Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute, 20713 [2021-08165]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 75 / Wednesday, April 21, 2021 / Notices
plain language description of the
accused products or category of accused
products, which defines the scope of the
investigation, is ‘‘skin resurfacing
devices, punctile resurfacing systems,
radio-frequency microneedling systems,
and components of each’’;
(3) For the purpose of the
investigation so instituted, the following
are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainants are:
InMode Ltd., Tavor Building Shaar
Yokneam, P.O. Box 533, Yokneam
2069206, Israel
Invasix Inc. d/b/a InMode, 20996 Bake
Parkway, Suite 106, Lake Forest, CA
92630
(b) The respondents are the following
entities alleged to be in violation of
section 337, and the parties upon which
the complaint is to be served:
ILOODA Co., Ltd., 120 Jangan-ro
458beon-gil, Jangan-gu Suwon, 16200,
Republic of Korea
Cutera, Inc., 3240 Bayshore Boulevard,
Brisbane, CA 94005
(4) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
The Office of Unfair Import
Investigations is not a party to this
investigation.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondents in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(e) and 210.13(a), as
amended in 85 FR 15798 (March 19,
2020), such responses will be
considered by the Commission if
received not later than 20 days after the
date of service by the complainants of
the complaint and the notice of
investigation. Extensions of time for
submitting responses to the complaint
and the notice of investigation will not
be granted unless good cause therefor is
shown.
Failure of a respondent to file a timely
response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
and a final determination containing
such findings, and may result in the
VerDate Sep<11>2014
18:12 Apr 20, 2021
Jkt 253001
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: April 15, 2021.
Lisa Barton
Secretary to the Commission.
20713
other activity for this drug code is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–08165 Filed 4–20–21; 8:45 am]
BILLING CODE P
[FR Doc. 2021–08159 Filed 4–20–21; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 7020–02–P
Drug Enforcement Administration
[Docket No. 17–11]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–823]
Bulk Manufacturer of Controlled
Substances Application: Research
Triangle Institute
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of application.
AGENCY:
Research Triangle Institute,
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplementary Information listed below
for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before June 21, 2021. Such persons
may also file a written request for a
hearing on the application on or before
June 21, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 18, 2021,
Research Triangle Institute, 3040 East
Cornwallis Road, Hermann Building,
Room 106, Research Triangle Park,
North Carolina 27709, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Tetrahydrocannabinols ....
I
Schedule
7370
II
The company plans to bulk
manufacture the listed controlled
substance synthetically only for
distribution to its customers for research
and analytical reference standards. No
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Mark A. Wimbley, M.D.; Decision and
Order
I. Procedural History
On October 20, 2016, a former
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Mark A.
Wimbley, M.D. (hereinafter,
Respondent), of Costa Mesa, California.
Administrative Law Judge (hereinafter,
ALJ) Exhibit (hereinafter, ALJX) 1,
(OSC) at 1. The OSC proposed the
revocation of and denial of any pending
application to modify or renew
Respondent’s Certificate of Registration
No. BW5359004 pursuant to 21 U.S.C.
823(f) and 824(a)(4) for the reason that
‘‘[his] continued registration is
inconsistent with the public interest, as
that term is defined in 21 U.S.C. 823(f).’’
Id.
The OSC alleged that Respondent
issued prescriptions for controlled
substances to four 1 individuals outside
the usual course of the professional
practice in violation of 21 CFR
1306.04(a) and in violation of California
law and the minimum standards of
medical practice in California. Id. at 2–
8. Specifically, the OSC alleged that
Respondent ‘‘issued these orders for
controlled substances without meeting
the minimal medical standards required
under California law, including those
listed in the ‘Guide to the Laws
Governing the Practice of Medicine by
Physicians and Surgeons,’ Medical
Board of California, 7th Ed. 2013.’’ Id.
at 7. Additionally, the OSC alleged that
for the four listed patients, Respondent
failed to do one or more of the
following:
perform a physical examination; take
appropriate medical history; assess pain,
physical and psychological function; make
an assessment of any underlying or
coexisting diseases or conditions; confirm the
patient was taking previously prescribed
1 The Government withdrew allegations related to
one of the patients in its Supplemental Prehearing
Statement, so this matter is limited to three
patients. ALJX 7, 7–8.
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Page 20713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08165]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-823]
Bulk Manufacturer of Controlled Substances Application: Research
Triangle Institute
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Research Triangle Institute, has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before June 21, 2021.
Such persons may also file a written request for a hearing on the
application on or before June 21, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 18, 2021, Research Triangle Institute, 3040
East Cornwallis Road, Hermann Building, Room 106, Research Triangle
Park, North Carolina 27709, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substance synthetically only for distribution to its customers for
research and analytical reference standards. No other activity for this
drug code is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08165 Filed 4-20-21; 8:45 am]
BILLING CODE P
