Bulk Manufacturer of Controlled Substances Registration, 55205 [2018-24005]
Download as PDF
<![CDATA[
55205
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Notices
Cambridge, UK; Clear Scientific, LLC,
Cambridge, MA; Cornerstone
Government Affairs, Inc., Washington,
DC; DePuy Synthes Products, Inc.,
Raynham, MA; Dignitas Technologies,
Orlando, FL; ECM Therapeutics, Inc.,
Warrendale, PA; ElMindA Ltd.,
Herzliya, Israel; Family Health
International DBA FHI 360, Durham,
NC; Hypatia Project, Reston, VA;
Institutes for Behavior Resources, Inc.
(IBR), Baltimore, MD; Integrated
MicroSciences, LLC, Frederick, MD; J.
Craig Venter Institute (JCVI), Rockville,
MD; KaloCyte, Inc., St. Louis, MO;
Lieber Institute, Inc., Baltimore, MD;
NanoDirect, LLC, Baltimore, MD;
OXYVITA, Inc., Middletown, NY;
Parsons Government Services, Inc.,
Pasadena, CA; Protocentral, Inc.,
Woburn, MA; Q2Pharma, Haifa, Israel;
RAIN Scientific, Inc., Asheville, NC;
Rehat, LLC, Pittsburgh, PA; Research
Foundation for Mental Hygiene, Inc.
(NYSPI), New York, NY; Responde2
Corporation, Mountain View, CA; Saint
Barnabas Medical Center (SBMC),
Livingston, NJ; San Diego Blood Bank,
San Diego, CA; SmartMD Systems, Inc.,
Manchester Center, VT; Sonica LLC,
Evanston, IL; Spire, San Francisco, CA;
Syracuse University, Syracuse, NY; The
Charles Stark Draper Laboratory, Inc.
(Draper), Cambridge, MA; The
University of Arizona, Defense and
Security Research Institute (DSRI),
Tucson, AZ; Trauma Insight, LLC, San
Antonio, TX; Trustees of Boston
University, Boston, MA; University of
Central Florida Research Foundation,
Inc., Orlando, FL; University of
Houston—Cullen College of
Engineering, Houston, TX; Vivonics,
Inc., Bedford, MA; and Washington
State University, Pullman, WA; have
been added as parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and MTEC
intends to file additional written
notifications disclosing all changes in
membership.
On May 9, 2014, MTEC filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on June 9, 2014 (79 FR 32999).
The last notification was filed with
the Department on May 3, 2018. A
notice was published in the Federal
VerDate Sep<11>2014
17:57 Nov 01, 2018
Jkt 247001
Register pursuant to Section 6(b) of the
Act on June 19, 2018 (83 FR 28448).
Suzanne Morris,
Chief, Premerger and Division Statistics Unit
Antitrust Division.
Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–24005 Filed 11–1–18; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2018–23989 Filed 11–1–18; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUMMARY:
The
companies listed below applied to be
registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
SUPPLEMENTARY INFORMATION:
FR citation
Chemtos,
83 FR 37520
LLC.
Johnson
83 FR 34880
Matthey Inc.
AMRI
83 FR 38179
Rensselaer,
Inc.
Published
August 1,
2018.
July 23,
2018.
August 3,
2018.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable basic classes
of controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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 January 2, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Notice of registration.
Company
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceuticals, Inc.
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
1301.33(a), this is notice that on
September 13, 2018, Janssen
Pharmaceuticals, Inc., Buildings 1–5 &
7–14, 1440 Olympic Drive, Athens,
Georgia 30601 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
Methylphenidate ...............
Hydromorphone ................
Hydrocodone ....................
Oripavine ..........................
Thebaine ...........................
Tapentadol ........................
1724
9150
9193
9330
9333
9780
II
II
II
II
II
II
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Notices]
[Page 55205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24005]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: The registrants listed below have applied for and been granted
registration by the Drug Enforcement Administration (DEA) as bulk
manufacturers of various classes of schedule I and II controlled
substances.
SUPPLEMENTARY INFORMATION: The companies listed below applied to be
registered as bulk manufacturers of various basic classes of controlled
substances. Information on previously published notices is listed in
the table below. No comments or objections were submitted for these
notices.
------------------------------------------------------------------------
Company FR citation Published
------------------------------------------------------------------------
Chemtos, LLC.................... 83 FR 37520....... August 1, 2018.
Johnson Matthey Inc............. 83 FR 34880....... July 23, 2018.
AMRI Rensselaer, Inc............ 83 FR 38179....... August 3, 2018.
------------------------------------------------------------------------
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of these registrants to manufacture
the applicable basic classes of controlled substances is consistent
with the public interest and with United States obligations under
international treaties, conventions, or protocols in effect on May 1,
1971. The DEA investigated each of the company's maintenance of
effective controls against diversion by inspecting and testing each
company's physical security systems, verifying each company's
compliance with state and local laws, and reviewing each company's
background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer
to the above listed companies.
Dated: October 24, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-24005 Filed 11-1-18; 8:45 am]
BILLING CODE 4410-09-P
