Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc, 13586 [2021-04809]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 13586 Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Notices calendarpad/calendar.html. Interested parties should check the Commission’s website periodically for updates. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before May 6, 2021. A nonparty who has testimony that may aid the Commission’s deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference to be held at 9:30 a.m. on May 7, 2021, if deemed necessary. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission’s rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 business days prior to the date of the hearing. Written submissions.—Each party who is an interested party shall submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of § 207.23 of the Commission’s rules; the deadline for filing is May 4, 2021. Parties may also file written testimony in connection with their presentation at the hearing, as provided in § 207.24 of the Commission’s rules, and posthearing briefs, which must conform with the provisions of section 207.25 of the Commission’s rules. The deadline for filing posthearing briefs is May 17, 2021. In addition, any person who has not entered an appearance as a party to the investigations may submit a written statement of information pertinent to the subject of the investigations, including statements of support or opposition to the petition, on or before May 17, 2021. On June 4, 2021, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before June 8, 2021, but such final comments must not contain new factual information and must otherwise comply with § 207.30 of the Commission’s rules. 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 VerDate Sep<11>2014 17:03 Mar 08, 2021 Jkt 253001 upon the Commission’s procedures with respect to filings. Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission’s rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff. In accordance with §§ 201.16(c) and 207.3 of the Commission’s 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. Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.21 of the Commission’s rules. In accordance with 21 CFR 1301.33(a), this is notice that on February 2, 2021, Patheon Pharmaceuticals Inc, 2110 East Galbraith Road, Cincinnati, Ohio 45237–1625, applied to be registered as a bulk manufacturer of the following basic class of controlled substance: SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. Drug code Schedule 2010 I The company plans to manufacture the above-listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into Food and Drug Administrationapproved dosage forms. No other activities for this drug code are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2021–04809 Filed 3–8–21; 8:45 am] By order of the Commission. Issued: March 4, 2021. Lisa Barton, Secretary to the Commission. BILLING CODE 4410–09–P [FR Doc. 2021–04860 Filed 3–8–21; 8:45 am] Drug Enforcement Administration DEPARTMENT OF JUSTICE BILLING CODE 7020–02–P [Docket No. DEA–804] DEPARTMENT OF JUSTICE Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Patheon Pharmaceuticals 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 May 10, 2021. Such persons may also file a written request for a hearing on the application on or before May 10, 2021. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: Frm 00068 Fmt 4703 Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: [Docket No. DEA–802] PO 00000 Bulk Manufacturer of Controlled Substances Application: Stepan Company Sfmt 4703 Stepan Company 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 file written comments on or objections to the issuance of the proposed registration on or before May 10, 2021. Such persons may also file a written request for a hearing on the application on or before May 10, 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 February 8, 2021, Stepan Company, 100 West Hunter Avenue, Maywood, New Jersey 07607– SUPPLEMENTARY INFORMATION: E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Page 13586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04809]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-802]


Bulk Manufacturer of Controlled Substances Application: Patheon 
Pharmaceuticals Inc

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Patheon Pharmaceuticals 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 May 10, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before May 10, 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 February 2, 2021, Patheon Pharmaceuticals Inc, 2110 
East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be 
registered as a bulk manufacturer of the following basic class of 
controlled substance:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............    2010  I
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substance as Active Pharmaceutical Ingredient (API) that will be 
further synthesized into Food and Drug Administration-approved dosage 
forms. No other activities for this drug code are authorized for this 
registration.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-04809 Filed 3-8-21; 8:45 am]
BILLING CODE 4410-09-P
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