Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 5274 [2018-02345]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES 5274 Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Notices 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 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. 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 and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (‘‘Docket No. 3292) in a prominent place on the cover page and/ or the first page. (See Handbook for Electonic 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. Issued: February 1, 2018. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2018–02288 Filed 2–5–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc. ACTION: 1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_ filing_procedures.pdf. VerDate Sep<11>2014 19:02 Feb 05, 2018 Jkt 244001 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 in accordance with 21 CFR 1301.33(a) on or before April 9, 2018. DATES: contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Dated: January 30, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–02345 Filed 2–5–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of application. 2 All 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 redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 December 11, 2017, Patheon Pharmaceuticals, Inc., 2110 E Galbraith Road, Cincinnati, OH 45237 applied for renewal of their registration as a bulk manufacturer of the Schedule I control substance Gamma Hydroxybutyric Acid (2010) the basic class of controlled substances. The Gama Hydroxybutyric Acid will be produced during the process of converting gamma-butyrolactone (GBL) into a new product for development. The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into dosage forms of a new product. No other activities for this drug code are authorized for this registration. ADDRESSES: Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: E:\FR\FM\06FEN1.SGM 06FEN1

Agencies

[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02345]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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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 in accordance with 21 CFR 
1301.33(a) on or before April 9, 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 redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 
December 11, 2017, Patheon Pharmaceuticals, Inc., 2110 E Galbraith 
Road, Cincinnati, OH 45237 applied for renewal of their registration as 
a bulk manufacturer of the Schedule I control substance Gamma 
Hydroxybutyric Acid (2010) the basic class of controlled substances.
    The Gama Hydroxybutyric Acid will be produced during the process of 
converting gamma-butyrolactone (GBL) into a new product for 
development. The company plans to manufacture the above listed 
controlled substance as Active Pharmaceutical Ingredient (API) that 
will be further synthesized into dosage forms of a new product.
    No other activities for this drug code are authorized for this 
registration.

    Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02345 Filed 2-5-18; 8:45 am]
 BILLING CODE 4410-09-P
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