Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc., 49663 [2017-23328]

Download as PDF Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices ethrower on DSK3G9T082PROD with NOTICES 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. 3266’’) 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. VerDate Sep<11>2014 17:29 Oct 25, 2017 Jkt 244001 Issued: October 20, 2017. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2017–23233 Filed 10–25–17; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Galephar Pharmaceutical Research, Inc. 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 on or before November 27, 2017. Such persons may also file a written request for a hearing on the application on or before November 27, 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 August 2, 2017, Galephar Pharmaceutical DATES: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 49663 Research, Inc., #100 Carr 198, Industrial Park, Juncos, Puerto Rico 00777–3873 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes. The import of this class of controlled substance 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. Dated: October 18, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–23328 Filed 10–25–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 17–28] Yoon H. Choi, M.D.; Decision and Order On April 4, 2017, the Assistant Administrator, Division of Diversion Control, issued an Order to Show Cause to Yoon H. Choi, M.D. (Respondent), of Brockton, Massachusetts. The Show Cause Order proposed the revocation of Respondent’s DEA Certificate of Registration as a practitioner, on the ground that he does not have authority to dispense controlled substances in Massachusetts, the State in which he is registered with the Agency. Show Cause Order, at 1. As to the Agency’s jurisdiction, the Show Cause Order alleged that Respondent holds DEA Certificate of Registration No. BC6966381, which authorizes him to dispense controlled substances in schedules II through V as a practitioner, at the registered address of Steward Medical Group, One Pearl Street, Suite 2200, Brockton, Massachusetts. Id. The Show Cause Order alleged that this registration does not expire until August 31, 2018. Id. As to the substantive ground for the proceeding, the Show Cause Order alleged that ‘‘[o]n January 5, 2017, the Commonwealth of Massachusetts Board of Registration in Medicine indefinitely suspended [his] medical license’’ and that ‘‘[t]his order remains in effect.’’ Id. The Order thus alleged that Respondent is ‘‘without authority to handle controlled substances in . . . Massachusetts, the [S]tate in which [he is] registered,’’ that he is ‘‘required to E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Page 49663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23328]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research, 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 on or before November 27, 2017. 
Such persons may also file a written request for a hearing on the 
application on or before November 27, 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 August 
2, 2017, Galephar Pharmaceutical Research, Inc., #100 Carr 198, 
Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be 
registered as an importer of hydromorphone (9150), a basic class of 
controlled substance in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.
    The import of this class of controlled substance 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.

    Dated: October 18, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-23328 Filed 10-25-17; 8:45 am]
 BILLING CODE 4410-09-P