80 FR 63835 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 203 (October 21, 2015)

Page Range		63835-63835
FR Document		2015-26682

Federal Register, Volume 80 Issue 203 (Wednesday, October 21, 2015)

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Page 63835]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26682]



[[Page 63835]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Chattem 
Chemicals, 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 21, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 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 22, 2015, Chattem Chemicals, 
Inc., 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.

    Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-26682 Filed 10-20-15; 8:45 am]
BILLING CODE 4410-09-P

Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63835

DEPARTMENT OF JUSTICE Controlled substance Schedule respect to the promulgation and
implementation of 21 CFR part 1301,
Drug Enforcement Administration Hydromorphone (9150) ................ II incident to the registration of
Hydrocodone (9193) ..................... II manufacturers, distributors, dispensers,
[Docket No. DEA–392] Meperidine (9230) ........................ II importers, and exporters of controlled
Meperidine intermediate-A (9232) II substances (other than final orders in
Bulk Manufacturer of Controlled Meperidine intermediate-B (9233) II
Substances Application: Chattem Meperidine intermediate-C (9234) II
connection with suspension, denial, or
Chemicals, Inc. Methadone (9250) ........................ II revocation of registration) has been
Methadone intermediate (9254) ... II redelegated to the Deputy Assistant
ACTION: Notice of application. Morphine (9300) ........................... II Administrator of the DEA Office of
Oripavine (9330) ........................... II Diversion Control (‘‘Deputy Assistant
DATES: Registered bulk manufacturers of Thebaine (9333) ........................... II Administrator’’) pursuant to section 7 of
the affected basic classes, and Opium tincture (9630) .................. II 28 CFR part 0, appendix to subpart R.
applicants therefore, may file written Opium, powdered (9639) ............. II
comments on or objections to the Opium, granulated (9640) ............ II
In accordance with 21 CFR
issuance of the proposed registration in Oxymorphone (9652) ................... II 1301.33(a), this is notice that on March
accordance with 21 CFR 1301.33(a) on Noroxymorphone (9668) .............. II 17, 2015, Cody Laboratories, Inc., Steve
or before December 21, 2015. Alfentanil (9737) ........................... II Hartman—Vice President of
Remifentanil (9739) ...................... II Compliance, 601 Yellowstone Avenue,
ADDRESSES: Written comments should Sufentanil (9740) .......................... II Cody, Wyoming applied to be registered
be sent to: Drug Enforcement Tapentadol (9780) ........................ II as a bulk manufacturer of methadone
Administration, Attention: DEA Federal Fentanyl (9801) ............................ II intermediate (9254), a basic class of
Register Representative/ODXL, 8701 controlled substance listed in schedule
Morrissette Drive, Springfield, Virginia The company plans to manufacture II.
22152. Request for hearings should be the listed controlled substances in bulk The company plans to manufacture
sent to: Drug Enforcement for distribution and sale to its the listed controlled substance as an
Administration, Attention: Hearing customers. intermediate in the manufacture of an
Clerk/LJ, 8701 Morrissette Drive, Dated: October 13, 2015. active pharmaceutical ingredient to sell
Springfield, Virginia 22152. Louis J. Milione, to its customers.
SUPPLEMENTARY INFORMATION: The
Deputy Assistant Administrator. Dated: October 13, 2015.
Attorney General has delegated her
[FR Doc. 2015–26682 Filed 10–20–15; 8:45 am] Louis J. Milione,
authority under the Controlled
BILLING CODE 4410–09–P Deputy Assistant Administrator.
Substances Act to the Administrator of
the Drug Enforcement Administration [FR Doc. 2015–26670 Filed 10–20–15; 8:45 am]
(DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P
exercise all necessary functions with
respect to the promulgation and Drug Enforcement Administration
implementation of 21 CFR part 1301, DEPARTMENT OF JUSTICE
incident to the registration of [Docket No. DEA–392]
manufacturers, distributors, dispensers, Drug Enforcement Administration
Bulk Manufacturer of Controlled
importers, and exporters of controlled
Substances Application: Cody [Docket No. DEA–392]
substances (other than final orders in
Laboratories, Inc.
connection with suspension, denial, or Bulk Manufacturer of Controlled
revocation of registration) has been ACTION: Notice of application. Substances Application: Cambrex
redelegated to the Deputy Assistant Charles City
Administrator of the DEA Office of DATES: Registered bulk manufacturers of
Diversion Control (‘‘Deputy Assistant the affected basic class, and applicants ACTION: Notice of application.
Administrator’’) pursuant to section 7 of therefore, may file written comments on
28 CFR part 0, appendix to subpart R. or objections to the issuance of the DATES: Registered bulk manufacturers of
In accordance with 21 CFR 1301.33(a), proposed registration in accordance the affected basic classes, and
this is notice that on July 22, 2015, with 21 CFR 1301.33(a) on or before applicants therefore, may file written
Chattem Chemicals, Inc., 3801 St Elmo December 21, 2015. comments on or objections to the
Avenue, Chattanooga, Tennessee 37409 ADDRESSES: Written comments should issuance of the proposed registration in
applied to be registered as a bulk be sent to: Drug Enforcement accordance with 21 CFR 1301.33(a) on
manufacturer of the following basic Administration, Attention: DEA Federal or before December 21, 2015.
classes of controlled substances: Register Representative/ODXL, 8701 ADDRESSES: Written comments should
Morrissette Drive, Springfield, Virginia be sent to: Drug Enforcement
Controlled substance Schedule 22152. Request for hearings should be Administration, Attention: DEA Federal
Gamma Hydroxybutyric Acid I
sent to: Drug Enforcement Register Representative/ODXL, 8701
(2010). Administration, Attention: Hearing Morrissette Drive, Springfield, Virginia
4-Methoxyamphetamine (7411) ... I Clerk/LJ, 8701 Morrissette Drive, 22152. Request for hearings should be
Dihydromorphine (9145) ............... I Springfield, Virginia 22152. sent to: Drug Enforcement
tkelley on DSK3SPTVN1PROD with NOTICES

Amphetamine (1100) .................... II SUPPLEMENTARY INFORMATION: The Administration, Attention: Hearing
Methamphetamine (1105) ............ II Attorney General has delegated her Clerk/LJ, 8701 Morrissette Drive,
Lisdexamfetamine (1205) ............. II authority under the Controlled
Methylphenidate (1724) ................ II
Springfield, Virginia 22152. Comments
Pentobarbital (2270) ..................... II Substances Act to the Administrator of and requests for hearings on
Codeine (9050) ............................. II the Drug Enforcement Administration applications to import raw material are
Dihydrocodeine (9120) ................. II (DEA), 28 CFR 0.100(b). Authority to not appropriate. 72 FR 3417 (January 25,
Oxycodone (9143) ........................ II exercise all necessary functions with 2007).

VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1

Document Created: 2018-02-27 08:54:03
Document Modified: 2018-02-27 08:54:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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 21, 2015.
FR Citation		80 FR 63835

80 FR 63835 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 203 (October 21, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration