83_FR_13580 83 FR 13519 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.

83 FR 13519 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

Page Range13519-13519
FR Document2018-06327

The Drug Enforcement Administration (DEA) published a document in the Federal Register on February 6, 2018, concerning a notice of application that inadvertently did not include the controlled substance levorphanol (9220).

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018)
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13519]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06327]


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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; Correction.

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

SUMMARY: The Drug Enforcement Administration (DEA) published a document 
in the Federal Register on February 6, 2018, concerning a notice of 
application that inadvertently did not include the controlled substance 
levorphanol (9220).

Correction

    In the Federal Register on February 6, 2018, in FR Doc No: 2018-
02343 (83 FR 5274), correct the table to include the following basic 
class of controlled substance:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Levorphanol..........................        9220  II
------------------------------------------------------------------------


    Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06327 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                             Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices                                                      13519

                                                patent the Commission determined to                     imported by or on behalf of                           document in the Federal Register on
                                                review (1) the ID’s finding that a                      Respondents or any of their affiliated                February 6, 2018, concerning a notice of
                                                combination of prior art references                     companies, parents, subsidiaries, agents,             application that inadvertently did not
                                                Doppelt, Jacobs, and Gilbert fail to                    or other related business entities, or                include the controlled substance
                                                render the asserted claims obvious; and                 their successors or assigns, are excluded             levorphanol (9220).
                                                (2) the ID’s finding that a combination                 from entry for consumption into the                   Correction
                                                of prior art references Matsuoka,                       United States, entry for consumption
                                                Doppelt, and Eckel fail to render the                   from a foreign-trade zone, or withdrawal                In the Federal Register on February 6,
                                                asserted claims obvious. For the ’336                   from a warehouse for consumption, for                 2018, in FR Doc No: 2018–02343 (83 FR
                                                patent the Commission determined to                     the remaining term of the ’319 patent                 5274), correct the table to include the
                                                review (1) the ID’s finding that claim 34               except under license of the patent                    following basic class of controlled
                                                recites ineligible patent subject matter                owner or as provided by law; and (2)                  substance:
                                                under 35 U.S.C. 101; and (2) the ID’s                   cease and desist orders prohibiting TTi
                                                finding that Pruessel, either alone or in                                                                           Controlled
                                                                                                        HK, TTi NA, One World, and OWT from                         substance            Drug code   Schedule
                                                combination with Koestler, fails to                     conducting any of the following
                                                render claim 34 obvious. The                            activities in the United States:                      Levorphanol ............        9220   II
                                                Commission requested the parties to                     Importing, selling, marketing,
                                                brief certain issues. Id. On January 5,                 advertising, distributing, transferring                 Dated: March 15, 2018.
                                                2018, the parties filed submissions to                  (except for exportation), and soliciting
                                                the Commission’s question and on                                                                              Susan A. Gibson,
                                                                                                        U.S. agents or distributors for, access
                                                remedy, the public interest, and                                                                              Deputy Assistant Administrator.
                                                                                                        control systems and components thereof
                                                bonding. See Complainant’s Response to                                                                        [FR Doc. 2018–06327 Filed 3–28–18; 8:45 am]
                                                                                                        covered by one or more of claims 1–4,
                                                Request for Written Submissions                         7–12, 15, and 16 of the ’319 patent.                  BILLING CODE 4410–09–P
                                                Regarding Issues Under Review;                             The Commission has also determined
                                                Respondents’ Response to Request for                    that the public interest factors
                                                Written Submissions Regarding Issues                    enumerated in section 337(d) and (f) (19              DEPARTMENT OF JUSTICE
                                                Under Review. On January 12, 2018, the                  U.S.C. 1337(d) and (f)) do not preclude               Drug Enforcement Administration
                                                parties filed reply submissions. See                    issuance of the limited exclusion order
                                                Complainant’s Reply to Respondents’                     or cease and desist orders. Finally, the              [Docket No. DEA–392]
                                                Submission Addressing the                               Commission has determined that a bond
                                                Commission’s December 22, 2017                          in the amount of zero is required to                  Importer of Controlled Substances
                                                Notice; Respondents’ Reply to                           permit temporary importation during                   Application: Fisher Clinical Services,
                                                Complainant’s Submission Regarding                                                                            Inc.
                                                                                                        the period of Presidential review (19
                                                Issues Under Review.                                    U.S.C. 1337(j)) of access control system
                                                   Having examined the record of this                                                                         ACTION:   Notice of application.
                                                                                                        and components thereof that are subject
                                                investigation, including the final ID, and              to the remedial orders. The                           DATES:  Registered bulk manufacturers of
                                                the parties’ submissions, for the ’319                  Commission’s orders and opinion were                  the affected basic classes and applicants
                                                patent the Commission has determined                    delivered to the President and to the                 therefore, may file written comments on
                                                to (1) affirm the ALJ’s finding that a                  United States Trade Representative on                 or objections to the issuance of the
                                                combination of prior art references                     the day of their issuance.                            proposed registration on or before April
                                                Doppelt, Jacobs, and Gilbert fail to                       The authority for the Commission’s                 30, 2018. Such persons may also file a
                                                render the asserted claims obvious and                  determination is contained in section                 written request for a hearing on the
                                                (2) affirm the ALJ’s finding that a                     337 of the Tariff Act of 1930, as                     application on or before April 30, 2018.
                                                combination of prior art references                     amended (19 U.S.C. 1337), and in Part
                                                Matsuoka, Doppelt, and Eckel fail to                                                                          ADDRESSES: Written comments should
                                                                                                        210 of the Commission’s Rules of                      be sent to: Drug Enforcement
                                                render the asserted claims obvious, but                 Practice and Procedure (19 CFR part
                                                reverse the ALJ’s finding that Eckel is                                                                       Administration, Attention: DEA Federal
                                                                                                        210).                                                 Register Representative/DRW, 8701
                                                analogous art. For the ’336 patent the
                                                Commission has determined to (1)                          By order of the Commission.                         Morrissette Drive, Springfield, Virginia
                                                affirm the ALJ’s finding that Pruessel,                   Issued: March 23, 2018.                             22152. All requests for hearing must be
                                                either alone or in combination with                     Katherine Hiner,                                      sent to: Drug Enforcement
                                                Koestler, fails to render claim 34                      Supervisory Attorney.                                 Administration, Attn: Administrator,
                                                obvious and (2) take no position on the                 [FR Doc. 2018–06293 Filed 3–28–18; 8:45 am]
                                                                                                                                                              8701 Morrissette Drive, Springfield,
                                                ALJ’s finding that claim 34 recites                                                                           Virginia 22152. All requests for hearing
                                                                                                        BILLING CODE 7020–02–P
                                                ineligible patent subject matter under 35                                                                     should also be sent to: (1) Drug
                                                U.S.C. 101. The Commission adopts the                                                                         Enforcement Administration, Attn:
                                                ID’s findings to the extent they are not                                                                      Hearing Clerk/LJ, 8701 Morrissette
                                                                                                        DEPARTMENT OF JUSTICE                                 Drive, Springfield, Virginia 22152; and
                                                inconsistent with the Commission
                                                opinion issued herewith.                                Drug Enforcement Administration                       (2) Drug Enforcement Administration,
                                                   Having found a violation of section                                                                        Attn: DEA Federal Register
                                                337 in this investigation, the                          [Docket No. DEA–392]                                  Representative/DRW, 8701 Morrissette
                                                                                                                                                              Drive, Springfield, Virginia 22152.
sradovich on DSK3GMQ082PROD with NOTICES




                                                Commission has determined that the
                                                appropriate form of relief is: (1) A                    Bulk Manufacturer of Controlled
                                                                                                                                                              SUPPLEMENTARY INFORMATION:
                                                limited exclusion order prohibiting the                 Substances Application: Chattem                         The Attorney General has delegated
                                                unlicensed entry of access control                      Chemicals, Inc.                                       his authority under the Controlled
                                                systems and components thereof that                     ACTION:   Notice; Correction.                         Substances Act to the Administrator of
                                                infringe one or more of claims 1–4, 7–                                                                        the Drug Enforcement Administration
                                                12, 15, and 16 of the ’319 patent that are              SUMMARY: The Drug Enforcement                         (DEA), 28 CFR 0.100(b). Authority to
                                                manufactured by, or on behalf of, or are                Administration (DEA) published a                      exercise all necessary functions with


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Document Created: 2018-03-29 00:25:21
Document Modified: 2018-03-29 00:25:21
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; Correction.
FR Citation83 FR 13519 

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