Importer of Controlled Substances Application: Lyndra Therapeutics, 76086 [2022-26920]
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76086
Federal Register / Vol. 87, No. 237 / Monday, December 12, 2022 / Notices
Controlled substance
Drug code
Meperidine intermediate-C ..............................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
14-Hydroxmorphone ........................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Phenazocine ....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic cannabidiol
and a synthetic tetrahydrocannabinol.
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. 2022–26925 Filed 12–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1113]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
18:08 Dec 09, 2022
Jkt 259001
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 14, 2022,
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):
SUPPLEMENTARY INFORMATION:
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 January 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before January 11, 2023.
SUMMARY:
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.
ADDRESSES:
Controlled substance
Methadone .....................
Drug
code
9250
Schedule
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.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
9234
9250
9254
9273
9300
9333
9652
9665
9668
9715
9740
9743
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
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. 2022–26920 Filed 12–9–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On December 6, 2022, the Department
of Justice lodged a proposed consent
decree with the United States District
Court for the District of Puerto Rico in
the lawsuit entitled United States v.
Puerto Rico Industrial Development
Company, Civil Action No. 3:15–cv–
2328.
In that action, the United States
sought, pursuant to the Comprehensive
Environmental Response,
Compensation, and Liability Act
(‘‘CERCLA’’), 42 U.S.C. 9601, et seq.,
recovery of response costs regarding the
Maunabo Groundwater Superfund Site
in Maunabo, Puerto Rico (the ‘‘Site’’).
The proposed consent decree will
require the Puerto Rico Industrial
Development Company to reimburse the
U.S. Environmental Protection Agency
for $11 million of its past costs at the
Site. The reimbursements are to be
made in quarterly installments over
seven years, with interest.
The publication of this notice opens
a period for public comment on the
proposed consent decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
E:\FR\FM\12DEN1.SGM
12DEN1
]]>Agencies
[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Page 76086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26920]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1113]
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
January 11, 2023. Such persons may also file a written request for a
hearing on the application on or before January 11, 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 October 14, 2022, 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-26920 Filed 12-9-22; 8:45 am]
BILLING CODE P
