Importer of Controlled Substances Application: Mylan Pharmaceuticals, 68090 [2020-23766]
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68090
Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Notices
notice in the Federal Register on May
13, 2020 (85 FR 28663). In light of the
restrictions on access to the Commission
building due to the COVID–19
pandemic, the Commission conducted
its hearing through written testimony
and video conference on August 25,
2020. All persons who requested the
opportunity were permitted to
participate.
The Commission made these
determinations pursuant to section
751(c) of the Act (19 U.S.C. 1675(c)).
The Commission determined that these
reviews were extraordinarily
complicated and extended the review
period by up to 90 days. It completed
and filed its determinations in these
reviews on October 21, 2020. The views
of the Commission are contained in
USITC Publication 5127 (October 2020),
entitled Monosodium Glutamate from
China and Indonesia: Investigation Nos.
731–TA–1229–1230 (Review).
By order of the Commission.
Issued: October 21, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–23696 Filed 10–26–20; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–736]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Pharmaceuticals has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
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 November 27, 2020. Such
persons may also file a written request
for a hearing on the application on or
before November 27, 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,
jbell on DSKJLSW7X2PROD with NOTICES
VerDate Sep<11>2014
18:26 Oct 26, 2020
Jkt 253001
Controlled substance
Drug
code
Schedule
Amphetamine ...................
Methylphenidate ...............
Oxycodone .......................
Hydromorphone ................
Methadone ........................
Morphine ...........................
Fentanyl ............................
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import finished
dosage forms for analytical testing and
distribution for clinical trials. No other
activity for these drug codes 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
BILLING CODE 7020–02–P
SUMMARY:
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 October 7, 2020, Mylan
Pharmaceuticals, Incorporated, 3711
Collins Ferry Road, Morgantown, West
Virginia 26505–2362, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–23766 Filed 10–26–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–738]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: API
GLOBAL LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to
proposed regulations that, if finalized,
would govern the program of growing
marihuana for scientific and medical
research under DEA registration.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 28, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket No -.
DEA–738 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
file written comments on or objections
of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA
proposes to conduct this evaluation in
the manner described in the rule
proposed at 85 FR 16292, published on
March 23, 2020, if finalized.
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Page 68090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23766]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-736]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Pharmaceuticals has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
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 November 27,
2020. Such persons may also file a written request for a hearing on the
application on or before November 27, 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 October 7, 2020, Mylan Pharmaceuticals, Incorporated,
3711 Collins Ferry Road, Morgantown, West Virginia 26505-2362, applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Methylphenidate......................... 1724 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Methadone............................... 9250 II
Morphine................................ 9300 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to import finished dosage forms for analytical
testing and distribution for clinical trials. No other activity for
these drug codes 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-23766 Filed 10-26-20; 8:45 am]
BILLING CODE P
