Bulk Manufacturer of Controlled Substances Registration, 45468 [2018-19444]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES 45468 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers. In particular, the Commission is interested in comments that: (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States; (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders; (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded; (iv) indicate whether complainant, complainant’s licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and (v) explain how the requested remedial orders would impact United States consumers. Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues should be filed no later than by close of business nine calendar days after the date of publication of this notice in the Federal Register. Complainant may file a reply to any written submission no later than the date on which complainant’s reply would be due under § 210.8(c)(2) of the Commission’s Rules of Practice and Procedure (19 CFR 210.8(c)(2)). Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission’s Rules of Practice VerDate Sep<11>2014 17:55 Sep 06, 2018 Jkt 244001 and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (‘‘Docket No. 3336’’) in a prominent place on the cover page and/ or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures.1) Persons with questions regarding filing should contact the Secretary (202–205–2000). Any person desiring to submit a document to the Commission in confidence must request confidential treatment. 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 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)). By order of the Commission. 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00058 Fmt 4703 Sfmt 9990 Issued: August 31, 2018. Katherine Hiner, Supervisory Attorney. [FR Doc. 2018–19386 Filed 9–6–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. Registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances. SUMMARY: The company listed below applied to be registered as a bulk manufacturer 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 for this notice. SUPPLEMENTARY INFORMATION: Company FR docket Published Patheon API Manufacturing, Inc. 83 FR 22516 May 15, 2018. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant 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. Dated: August 23, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–19444 Filed 9–6–18; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Page 45468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19444]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: Registrant listed below has applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as a bulk 
manufacturer of various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION:  The company listed below applied to be 
registered as a bulk manufacturer 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 
for this notice.

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             Company                  FR docket           Published
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Patheon API Manufacturing, Inc..  83 FR 22516        May 15, 2018.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of this registrant 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.

    Dated: August 23, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-19444 Filed 9-6-18; 8:45 am]
 BILLING CODE 4410-09-P