Importer of Controlled Substances Application: Sanyal Biotechnology LLC, 12407 [2018-05724]
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12407
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices
request a hearing and ‘‘has not
otherwise corresponded or
communicated with [the Agency]
regarding the Order . . . including the
filing of any written statement in lieu of
a hearing.’’ RFAA, at 1–2. Based on the
Government’s representation I find that
more than 30 days have now passed
since Registrant was served with the
Show Cause Order and that he has not
requested a hearing or filed a written
statement of position; I further find that
Registrant has not filed a Corrective
Action Plan. Accordingly, I find that
Registrant has waived his right to a
hearing or to submit a written statement
while waiving his right to a hearing; I
also find that Registrant has waived his
right to submit a Corrective Action Plan.
21 CFR 1301.43(d).
In the RFAA, the Government seeks a
final order revoking Registrant’s
registration. As support for the proposed
sanction, the Government’s evidence
includes a copy of the Stipulation and
Order issued by the Minnesota Board on
February 3, 2017, pursuant to which it
accepted Registrant’s voluntary
surrender of his dental license. GX 3.
The Government also submitted a
Certification of Registration History,
which was sworn to on October 30,
2017. GX 1. Therein, the Associate Chief
of the Registration and Program Support
Section states that Registration No.
BO1259983 ‘‘expires on December 31,
2017,’’ and that ‘‘Keith F. Ostrosky,
D.D.S., has no other pending or valid
DEA registration(s) in Minnesota.’’ Id. at
1–2.
Pursuant to 5 U.S.C. § 556(e), I take
official notice of Registrant’s registration
record with Agency. According to that
record, Registration No. BO1259983
expired on December 31, 2017 and
Registrant has not filed an application,
whether timely or not, to renew his
registration or for any other registration
in the State of Minnesota.
DEA has long held that ‘‘ ‘if a
registrant has not submitted a timely
renewal application prior to the
expiration date, then the registration
expires and there is nothing to revoke.’ ’’
Donald Brooks Reece II, M.D., 77 FR
35054, 35055 (2012) (quoting Ronald J.
Riegel, 63 FR 67312, 67133 (1998)); see
also Thomas E. Mitchell, 76 FR 20032,
20033 (2011). ‘‘Moreover, in the absence
of an application (whether timely filed
or not), there is nothing to act upon.’’
Reece, 77 FR at 35055. Accordingly,
because Registrant has allowed his
registration to expire and has not filed
any application for registration in
Minnesota, this case is now moot and
will be dismissed.
VerDate Sep<11>2014
18:34 Mar 20, 2018
Jkt 244001
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b), I hereby order that the Order
to Show Cause issued to Keith F.
Ostrosky, D.D.S., be, and it hereby is,
dismissed. This Order is effective
immediately.
Dated: March 13, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018–05746 Filed 3–20–18; 8:45 am]
BILLING CODE 4410–09–P
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:
Controlled
substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sanyal Biotechnology
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 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
DATES:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Marihuana Extract ........
Tetrahydrocannabinols
Drug
code
7350
7370
Schedule
I
I
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 nonapproved 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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Rhodes
Technologies
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 May 21, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Sanyal
Biotechnology LLC
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 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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
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
