Importer of Controlled Substances Application: MYODERM, 7633-7634 [2015-02823]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
health and welfare, (2) competitive
conditions in the U.S. economy, (3) U.S.
production of articles that are like or
directly competitive with those that are
subject to investigation, and (4) U.S.
consumers. The Commission is
therefore interested in receiving written
submissions that address the
aforementioned public interest factors
in the context of this investigation.
If the Commission orders some form
of remedy, the U.S. Trade
Representative, as delegated by the
President, has 60 days to approve or
disapprove the Commission’s action.
See Presidential Memorandum of July
21, 2005, 70 FR 43251 (July 26, 2005).
During this period, the subject articles
would be entitled to enter the United
States under bond, in an amount
determined by the Commission and
prescribed by the Secretary of the
Treasury. The Commission is therefore
interested in receiving submissions
concerning the amount of the bond that
should be imposed if a remedy is
ordered.
Written Submissions: The parties to
the investigation are requested to file
written submissions on all of the issues
identified in this notice. Parties to the
investigation, interested government
agencies, and any other interested
parties are encouraged to file written
submissions on the issues of remedy,
the public interest, and bonding. Such
submissions should address the
recommended determination by the ALJ
on remedy and bonding. Complainant
Springfree is also requested to submit
proposed remedial orders for the
Commission’s consideration. Springfree
is also requested to state the date that
the asserted patent expires and the
HTSUS numbers under which the
accused products are imported, and
provide identification information for
all known importers of the subject
articles. Initial written submissions and
proposed remedial orders must be filed
no later than close of business on
Thursday, February 19, 2015. Initial
written submissions by the parties shall
be no more than 40 pages, excluding
any exhibits. Reply submissions must be
filed no later than the close of business
on Monday, March 2, 2015. Reply
submissions by the parties shall be no
more than 20 pages, excluding any
exhibits. No further submissions on
these issues will be permitted unless
otherwise ordered by the Commission.
Persons filing written submissions must
file the original document electronically
on or before the deadlines stated above
and submit 8 true paper copies to the
Office of the Secretary by noon the next
day pursuant to section 210.4(f) of the
Commission’s Rules of Practice and
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
Procedure (19 CFR 210.4(f)).
Submissions should refer to the
investigation number (‘‘Inv. No. 337–
TA–908’’) in a prominent place on the
cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/fed_reg_notices/rules/
handbook_on_electronic_filing.pdf).
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. A redacted nonconfidential version of the document
must also be filed simultaneously with
the any confidential filing. All
nonconfidential written submissions
will be available for public inspection at
the Office of the Secretary and on EDIS.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in Part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: February 5, 2015.
Lisa R. Barton,
Secretary to the Commission.
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: MYODERM
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 March 13, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before March 13,
2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
DATES:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
6, 2014, 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
[FR Doc. 2015–02782 Filed 2–10–15; 8:45 am]
ACTION:
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.
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, and
research.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing and
clinical trials. This authorization does
not extend to the import of a finished
FDA approved or non-approved dosage
form for commercial distribution in the
United States.
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Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
(9041), a basic class of controlled
substance listed in schedule II.
The company plans to import small
quantities of ioflupane, in the form of
three separate analogues of cocaine, to
validate production and quality control
systems, for a reference standard, and
for producing material for a future
investigational new drug (IND)
submission.
[FR Doc. 2015–02823 Filed 2–10–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: GE Healthcare
Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–02826 Filed 2–10–15; 8:45 am]
ACTION:
tkelley on DSK3SPTVN1PROD with NOTICES
Controlled substance
BILLING CODE 4410–09–P
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 March 13, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before March 13,
2015.
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. Comments
and request for hearings on applications
to import narcotic raw material are not
appropriate.
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, dispenser,
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
September 12, 2014, GE Healthcare,
3350 North Ridge Avenue, Arlington
Heights, Illinois 60004–1412 applied to
be registered as an importer of cocaine
DATES:
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mallinckrodt LLC
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 March 13, 2015. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before March 13,
2015.
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. 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 Deputy Assistant
DATES:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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 January
16, 2014, Mallinckrodt LLC, 3600 North
Second Street, St. Louis, Missouri
63147, applied to be registered as an
importer of the following basic classes
of controlled substances:
Phenylacetone (8501) ..................
Coca Leaves (9040) .....................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
The company plans to import the
listed controlled substances for the
manufacture of controlled substances in
bulk for distribution to its customers.
In reference to Phenylacetone (8501),
the company plans to import the
controlled substance for the bulk
manufacture of amphetamine products
for sale to its customers.
Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–02824 Filed 2–10–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Siegfried
USA, LLC
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 1301.33(a) on
or before April 13, 2015.
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 his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
DATES:
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7633-7634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02823]
=======================================================================
-----------------------------------------------------------------------
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 March 13, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before March 13, 2015.
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 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 Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy Assistant Administrator'') pursuant to section 7 of
28 CFR part appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on
October 6, 2014, 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, and research.
The import of the above listed basic classes of controlled
substances will be granted only for analytical testing and clinical
trials. This authorization does not extend to the import of a finished
FDA approved or non-approved dosage form for commercial distribution in
the United States.
[[Page 7634]]
Dated: February 5, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-02823 Filed 2-10-15; 8:45 am]
BILLING CODE P
