83 FR 22519 - Importer of Controlled Substances Application: Xcelience
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 94 (May 15, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22519-22519 | |
| FR Document | 2018-10300 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Page 22519] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10300] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Xcelience ACTION: Notice of application. ----------------------------------------------------------------------- DATES: Registered bulk importers 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 June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 2018. 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. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007) 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 April 11, 2018, Xcelience, 4901 West Grace Street, Tampa, FL 33607 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Amphetamine........................ 1100 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: April 25, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-10300 Filed 5-14-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22519
Company FR Docket Published
Patheon Pharmaceuticals, Inc ................................................................ 83 FR 5274 .................................... February 6, 2018.
Chattem Chemicals, Inc .......................................................................... 83 FR 5274 .................................... February 6, 2018.
INSYS Manufacturing LLC ...................................................................... 83 FR 5810 .................................... February 9, 2018.
Siemens Healthcare Diagnostics Inc ...................................................... 83 FR 5812 .................................... February 9, 2018.
Cerilliant Corporation ............................................................................... 83 FR 5809 .................................... February 9, 2018.
Noramco, Inc ........................................................................................... 83 FR 5808 .................................... February 9, 2018.
Johnson Matthey, Inc .............................................................................. 83 FR 7221 .................................... February 20, 2018.
The DEA has considered the factors in should also be sent to: (1) Drug Dated: April 25, 2018.
21 U.S.C. 823(a) and determined that Enforcement Administration, Attn: Susan A. Gibson,
the registration of these registrants to Hearing Clerk/LJ, 8701 Morrissette Deputy Assistant Administrator.
manufacture the applicable basic classes Drive, Springfield, Virginia 22152; and [FR Doc. 2018–10300 Filed 5–14–18; 8:45 am]
of controlled substances is consistent (2) Drug Enforcement Administration, BILLING CODE 4410–09–P
with the public interest and with United Attn: DEA Federal Register
States obligations under international Representative/DRW, 8701 Morrissette
treaties, conventions, or protocols in Drive, Springfield, Virginia 22152. DEPARTMENT OF JUSTICE
effect on May 1, 1971. The DEA Comments and requests for hearings on [OMB Number 1110–0064]
investigated each of the company’s applications to import narcotic raw
maintenance of effective controls material are not appropriate. 72 FR Agency Information Collection
against diversion by inspecting and 3417, (January 25, 2007) Activities; Proposed eCollection
testing each company’s physical eComments Requested; Extension,
security systems, verifying each SUPPLEMENTARY INFORMATION: The
Without Change, of a Currently
company’s compliance with state and Attorney General has delegated his
Approved Collection; FBI
local laws, and reviewing each authority under the Controlled
Expungement Form (FD–1114)
company’s background and history. Substances Act to the Administrator of
Therefore, pursuant to 21 U.S.C. the Drug Enforcement Administration AGENCY: Criminal Justice Information
823(a), and in accordance with 21 CFR (DEA), 28 CFR 0.100(b). Authority to Services Division, Federal Bureau of
1301.33, the DEA has granted a exercise all necessary functions with Investigation, Department of Justice.
registration as a bulk manufacturer to respect to the promulgation and ACTION: 60-Day notice.
the above listed companies. implementation of 21 CFR part 1301,
incident to the registration of SUMMARY: The Department of Justice
Dated: May 7, 2018. (DOJ), Federal Bureau of Investigation
manufacturers, distributors, dispensers,
John J. Martin,
importers, and exporters of controlled (FBI), Criminal Justice Information
Assistant Administrator. substances (other than final orders in Services (CJIS) Division, will be
[FR Doc. 2018–10304 Filed 5–14–18; 8:45 am] connection with suspension, denial, or submitting the following information
BILLING CODE 4410–09–P revocation of registration) has been collection request to the Office of
redelegated to the Assistant Management and Budget (OMB) for
Administrator of the DEA Diversion review and approval in accordance with
DEPARTMENT OF JUSTICE Control Division (‘‘Assistant the Paperwork Reduction Act of 1995.
The proposed information collection is
Administrator’’) pursuant to section 7 of
Drug Enforcement Administration published to obtain comments from the
28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392]
public and affected agencies.
In accordance with 21 CFR DATES: Comments are encouraged and
Importer of Controlled Substances 1301.34(a), this is notice that on April will be accepted for 60 days until July
Application: Xcelience 11, 2018, Xcelience, 4901 West Grace 16, 2018.
Street, Tampa, FL 33607 applied to be FOR FURTHER INFORMATION CONTACT:
ACTION: Notice of application. registered as an importer of the If you have additional comments
following basic classes of controlled especially on the estimated public
DATES: Registered bulk importers of the substances: burden or associated response time,
affected basic classes, and applicants suggestions, or need a copy of the
therefore, may file written comments on Controlled proposed information collection
Drug code Schedule
or objections to the issuance of the substance
instrument with instructions or
proposed registration on or before June additional information, please contact
Amphetamine ... 1100 II
14, 2018. Such persons may also file a Gerry Lynn Brovey, Supervisory
written request for a hearing on the Information Liaison Specialist, FBI,
application on or before June 14, 2018. The company plans to import the CJIS, Resources Management Section,
ADDRESSES: Written comments should
listed controlled substance in finished Administrative Unit, Module C–2, 1000
be sent to: Drug Enforcement dosage form for clinical trials, research Custer Hollow Road, Clarksburg, West
Administration, Attention: DEA Federal and analytical purposes. Virginia, 26306 (facsimile: 304–625–
daltland on DSKBBV9HB2PROD with NOTICES
Register Representative/DRW, 8701 The import of this class of controlled 5093) or email glbrovey@ic.fbi.gov.
Morrissette Drive, Springfield, Virginia substance will be granted only for Written comments and/or suggestions
22152. All requests for hearing must be analytical testing, research and clinical can also be sent to the Office of
sent to: Drug Enforcement trials. This authorization does not Management and Budget, Office of
Administration, Attn: Administrator, extend to the import of a finished FDA Information and Regulatory Affairs,
8701 Morrissette Drive, Springfield, approved or non-approved dosage form Attention Department of Justice Desk
Virginia 22152. All request for hearing for commercial sale. Officer, Washington, DC 20503.
VerDate Sep<11>2014 20:27 May 14, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\15MYN1.SGM 15MYN1](https://thefederalregister.org/doc/83_FR_22613/page/1.svg)
Document Created: 2018-05-15 00:32:56
Document Modified: 2018-05-15 00:32:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| Dates | Registered bulk importers 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 June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 2018. | |
| FR Citation | 83 FR 22519 |
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