Importer of Controlled Substances Application: Mylan Inc., 10387-10388 [2022-03907]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices
Commission, 500 E Street SW, Suite
401, Washington, DC 20436; and
(5) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondent in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(e) and 210.13(a), as
amended in 85 FR 15798 (March 19,
2020), such responses will be
considered by the Commission if
received not later than 20 days after the
date of service by the complainants of
the complaint and the notice of
investigation. Extensions of time for
submitting responses to the complaint
and the notice of investigation will not
be granted unless good cause therefor is
shown.
Failure of a/the respondent to file a
timely response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
and a final determination containing
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: February 17, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022–03882 Filed 2–23–22; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–962]
jspears on DSK121TN23PROD with NOTICES1
Importer of Controlled Substances
Application: Scottsdale Research
Institute
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Scottsdale Research Institute
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTAL
SUMMARY:
VerDate Sep<11>2014
16:46 Feb 23, 2022
Jkt 256001
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 March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
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 January 5, 2022,
Scottsdale Research Institute, 5436 East
Tapekim Road, Cave Creek, Arizona
85331, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7350
7360
7370
7437
7438
I
I
I
I
I
The company plans to import
Marihuana Extract (7350), Marijuana
(7360) and Tetrahydrocannabinols
(7370) as flowering plants to support
analytical purposes, research, and the
manufacturing of dosage forms for
clinical trials. This notice does not
constitute an evaluation or
determination of the merits of the
company’s application. The company
plans to import fungi material from
which Psilocybin (7437) and Psilocyn
(7438) will be produced for further
manufacturing prior to use in research
and 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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
10387
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03904 Filed 2–23–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–957]
Importer of Controlled Substances
Application: Mylan Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Inc. 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.
SUMMARY:
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 March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to https://
www.regulations.gov and follow the
online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
DATES:
E:\FR\FM\24FEN1.SGM
24FEN1
10388
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 15, 2021,
Mylan Inc., 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):
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Methadone ......................
Morphine ..........................
Fentanyl ...........................
Drug
code
Schedule
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 the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
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 March 28, 2022. Such persons
may also file a written request for a
hearing on the application on or before
March 28, 2022.
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 request 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 December 10, 2021,
Myonex Inc., 100 Progress Drive,
Horsham, Pennsylvania 19044, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
[FR Doc. 2022–03907 Filed 2–23–22; 8:45 am]
Controlled substance
BILLING CODE P
Amphetamine ..................
Lisdexamfetamine ...........
Methylphenidate ..............
Nabilone ..........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Morphine ..........................
Oxymorphone ..................
Fentanyl ...........................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–960]
Importer of Controlled Substances
Application: Myonex Inc.
Drug
code
Schedule
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
II
II
II
II
II
II
II
II
II
II
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–03903 Filed 2–23–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–953]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Therapeutics Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Therapeutics Inc.,
has applied to be registered as a bulk
manufacturer 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 April 25, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 25, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 16, 2021,
Benuvia Therapeutics Inc., 2700
Oakmont Drive, Round Rock, Texas
78665, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Myonex Inc. has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTAL INFORMATION
SUMMARY:
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.
The company plans to import the
listed controlled substances for clinical
trials, research, and analytical purposes.
No other activity for these drug codes is
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
jspears on DSK121TN23PROD with NOTICES1
Controlled substance
Drug code
Tetrahydrocannabinols ....................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
VerDate Sep<11>2014
16:46 Feb 23, 2022
Jkt 256001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\24FEN1.SGM
24FEN1
7370
7400
7405
7431
7435
7437
7438
7439
Schedule
I
I
I
I
I
I
I
I
]]>Agencies
[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10387-10388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03907]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-957]
Importer of Controlled Substances Application: Mylan Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Inc. 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 March 28, 2022.
Such persons may also file a written request for a hearing on the
application on or before March 28, 2022.
ADDRESSES: The DEA requires that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides
the ability to type short comments directly into the comment field on
the web page or attach a file for lengthier comments. Please go to
https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon submission of your comment, you will
receive a Comment Tracking Number. Please be aware that submitted
comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
your comment has been successfully submitted and there is no need to
resubmit the same comment. All requests for a hearing must 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. All requests
for a hearing should also be sent to: Drug Enforcement Administration,
Attn: Administrator,
[[Page 10388]]
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on December 15, 2021, Mylan Inc., 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 the Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03907 Filed 2-23-22; 8:45 am]
BILLING CODE P
