Importer of Controlled Substances Application: Akorn, Inc., 34465-34466 [2020-12080]
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34465
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices
4, 2020, and made available to persons
on the Administrative Protective Order
service list for this review. A public
version will be issued thereafter,
pursuant to section 207.62(d)(4) of the
Commission’s rules.
Written submissions.—As provided in
section 207.62(d) of the Commission’s
rules, interested parties that are parties
to the review and that have provided
individually adequate responses to the
notice of institution,2 and any party
other than an interested party to the
review may file written comments with
the Secretary on what determination the
Commission should reach in the review.
Comments are due on or before June 11,
2020 and may not contain new factual
information. Any person that is neither
a party to the five-year review nor an
interested party may submit a brief
written statement (which shall not
contain any new factual information)
pertinent to the review by June 11, 2020.
However, should the Department of
Commerce (‘‘Commerce’’) extend the
time limit for its completion of the final
results of its review, the deadline for
comments (which may not contain new
factual information) on Commerce’s
final results is three business days after
the issuance of Commerce’s results. If
comments contain business proprietary
information (BPI), they must conform
with the requirements of sections 201.6,
207.3, and 207.7 of the Commission’s
rules. The Commission’s rules with
respect to filing were revised effective
July 25, 2014. See 79 FR 35920 (June 25,
2014). The Commission’s Handbook on
Filing Procedures, available on the
Commission’s website at https://
www.usitc.gov/documents/handbook_
on_filing_procedures.pdf, elaborates
upon the Commission’s procedures with
respect to filings.
In accordance with sections 201.16(c)
and 207.3 of the rules, each document
filed by a party to the review must be
served on all other parties to the review
(as identified by either the public or BPI
service list), and a certificate of service
must be timely filed. The Secretary will
not accept a document for filing without
a certificate of service.
Determination.—The Commission has
determined this review is
extraordinarily complicated and
therefore has determined to exercise its
authority to extend the review period by
up to 90 days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: This review is being conducted
under authority of title VII of the Tariff Act
2 The
Commission has found the response
submitted by Agri-Fab, Inc. to be individually
adequate. Comments from other interested parties
will not be accepted (see 19 CFR 207.62(d)(2)).
VerDate Sep<11>2014
17:24 Jun 03, 2020
Jkt 250001
of 1930; this notice is published pursuant to
section 207.62 of the Commission’s rules.
By order of the Commission.
Issued: May 29, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–12021 Filed 6–3–20; 8:45 am]
BILLING CODE 7020–02–P
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of the Food and Drug
Administration (FDA)-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2020–12086 Filed 6–3–20; 8:45 am]
Drug Enforcement Administration
BILLING CODE 4410–09–P
[Docket No. DEA–652]
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, LLC
ACTION:
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 (DEA), 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 8, 2020, Catalent
Pharma Solutions, LLC, 3031 Red Lion
Road, Philadelphia, Pennsylvania
19114, applied to be registered as an
importer of the following basic class(es)
of controlled substance:
DATES:
Drug
code
Gamma Hydroxybutyric Acid ..
2010
Schedule
I
The company plans to import finished
dosage unit products containing Gamma
Hydroxybutyric Acid for clinical trials,
research, and analytical activities. No
other activity for this drug code is
authorized for this registration.
Approval of permit applications will
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–653]
Notice of application.
Controlled substance
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Akorn, Inc.
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.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 14, 2020, Akorn,
Inc., 1222 West Grand Avenue, Decatur,
Illinois 62522–1412, applied to be
registered as an importer of the
following basic class(es) of a controlled
substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
Remifentanil ..................
9739
II
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04JNN1
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
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]]>Agencies
[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Pages 34465-34466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12080]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-653]
Importer of Controlled Substances Application: Akorn, Inc.
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 14, 2020, Akorn, Inc., 1222 West Grand Avenue,
Decatur, Illinois 62522-1412, applied to be registered as an importer
of the following basic class(es) of a controlled substance:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil.......................... 9739 II
------------------------------------------------------------------------
[[Page 34466]]
The company plans to import the listed controlled substance for
research purposes.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-12080 Filed 6-3-20; 8:45 am]
BILLING CODE 4410-09-P
