81 FR 1207 - Importer of Controlled Substances Application: Sharp Clinical Services, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 6 (January 11, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 6 (January 11, 2016)
| Page Range | 1207-1207 | |
| FR Document | 2016-00214 |
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)] [Notices] [Page 1207] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00214] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Sharp Clinical Services, Inc. ACTION: Notice of application. ----------------------------------------------------------------------- DATES: 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 1301.34(a) on or before February 10, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before February 10, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy 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 July 29, 2015, Sharp Clinical Services, Inc., 300 Kimberton Road, Phoenixville, Pennsylvania 19460 applied to be registered as an importer of marihuana (7360), a basic class of controlled substance listed in schedule I. The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies. This compound is listed under drug code 7360. No other activity for this drug code is authorized for this registration. Approval of permits applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non- approved finished dosage forms for commercial sale. Dated: January 4, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-00214 Filed 1-8-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices 1207
No other changes have been made in substances (other than final orders in Clerk/LJ, 8701 Morrissette Drive,
either the membership or planned connection with suspension, denial, or Springfield, Virginia 22152.
activity of the group research project. revocation of registration) has been
SUPPLEMENTARY INFORMATION: The
Membership in this group research redelegated to the Deputy Assistant
Attorney General has delegated her
project remains open, and TOG intends Administrator of the DEA Office of
to file additional written notifications Diversion Control (‘‘Deputy Assistant authority under the Controlled
disclosing all changes in membership. Administrator’’) pursuant to section 7 of Substances Act to the Administrator of
On April 21, 1997, TOG filed its 28 CFR part 0, appendix to subpart R. the Drug Enforcement Administration
original notification pursuant to section In accordance with 21 CFR (DEA), 28 CFR 0.100(b). Authority to
6(a) of the Act. The Department of 1301.34(a), this is notice that on July 29, exercise all necessary functions with
Justice published a notice in the Federal 2015, Sharp Clinical Services, Inc., 300 respect to the promulgation and
Register pursuant to section 6(b) of the Kimberton Road, Phoenixville, implementation of 21 CFR part 1301,
Act on June 13, 1997 (62 FR 32371). Pennsylvania 19460 applied to be incident to the registration of
The last notification was filed with registered as an importer of marihuana manufacturers, distributors, dispensers,
the Department on September 9, 2015. (7360), a basic class of controlled importers, and exporters of controlled
A notice was published in the Federal substance listed in schedule I. substances (other than final orders in
Register pursuant to section 6(b) of the The company plans to import finished connection with suspension, denial, or
Act on October 2, 2015 (80 FR 59816). pharmaceutical products containing revocation of registration) has been
cannabis extracts in dosage form for redelegated to the Deputy Assistant
Patricia A. Brink, Administrator of the DEA Office of
Director of Civil Enforcement, Antitrust
clinical trial studies.
This compound is listed under drug Diversion Control (‘‘Deputy Assistant
Division. Administrator’’) pursuant to section 7 of
[FR Doc. 2016–00325 Filed 1–8–16; 8:45 am]
code 7360. No other activity for this
drug code is authorized for this 28 CFR part 0, appendix to subpart R.
BILLING CODE P
registration. Approval of permits In accordance with 21 CFR
applications will occur only when the 1301.34(a), this is notice that on October
DEPARTMENT OF JUSTICE registrant’s business activity is 9, 2015, Myoderm, 48 East Main Street,
consistent with what is authorized Norristown, Pennsylvania 19401
Drug Enforcement Administration under 21 U.S.C. 952(a)(2). Authorization applied to be registered as an importer
will not extend to the import of FDA of the following basic classes of
[Docket No. DEA–392]
approved or non-approved finished controlled substances:
Importer of Controlled Substances dosage forms for commercial sale.
Application: Sharp Clinical Services, Dated: January 4, 2016. Controlled substance Schedule
Inc. Louis J. Milione,
Amphetamine (1100) .................... II
Deputy Assistant Administrator. Lisdexamfetamine (1205) ............. II
ACTION: Notice of application.
[FR Doc. 2016–00214 Filed 1–8–16; 8:45 am] Methylphenidate (1724) ................ II
DATES: Registered bulk manufacturers of BILLING CODE 4410–09–P Pentobarbital (2270) ..................... II
the affected basic class, and applicants Nabilone (7379) ............................ II
therefore, may file written comments on Codeine (9050) ............................. II
or objections to the issuance of the DEPARTMENT OF JUSTICE Oxycodone (9143) ........................ II
proposed registration in accordance Hydromorphone (9150) ................ II
Drug Enforcement Administration Hydrocodone (9193) ..................... II
with 21 CFR 1301.34(a) on or before
February 10, 2016. Such persons may Levomethorphan (9210) ............... II
[Docket No. DEA–392] Meperidine (9230) ........................ II
also file a written request for a hearing
on the application pursuant to 21 CFR Methadone (9250) ........................ II
Importer of Controlled Substances Methadone intermediate (9254) ... II
1301.43 on or before February 10, 2016. Application: Myoderm Morphine (9300) ........................... II
ADDRESSES: Written comments should
Oxymorphone (9652) ................... II
be sent to: Drug Enforcement ACTION: Notice of application.
Fentanyl (9801) ............................ II
Administration, Attention: DEA Federal
Register Representative/ODW, 8701 DATES: Registered bulk manufacturers of
Morrissette Drive, Springfield, Virginia the affected basic classes, and The company plans to import the
22152. Request for hearings should be applicants therefore, may file written listed controlled substances in finished
sent to: Drug Enforcement comments on or objections to the dosage form for clinical trials, research,
Administration, Attention: Hearing issuance of the proposed registration in and analytical purposes.
Clerk/LJ, 8701 Morrissette Drive, accordance with 21 CFR 1301.34(a) on The import of the above listed basic
Springfield, Virginia 22152. or before February 10, 2016. Such classes of controlled substances will be
SUPPLEMENTARY INFORMATION: The persons may also file a written request granted only for analytical testing,
Attorney General has delegated her for a hearing on the application research, and clinical trials. This
authority under the Controlled pursuant to 21 CFR 1301.43 on or before authorization does not extend to the
Substances Act to the Administrator of February 10, 2016. import of a finished FDA approved or
the Drug Enforcement Administration ADDRESSES: Written comments should non-approved dosage form for
ebenthall on DSK6SPTVN1PROD with NOTICES
(DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement commercial sale.
exercise all necessary functions with Administration, Attention: DEA Federal Dated: January 4, 2016.
respect to the promulgation and Register Representative/ODW, 8701
Louis J. Milione,
implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia
incident to the registration of 22152. Request for hearings should be Deputy Assistant Administrator.
manufacturers, distributors, dispensers, sent to: Drug Enforcement [FR Doc. 2016–00213 Filed 1–8–16; 8:45 am]
importers, and exporters of controlled Administration, Attention: Hearing BILLING CODE 4410–09–P
VerDate Sep<11>2014 21:33 Jan 14, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1](https://thefederalregister.org/doc/81_FR_1213/page/1.svg)
Document Created: 2016-01-16 01:07:06
Document Modified: 2016-01-16 01:07:06
| 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 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 1301.34(a) on or before February 10, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before February 10, 2016. | |
| FR Citation | 81 FR 1207 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR