Importer of Controlled Substances Application: SpecGx LLC, 13954-13955 [2019-06852]

Download as PDF 13954 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Importer of Controlled Substances Registration Importer of Controlled Substances Registration [Docket No. DEA–392] ACTION: Notice of registration. ACTION: SUMMARY: The applicant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become an importer of a schedule I controlled substance. SUMMARY: The company listed below applied to be registered as an importer of a basic class of controlled substance. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for this notice. SUPPLEMENTARY INFORMATION: Company FR docket Almac Clinical Services Incorp (ACSI). 84 FR 3253 The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice. Published February 11, 2019. Company FR docket Usona Institute ....................... 83 FR 64365 ACTION: Notice of registration. The registrant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of various classes of schedule I controlled substances. SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as a bulk manufacturer of basic classes of schedule I controlled substances. Information on a previously published notice is listed below. No comments or objections were submitted for the notice. SUMMARY: The applicant listed below has submitted an application for registration to the Drug Enforcement Administration (DEA) to become an importer of schedule I controlled substances. SUPPLEMENTARY INFORMATION: jbell on DSK30RV082PROD with NOTICES Notice of registration. Bulk Manufacturer of Controlled Substances Registration Published December 14, 2018. Company FR docket Usona Institute .......... 83 FR 64364 Published December 14, 2018. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this applicant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed applicant to import the applicable basic class of schedule I controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security system, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer of a schedule I controlled substance to the above listed company. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed applicant to import the applicable basic classes of schedule I controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I controlled substances to the above listed company. Dated: March 21, 2019. John J. Martin, Assistant Administrator. Dated: March 21, 2019. John J. Martin, Assistant Administrator. Drug Enforcement Administration [FR Doc. 2019–06845 Filed 4–5–19; 8:45 am] [FR Doc. 2019–06847 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P Importer of Controlled Substances Application: SpecGx LLC Dated: March 21, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–06848 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [Docket No. DEA–392] ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices comments on or objections to the issuance of the proposed registration on or before May 8, 2019. Such persons may also file a written request for a hearing on the application on or before May 8, 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. Comments and requests for hearings on applications to import narcotic raw materials are not appropriate. 72 FR 3417 (January 25, 2007). 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 February 1, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances: jbell on DSK30RV082PROD with NOTICES Controlled substance Drug code Marihuana .............. Phenylacetone ....... Coca Leaves ......... Opium, raw ............ Poppy Straw Concentrate. 7360 8501 9040 9600 9670 Schedule I II II II II The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 Ingredients (API) for distribution to its customers. In reference to drug code 7360 (marihuana), the company plans to import synthetic cannabidiol. No other activity for this drug code is authorized for this registration. Placement of these codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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 FDA approved or nonapproved finished dosage forms for commercial sale. Dated: March 21, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–06852 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 19–3] Martin A. Barrios, M.D.; Decision and Order On October 22, 2018, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Martin A. Barrios, M.D. (hereinafter, Respondent), of Jackson, Kentucky. Order to Show Cause (hereinafter, OSC), at 1. The Show Cause Order proposes the revocation of Respondent’s Certificate of Registration on the ground that he does ‘‘not have authority to handle controlled substances in the State of Kentucky, the state in which . . . [he is] registered with the DEA.’’ Id. (citing 21 U.S.C. 823(f) and 824(a)(3)). Regarding jurisdiction, the Show Cause Order alleges that Respondent holds DEA Certificate of Registration No. FB0348563 at the registered address of 540 Jett Drive, Jackson, Kentucky 41339. OSC, at 1. This registration is alleged to authorize Respondent to dispense controlled substances in schedules II through V as a practitioner. The Show Cause Order alleges that this registration expires on July 31, 2019. Id. The substantive ground for the proceeding, as alleged in the Show Cause Order, is that Respondent is ‘‘without authority to handle controlled substances in the State of Kentucky, the state in which . . . [he is] registered PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 13955 . . . with the DEA.’’ Id. at 2. Specifically, the Show Cause Order alleges that, on or about May 18, 2018, the Commonwealth of Kentucky Board of Medical Licensure (hereinafter, Kentucky Board) issued an Amended Emergency Order of Restriction prohibiting Respondent from ‘‘prescribing, dispensing, or otherwise professionally utilizing controlled substances until the Board’s hearing panel has finally resolved the Complaint after receipt of the court documents resolving the criminal charges in the [criminal] indictment . . . or until such further Order of the Board.’’ Id. The Show Cause Order notifies Respondent of his right to request a hearing on the allegations or to submit a written statement while waiving his 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 Show Cause Order also notifies Respondent of the opportunity to submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 824(c)(2)(C)). By letter dated November 12, 2018, Respondent timely requested a hearing.1 Hearing Request, at 1. According to the Hearing Request, Respondent’s ‘‘interest in the proceedings is to defend . . . [his] innocence.’’ Id. Respondent’s Hearing Request ‘‘acknowledge[s] . . . the actions taken by both the Kentucky medical board and American Board of [S]urgery.’’ Id. at 2. It states that Respondent is ‘‘in the process of appealing the American Board of Surgery’s action.’’ Id. The Office of Administrative Law Judges put the matter on the docket and assigned it to Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ). The ALJ issued a Briefing Schedule for Lack of State Authority Allegations dated November 16, 2018. The Government timely complied with the Briefing Schedule by filing a Motion for Summary Disposition on November 30, 2018 (hereinafter, Government Motion). Order Granting Summary Disposition and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision dated December 20, 2018 (hereinafter, R.D.), at 2. In its motion, the Government stated that Respondent lacks authority to handle controlled substances in Kentucky, the State in which he is registered with the DEA and argued that, therefore, DEA must revoke his registration. Id. Respondent did not 1 The Hearing Request was filed on November 15, 2018. Briefing Schedule for Lack of State Authority Allegations dated November 16, 2018, at 1. I, thus, find that the Government’s service of the OSC was adequate. E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13954-13955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06852]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: SpecGx LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written

[[Page 13955]]

comments on or objections to the issuance of the proposed registration 
on or before May 8, 2019. Such persons may also file a written request 
for a hearing on the application on or before May 8, 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. Comments and requests for hearings on 
applications to import narcotic raw materials are not appropriate. 72 
FR 3417 (January 25, 2007).

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 
February 1, 2019, SpecGx LLC, 3600 North Second Street, Saint Louis, 
Missouri 63147 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Marihuana............................         7360  I
Phenylacetone........................         8501  II
Coca Leaves..........................         9040  II
Opium, raw...........................         9600  II
Poppy Straw Concentrate..............         9670  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances to 
bulk manufacture into Active Pharmaceutical Ingredients (API) for 
distribution to its customers. In reference to drug code 7360 
(marihuana), the company plans to import synthetic cannabidiol. No 
other activity for this drug code is authorized for this registration. 
Placement of these codes onto the company's registration does not 
translate into automatic approval of subsequent permit applications to 
import controlled substances. 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 FDA approved or non-approved finished dosage 
forms for commercial sale.

    Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06852 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P