Importer of Controlled Substances Application: Lyndra Therapeutics, 19327-19328 [2023-06648]

Download as PDF 19327 Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices The company plans to bulk manufacture the listed controlled substances for the production of active pharmaceutical ingredients (API) and analytical reference standards for sale to its customers. The company plans to manufacture the above listed controlled substances as clinical trial and starting materials to make compounds for distribution to its customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06687 Filed 3–30–23; 8:45 am] BILLING CODE P 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 February 22, 2023, PerkinElmer, Inc., 120 East Dedham Street, Boston, Massachusetts 02118– 2852, 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 Lysergic Acid Diethylamide. Thebaine ....................... [Docket No. DEA–1167] Importer of Controlled Substances Application: PerkinElmer, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PerkinElmer, 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 May 1, 2023. Such persons may also file a written request for a hearing on the application on or before May 1, 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 Drug code Schedule 7315 I 9333 II The company plans to import the listed controlled substances for bulk manufacturing into radioactive formulations for sale to its customers for research purposes. Drug code 9333 (Thebaine) will be used to import the Thebaine derivative Diprenorphine. 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06696 Filed 3–30–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 30, 2023. Such persons may also file a written request for a hearing on the application on or before May 30, 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. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on March 3, 2023, ANI Pharmaceuticals, Inc., 70 Lake Drive, East Windsor, New Jersey 08520, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): DATES: Controlled substance Psilocybin ..................... Levorphanol .................. Drug code 7437 9220 Schedule I I The company plans to bulk manufacture the listed controlled substances for the internal use or for sale to its customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06700 Filed 3–30–23; 8:45 am] [Docket No. DEA–1173] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc. DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. Drug Enforcement Administration ANI Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. Importer of Controlled Substances Application: Lyndra Therapeutics AGENCY: SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 [Docket No. DEA–1165] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\31MRN1.SGM 31MRN1 19328 Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices 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 1, 2023. Such persons may also file a written request for a hearing on the application on or before May 1, 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 February 20, 2023, Lyndra Therapeutics, 65 Grove Street Suite 301, Watertown, Massachusetts 02472 applied to be registered as an importer of the following basic class(es) of controlled substance(s): ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: Controlled substance Drug 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 VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 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. 2023–06648 Filed 3–30–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On March 27, 2023, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of New Mexico in the lawsuit entitled United States of America and New Mexico Environment Department v. Matador Production Company, Civil Action No. 23–cv– 00260. In this action, the United States, on behalf of the U.S. Environmental Protection Agency, and the New Mexico Environment Department filed a complaint alleging that Matador Production Company (‘‘Defendant’’) violated the Clean Air Act, the New Mexico Air Quality Control Act, and the implementing regulations at 25 of Defendant’s oil and natural gas production facilities in New Mexico by, inter alia, failing to comply with applicable emissions standards for VOC, NOX and CO and failing to submit a Notice of Intent or register for a General Construction Permit as required. The complaint seeks an Order enjoining Defendant from further violating applicable requirements and requiring Defendant to remedy, mitigate, and offset the harm to public health and the environment caused by the violations and to pay a civil penalty. Under the proposed settlement, Defendant agrees to pay a civil penalty of $1,150,000 (of which $650,000 is to be paid to the United States and $500,000 is to be paid to the State of New Mexico) and to spend at least $1,250,000 on a diesel emission reduction Supplemental Environmental Project (‘‘SEP’’) and at least $500,000 on a state aerial emission monitoring SEP. In addition, the settlement requires the Defendant to ensure ongoing compliance with all applicable regulatory requirements at all 255 of its oil and natural gas production facilities in New Mexico. Specifically, the settlement requires the Defendant to identify and remedy any compromised PO 00000 Frm 00091 Fmt 4703 Sfmt 9990 equipment, undertake a design analysis to ensure adequate design and sizing of the vapor control system, install and operate extensive monitoring systems, implement a robust inspection and maintenance program, and hire an independent third party to verify compliance. 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 Natural Resources Division, and should refer to United States and New Mexico Environment Department v. Matador Production Company, D.J. Ref. No. 90– 5–2–1–12297. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail: To submit comments: Send them to: By email ....... pubcomment-ees.enrd@ usdoj.gov. Assistant Attorney General, U.S. DOJ–ENRD, P.O. Box 7611, Washington, DC 20044–7611. By mail ......... During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. We will provide a paper copy of the proposed consent decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ–ENRD, P.O. Box 7611, Washington, DC 20044–7611. Please enclose a check or money order for $33.75 (25 cents per page reproduction cost) payable to the United States Treasury. Thomas Carroll, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2023–06651 Filed 3–30–23; 8:45 am] BILLING CODE 4410–15–P E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19327-19328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06648]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1165]


Importer of Controlled Substances Application: Lyndra 
Therapeutics

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

[[Page 19328]]

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 1, 2023. Such persons may also file a written request for a hearing 
on the application on or before May 1, 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 February 20, 2023, Lyndra Therapeutics, 65 Grove 
Street Suite 301, Watertown, Massachusetts 02472 applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
         Controlled substance           Drug 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. 2023-06648 Filed 3-30-23; 8:45 am]
BILLING CODE P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.