[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Page 12407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05724]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sanyal 
Biotechnology 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 April 20, 2018. Such 
persons may also file a written request for a hearing on the 
application on or before April 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 
December 29, 2017, Sanyal Biotechnology LLC, 700 West Olney Road, 
Marioneaux Lab--Room 3159, Norfolk, Virginia 23507-1607 applied to be 
registered as an importer the following basic classes of controlled 
substances:

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                                           Drug
          Controlled substance             code          Schedule
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Marihuana Extract......................     7350  I
Tetrahydrocannabinols..................     7370  I
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    This company plans to import finished dosage unit products 
containing gamma-hydroxybutyric acid and cannabis extracts for clinical 
trial studies.
    This cannabis extracts compounds are listed under drug code 7350. 
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 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: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-05724 Filed 3-20-18; 8:45 am]
 BILLING CODE 4410-09-P