83 FR 539 - Importer of Controlled Substances Application: Sharp (Bethlehem), LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 3 (January 4, 2018)

Page Range539-540
FR Document2017-28471

Federal Register, Volume 83 Issue 3 (Thursday, January 4, 2018)
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Notices]
[Pages 539-540]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28471]


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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 February 5, 2018. 
Such persons may also file a written request for a hearing on the 
application pursuant on or before February 5, 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 June 
15, 2017, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, 
Pennsylvania 18020 applied to be registered as an importer of the 
following basic classes of controlled substances:

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                                          Drug
          Controlled substance            code           Schedule
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3,4-Methylenedioxy methamphetamine.....    7405  I
Psilocybin.............................    7437  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
clinical trials. No other activity for these drug codes is authorized 
for this registration. Approval of permits 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-

[[Page 540]]

approved finished dosage forms for commercial sale.

    Dated: December 28, 2017.
Neil D. Doherty,
Deputy Assistant Administrator.
[FR Doc. 2017-28471 Filed 1-3-18; 8:45 am]
 BILLING CODE 4410-09-P


Current View
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 February 5, 2018. Such persons may also file a written request for a hearing on the application pursuant on or before February 5, 2018.
FR Citation83 FR 539 

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