Importer of Controlled Substances Application: Sharp (Bethlehem), LLC, 54612 [2018-23705]

Download as PDF 54612 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852–1717, applied to be registered as an importer of the following basic class of the controlled substance: Controlled substance Drug code Oxymorphone ......... 9652 Schedule II The company plans to import the bulk controlled substance for distribution of analytical reference standards to its customers for research and analytical purposes. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23701 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P 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 30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, applied to be registered as an importer of the following basic class of controlled substances: Controlled substance DEPARTMENT OF JUSTICE Gamma Hydroxybutyric Acid. Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp (Bethlehem), LLC ACTION: Notice of application. 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 khammond on DSK30JT082PROD with NOTICES DATES: VerDate Sep<11>2014 19:27 Oct 29, 2018 Jkt 247001 Drug code 2010 Schedule I The company plans to import dosage forms of the listed controlled substances to conduct clinical trials. Approval of permit applications will occur only when the registrant’s 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 nonapproved finished dosage forms for commercial sale. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23705 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. 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 November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on August 17, 2018, Fisher Clinical Services Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Psilocybin ......... Methylphenidate Levorphanol ...... Noroxymorphone. Tapentadol ........ Schedule 7437 1724 9220 9668 I II II II 9780 II DATES: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 The company plans to import the listed controlled substances for clinical trials. Dated: October 22, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–23702 Filed 10–29–18; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Page 54612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23705]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sharp (Bethlehem), 
LLC

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 November 29, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 29, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: 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 1301.34(a), this is notice that on August 
30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, 
Pennsylvania 18020, applied to be registered as an importer of the 
following basic class of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
------------------------------------------------------------------------

    The company plans to import dosage forms of the listed controlled 
substances to conduct clinical trials.
    Approval of permit applications will occur only when the 
registrant's 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: October 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23705 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P