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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 Commissions 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 Commissions 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 201.6b2, 201.13f, and 207.24 of the Commissions 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 Commissions 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 Commissions rules, and posthearing briefs, which must conform with the provisions of section 207.25 of the Commissions 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 Commissions rules.
All written submissions must conform with the provisions of 201.8 of the Commissions rules; any submissions that contain BPI must also conform with the requirements of 201.6, 207.3, and 207.7 of the Commissions rules. The Commissions Handbook on Filing Procedures, available on the Commissions website at https
www.usitc.gov/documents/handbook_
on_filing_procedures.pdf, elaborates
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upon the Commissions procedures with respect to filings.
Additional written submissions to the Commission, including requests pursuant to 201.12 of the Commissions 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 201.16c and 207.3 of the Commissions 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 Commissions rules.

In accordance with 21 CFR 1301.33a, this is notice that on February 2, 2021, Patheon Pharmaceuticals Inc, 2110 East Galbraith Road, Cincinnati, Ohio 452371625, 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. 202104809 Filed 3821; 8:45 am
By order of the Commission.
Issued: March 4, 2021.
Lisa Barton, Secretary to the Commission.

BILLING CODE 441009P

FR Doc. 202104860 Filed 3821; 8:45 am
Drug Enforcement Administration
DEPARTMENT OF JUSTICE

BILLING CODE 702002P

Docket No. DEA804

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 classes of controlled substances. Refer to Supplemental Information listed below for further drug information.
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 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. DEA802

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 classes of controlled substances. Refer to SUPPLEMENTARY
INFORMATION listed below for further drug information.
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 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 1301.33a, this is notice that on February 8, 2021, Stepan Company, 100 West Hunter Avenue, Maywood, New Jersey 07607

SUPPLEMENTARY INFORMATION:

E:FRFM09MRN1.SGM

09MRN1