[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Page 13953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06854]
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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 May 8, 2019. Such
persons may also file a written request for a hearing on the
application on or before May 8, 2019.
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 a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a 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
January 7, 2019, Sanyal Biotechnology, LLC, 700 West Olney Road,
Marioneaux Lab--Room 3159, Norfolk, Virginia 23507-1607 applied to be
registered as an importer of the following basic class of controlled
substances:
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Controlled substance Drug code Schedule
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Marihuana Extract.................... 7350 I
Tetrahydrocannabinols................ 7370 I
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The company plans to import finished dosage unit products
containing marihuana extract for clinical trial studies. These 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 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 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06854 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P