83_FR_28782 83 FR 28663 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

83 FR 28663 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 119 (June 20, 2018)

Page Range28663-28663
FR Document2018-13224

Federal Register, Volume 83 Issue 119 (Wednesday, June 20, 2018)
[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)]
[Notices]
[Page 28663]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13224]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fisher Clinical 
Services, Inc.

ACTION: Notice of application.

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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 July 20, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before July 20, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 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 1301.34(a), this is notice that on March 
16, 2018, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown, 
Pennsylvania 18106 applied to be registered as an importer of 1-[1-(2-
Thienyl)cyclohexyl]pyrrolidine (7473), a basic class of controlled 
substance listed in schedule I.
    The company plans to import the controlled substance in finished 
dosage form for testing and clinical trials purposes only.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under to 21 U.S.C. 952(a)(2). Authorization will not extend to the 
import of FDA approved or non-approved finished dosage forms for 
commercial sale.

    Dated: June 12, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-13224 Filed 6-19-18; 8:45 am]
BILLING CODE 4410-09-P



                                                                                       Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices                                                                               28663

                                                may also be obtained by accessing its                                     Register Representative/DRW, 8701                                             The company plans to import the
                                                website (http://www.usitc.gov). Persons                                   Morrissette Drive, Springfield, Virginia                                   controlled substance in finished dosage
                                                with mobility impairments who will                                        22152. All requests for hearing must be                                    form for testing and clinical trials
                                                need special assistance in gaining access                                 sent to: Drug Enforcement                                                  purposes only.
                                                to the Commission should contact the                                      Administration, Attn: Administrator,                                          Approval of permit applications will
                                                Office of the Secretary at 202–205–2000.                                  8701 Morrissette Drive, Springfield,                                       occur only when the registrant’s
                                                  Background: All dates and other                                         Virginia 22152. All requests for hearing                                   business activity is consistent with what
                                                information relating to this investigation                                should also be sent to: (1) Drug                                           is authorized under to 21 U.S.C.
                                                remain the same as in the Commission’s                                    Enforcement Administration, Attn:                                          952(a)(2). Authorization will not extend
                                                notice of investigation and public                                        Hearing Clerk/LJ, 8701 Morrissette                                         to the import of FDA approved or non-
                                                hearing issued on May 23, 2018 and                                        Drive, Springfield, Virginia 22152; and                                    approved finished dosage forms for
                                                published in the Federal Register of                                      (2) Drug Enforcement Administration,                                       commercial sale.
                                                May 25, 2018 (83 FR 24342).                                               Attn: DEA Federal Register                                                   Dated: June 12, 2018.
                                                  By order of the Commission.                                             Representative/DRW, 8701 Morrissette                                       John J. Martin,
                                                  Issued: June 14, 2018.                                                  Drive, Springfield, Virginia 22152.
                                                                                                                                                                                                     Assistant Administrator.
                                                Lisa Barton,                                                              SUPPLEMENTARY INFORMATION: The
                                                                                                                                                                                                     [FR Doc. 2018–13224 Filed 6–19–18; 8:45 am]
                                                Secretary to the Commission.                                              Attorney General has delegated his
                                                                                                                                                                                                     BILLING CODE 4410–09–P
                                                [FR Doc. 2018–13176 Filed 6–19–18; 8:45 am]                               authority under the Controlled
                                                BILLING CODE 7020–02–P                                                    Substances Act to the Administrator of
                                                                                                                          the Drug Enforcement Administration                                        DEPARTMENT OF JUSTICE
                                                                                                                          (DEA), 28 CFR 0.100(b). Authority to
                                                DEPARTMENT OF JUSTICE                                                     exercise all necessary functions with                                      Drug Enforcement Administration
                                                                                                                          respect to the promulgation and
                                                Drug Enforcement Administration                                           implementation of 21 CFR part 1301,                                        [Docket No. DEA–392]
                                                                                                                          incident to the registration of
                                                [Docket No. DEA–392]
                                                                                                                          manufacturers, distributors, dispensers,                                   Bulk Manufacturer of Controlled
                                                Importer of Controlled Substances                                         importers, and exporters of controlled                                     Substances Registration
                                                Application: Fisher Clinical Services,                                    substances (other than final orders in
                                                Inc.                                                                      connection with suspension, denial, or                                     ACTION:       Notice of registration.
                                                                                                                          revocation of registration) has been
                                                ACTION:      Notice of application.                                       redelegated to the Assistant                                               SUMMARY:   Registrants listed below have
                                                                                                                          Administrator of the DEA Diversion                                         applied for and been granted
                                                DATES:  Registered bulk manufacturers of                                  Control Division (‘‘Assistant                                              registration by the Drug Enforcement
                                                the affected basic classes, and                                           Administrator’’) pursuant to section 7 of                                  Administration (DEA) as bulk
                                                applicants therefore, may file written                                    28 CFR part 0, appendix to subpart R.                                      manufacturers of various classes of
                                                comments on or objections to the                                             In accordance with 21 CFR                                               schedule I and II controlled substances.
                                                issuance of the proposed registration on                                  1301.34(a), this is notice that on March                                   SUPPLEMENTARY INFORMATION: The
                                                or before July 20, 2018. Such persons                                     16, 2018, Fisher Clinical Services, Inc.,                                  companies listed below applied to be
                                                may also file a written request for a                                     7554 Schantz Road, Allentown,                                              registered as bulk manufacturers of
                                                hearing on the application on or before                                   Pennsylvania 18106 applied to be                                           various basic classes of controlled
                                                July 20, 2018.                                                            registered as an importer of 1-[1-(2-                                      substances. Information on previously
                                                ADDRESSES: Written comments should                                        Thienyl)cyclohexyl]pyrrolidine (7473),                                     published notices is listed in the table
                                                be sent to: Drug Enforcement                                              a basic class of controlled substance                                      below. No comments or objections were
                                                Administration, Attention: DEA Federal                                    listed in schedule I.                                                      submitted for these notices.

                                                                                                                        Company                                                                                      FR Docket         Published

                                                AMRI Rensselaer, Inc ....................................................................................................................................            83 FR 5808   February 9, 2018.
                                                Stepan Company ...........................................................................................................................................           83 FR 9029   March 2, 2018.
                                                Research Triangle Institute ............................................................................................................................            83 FR 10523   March 9, 2018.
                                                Rhodes Technologies ....................................................................................................................................            83 FR 12407   March 21, 2018.
                                                Synthcon, LLC ...............................................................................................................................................       83 FR 13141   March 27, 2018.
                                                National Center for Natural Products—Research NIDA MPROJECT ..........................................................                                              83 FR 13522   March 29, 2018.
                                                Insys Manufacturing LLC ...............................................................................................................................             83 FR 13522   March 29, 2018.
                                                Navinta LLC ...................................................................................................................................................     83 FR 13521   March 29, 2018.



                                                   The DEA has considered the factors in                                  against diversion by inspecting and                                          Dated: June 12, 2018.
                                                21 U.S.C. 823(a) and determined that                                      testing each company’s physical                                            John J. Martin,
                                                the registration of these registrants to                                  security systems, verifying each                                           Assistant Administrator.
                                                manufacture the applicable basic classes                                  company’s compliance with state and                                        [FR Doc. 2018–13223 Filed 6–19–18; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES




                                                of controlled substances is consistent                                    local laws, and reviewing each                                             BILLING CODE 4410–09–P
                                                with the public interest and with United                                  company’s background and history.
                                                States obligations under international                                      Therefore, pursuant to 21 U.S.C.
                                                treaties, conventions, or protocols in                                    823(a), and in accordance with 21 CFR
                                                effect on May 1, 1971. The DEA                                            1301.33, the DEA has granted a
                                                investigated each of the company’s                                        registration as a bulk manufacturer to
                                                maintenance of effective controls                                         the above listed companies.


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Document Created: 2018-06-20 00:20:24
Document Modified: 2018-06-20 00:20:24
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 July 20, 2018. Such persons may also file a written request for a hearing on the application on or before July 20, 2018.
FR Citation83 FR 28663 

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