Importer of Controlled Substances Application: Myoderm, 13134-13135 [2017-04646]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 13134 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 3. Please explain how ‘‘antitrust injury’’ standing, as required for private litigants in federal district courts asserting antitrust claims, see, e.g., Atl. Richfield Co. v. USA Petroleum Co., 495 U.S. 328, 335 (1990), compares to, or differs from, the injury requirement under Section 337(a)(1)(A). Please include an analysis of any relevant statutory language, legislative history, Commission determinations, case law, or other authority. In discussing this question, please explain the chronology of the adoption of the ‘‘antitrust injury’’ standing requirement in relation to the injury requirement under Section 337(a)(1)(A). 4. Please explain whether ‘‘antitrust injury’’ standing is, or should be, required for establishing a Section 337 violation based on a claim alleging a conspiracy to fix prices and control output and export volumes as a matter of law and/or policy. Please include an analysis of any relevant statutory language, legislative history, Commission determinations, case law, or other authority. The parties to this investigation, including the Office of Unfair Import Investigations, may file submissions in response to any written submission(s) that are submitted by the public or any interested government agencies. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission. Written Submissions: Written submissions from entities other than the parties and/or government agencies shall include a Statement of Interest including: (1) A concise statement of the identity of the entity filing the written submission, its interest in the case, and the reasons why the written submission is relevant to the disposition of the issues in dispute; and (2) a statement indicating whether: (i) A party’s counsel authored the written submission in whole or in part; (ii) a party or party’s counsel contributed money that was intended to fund preparing or submitting the written submission; and (iii) a person—other than the entity, its members, or its counsel—contributed money that was specifically intended to fund preparing or submitting the written submission and, if so, each such person shall be identified. Written submissions from individuals shall also include a curriculum vitae (‘‘CV’’). Written submissions must be filed no later than close of business on March 27, 2017, may not exceed 20 pages in length, exclusive of any exhibits, Statement of Interest, and CV, and shall be doublespaced. Responsive submissions from the parties must be filed no later than the close of business on April 3, 2017, VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 may not exceed 20 pages in length, exclusive of any exhibits, and shall be double-spaced. 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 (8) 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–1002’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https://www.usitc.gov/ secretary/documents/handbook_on_ filing_procedures.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 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. Commission Oral Argument: The Commission has also determined to reschedule the oral argument to April 20, 2017, in order to provide sufficient time for the Commission to receive and review any written submissions and any responses thereto. The Commission will hold the public oral argument in the Commission’s Main Hearing Room 1 All contract personnel will sign appropriate nondisclosure agreements. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 (Room 101), 500 E Street SW., Washington, DC 20436, beginning at 9:30 a.m. While any member of the public may attend the oral argument, only counsel for the parties to the investigation, including the Office of Unfair Import Investigations, and representatives of interested government agencies may participate and/or argue at the oral argument. At the oral argument, counsel for each party and representatives of interested government agencies will be given an opportunity to comment in opening remarks for no more than 10 minutes, and the Commissioners may ask questions of those appearing. Details as to the format of the hearing will be provided at a later date. This is a public proceeding; confidential business information (‘‘CBI’’) shall not be discussed. A party, however, can draw the Commission’s attention to CBI, if necessary, by pointing to where in the record the information can be found. The oral argument will be limited in scope to the issues identified in the ID (Order No. 38); the Commission’s December 19, 2016, Notice; the present Notice; and any related petition, written submissions, and responses thereto. After the conclusion of the oral argument, no additional written submissions or arguments will be permitted. Notice of Appearance: Counsel for the parties to the investigation or any representatives of interested government agencies who wish to participate in the oral argument must file a written request to appear at the Commission oral argument by April 6, 2017 and must provide their email addresses as part of their contact information. 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). By order of the Commission. Issued: March 3, 2017. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2017–04597 Filed 3–8–17; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Myoderm ACTION: E:\FR\FM\09MRN1.SGM Notice of application. 09MRN1 13135 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 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 1301.34(a) on or before April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, DATES: 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on November 11, 2016, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Amphetamine ............................................................................................................................................................. Lisdexamfetamine ...................................................................................................................................................... Methylphenidate ......................................................................................................................................................... Nabilone ..................................................................................................................................................................... Oxycodone ................................................................................................................................................................. Hydromorphone .......................................................................................................................................................... Hydrocodone .............................................................................................................................................................. Morphine .................................................................................................................................................................... Oxymorphone ............................................................................................................................................................. Fentanyl ...................................................................................................................................................................... The company plans to import the listed controlled substances in finished dosage form for clinical trials, research, and analytical purposes. The import of the above listed basic classes of controlled substances will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–04646 Filed 3–8–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES [Docket No. DEA–392] Importer of Controlled Substances Application: Meridian Medical Technologies 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 1301.34(a) on DATES: VerDate Sep<11>2014 18:42 Mar 08, 2017 Jkt 241001 or before April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 1100 1205 1724 7379 9143 9150 9193 9300 9652 9801 Schedule II II II II II II II II II II 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 1301.34(a), this is notice that on December 29, 2016, Meridian Medical Technologies, 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of morphine (9300), a basic class of controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13134-13135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04646]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Myoderm

ACTION: Notice of application.

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[[Page 13135]]


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 
1301.34(a) on or before April 10, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 10, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: 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 Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
November 11, 2016, Myoderm, 48 East Main Street, Norristown, 
Pennsylvania 19401 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
       Controlled substance           Drug code           Schedule
------------------------------------------------------------------------
Amphetamine......................            1100  II
Lisdexamfetamine.................            1205  II
Methylphenidate..................            1724  II
Nabilone.........................            7379  II
Oxycodone........................            9143  II
Hydromorphone....................            9150  II
Hydrocodone......................            9193  II
Morphine.........................            9300  II
Oxymorphone......................            9652  II
Fentanyl.........................            9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form for clinical trials, research, and analytical 
purposes.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing, research, and 
clinical trials. This authorization does not extend to the import of a 
finished FDA approved or non-approved dosage form for commercial sale.

Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04646 Filed 3-8-17; 8:45 am]
 BILLING CODE 4410-09-P