Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc., 106579-106580 [2024-31293]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. Conference.—The Office of Investigations will hold a staff conference in connection with the preliminary phase of these investigations beginning at 9:30 a.m. on Wednesday, May 15, 2024. Requests to appear at the conference should be emailed to preliminaryconferences@ usitc.gov (DO NOT FILE ON EDIS) on or before 5:15 p.m. on Monday, May 13, 2024. Please provide an email address for each conference participant in the email. Information on conference procedures, format, and participation, including guidance for requests to appear as a witness via videoconference, will be available on the Commission’s Public Calendar (Calendar (USITC) √ United States International Trade Commission). A nonparty who has testimony that may aid the Commission’s deliberations may request permission to participate by submitting a short statement. 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. Written submissions.—As provided in §§ 201.8 and 207.15 of the Commission’s rules, any person may submit to the Commission on or before 5:15 p.m. on May 20, 2024, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties shall file written testimony and supplementary material in connection with their presentation at the conference no later than noon on Tuesday, May 14. All written submissions must conform with the provisions of § 201.8 of the Commission’s rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission’s rules. The Commission’s Handbook on Filing Procedures, available on the Commission’s website at https:// www.usitc.gov/documents/handbook_ on_filing_procedures.pdf, elaborates upon the Commission’s procedures with respect to filings. VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service. Certification.—Pursuant to § 207.3 of the Commission’s rules, any person submitting information to the Commission in connection with these investigations must certify that the information is accurate and complete to the best of the submitter’s knowledge. In making the certification, the submitter will acknowledge that any information that it submits to the Commission during these investigations 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 these or related investigations or reviews, 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, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.12 of the Commission’s rules. By order of the Commission. Issued: December 20, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–31088 Filed 12–27–24; 8:45 am] BILLING CODE 7020–02–P JUDICIAL CONFERENCE OF THE UNITED STATES Advisory Committee on Evidence Rules; Hearing of the Judicial Conference Judicial Conference of the United States. ACTION: Advisory Committee on Evidence Rules; notice of cancellation of open hearing. AGENCY: The following public hearing on proposed amendments to the Federal Rules of Evidence has been canceled: Evidence Rules Hearing on January 22, 2025. DATES: January 22, 2025. SUMMARY: PO 00000 Frm 00174 Fmt 4703 Sfmt 4703 106579 H. Thomas Byron III, Esq., Chief Counsel, Rules Committee Staff, Administrative Office of the U.S. Courts, Thurgood Marshall Federal Judiciary Building, One Columbus Circle NE, Suite 7–300, Washington, DC 20544, Phone (202) 502–1820, RulesCommittee_Secretary@ ao.uscourts.gov. FOR FURTHER INFORMATION CONTACT: The announcement for this hearing was previously published in the Federal Register on July 31, 2024 at 89 FR 61498. SUPPLEMENTARY INFORMATION: (Authority: 28 U.S.C. 2073.) Dated: December 23, 2024. Shelly L. Cox, Management Analyst, Rules Committee Staff. [FR Doc. 2024–31251 Filed 12–27–24; 8:45 am] BILLING CODE 2210–55–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1461] Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Irvine Labs 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. 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 February 28, 2025. Such persons may also file a written request for a hearing on the application on or before February 28, 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 SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1 106580 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices Number, your comment has been successfully submitted and there is no need to resubmit the same comment. In accordance with 21 CFR 1301.33(a), this is notice that on August 26, 2024, Irvine Labs Inc., 7305 Murdy Circle, SUPPLEMENTARY INFORMATION: Huntington Beach, California 92647– 3533, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Lysergic acid diethylamide ...................................................................................................................................... Mescaline ................................................................................................................................................................. Peyote ...................................................................................................................................................................... Diethyltryptamine ..................................................................................................................................................... Dimethyltryptamine .................................................................................................................................................. Psilocybin ................................................................................................................................................................. Psilocyn .................................................................................................................................................................... The company plans to bulk manufacture the above listed controlled substances for research and development purposes internally and for distribution to its research customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–31293 Filed 12–27–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ddrumheller on DSK120RN23PROD with NOTICES1 Soroosh Armandi, D.O.; Decision and Order On February 1, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Soroosh Armandi, D.O., of San Pedro, California (Registrant). Request for Final Agency Action (RFAA), Attachment (RFAAX) A, at 1, 3. The OSC proposed the revocation of Registrant’s Certificate of Registration No. FA0060359, alleging that Registrant’s registration should be revoked because Registrant is ‘‘currently without authority to handle controlled substances in the State of California, the state in which [he is] registered with DEA.’’ Id. at 2 (citing 21 U.S.C. 824(a)(3)).1 The OSC notified Registrant of his right to file a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default. Id. (citing 21 CFR 1301.43). Here, Registrant did not request a 1 According to Agency records, Registrant’s registration expired on June 30, 2024. The fact that a registrant allows his registration to expire during the pendency of an OSC does not impact the Agency’s jurisdiction or prerogative under the Controlled Substances Act (CSA) to adjudicate the OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68474, 68476–68479 (2019). VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 hearing. RFAA, at 2.2 ‘‘A default, unless excused, shall be deemed to constitute a waiver of the [registrant’s] right to a hearing and an admission of the factual allegations of the [OSC].’’ 21 CFR 1301.43(e). Further, ‘‘[i]n the event that a registrant . . . is deemed to be in default . . . DEA may then file a request for final agency action with the Administrator, along with a record to support its request. In such circumstances, the Administrator may enter a default final order pursuant to [21 CFR] § 1316.67.’’ Id. § 1301.43(f)(1). Here, the Government has requested final agency action based on Registrant’s default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 1; see also 21 CFR 1316.67. Findings of Fact The Agency finds that, in light of Registrant’s default, the factual allegations in the OSC are admitted. According to the OSC, Registrant’s California medical license expired on March 31, 2023. RFAAX A, at 2. Further, effective June 29, 2023, the 2 Based on the Government’s submissions in its RFAA dated May 24, 2024, the Agency finds that service of the OSC on Registrant was adequate. The included declaration from a DEA Diversion Investigator (DI) indicates that she was ‘‘unable to locate Registrant and [she was] under the belief that Registrant was out of the country;’’ accordingly, on February 2, 2024, the DI emailed a copy of the OSC to Registrant’s registered email address. RFAAX 1, at 2. The DI did not state that an undeliverable message was ever received. Id. On the same date, the DI mailed a copy of the OSC to Registrant’s registered address. Id. On February 5, 2024, however, the OSC was returned to the DI, along with a notice of a forwarding address for Registrant. Id.; see also id., Attachment B. On February 14, 2024, the DI mailed a copy of the OSC to Registrant’s forwarding address and later received confirmation via the certified mailing receipt that the OSC was successfully delivered on February 17, 2024. Id. at 2; see also id., Attachment C. The Agency finds that the DI’s efforts to serve Registrant were ‘‘ ‘reasonably calculated, under all the circumstances, to apprise [Registrant] of the pendency of the action.’ ’’ Jones v. Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)). Therefore, due process notice requirements have been satisfied. PO 00000 Frm 00175 Fmt 4703 Sfmt 4703 7315 7381 7415 7434 7435 7437 7438 Schedule I I I I I I I Osteopathic Medical Board of California revoked Registrant’s California medical license. Id. According to California online records, of which the Agency takes official notice, Registrant’s California medical license remains revoked.3 California DCA License Search, https://search.dca.ca.gov (last visited date of signature of this Order).4 Accordingly, the Agency finds that Registrant is not licensed to practice medicine in California, the state in which he is registered with DEA. Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 ‘‘upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.’’ With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner’s registration. Gonzales v. 3 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Registrant may dispute the Agency’s finding by filing a properly supported motion for reconsideration of findings of fact within fifteen calendar days of the date of this Order. Any such motion and response shall be filed and served by email to the other party and to Office of the Administrator, Drug Enforcement Administration at dea.addo.attorneys@dea.gov. 4 The OSC lists the number for Registrant’s California medical license as 20A9741, RFAAX A, at 1; however, the California DCA License Search lists Registrant’s California medical license number as 9741. E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106579-106580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31293]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1461]


Bulk Manufacturer of Controlled Substances Application: Irvine 
Labs Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Irvine Labs 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.

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 
February 28, 2025. Such persons may also file a written request for a 
hearing on the application on or before February 28, 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

[[Page 106580]]

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 August 26, 2024, Irvine Labs Inc., 7305 Murdy Circle, 
Huntington Beach, California 92647-3533, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide..............            7315               I
Mescaline...............................            7381               I
Peyote..................................            7415               I
Diethyltryptamine.......................            7434               I
Dimethyltryptamine......................            7435               I
Psilocybin..............................            7437               I
Psilocyn................................            7438               I
------------------------------------------------------------------------

    The company plans to bulk manufacture the above listed controlled 
substances for research and development purposes internally and for 
distribution to its research customers. No other activities for these 
drug codes are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-31293 Filed 12-27-24; 8:45 am]
BILLING CODE 4410-09-P
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