Importer of Controlled Substances Application: Lyndra Therapeutics, 24865 [2024-07529]
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24865
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
Controlled substance
Sufentanil ........................................................................................................................................................................................
Carfentanil ......................................................................................................................................................................................
Tapentadol ......................................................................................................................................................................................
Fentanyl ..........................................................................................................................................................................................
DEPARTMENT OF JUSTICE
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.
Drug Enforcement Administration
SUPPLEMENTARY INFORMATION:
The company plans to import the
listed controlled substances for
distribution for analytical testing
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.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–07525 Filed 4–8–24; 8:45 am]
BILLING CODE P
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 6, 2024, Lyndra
Therapeutics, 60 Westview Street,
Lexington, Massachusetts 02421–3108,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
[Docket No. DEA–1355]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lyndra Therapeutics 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 May 9, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 9, 2024.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:57 Apr 08, 2024
Jkt 262001
Drug
code
Controlled substance
Methadone ....................
I
9250
Schedule
III
The company plans to import the
above controlled substance for use in
preclinical research and human clinical
trials. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–07529 Filed 4–8–24; 8:45 am]
BILLING CODE P
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Drug
code
Schedule
9740
9743
9780
9801
II
II
II
II
DEPARTMENT OF JUSTICE
[OMB Number 1123–1NEW]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; New
Collection; Application for Remission
of Financial Penalties
Office of the Pardon Attorney,
Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Office of the Pardon
Attorney, Department of Justice (DOJ),
will be submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 60 days until June
10, 2024.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Kira Gillespie, Deputy Pardon Attorney,
Office of the Pardon Attorney, 950
Pennsylvania Avenue NW, Main
Justice—RFK Building, Washington, DC
20530; uspardon.attorney@usdoj.gov;
202–616–6070.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the Bureau of Justice
Statistics, including whether the
information will have practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
SUMMARY:
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Page 24865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07529]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1355]
Importer of Controlled Substances Application: Lyndra
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Lyndra Therapeutics 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
May 9, 2024. Such persons may also file a written request for a hearing
on the application on or before May 9, 2024.
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 March 6, 2024, Lyndra Therapeutics, 60 Westview
Street, Lexington, Massachusetts 02421-3108, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methadone.............................. 9250 II
------------------------------------------------------------------------
The company plans to import the above controlled substance for use
in preclinical research and human clinical trials. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-07529 Filed 4-8-24; 8:45 am]
BILLING CODE P
