Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 9556-9557 [2025-02599]
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9556
Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on December 30, 2024,
Maridose LLC, 74 Orion Street, Unit 7,
Brunswick, Maine 04011, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
Controlled substance
Marihuana Extract ...........
Marihuana ........................
Tetrahydrocannabinols ....
I
Drug
code
Schedule
7350
7360
7370
I
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to supply the Drug
Enforcement Administration-registered
researchers for their approval studies.
No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–02596 Filed 2–12–25; 8:45 am]
BILLING CODE P
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before March 17, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 17, 2025.
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 10, 2024,
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):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1486]
Amphetamine ..................
Methylphenidate ..............
Oxycodone ......................
Hydromorphone ...............
Methadone ......................
Morphine ..........................
Fentanyl ...........................
Importer of Controlled Substances
Application: Mylan Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
Mylan Inc. 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
SUMMARY:
VerDate Sep<11>2014
16:39 Feb 12, 2025
Jkt 265001
Drug
code
Schedule
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances as bulk
active pharmaceutical ingredients for
internal testing purposes only and
finished dosage forms for analytical
testing and distribution for clinical trials
to support foreign market participation.
No other activities for these drug codes
are authorized for this registration.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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. 2025–02594 Filed 2–12–25; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1490]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen Pharmaceuticals Inc.
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 17, 2025. Such
persons may also file a written request
for a hearing on the application on or
before March 17, 2025.
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
SUMMARY:
E:\FR\FM\13FEN1.SGM
13FEN1
9557
Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices
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 5, 2024,
Janssen Pharmaceuticals, Inc., 1440
Olympic Drive, Buildings 1–5 & 7–14,
Athens, Georgia 30601–1645, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) ...............................................................................................................
Methylphenidate .............................................................................................................................................................................
The company plans to import for
analytical purposes. 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. 2025–02599 Filed 2–12–25; 8:45 am]
BILLING CODE P
OFFICE OF THE DIRECTOR OF
NATIONAL INTELLIGENCE
Notice of Meeting: National Intelligence
University Board of Visitors
National Intelligence
University (NIU), Office of the Director
of National Intelligence (ODNI).
ACTION: Notice of Federal Advisory
Committee meeting of the National
Intelligence University Board of
Visitors.
AGENCY:
ODNI is publishing this
notice to announce that the following
Federal Advisory Committee meeting of
the NIU Board of Visitors (BoV) will
take place. This meeting is closed to the
public.
DATES: Thursday, 27 March, 2025 8:30
a.m. to 5:00 p.m., Bethesda, MD.
ADDRESSES: National Intelligence
University, 4600 Sangamore Road,
Bethesda, MD 20816.
FOR FURTHER INFORMATION CONTACT: Ms.
Patricia ‘‘Patty’’ Larsen, Designated
Federal Officer, (301) 243–2118 (Voice),
excom@odni.gov (email). Mailing
address is National Intelligence
University, Roberdeau Hall,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:39 Feb 12, 2025
Jkt 265001
Washington, DC 20511. Website: https://
ni-u.edu/wp/about-niu/leadership-2/
board-of-visitors/.
SUPPLEMENTARY INFORMATION: This
meeting is being held under the
provisions of the Federal Advisory
Committee Act of 1972 (5 U.S.C. 1001–
1014), the Government in the Sunshine
Act of 1976 (5 U.S.C. 552b), and 41 CFR
102–3.140 and 102–3.150. The meeting
includes the discussion of classified
information and classified materials
regarding intelligence education issues,
internal personnel rules and practices of
NIU, and pre-decisional strategic
planning matters; and the Director of
National Intelligence, or her designee, in
consultation with the ODNI Office of
General Counsel, has determined the
meeting will be closed to the public
under the exemptions set forth in 5
U.S.C. 552b(c)(1), 552b(c)(2), and
552b(c)(9)(B).
I. Purpose of the Meeting: The Board
will discuss and provide written
observations and recommendations on
matters relating to NIU personnel,
budget, facilities, strategic planning,
information technology, intelligence
programs, and whole of institution
assessment data, as well as discuss
current classified intelligence education
issues.
II. Agenda: Welcome and Call to
Order; Opening Remarks; Resources—
Budget, Information Technology,
Personnel, Whole of Institution
Assessment Data, Strategic Planning,
Break for Lunch; Administrative
Session, Executive Session.
III. Meeting Accessibility: The public
or interested organizations may submit
written statements to the NIU BoV about
its mission and functions. Written
statements may be submitted at any
time or in response to the stated agenda
of a planned meeting of the NIU BoV.
IV. Written Statements: All written
statements shall be submitted to the
Designated Federal Officer for the NIU
BoV, and this individual will ensure
PO 00000
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Fmt 4703
Sfmt 4703
Drug
code
Schedule
1727
1724
I
II
that the written statements are provided
to the membership for their
consideration.
Dated: January 27, 2025.
Robert A. Newton,
Committee Management Officer and Deputy
Chief Operating Officer.
[FR Doc. 2025–02539 Filed 2–12–25; 8:45 am]
BILLING CODE 9500–01–P–P
POSTAL REGULATORY COMMISSION
[Docket Nos. CP2024–418; MC2025–1177
and K2025–1177; MC2025–1178 and K2025–
1178; MC2025–1179 and K2025–1179]
New Postal Products
Postal Regulatory Commission.
Notice.
AGENCY:
ACTION:
The Commission is noticing a
recent Postal Service filing for the
Commission’s consideration concerning
a negotiated service agreement. This
notice informs the public of the filing,
invites public comment, and takes other
administrative steps.
DATES: Comments are due: February 18,
2025.
ADDRESSES: Submit comments
electronically via the Commission’s
Filing Online system at https://
www.prc.gov. Those who cannot submit
comments electronically should contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section by
telephone for advice on filing
alternatives.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
David A. Trissell, General Counsel, at
202–789–6820.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Public Proceeding(s)
III. Summary Proceeding(s)
E:\FR\FM\13FEN1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 29 (Thursday, February 13, 2025)]
[Notices]
[Pages 9556-9557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02599]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1490]
Importer of Controlled Substances Application: Janssen
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Janssen Pharmaceuticals Inc. 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 17, 2025. Such persons may also file a written request for a
hearing on the application on or before March 17, 2025.
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
[[Page 9557]]
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 5, 2024, Janssen Pharmaceuticals, Inc., 1440
Olympic Drive, Buildings 1-5 & 7-14, Athens, Georgia 30601-1645,
applied to be registered as an importer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2- 1727 I
yl)acetate).
Methylphenidate............................... 1724 II
------------------------------------------------------------------------
The company plans to import for analytical purposes. 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. 2025-02599 Filed 2-12-25; 8:45 am]
BILLING CODE P
