Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC, 23066-23067 [2017-10230]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 23066 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered. Written Submissions: The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding. Complainants are requested to submit proposed remedial orders for the Commission’s consideration. Complainants are also requested to state the date that the patent expires and the HTSUS numbers under which the accused products are imported. Complainants are further requested to supply the names of known importers of the Nautilus products at issue in this investigation. The written submissions and proposed remedial orders must be filed no later than close of business on May 25, 2017. Reply submissions must be filed no later than the close of business on June 1, 2017. Opening submissions are limited to 50 pages. Reply submissions are limited to 25 pages. Such submissions should address the ALJ’s recommended determinations on remedy and bonding. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission. Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission’s Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–989’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, http://www.usitc.gov/ secretary/fed_reg_notices/rules/ handbook_on_electronic_filing.pdf). 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 VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 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,1 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission’s Rules of Practice and Procedure (19 CFR part 210). rules-policies/records-and-archivesrules-committees/agenda-books. DATES: June 12–13, 2017. TIME: June 12—1:30 p.m.–5:00 p.m. June 13—8:30 a.m.–3:00 p.m. ADDRESSES: Thurgood Marshall Federal Judiciary Building, Mecham Conference Center, Administrative Office of the United States Courts, One Columbus Circle NE., Washington, DC 20544. FOR FURTHER INFORMATION CONTACT: Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502–1820. By order of the Commission. Issued: May 15, 2017. William R. Bishop, Supervisory Hearings and Information Officer. DATES: [FR Doc. 2017–10144 Filed 5–18–17; 8:45 am] BILLING CODE 7020–02–P JUDICIAL CONFERENCE OF THE UNITED STATES Meeting of the Judicial Conference; Committee on Rules of Practice and Procedure Committee on Rules of Practice and Procedure, Judicial Conference of the United States. ACTION: Notice of open meeting. AGENCY: The Committee on Rules of Practice and Procedure will hold a meeting on June 12–13, 2017. The meeting will be open to public observation but not participation. An agenda and supporting materials will be posted at least 7 days in advance of the meeting at: http://www.uscourts.gov/ SUMMARY: 1 All contract personnel will sign appropriate nondisclosure agreements. PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 Dated: May 15, 2017. Rebecca A. Womeldorf, Rules Committee Secretary. [FR Doc. 2017–10151 Filed 5–18–17; 8:45 am] BILLING CODE 2210–55–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC ACTION: Notice of application. 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 July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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 Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant SUPPLEMENTARY INFORMATION: E:\FR\FM\19MYN1.SGM 19MYN1 23067 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices [Docket No. DEA–392] 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 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 December 2, 2016, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237 applied to be registered as a bulk manufacturer of gamma hydroxybutyric acid (2010) a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for product development. Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. 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 March 21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes is authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10230 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2017–10238 Filed 5–18–17; 8:45 am] ACTION: Notice of application. BILLING CODE 4410–09–P Registered bulk manufacturers of the affected basic class, 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 July 18, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW 8701 DATES: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Registered bulk manufacturers of the affected basic class, 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 July 18, 2017. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 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 March 3, 2017, Eli-Elsohly Laboratories, Mahmoud A. Elsohly Ph. D., 5 Industrial Park Drive, Oxford, Mississippi 38655 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories ACTION: Notice of application. asabaliauskas on DSK3SPTVN1PROD with NOTICES Controlled substance Drug code Marihuana Extract ........................................................................................................................................................... Marihuana ........................................................................................................................................................................ Tetrahydrocannabinols .................................................................................................................................................... Dihydromorphine ............................................................................................................................................................. Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Morphine .......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1 7350 7360 7370 9145 1100 1105 9041 9050 9120 9143 9150 9180 9193 9300 9333 Schedule I I I I II II II II II II II II II II II

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23066-23067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10230]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Insys 
Manufacturing, LLC

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 July 18, 2017.

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 Assistant Administrator of the DEA Diversion Control Division 
(``Assistant

[[Page 23067]]

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 March 
21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, 
Texas 78665 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
------------------------------------------------------------------------

    The company plans to manufacture bulk synthetic active 
pharmaceutical ingredients (APIs) for product development and 
distribution to its customers. No other activity for these drug codes 
is authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10230 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P