Bulk Manufacturer of Controlled Substances Application: Organix Inc., 32279-32280 [2021-12817]

Download as PDF 32279 Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Notices 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)). Drug Enforcement Administration Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 19, 2021. Such persons may also file a written request for a hearing on the application on or before July 19, 2021. 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: In accordance with 21 CFR 1301.34(a), this is notice that on April 28, 2021, Xcelience, 4901 West Grace Street, Tampa, Florida 33607–3805, applied to be registered as an importer of the following basic class(es) of controlled substance(s): [Docket No. DEA–854] Controlled substance Drug code Importer of Controlled Substances Application: Xcelience Psilocybin ................ 7437 By order of the Commission. Issued: June 11, 2021. Lisa Barton, Secretary to the Commission. [FR Doc. 2021–12811 Filed 6–16–21; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Xcelience 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: DATES: Schedule I The company plans to import drug code 7437 (Psilocybin) as finished dosage form for clinical trials, research, and analytical purposes. 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. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12816 Filed 6–16–21; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–855] Bulk Manufacturer of Controlled Substances Application: Organix Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Organix Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 16, 2021. Such persons may also file a written request for a hearing on the application on or before August 16, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: In accordance with 21 CFR 1301.33(a), this is notice that on April 27, 2021, Organix Inc., 240 Salem Street, Woburn, Massachusetts 01801–2029, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code lotter on DSK11XQN23PROD with NOTICES1 Mescaline ......................................................................................................................................................................... 3,4,5-trimethoxyamphetamine ......................................................................................................................................... 4-bromo-2,5-dimethoxyphenethylamine .......................................................................................................................... 3,4-methylenedioxyamphetamine .................................................................................................................................... 3,4-methylenedioxymethamphetamine ............................................................................................................................ 2-(2,5-dimethoxyphenyl)ethanamine ............................................................................................................................... 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine .................................................................................................................... 2 All contract personnel will sign appropriate nondisclosure agreements. VerDate Sep<11>2014 18:41 Jun 16, 2021 Jkt 253001 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1 7381 7390 7392 7400 7405 7517 7518 Schedule I I I I I I I 32280 Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Notices The company plans to bulk manufacture small quantities of the above controlled substances for use in clinical research. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2021–12817 Filed 6–16–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–853] Importer of Controlled Substances Application: Andersonbrecon Inc. DBA PCI of Illinois lotter on DSK11XQN23PROD with NOTICES1 18:41 Jun 16, 2021 Jkt 253001 7370 II The company plans to import the listed controlled substance for clinical trial studies only. No other activity for these drug codes 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 the Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. BILLING CODE 4410–09–P Andersonbrecon Inc. DBA PCI of Illinois 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 file written comments on or objections to the issuance of the proposed registration on or before July 19, 2021. Such persons may also file a written request for a hearing on the application on or before July 19, 2021. 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 request 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: In accordance with 21 CFR 1301.34(a), this is notice that on May 17, 2021, Andersonbrecon Inc. DBA PCI of Illinois, 5775 Logistics Parkway, Rockford, Illinois 61109–3608 applied to be registered as an importer of the following basic class(es) of controlled substance(s): VerDate Sep<11>2014 I Tetrahydrocannabinols Schedule [FR Doc. 2021–12819 Filed 6–16–21; 8:45 am] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: SUMMARY: Drug code Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration Johnny C. Benjamin, Jr., M.D.; Decision and Order I. Procedural Background On September 28, 2018, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Johnny C. Benjamin, Jr., M.D. (hereinafter, Registrant) of Vero Beach, Florida. OSC, at 1. The OSC proposed the revocation of Registrant’s Certificate of Registration No. BB3725732. Id. It alleged that Registrant has ‘‘been convicted of a felony relating to controlled substances and ha[s] no state authority to handle controlled substances.’’ Id. (citing 21 U.S.C. 824(a)(2) & (a)(3)). Specifically, the OSC alleged that on April 27, 2018, Registrant was convicted by a Federal jury of: Conspiracy to possess with intent to distribute furanyl fentanyl resulting in death, in violation of 21 U.S.C. 846; distribution of furanyl fentanyl resulting in death, in violation of 21 U.S.C. 841(a)(1); attempt to possess with intent to distribute acetyl fentanyl, in violation of 21 U.S.C. 846; possession with intent to distribute oxycodone, in violation of 21 U.S.C. 841(a)(1); and conspiracy to possess with intent to distribute hydrocodone and oxycodone, in violation of 21 U.S.C. 846. Id. at 2. The OSC alleged that on July 6, 2018, the court issued its Judgment and sentenced Registrant to life in prison. Id. The OSC also alleged that, on May 3, 2018, ‘‘the State of PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Florida Department of Health immediately suspended Registrant’s Florida Medical License.’’ Id. The OSC further alleged that, as a result, Registrant is ‘‘currently without authority to handle controlled substances in the State of Florida, the state in which [Registrant] is registered with the DEA.’’ Id. (citing 21 U.S.C. 824(a)(3); 21 CFR 1301.37(b)). The OSC concluded that ‘‘DEA must revoke . . . [Registrant’s] DEA registration based on [his] lack of authority to handle controlled substances in the State of Florida.’’ OSC, at 2. The OSC notified Registrant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2–3 (citing 21 CFR 1301.43). The OSC also notified Registrant of the opportunity to submit a corrective action plan. OSC, at 3–4 (citing 21 U.S.C. 824(c)(2)(C)). II. Adequacy of Service In a sworn Declaration, dated January 17, 2019, a DEA Diversion Investigator assigned to the West Palm Beach District Office of the Miami Division (hereinafter, DI) stated that she ‘‘spoke by telephone with United States Penitentiary Coleman SIS Technician [T.B.] to determine what procedures the prison had in place for serving legal documents on prisoners and [to] make arrangements for service of the [OSC] on Registrant.’’ Government’s Request for Final Agency Action (hereinafter, RFAA) Exhibit (hereinafter, RFAAX) 7 (DI Declaration), at 1. DI stated that T.B. explained that T.B. ‘‘would personally serve the [OSC] on [Registrant].’’ Id. Accordingly, DI stated that, on October 10, 2018, she sent the OSC via FedEx addressed to T.B. along with an unsigned Form DEA–12, Receipt for Cash or Other items. Id. DI further declared that on October 18, 2018, she ‘‘received a FedEx package . . . from [T.B.] with the Form DEA–12 which had been signed by Registrant and witnessed by [T.B.], dated October 16, 2018.’’ Id.; see also RFAAX 7, Attachment (Form DEA–12). Additionally, on September 28, 2018, the DEA Office of Chief Counsel (hereinafter, CC) mailed the OSC to Registrant at both his registered address and his prison address. RFAAX 6 (CC Declaration of Service). Neither letter was returned to the Office of Chief Counsel as undeliverable. Id. The Government forwarded its RFAA, along with the evidentiary record, to this office on January 23, 2019. In its RFAA, the Government represents that E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 86, Number 115 (Thursday, June 17, 2021)]
[Notices]
[Pages 32279-32280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12817]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-855]


Bulk Manufacturer of Controlled Substances Application: Organix 
Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Organix Inc. has applied to be registered as a bulk 
manufacturer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before August 16, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before August 16, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on April 27, 2021, Organix Inc., 240 Salem Street, 
Woburn, Massachusetts 01801-2029, applied to be registered as an bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Mescaline..........................            7381  I
3,4,5-trimethoxyamphetamine........            7390  I
4-bromo-2,5-dimethoxyphenethylamine            7392  I
3,4-methylenedioxyamphetamine......            7400  I
3,4-methylenedioxymethamphetamine..            7405  I
2-(2,5-dimethoxyphenyl)ethanamine..            7517  I
2-(4-Iodo-2,5-                                 7518  I
 dimethoxyphenyl)ethanamine.
------------------------------------------------------------------------


[[Page 32280]]

    The company plans to bulk manufacture small quantities of the above 
controlled substances for use in clinical research. No other activities 
for these drug codes are authorized for this registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12817 Filed 6-16-21; 8:45 am]
BILLING CODE 4410-09-P
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