Importer of Controlled Substances Application: Bellwyck Clinical Services, 34466 [2020-12082]
Download as PDF
34466
Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices
The company plans to import the
listed controlled substance for research
purposes.
William T. McDermott,
Assistant Administrator.
Authorization will not extend to the
import of Food and Drug
Administration (FDA)-approved or nonapproved finished dosage forms for
commercial sale.
To submit comments:
Send them to:
By email ....................
pubcommentees.enrd@
usdoj.gov.
Assistant Attorney
General, U.S.
DOJ—ENRD, P.O.
Box 7611, Washington, DC 20044–
7611.
By mail ......................
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–12080 Filed 6–3–20; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2020–12082 Filed 6–3–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–654]
Importer of Controlled Substances
Application: Bellwyck Clinical Services
ACTION:
Notice of application.
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 July 6, 2020. Such persons
may also file a written request for a
hearing on the application on or before
July 6, 2020.
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: In
accordance with 21 CFR 1301.34(a), this
is notice that on May 19, 2020, Bellwyck
Clinical Services, 8946 Global Way,
West Chester, Ohio 45069, applied to be
registered as an importer of the
following basic class(es) of controlled
substances:
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Controlled substances
Amphetamine ...............
Methylphenidate ...........
Oxycodone ...................
Drug
code
1100
1724
9143
Schedule
II
II
II
The company plans to import the
listed controlled substances in dosage
form to conduct clinical trials. Approval
of permit applications will occur only
when the registrant’s activity is
consistent with what is authorized
under 21 U.S.C. 952(a) (2).
VerDate Sep<11>2014
17:24 Jun 03, 2020
Jkt 250001
During the public comment period,
the consent decree may be examined
and downloaded at this Justice
Notice of Lodging of Proposed
Department website: https://
Consent Decree Under the Clean Air
www.justice.gov/enrd/consent-decrees.
Act
Paper copies of the consent decree are
On May 29, 2020, the Department of
available upon written request and
Justice lodged a proposed consent
payment of reproduction costs. Such
decree with the United States District
requests and payments should be
Court for the District of Massachusetts,
addressed to: Consent Decree Library,
in the lawsuit entitled United States and U.S. DOJ—ENRD, P.O. Box 7611,
Commonwealth of Massachusetts v.
Washington, DC 20044–7611.
Sprague Resources LP and Sprague
With each such request, please
Operating Resources, LLC, Civil Action
enclose a check or money order for
No. 1:20–cv–11026.
$14.75 (25 cents per page reproduction
The United States filed this lawsuit
cost) per paper copy, payable to the
under Section 113(a)(1) of the Clean Air United States Treasury.
Act, 42 U.S.C. 7413(a)(1), and the
Massachusetts, Maine, New Hampshire, Henry S. Friedman,
Assistant Section Chief, Environmental
and Rhode Island state implementation
Enforcement Section, Environment and
plans. The Commonwealth of
Natural Resources Division.
Massachusetts is a co-plaintiff and
[FR Doc. 2020–12022 Filed 6–3–20; 8:45 am]
brings claims arising under the
Massachusetts Clean Air Act and
BILLING CODE 4410–15–P
Massachusetts air pollution control
regulations. The complaint seeks civil
DEPARTMENT OF JUSTICE
penalties and injunctive relief arising
from alleged emissions of volatile
Office of Justice Programs
organic compounds (VOC) without
required permits at the defendants’
[OJP (BJA) Docket No. 1779]
heated petroleum (asphalt and #6 oil)
Meeting of the Public Safety Officer
storage and distribution facilities in
Medal of Valor Review Board
Everett and Quincy, Massachusetts;
Searsport and South Portland, Maine;
AGENCY: Office of Justice Programs
Newington (River Road), New
(OJP), Bureau of Justice Assistance
Hampshire; and Providence, Rhode
(BJA).
Island.
ACTION
: Notice of meeting.
The consent decree requires the
defendants to pay civil penalties of
SUMMARY: This is an announcement of a
$350,000, including $205,000, plus
meeting (via WebEx/conference call-in)
interest, to the United States and
of the Public Safety Officer Medal of
$145,000 to the Commonwealth of
Valor Review Board to consider a range
Massachusetts; and to perform certain
of issues of importance to the Board, to
measures at the facilities to limit future
include but not limited to: Membership/
VOC emissions.
terms; nomination eligibility; pending
The publication of this notice opens
2018–2019 recommendations; pending
a period for public comment on the
2019–2020 nominations; program
consent decree. Comments should be
marketing and outreach. The meeting
addressed to the Assistant Attorney
date and time is listed below.
General, Environment and Natural
DATES
: August 3, 2020, from 1:00 p.m.
Resources Division, and should refer to
to 2:00 p.m. EDT.
United States, et al. v. Sprague
ADDRESSES: This meeting will take place
Resources LP, et al., D.J. Ref. No. 90–5–
via WebEx/conference call-in. Public
2–1–11436. All comments must be
access to the meeting will be provided
submitted no later than thirty (30) days
by the Bureau of Justice Assistance,
after the publication date of this notice.
Office of Justice Programs upon request
Comments may be submitted either by
and subsequent invitation. (See
email or by mail:
DEPARTMENT OF JUSTICE
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
E:\FR\FM\04JNN1.SGM
04JNN1
Agencies
[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Page 34466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12082]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-654]
Importer of Controlled Substances Application: Bellwyck Clinical
Services
ACTION: Notice of application.
-----------------------------------------------------------------------
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 July 6, 2020.
Such persons may also file a written request for a hearing on the
application on or before July 6, 2020.
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: In accordance with 21 CFR 1301.34(a), this
is notice that on May 19, 2020, Bellwyck Clinical Services, 8946 Global
Way, West Chester, Ohio 45069, applied to be registered as an importer
of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substances code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
dosage form to conduct clinical trials. Approval of permit applications
will occur only when the registrant's activity is consistent with what
is authorized under 21 U.S.C. 952(a) (2). Authorization will not extend
to the import of Food and Drug Administration (FDA)-approved or non-
approved finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-12082 Filed 6-3-20; 8:45 am]
BILLING CODE 4410-09-P