Importer of Controlled Substances Application: Bellwyck Clinical Services, 45613 [2017-20941]
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45613
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
DEPARTMENT OF JUSTICE
Controlled substance
Drug
code
Schedule
Drug Enforcement Administration
Amphetamine ...............
Methylphenidate ...........
Oxycodone ...................
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Bellwyck Clinical Services
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 in
accordance with 21 CFR 1301.34(a) on
or before October 30, 2017. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
October 30, 2017.
DATES:
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 request 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.
ADDRESSES:
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 June
30, 2017, Bellwyck Clinical Services,
8946 Global Way, West Chester, Ohio
45069 applied to be registered as an
importer of the following basic classes
of controlled substances:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:50 Sep 28, 2017
Jkt 241001
1100
1724
9143
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: September 21, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–20941 Filed 9–28–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Research
Triangle Institute
ACTION:
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 March
31, 2017, Research Triangle Institute,
3040 East Cornwallis Road, Hermann
Building, Room 106, Research Triangle
Park, North Carolina 27709–2194
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
Drug
code
7360
7370
Schedule
I
I
The company will manufacture
marihuana (7360) and
tetrahydrocannabinols (7370) for use by
their researchers under the above listed
controlled substances as Active
Pharmaceutical Ingredient (API) for
clinical trials.
In reference to drug code (7370) the
company plans to bulk manufacture a
synthetic tetrahydrocannabinol. No
other activities for this drug code are
authorized for this registration.
Dated: September 21, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–20947 Filed 9–28–17; 8:45 am]
BILLING CODE 4410–09–P
Notice of application.
DEPARTMENT OF JUSTICE
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 November 28, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On September 19, 2017, the
Department of Justice lodged a proposed
Consent Decree with the United States
District Court for the District of South
Carolina in the lawsuit entitled United
States v. JW Aluminum Company, Civil
Action No. 17–cv–02490–DCN.
The United States filed this lawsuit
under the Clean Air Act. The United
States’ complaint seeks injunctive relief
and civil penalties for violations of the
regulations that govern secondary
aluminum production at the defendant’s
facility in Mount Holly, South Carolina.
The consent decree requires the
defendant to perform injunctive relief
and pay a $230,000 civil penalty.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States v. JW Aluminum
Company, D.J. Ref. No. 90–5–2–1–
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Page 45613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20941]
[[Page 45613]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Bellwyck Clinical
Services
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 in accordance with 21 CFR
1301.34(a) on or before October 30, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 30, 2017.
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
request 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 June
30, 2017, Bellwyck Clinical Services, 8946 Global Way, West Chester,
Ohio 45069 applied to be registered as an importer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF. This analysis is required
to allow the company to export domestically-manufactured FDF to foreign
markets. Authorization will not extend to the import of FDA approved or
non-approved finished dosage forms for commercial sale.
Dated: September 21, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-20941 Filed 9-28-17; 8:45 am]
BILLING CODE 4410-09-P
