Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 34465 [2020-12086]
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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
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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
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Page 34465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12086]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-652]
Importer of Controlled Substances Application: Catalent Pharma
Solutions, LLC
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 (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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 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
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 non-approved finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-12086 Filed 6-3-20; 8:45 am]
BILLING CODE 4410-09-P
