Importer of Controlled Substances Application: Myoderm, 1207 [2016-213]
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Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and TOG intends
to file additional written notifications
disclosing all changes in membership.
On April 21, 1997, TOG filed its
original notification pursuant to section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to section 6(b) of the
Act on June 13, 1997 (62 FR 32371).
The last notification was filed with
the Department on September 9, 2015.
A notice was published in the Federal
Register pursuant to section 6(b) of the
Act on October 2, 2015 (80 FR 59816).
Patricia A. Brink,
Director of Civil Enforcement, Antitrust
Division.
[FR Doc. 2016–325 Filed 1–8–16; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sharp Clinical Services,
Inc.
ACTION:
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2016–214 Filed 1–8–16; 8:45 am]
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
VerDate Sep<11>2014
18:17 Jan 08, 2016
Jkt 238001
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Myoderm
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 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
DATES:
PO 00000
Frm 00045
Fmt 4703
Sfmt 9990
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
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 October
9, 2015, Myoderm, 48 East Main Street,
Norristown, Pennsylvania 19401
applied to be registered as an importer
of the following basic classes of
controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Notice of application.
DATES:
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.
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Nabilone (7379) ............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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.
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–213 Filed 1–8–16; 8:45 am]
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11JAN1
]]>Agencies
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)]
[Notices]
[Page 1207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-213]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Myoderm
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 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
October 9, 2015, 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 Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Nabilone (7379)............................ II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levomethorphan (9210)...................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Methadone intermediate (9254).............. 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.
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-213 Filed 1-8-16; 8:45 am]
BILLING CODE 4410-09-P
