Importer of Controlled Substances Application: Persist Al Formulations Corp, 10383 [2023-03386]
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10383
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
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,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 2, 2022,
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
lotter on DSK11XQN23PROD with NOTICES1
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 bulk
active pharmaceutical ingredients for
internal testing purposes only and
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 Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–03395 Filed 2–16–23; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
following basic class(es) of controlled
substance(s).
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1138]
Importer of Controlled Substances
Application: Persist Al Formulations
Corp
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Persist Al Formulations Corp
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before March 20, 2023. Such
persons may also file a written request
for a hearing on the application on or
before March 20, 2023.
ADDRESSES: The Drug Enforcement
Administration 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,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 19, 2022,
Persist AI Formulations Corp, 1100
Main Street, Suite 300–PB, Woodland,
California 95695–3513, applied to be
registered as an importer of the
SUMMARY:
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
Psilocybin .....................
Drug
code
7437
Schedule
I
The company plans to import the
listed controlled substance as bulk
material for research and development
activities. No other activities for these
drug codes are 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–03386 Filed 2–16–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Modification to Partial Consent Decree
Under the Clean Water Act
On February 13, 2023, the Department
of Justice lodged a proposed
Modification to Partial Consent Decree
with the United States District Court for
the Middle District of Pennsylvania in
the lawsuit entitled United States and
Commonwealth of Pennsylvania
Department of Environmental
Protection v. Capital Region Water and
the City of Harrisburg, PA, Civil Action
No. 1:15–cv–00291–CCC.
The United States and the
Pennsylvania Department of
Environmental Protection (‘‘PADEP’’)
jointly filed this lawsuit in February
2015 against Capital Region Water
(‘‘CRW’’) and the City of Harrisburg
alleging violations of the Clean Water
Act and the Pennsylvania Clean Streams
Law. The complaint sought injunctive
relief and civil penalties for alleged
unpermitted discharges from the sewer
system in Harrisburg, failure to prepare
a Long-Term Control Plan in
compliance with EPA’s 1994 Combined
Sewer Overflow Control Policy (‘‘CSO
Policy’’), and failure to comply with
other requirements of sewer and
stormwater National Pollutant Discharge
Elimination System (‘‘NPDES’’) permits.
At the same time, the United States and
PADEP also lodged a Partial Consent
Decree that required CRW to perform
injunctive relief to address the alleged
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Page 10383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03386]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1138]
Importer of Controlled Substances Application: Persist Al
Formulations Corp
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Persist Al Formulations Corp has applied to be registered as
an importer of basic class(es) of controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
March 20, 2023. Such persons may also file a written request for a
hearing on the application on or before March 20, 2023.
ADDRESSES: The Drug Enforcement Administration 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, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on December 19, 2022, Persist AI Formulations Corp, 1100
Main Street, Suite 300-PB, Woodland, California 95695-3513, applied to
be registered as an importer of the following basic class(es) of
controlled substance(s).
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin............................. 7437 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance as bulk
material for research and development activities. No other activities
for these drug codes are 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-03386 Filed 2-16-23; 8:45 am]
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