Importer of Controlled Substances Application: AndersonBrecon Inc. DBA PCI of Illinois, 21811 [2019-10006]

Download as PDF Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: AndersonBrecon Inc. DBA PCI of Illinois ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before June 14, 2019. Such persons may also file a written request for a hearing on the application on or before June 14, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also 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. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on March 5, 2019, AndersonBrecon Inc., DBA PCI of Illinois, 5775 Logistics Parkway, Rockford, Illinois 61109 applied to be registered as an importer of the following basic class of controlled substance: jbell on DSK3GLQ082PROD with NOTICES DATES: Controlled substance Tetrahydrocannabinols .. VerDate Sep<11>2014 Drug code 7370 22:43 May 14, 2019 Schedule I Jkt 247001 The company plans to import the listed controlled substance for clinical trials only. Approval of permit application 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 FDA approved or non-approved finished dosage forms for commercial sale. Dated: April 27, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–10006 Filed 5–14–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Fred J. Powell, M.D.; Decision and Order On January 25, 2018, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Fred J. Powell. (hereinafter, Registrant), of St. Augustine, Florida. Order to Show Cause (hereinafter, OSC), at 1. The OSC proposes the revocation of Registrant’s Certificate of Registration (hereinafter, COR) on the ground that he is without authority to handle controlled substances in Florida, the State in which he is registered with the DEA. Id. at 2. The OSC cites the operative statutory provisions that spell out the requirements for registration upon which the DEA alleges that Registrant is deficient, and the DEA’s authority to revoke his registration. Id., at 1–2 (citing 21 U.S.C. 824(a)(3)). Jurisdiction This Agency has jurisdiction to decide this case based upon the OSC allegation that Registrant holds a DEA COR (No. AP8271138) at the registered address of 35 Townsend Pl., St. Augustine, FL 32092–3209. OSC, at 1. That registration authorizes Registrant, as a practitioner, to dispense controlled substances in schedules II through V and expires on March 31, 2020. Id. Substantive Ground for Revocation of COR Alleged in OSC The substantive ground for the proceeding, as alleged in the OSC, is that Registrant agreed to a permanent restriction prohibiting him from prescribing and ordering Schedule I through V controlled substances and thus is ‘‘currently without authority to handle controlled substances in the State of Florida,’’ the State in which he PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 21811 is registered with the DEA under DEA COR No. AP8271138. OSC, at 2. The OSC notified Registrant of his right to request a hearing on the allegations or to submit a written statement if he chooses to waive his right to a hearing, the procedures for electing each option, and the consequences for failing to elect one of those options. Id. (citing 21 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan, the specific procedures for filing a corrective action plan, and the statutory provision that governs such a plan. Id. at 2–3 (citing 21 U.S.C. 824(c)(2)(C)). By letter dated March 27, 2018, Registrant timely submitted a corrective action plan (hereinafter, CAP). Request for Final Agency Action dated April 10, 2018 (hereinafter, RFAA), Exhibit (hereinafter, Exh.) 5.1 Registrant’s CAP consists of thirteen paragraphs containing assertions. The Assistant Administrator of the Diversion Control Division denied Registrant’s CAP by letter dated April 6, 2018. Exh. 6. In its RFAA, the Government represents that, ‘‘At least 30 days have passed since the time the . . . [OSC] was served on Registrant. Registrant has not requested a hearing.’’ RFAA, at 2. The Government requests the issuance of a ‘‘Final Order revoking Registrant’s DEA registration.’’ Id. at 4. The very existence of the CAP evidences that service of the OSC on Registrant was adequate. In addition, Registrant did not dispute service. Based on the Government’s written representations and my review of the record, I find that more than thirty days have now passed since the date the Government served the OSC. I find that Registrant timely submitted a CAP and that the Assistant Administrator of the Diversion Control Division denied Registrant’s CAP by letter dated April 6, 2018. Further, based on the Government’s written representations, I find that neither Registrant, nor anyone purporting to represent him, requested a hearing or submitted a written statement while waiving Registrant’s right to a hearing. Accordingly, I find that Registrant has waived his right to a hearing and his right to submit a written statement. 21 CFR 1301.43(d). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e). 1 Also attached to the RFAA is a ‘‘Declaration’’ of a DEA Diversion Investigator (hereinafter, DI Declaration). Exh. 4. According to the DI Declaration, two Diversion Investigators personally served the OSC on Registrant on January 26, 2018. E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Page 21811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10006]



[[Page 21811]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: AndersonBrecon 
Inc. DBA PCI of Illinois

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before June 14, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before June 14, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on March 
5, 2019, AndersonBrecon Inc., DBA PCI of Illinois, 5775 Logistics 
Parkway, Rockford, Illinois 61109 applied to be registered as an 
importer of the following basic class of controlled substance:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................         7370  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substance for 
clinical trials only. Approval of permit application 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 FDA approved or non-approved finished dosage forms for 
commercial sale.

    Dated: April 27, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-10006 Filed 5-14-19; 8:45 am]
 BILLING CODE 4410-09-P