Importer of Controlled Substances Application: Bellwyck Clinical Services, 45613 [2017-20941]

Download as PDF 45613 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices DEPARTMENT OF JUSTICE Controlled substance Drug code Schedule Drug Enforcement Administration Amphetamine ............... Methylphenidate ........... Oxycodone ................... [Docket No. DEA–392] Importer of Controlled Substances Application: Bellwyck Clinical Services 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 or before October 30, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 30, 2017. DATES: 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 request 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. 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 1301.34(a), this is notice that on June 30, 2017, Bellwyck Clinical Services, 8946 Global Way, West Chester, Ohio 45069 applied to be registered as an importer of the following basic classes of controlled substances: asabaliauskas on DSKBBXCHB2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 1100 1724 9143 II II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: September 21, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–20941 Filed 9–28–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute ACTION: 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 31, 2017, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709–2194 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Marihuana ..................... Tetrahydrocannabinols Drug code 7360 7370 Schedule I I The company will manufacture marihuana (7360) and tetrahydrocannabinols (7370) for use by their researchers under the above listed controlled substances as Active Pharmaceutical Ingredient (API) for clinical trials. In reference to drug code (7370) the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activities for this drug code are authorized for this registration. Dated: September 21, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–20947 Filed 9–28–17; 8:45 am] BILLING CODE 4410–09–P Notice of application. DEPARTMENT OF JUSTICE 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 28, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On September 19, 2017, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of South Carolina in the lawsuit entitled United States v. JW Aluminum Company, Civil Action No. 17–cv–02490–DCN. The United States filed this lawsuit under the Clean Air Act. The United States’ complaint seeks injunctive relief and civil penalties for violations of the regulations that govern secondary aluminum production at the defendant’s facility in Mount Holly, South Carolina. The consent decree requires the defendant to perform injunctive relief and pay a $230,000 civil penalty. The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to United States v. JW Aluminum Company, D.J. Ref. No. 90–5–2–1– E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Page 45613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20941]



[[Page 45613]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Bellwyck Clinical 
Services

ACTION: Notice of application.

-----------------------------------------------------------------------

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 October 30, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 30, 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 
request 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 June 
30, 2017, Bellwyck Clinical Services, 8946 Global Way, West Chester, 
Ohio 45069 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine............................     1100  II
Methylphenidate........................     1724  II
Oxycodone..............................     9143  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically-manufactured FDF to foreign 
markets. Authorization will not extend to the import of FDA approved or 
non-approved finished dosage forms for commercial sale.

    Dated: September 21, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-20941 Filed 9-28-17; 8:45 am]
BILLING CODE 4410-09-P