83_FR_56321 83 FR 56103 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals

83 FR 56103 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 218 (November 9, 2018)

Page Range56103-56104
FR Document2018-24485

Federal Register, Volume 83 Issue 218 (Friday, November 9, 2018)
[Federal Register Volume 83, Number 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56103-56104]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24485]


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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 on or before January 8, 2019.

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 redelegated 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 August 
2, 2018, Chattem Chemicals, 3801 Saint Elmo Avenue, Chattanooga, 
Tennessee 37409-1237 applied to be registered as a bulk manufacturer of 
the following basic classes of controlled substances:

 
------------------------------------------------------------------------
      Controlled substance           Drug code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......            2010  I
Marihuana.......................            7360  I
Tetrahydrocannabinols...........            7370  I
4-Methoxyamphetamine............            7411  I
Dihydromorphine.................            9145  I
Amphetamine.....................            1100  II
Methamphetamine.................            1105  II
Lisdexamfetamine................            1205  II
Methylphenidate.................            1724  II
Codeine.........................            9050  II
Dihydrocodeine..................            9120  II
Oxycodone.......................            9143  II
Hydromorphone...................            9150  II
Hydrocodone.....................            9193  II
Levorphanol.....................            9220  II
Methadone.......................            9250  II
Methadone intermediate..........            9254  II
Morphine........................            9300  II
Oripavine.......................            9330  II
Thebaine........................            9333  II
Oxymorphone.....................            9652  II
Noroxymorphone..................            9668  II

[[Page 56104]]

 
Tapentadol......................            9780  II
Fentanyl........................            9801  II
------------------------------------------------------------------------

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

    Dated: October 25, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24485 Filed 11-8-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                       Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices                                                                                   56103

                                                 On March 27, 2012, 3D PDF filed its                                          Company                  FR citation               Published             DATES:  Registered bulk manufacturers of
                                               original notification pursuant to Section                                                                                                               the affected basic classes, and
                                               6(a) of the Act. The Department of                                          Euticals Inc ...         83 FR 39129               August 8,                applicants therefore, may file written
                                               Justice published a notice in the Federal                                                                                        2018.                  comments on or objections to the
                                               Register pursuant to Section 6(b) of the                                                                                                                issuance of the proposed registration on
                                               Act on April 20, 2012 (77 FR 23754).                                           The DEA has considered the factors in                                    or before January 8, 2019.
                                                 The last notification was filed with                                      21 U.S.C. 823(a) and determined that
                                               the Department on August 15, 2018. A                                        the registration of this registrant to                                      ADDRESSES:   Written comments should
                                               notice was published in the Federal                                         manufacture the applicable basic classes                                    be sent to: Drug Enforcement
                                               Register pursuant to Section 6(b) of the                                    of controlled substances is consistent                                      Administration, Attention: DEA Federal
                                               Act on September 4, 2018 (83 FR                                             with the public interest and with United                                    Register Representative/DPW, 8701
                                               44904).                                                                     States obligations under international                                      Morrissette Drive, Springfield, Virginia
                                                                                                                           treaties, conventions, or protocols in                                      22152.
                                               Suzanne Morris,
                                                                                                                           effect on May 1, 1971. The DEA
                                               Chief, Premerger and Division Statistics Unit,                              investigated the company’s maintenance                                      SUPPLEMENTARY INFORMATION:
                                               Antitrust Division.
                                                                                                                           of effective controls against diversion by                                     The Attorney General has delegated
                                               [FR Doc. 2018–24542 Filed 11–8–18; 8:45 am]
                                                                                                                           inspecting and testing the company’s                                        his authority under the Controlled
                                               BILLING CODE 4410–11–P
                                                                                                                           physical security systems, verifying the                                    Substances Act to the Administrator of
                                                                                                                           company’s compliance with state and                                         the Drug Enforcement Administration
                                                                                                                           local laws, and reviewing the company’s                                     (DEA), 28 CFR 0.100(b). Authority to
                                               DEPARTMENT OF JUSTICE
                                                                                                                           background and history.                                                     exercise all necessary functions with
                                               Drug Enforcement Administration                                                Therefore, pursuant to 21 U.S.C.
                                                                                                                                                                                                       respect to the promulgation and
                                                                                                                           823(a), and in accordance with 21 CFR
                                               [Docket No. DEA–392]                                                                                                                                    implementation of 21 CFR part 1301,
                                                                                                                           1301.33, the DEA has granted a
                                                                                                                                                                                                       incident to the registration of
                                                                                                                           registration as a bulk manufacturer to
                                               Bulk Manufacturer of Controlled                                                                                                                         manufacturers, distributors, dispensers,
                                                                                                                           the above listed company.
                                               Substances Registration                                                                                                                                 importers, and exporters of controlled
                                                                                                                             Dated: October 29, 2018.                                                  substances (other than final orders in
                                               ACTION:       Notice of registration.                                       John J. Martin,                                                             connection with suspension, denial, or
                                               SUMMARY:   The registrant listed below                                      Assistant Administrator.                                                    revocation of registration) has been
                                               has applied for and been granted                                            [FR Doc. 2018–24484 Filed 11–8–18; 8:45 am]                                 redelegated to the Assistant
                                               registration by the Drug Enforcement                                        BILLING CODE 4410–09–P                                                      Administrator of the DEA Diversion
                                               Administration (DEA) as a bulk                                                                                                                          Control Division (‘‘Assistant
                                               manufacturer of various classes of                                                                                                                      Administrator’’) pursuant to section 7 of
                                               schedule I and II controlled substances.                                    DEPARTMENT OF JUSTICE                                                       28 CFR part 0, appendix to subpart R.
                                               SUPPLEMENTARY INFORMATION: The                                                                                                                             In accordance with 21 CFR
                                                                                                                           Drug Enforcement Administration
                                               company listed below applied to be                                                                                                                      1301.33(a), this is notice that on August
                                               registered as bulk manufacturer of                                          [Docket No. DEA–392]
                                                                                                                                                                                                       2, 2018, Chattem Chemicals, 3801 Saint
                                               various basic classes of controlled
                                                                                                                           Bulk Manufacturer of Controlled                                             Elmo Avenue, Chattanooga, Tennessee
                                               substances. Information on the
                                                                                                                           Substances Application: Chattem                                             37409–1237 applied to be registered as
                                               previously published notice is listed in
                                               the table below. No comments or                                             Chemicals                                                                   a bulk manufacturer of the following
                                               objections were submitted for this                                                                                                                      basic classes of controlled substances:
                                                                                                                           ACTION:       Notice of application.
                                               notice.



                                                                                                                    Controlled substance                                                                                     Drug code         Schedule

                                               Gamma Hydroxybutyric Acid ...................................................................................................................................                       2010   I
                                               Marihuana ................................................................................................................................................................          7360   I
                                               Tetrahydrocannabinols ............................................................................................................................................                  7370   I
                                               4-Methoxyamphetamine ..........................................................................................................................................                     7411   I
                                               Dihydromorphine .....................................................................................................................................................               9145   I
                                               Amphetamine ..........................................................................................................................................................              1100   II
                                               Methamphetamine ...................................................................................................................................................                 1105   II
                                               Lisdexamfetamine ...................................................................................................................................................                1205   II
                                               Methylphenidate ......................................................................................................................................................              1724   II
                                               Codeine ...................................................................................................................................................................         9050   II
                                               Dihydrocodeine ........................................................................................................................................................             9120   II
                                               Oxycodone ..............................................................................................................................................................            9143   II
                                               Hydromorphone .......................................................................................................................................................               9150   II
                                               Hydrocodone ...........................................................................................................................................................             9193   II
khammond on DSK30JT082PROD with NOTICES




                                               Levorphanol .............................................................................................................................................................           9220   II
                                               Methadone ...............................................................................................................................................................           9250   II
                                               Methadone intermediate ..........................................................................................................................................                   9254   II
                                               Morphine ..................................................................................................................................................................         9300   II
                                               Oripavine .................................................................................................................................................................         9330   II
                                               Thebaine ..................................................................................................................................................................         9333   II
                                               Oxymorphone ..........................................................................................................................................................              9652   II
                                               Noroxymorphone .....................................................................................................................................................                9668   II



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                                               56104                                   Federal Register / Vol. 83, No. 218 / Friday, November 9, 2018 / Notices



                                                                                                                    Controlled substance                                                                                      Drug code         Schedule

                                               Tapentadol ...............................................................................................................................................................           9780   II
                                               Fentanyl ...................................................................................................................................................................         9801   II



                                                  The company plans to manufacture                                         address one or more of the following                                         with each response taking
                                               the listed controlled substances in bulk                                    four points:                                                                 approximately two hours.
                                               for distribution and sale to its                                            —Evaluate whether the proposed                                                 6. An estimate of the total public
                                               customers.                                                                    collection of information is necessary                                     burden (in hours) associated with the
                                                  In reference to drug code 7360                                             for the proper performance of the                                          collection: There are an estimated 20
                                               (marihuana) and 7370                                                          functions of the agency, including                                         annual burden hours associated with
                                               (tetrahydrocannabinols) the company                                           whether the information will have                                          this collection, in total.
                                               plans to bulk manufacture these drugs                                         practical utility;                                                           If additional information is required
                                               as synthetic. No other activities for these                                 —Evaluate the accuracy of the agency’s                                       contact: Melody Braswell, Department
                                               drug codes are authorized for this                                            estimate of the burden of the                                              Clearance Officer, United States
                                               registration.                                                                 proposed collection of information,                                        Department of Justice, Justice
                                                                                                                             including the validity of the                                              Management Division, Policy and
                                                 Dated: October 25, 2018.
                                                                                                                             methodology and assumptions used;                                          Planning Staff, Two Constitution
                                               John J. Martin,
                                                                                                                           —Evaluate whether and if so how the                                          Square, 145 N Street NE, Suite 3E.405B,
                                               Assistant Administrator.                                                                                                                                 Washington, DC 20530.
                                                                                                                             quality, utility, and clarity of the
                                               [FR Doc. 2018–24485 Filed 11–8–18; 8:45 am]
                                                                                                                             information to be collected can be                                           Dated: November 6, 2018.
                                               BILLING CODE 4410–09–P
                                                                                                                             enhanced; and                                                              Melody Braswell,
                                                                                                                           —Minimize the burden of the collection                                       Department Clearance Officer, PRA, U.S.
                                                                                                                             of information on those who are to                                         Department of Justice.
                                               DEPARTMENT OF JUSTICE
                                                                                                                             respond, including through the use of                                      [FR Doc. 2018–24544 Filed 11–8–18; 8:45 am]
                                               [OMB Number 1105–0025]                                                        appropriate automated, electronic,                                         BILLING CODE 4410–12–P
                                                                                                                             mechanical, or other technological
                                               Agency Information Collection                                                 collection techniques or other forms
                                               Activities; Proposed eCollection                                              of information technology, e.g.,                                           DEPARTMENT OF JUSTICE
                                               eComments Requested; Extension                                                permitting electronic submission of
                                               Without Change, of a Previously                                               responses.                                                                 Notice of Lodging of Proposed
                                               Approved Collection; Federal Coal                                                                                                                        Consent Decree Under the Clean Water
                                               Lease Request                                                               Overview of This Information
                                                                                                                                                                                                        Act
                                                                                                                           Collection
                                               AGENCY:   Antitrust Division, Department                                                                                                                    On October 31, 2018, the Department
                                                                                                                              1. Type of Information Collection:
                                               of Justice.                                                                                                                                              of Justice lodged a proposed Consent
                                                                                                                           Extension of a currently approved
                                               ACTION: 30-Day notice.                                                                                                                                   Decree with the United States District
                                                                                                                           collection.
                                                                                                                              2. The Title of the Form/Collection:                                      Court for the Western District of
                                               SUMMARY:   The Department of Justice                                                                                                                     Louisiana in the lawsuit entitled United
                                               (DOJ), Antitrust Division (ATR), will be                                    Federal Coal Lease Reserves.
                                                                                                                              3. The agency form number, if any,                                        States and Louisiana Department of
                                               submitting the following information                                                                                                                     Environmental Quality v. Evangeline
                                               collection request to the Office of                                         and the applicable component of the
                                                                                                                           Department sponsoring the collection:                                        Enterprises LLC, Civil Action No. 17–
                                               Management and Budget (OMB) for                                                                                                                          01340.
                                               review and approval in accordance with                                      The form numbers are ATR–139 and
                                                                                                                           ATR–140. The applicable component                                               In this action, the United States, on
                                               the Paperwork Reduction Act of 1995.                                                                                                                     behalf of the U.S. Environmental
                                                                                                                           within the Department of Justice is the
                                               DATES: Comments are encouraged and                                                                                                                       Protection Agency, together with the
                                                                                                                           Antitrust Division.
                                               will be accepted for 30 days until                                             4. Affected public who will be asked                                      Louisiana Department of Environmental
                                               December 10, 2018.                                                          or required to respond, as well as a brief                                   Quality (‘‘LDEQ’’), sought penalties and
                                               FOR FURTHER INFORMATION CONTACT: If                                         abstract:                                                                    injunctive relief under the Clean Water
                                               you have additional comments                                                   Primary: Business or other for profit.                                    Act and the Louisiana Environmental
                                               especially on the estimated public                                          Other: None. The Department of Justice                                       Quality Act against Evangeline
                                               burden or associated response time,                                         evaluates the competitive impact of                                          Enterprises LLC (‘‘Evangeline’’) for
                                               suggestions, or need a copy of the                                          issuances, transfers and exchanges of                                        continuous unauthorized discharges of
                                               proposed information collection                                             federal coal leases. These forms seek                                        pollutants from Evangeline’s race horse
                                               instrument with instructions or                                             information regarding a prospective coal                                     training facility in Carencro, Louisiana
                                               additional information, please contact                                      lessee’s existing coal reserves. The                                         to waters of the United States and
                                               Jill Ptacek, Attorney, Antitrust Division,                                  Department uses this information to                                          waters of the State of Louisiana. The
                                               United States Department of Justice, 450                                    determine whether the issuance,                                              proposed Consent Decree will resolve
                                               Fifth Street NW, Suite 8000,                                                                                                                             the claims alleged by the United States
khammond on DSK30JT082PROD with NOTICES




                                                                                                                           transfer or exchange of the federal coal
                                               Washington, DC 20530 (phone: 202–                                           lease is consistent with the antitrust                                       and LDEQ and requires Evangeline to
                                               307–6607).                                                                  laws.                                                                        pay $300,000 in civil penalties and
                                               SUPPLEMENTARY INFORMATION: Written                                             5. An estimate of the total number of                                     perform injunctive relief to bring its
                                               comments and suggestions from the                                           respondents and the amount of time                                           facility into compliance with applicable
                                               public and affected agencies concerning                                     estimated for an average respondent to                                       federal and state laws and regulations to
                                               the proposed collection of information                                      respond: It is estimated that 10                                             prevent future discharges to area
                                               are encouraged. Your comments should                                        respondents will complete each form,                                         waterways.


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Document Created: 2018-11-09 03:33:33
Document Modified: 2018-11-09 03:33:33
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 January 8, 2019.
FR Citation83 FR 56103 

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