in the subject ID. She found that                Diversion Control (‘‘Deputy Assistant                 comments on or objections to the
                                                  the motion for termination by consent                   Administrator’’) pursuant to section 7 of             issuance of the proposed registration in
                                                  order stipulation complies with the                     28 CFR part 0, appendix to subpart R.                 accordance with 21 CFR 1301.34(a) on
                                                                                                            In accordance with 21 CFR                           or before September 23, 2016. Such
                                                  requirements of Commission Rule
                                                                                                          1301.33(a), this is notice that on July 27,           persons may also file a written request
                                                  210.21(c) and is in the public interest.
                                                                                                          2016, Chattem Chemicals, 3801 St. Elmo                for a hearing on the application
                                                  No petitions for review of the ID were
                                                                                                          Avenue, Chattanooga, Tennessee 37409                  pursuant to 21 CFR 1301.43 on or before
                                                  received.
                                                                                                          applied to be registered as a bulk                    September 23, 2016.
                                                     The Commission has determined not
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                          manufacturer of the following basic                   ADDRESSES: Written comments should
                                                  to review the subject ID and to issue a
                                                                                                          classes of controlled substances:                     be sent to: Drug Enforcement
                                                  consent order. The investigation is
                                                  terminated in its entirety.                                                                                   Administration, Attention: DEA Federal
                                                                                                                 Controlled substance               Schedule
                                                     The authority for the Commission’s                                                                         Register Representative/ODW, 8701
                                                  determination is contained in section                   Gamma     Hydroxybutyric  Acid            I           Morrissette Drive, Springfield, Virginia
                                                  337 of the Tariff Act of 1930, as                         (2010).                                             22152. All requests for hearing must be
                                                  amended, 19 U.S.C. 1337, and in Part                    4-Methoxyamphetamine (7411) ...           I           sent to: Drug Enforcement


                                             VerDate Sep<11>2014   20:16 Aug 23, 2016   Jkt 238001   PO 00000   Frm 00056   Fmt 4703   Sfmt 4703   E:\FR\FM\24AUN1.SGM   24AUN1



Document Created: 2016-08-24 03:02:14
Document Modified: 2016-08-24 03:02:14
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 October 24, 2016.
FR Citation81 FR 57932 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR