Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Lily's Eden Garden Farms Corporation, 51371-51372 [2024-13216]

Download as PDF 51371 Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 1). Please note the Secretary’s Office will accept only electronic filings during this time. Filings must be made through the Commission’s Electronic Document Information System (EDIS, https:// edis.usitc.gov.) No in-person paperbased filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov. Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: June 11, 2024. Lisa Barton, Secretary to the Commission. khammond on DSKJM1Z7X2PROD with NOTICES [FR Doc. 2024–13238 Filed 6–14–24; 8:45 am] BILLING CODE 7020–02–P 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 17:00 Jun 14, 2024 Jkt 262001 DEPARTMENT OF JUSTICE Drug Enforcement Administration to be registered as an importer of the following basic class(es) of controlled substance(s): [Docket No. DEA–1387] Controlled substance Importer of Controlled Substances Application: AndersonBrecon Inc. DBA PCI Pharma Services Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: AndersonBrecon, Inc. DBA PCI Pharma Services 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. SUMMARY: 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 July 17, 2024. Such persons may also file a written request for a hearing on the application on or before July 17, 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 May 9, 2024, AndersonBrecon, Inc. DBA PCI Pharma Services, 4545 Assembly Drive, Rockford, Illinois 61109–3081, applied DATES: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Tetrahydrocannabinols .... 3,4-Methylenedioxymethamphetamine. Dimethyltryptamine .......... Drug code Schedule 7370 7405 I I 7435 I The company plans to import the listed controlled substances for clinical trials. 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 L. Ikner, Acting Deputy Assistant Administrator. [FR Doc. 2024–13220 Filed 6–14–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 1386] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Lily’s Eden Garden Farms Corporation Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration. 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 August 16, 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 SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1 khammond on DSKJM1Z7X2PROD with NOTICES 51372 Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices 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: The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), the Drug Enforcement Administration (DEA) is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may submit electronic comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted. The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on May 6, 2024, Lily’s Eden Garden Farms Corporation, 1821 Waterman VerDate Sep<11>2014 17:00 Jun 14, 2024 Jkt 262001 Road, Delhi, New York 13753, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Drug code Controlled substance Marihuana Extract ........... Marihuana ........................ I 7350 7360 Schedule I II Marsha L. Ikner, Acting Deputy Assistant Administrator. addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. Santolubes, LLC, et al., 24–cv–807, D.J. Ref. No. 90–11–2–417/ 5. 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. [FR Doc. 2024–13216 Filed 6–14–24; 8:45 am] BILLING CODE P By mail ......... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act On June 10, 2024, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Eastern District of Missouri in the lawsuit entitled United States v. Santolubes, LLC, et al., Civil Action No. 24–cv–807. The proposed Consent Decree would resolve claims the United States has brought pursuant to sections 106 and 107(a) of the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9606 and 9607(a), as amended by the Superfund Amendments and Reauthorization Act of 1986 (‘‘CERCLA’’), regarding the Findett/ Hayford Bridge Road Groundwater Superfund Site Operable Unit 1 (‘‘OU1’’) in St. Charles County, Missouri. Under the Consent Decree, Santolubes, LLC, Santolubes Manufacturing, LLC, and Santolubes Spartanburg Holdings will pay $300,000 for response costs at the Sites. Of these funds $280,000 will be deposited into a court registry account to be transferred either to the Environmental Protection Agency or any parties performing work at the Site under an agreement with the United States. The remaining $20,000 will be transferred to EPA to perform response actions at the Site. In exchange, the United States and the State will provide covenants not to sue or to take administrative action against Defendants pursuant to sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a) regarding the Site. This settlement is based on an analysis of the Defendant’s limited ability to pay. The publication of this notice opens a period for public comment on the Consent Decree. Comments should be PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: https:// www.justice.gov/enrd/consent-decrees. If you require assistance accessing the proposed Consent Decree, you may request assistance by email or by mail to the addresses provided above for submitting comments. Kathryn C. Macdonald, Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. 2024–13204 Filed 6–14–24; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF LABOR Agency Information Collection Activities; Submission for OMB Review; Comment Request; Office of Federal Contract Compliance Programs Construction Recordkeeping and Reporting Requirements Notice of availability; request for comments. ACTION: The Department of Labor (DOL) is submitting this Office of Federal Contract Compliance Programs (OFCCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited. DATES: The OMB will consider all written comments that the agency receives on or before July 17, 2024. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51371-51372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13216]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1386]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Lily's Eden Garden Farms Corporation

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: The Drug Enforcement Administration (DEA) is providing notice 
of an application it has received from an entity applying to be 
registered to manufacture in bulk basic class(es) of controlled 
substances listed in schedule I. DEA intends to evaluate this and other 
pending applications according to its regulations governing the program 
of growing marihuana for scientific and medical research under DEA 
registration.

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 
August 16, 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

[[Page 51372]]

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: The Controlled Substances Act (CSA) 
prohibits the cultivation and distribution of marihuana except by 
persons who are registered under the CSA to do so for lawful purposes. 
In accordance with the purposes specified in 21 CFR 1301.33(a), the 
Drug Enforcement Administration (DEA) is providing notice that the 
entity identified below has applied for registration as a bulk 
manufacturer of schedule I controlled substances. In response, 
registered bulk manufacturers of the affected basic class(es), and 
applicants therefor, may submit electronic comments on or objections of 
the requested registration, as provided in this notice. This notice 
does not constitute any evaluation or determination of the merits of 
the application submitted.
    The applicant plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for product development and distribution to DEA 
registered researchers. If the application for registration is granted, 
the registrant would not be authorized to conduct other activity under 
this registration aside from those coincident activities specifically 
authorized by DEA regulations. DEA will evaluate the application for 
registration as a bulk manufacturer for compliance with all applicable 
laws, treaties, and regulations and to ensure adequate safeguards 
against diversion are in place.
    As this applicant has applied to become registered as a bulk 
manufacturer of marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the 
manner described in the rule published at 85 FR 82333 on December 18, 
2020, and reflected in DEA regulations at 21 CFR part 1318.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on May 6, 2024, Lily's Eden Garden Farms Corporation, 1821 Waterman 
Road, Delhi, New York 13753, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
------------------------------------------------------------------------


Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-13216 Filed 6-14-24; 8:45 am]
BILLING CODE P
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