Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation, 27628 [2018-12684]

Download as PDF 27628 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 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 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)). Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 13, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 delegated 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 1301.33(a), this is notice that on May 3rd, 2018, Alcami Wisconsin Corporation, W130 N10497 Washington Dr., Germantown, WI 53022 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance By order of the Commission. Issued: June 7, 2018. Lisa Barton, Secretary to the Commission. Drug code Thebaine ........... Alfentanil ........... [FR Doc. 2018–12651 Filed 6–12–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 9333 9737 Schedule II II The company plans to provide bulk active pharmaceutical ingredient to support clinical trials. Dated: June 6, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–12684 Filed 6–12–18; 8:45 am] [Docket No. DEA–392] BILLING CODE 4410–09–P amozie on DSK3GDR082PROD with NOTICES1 Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation ACTION: Notice of application. 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 DEPARTMENT OF JUSTICE Drug Enforcement Administration Gazelle A. Craig, D.O.; Decision and Order Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Gazelle A. Craig, D.O. (hereinafter, Respondent), of Houston, Texas. GX 2 (Order to Show Cause). The Show Cause Order proposed the revocation of Respondent’s Certificate of Registration on the ground that she does ‘‘not have authority to handle controlled substances in the State of Texas, the [S]tate in which . . . [she is] registered with the DEA.’’ Id. at 1 (citing 21 U.S.C. 823(f) and 824(a)(3)). As to the Agency’s jurisdiction, the Show Cause Order alleged that Respondent holds DEA Certificate of Registration No. FC1384306, which authorizes her to dispense controlled substances in schedules II through V as a practitioner, at the registered address of Gulfton Community Health Center, 6306 Gulfton St., Suite 101, Houston, Texas 77081. Id. The Show Cause Order alleged that this registration expires on August 31, 2018. Id. As the substantive ground for the proceeding, the Show Cause Order alleged that Respondent is ‘‘without authority to handle controlled substances in the State of Texas, the [S]tate in which . . . [she is] registered . . . with the DEA.’’ Id. It further alleged that, on July 28, 2017, the Texas Medical Board temporarily suspended Respondent’s medical license and that the Texas Medical Board order remains in effect. Id. The Show Cause Order asserted that Respondent is ‘‘required to possess authority from a [S]tate in order to obtain or retain a DEA Registration. . . . [and c]onsequently, the DEA must revoke . . . [her registration] based upon [her] lack of authority to handle controlled substances in the State of Texas.’’ Id. at 1–2. The Show Cause Order notified Respondent of her right to request a hearing on the allegations or to submit a written statement while waiving her right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2 (citing 21 CFR 1301.43). The Show Cause Order also notified Respondent of the opportunity to submit a Corrective Action Plan. Id. at 2–3 (citing 21 U.S.C. 824(c)(2)(C)). On September 20, 2017, the Acting Assistant Administrator, Diversion PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1

Agencies

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12684]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Alcami 
Wisconsin Corporation

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before August 13, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
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 delegated 
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 1301.33(a), this is notice that on May 
3rd, 2018, Alcami Wisconsin Corporation, W130 N10497 Washington Dr., 
Germantown, WI 53022 applied to be registered as a bulk manufacturer of 
the following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Thebaine...........................            9333  II
Alfentanil.........................            9737  II
------------------------------------------------------------------------

    The company plans to provide bulk active pharmaceutical ingredient 
to support clinical trials.

    Dated: June 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-12684 Filed 6-12-18; 8:45 am]
 BILLING CODE 4410-09-P