82_FR_43751 82 FR 43572 - Importer of Controlled Substances Application: Sharp Clinical Services, Inc.

82 FR 43572 - Importer of Controlled Substances Application: Sharp Clinical Services, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 179 (September 18, 2017)

Page Range43572-43572
FR Document2017-19836

Federal Register, Volume 82 Issue 179 (Monday, September 18, 2017)
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Page 43572]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19836]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sharp Clinical 
Services, 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 on or before October 18, 2017. 
Such persons may also file a written request for a hearing on the 
application on or before October 18, 2017.

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 August 
23, 2017, Sharp Clinical Services, Inc., 300 Kimberton Road, 
Phoenixville, Pennsylvania 19460 applied to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana...............................    7360  I
3,4-Methylenedioxymetham-phetamine......    7405  I
Psilocybin..............................    7437  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
analytical research, testing, and clinical trials. No other activity 
for these drug codes is authorized for this registration. Approval of 
permit applications will occur only when the registrant's business 
activity is consistent with what is authorized under 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: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19836 Filed 9-15-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                43572                     Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices

                                                for a hearing on the application                        DEPARTMENT OF JUSTICE                                        Controlled substance                    Drug       Schedule
                                                pursuant to 21 CFR 1301.43 on or before                                                                                                                      code
                                                October 18, 2017.                                       Drug Enforcement Administration                       Marihuana ................................     7360   I
                                                                                                                                                              3,4-Methylenedioxymetham-                      7405   I
                                                ADDRESSES:   Written comments should                                                                            phetamine.
                                                                                                        [Docket No. DEA–392]
                                                be sent to: Drug Enforcement                                                                                  Psilocybin .................................   7437   I
                                                Administration, Attention: DEA Federal                  Importer of Controlled Substances
                                                Register Representative/DRW, 8701                       Application: Sharp Clinical Services,                    The company plans to import the
                                                Morrissette Drive, Springfield, Virginia                Inc.                                                  listed controlled substances for
                                                22152. All requests for hearing must be                                                                       analytical research, testing, and clinical
                                                sent to: Drug Enforcement                               ACTION:   Notice of application.                      trials. No other activity for these drug
                                                Administration, Attn: Administrator,                                                                          codes is authorized for this registration.
                                                8701 Morrissette Drive, Springfield,                                                                          Approval of permit applications will
                                                                                                        DATES:  Registered bulk manufacturers of
                                                Virginia 22152. All requests for hearing                                                                      occur only when the registrant’s
                                                                                                        the affected basic classes, and
                                                should also be sent to: (1) Drug                                                                              business activity is consistent with what
                                                                                                        applicants therefore, may file written
                                                Enforcement Administration, Attn:                                                                             is authorized under 21 U.S.C. 952(a)(2).
                                                                                                        comments on or objections to the
                                                Hearing Clerk/LJ, 8701 Morrissette                                                                            Authorization will not extend to the
                                                                                                        issuance of the proposed registration on
                                                                                                                                                              import of FDA approved or non-
                                                Drive, Springfield, Virginia 22152; and                 or before October 18, 2017. Such
                                                                                                                                                              approved finished dosage forms for
                                                (2) Drug Enforcement Administration,                    persons may also file a written request
                                                                                                                                                              commercial sale.
                                                Attn: DEA Federal Register                              for a hearing on the application on or
                                                Representative/DRW, 8701 Morrissette                    before October 18, 2017.                                Dated: September 11, 2017.
                                                Drive, Springfield, Virginia 22152.                                                                           Demetra Ashley,
                                                                                                        ADDRESSES:   Written comments should
                                                                                                        be sent to: Drug Enforcement                          Acting Assistant Administrator.
                                                SUPPLEMENTARY INFORMATION:      The
                                                                                                        Administration, Attention: DEA Federal                [FR Doc. 2017–19836 Filed 9–15–17; 8:45 am]
                                                Attorney General has delegated his
                                                authority under the Controlled                          Register Representative/DRW, 8701                     BILLING CODE 4410–09–P

                                                Substances Act to the Administrator of                  Morrissette Drive, Springfield, Virginia
                                                the Drug Enforcement Administration                     22152. All requests for hearing must be
                                                                                                        sent to: Drug Enforcement                             DEPARTMENT OF JUSTICE
                                                (DEA), 28 CFR 0.100(b). Authority to
                                                                                                        Administration, Attn: Administrator,                  Drug Enforcement Administration
                                                exercise all necessary functions with
                                                                                                        8701 Morrissette Drive, Springfield,
                                                respect to the promulgation and
                                                                                                        Virginia 22152. All requests for hearing
                                                implementation of 21 CFR part 1301,                     should also be sent to: (1) Drug                      [Docket No. DEA–392]
                                                incident to the registration of                         Enforcement Administration, Attn:
                                                manufacturers, distributors, dispensers,                                                                      Importer of Controlled Substances
                                                                                                        Hearing Clerk/LJ, 8701 Morrissette
                                                importers, and exporters of controlled                                                                        Application: Mylan Pharmaceuticals,
                                                                                                        Drive, Springfield, Virginia 22152; and
                                                substances (other than final orders in                                                                        Inc.
                                                                                                        (2) Drug Enforcement Administration,
                                                connection with suspension, denial, or                  Attn: DEA Federal Register                            ACTION:       Notice of application.
                                                revocation of registration) has been                    Representative/DRW, 8701 Morrissette
                                                redelegated to the Assistant                            Drive, Springfield, Virginia 22152.                   DATES:  Registered bulk manufacturers of
                                                Administrator of the DEA Diversion
                                                                                                        SUPPLEMENTARY INFORMATION:      The                   the affected basic classes, and
                                                Control Division (‘‘Assistant                                                                                 applicants therefore, may file written
                                                                                                        Attorney General has delegated his
                                                Administrator’’) pursuant to section 7 of                                                                     comments on or objections to the
                                                                                                        authority under the Controlled
                                                28 CFR part 0, appendix to subpart R.                   Substances Act to the Administrator of                issuance of the proposed registration in
                                                   In accordance with 21 CFR                            the Drug Enforcement Administration                   accordance with 21 CFR 1301.34(a) on
                                                1301.34(a), this is notice that on April                (DEA), 28 CFR 0.100(b). Authority to                  or before October 18, 2017. Such
                                                19, 2017, Unither Manufacturing LLC,                    exercise all necessary functions with                 persons may also file a written request
                                                331 Clay Road, Rochester, New York                      respect to the promulgation and                       for a hearing on the application
                                                14623 applied to be registered as an                    implementation of 21 CFR part 1301,                   pursuant to 21 CFR 1301.43 on or before
                                                importer of methylphenidate (1724), a                   incident to the registration of                       October 18, 2017.
                                                basic class of controlled substance listed              manufacturers, distributors, dispensers,              ADDRESSES: Written comments should
                                                in schedule II.                                         importers, and exporters of controlled                be sent to: Drug Enforcement
                                                                                                        substances (other than final orders in                Administration, Attention: DEA Federal
                                                   The company plans to import the
                                                                                                        connection with suspension, denial, or                Register Representative/DRW, 8701
                                                listed substance solely for updated                     revocation of registration) has been
                                                analytical testing purposes for EU                                                                            Morrissette Drive, Springfield, Virginia
                                                                                                        redelegated to the Assistant                          22152. All requests for hearing must be
                                                customer requirements. This analysis is                 Administrator of the DEA Diversion                    sent to: Drug Enforcement
                                                required to allow the company to export                 Control Division (‘‘Assistant                         Administration, Attn: Administrator,
                                                domestically-manufactured FDF to                        Administrator’’) pursuant to section 7 of             8701 Morrissette Drive, Springfield,
                                                foreign markets.                                        28 CFR part 0, appendix to subpart R.                 Virginia 22152. All request for hearing
                                                  Dated: September 11, 2017.                              In accordance with 21 CFR                           should also be sent to: (1) Drug
sradovich on DSKBBY8HB2PROD with NOTICES




                                                Demetra Ashley,                                         1301.34(a), this is notice that on August             Enforcement Administration, Attn:
                                                Acting Assistant Administrator.                         23, 2017, Sharp Clinical Services, Inc.,              Hearing Clerk/LJ, 8701 Morrissette
                                                [FR Doc. 2017–19830 Filed 9–15–17; 8:45 am]
                                                                                                        300 Kimberton Road, Phoenixville,                     Drive, Springfield, Virginia 22152; and
                                                                                                        Pennsylvania 19460 applied to be                      (2) Drug Enforcement Administration,
                                                BILLING CODE 4410–09–P
                                                                                                        registered as an importer of the                      Attn: DEA Federal Register
                                                                                                        following basic classes of controlled                 Representative/DRW, 8701 Morrissette
                                                                                                        substances:                                           Drive, Springfield, Virginia 22152.


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Document Created: 2017-09-16 00:51:53
Document Modified: 2017-09-16 00:51:53
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 October 18, 2017. Such persons may also file a written request for a hearing on the application on or before October 18, 2017.
FR Citation82 FR 43572 

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