Importer of Controlled Substances; Notice of Application; Alkermes Gainesville, LLC, 6132 [2013-01837]
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6132
Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices
Dated: January 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
Technologies, Inc., 110 Lake Street,
Saint Albans, Vermont 05478, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
BILLING CODE 4410–09–P
Schedule
Methylphenidate (1724) ................
Fentanyl (9801) ............................
srobinson on DSK4SPTVN1PROD with
[FR Doc. 2013–01835 Filed 1–28–13; 8:45 am]
II
II
Drug Enforcement Administration
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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedule II, which
falls under the authority of section
1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)) may, in the circumstances
set forth in 21 U.S.C. 958(i), file
comments or objections to the issuance
of the proposed registration and may, at
the same time, file a written request for
a hearing on such application pursuant
to 21 CFR 1301.43 and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than February 28, 2013.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
§ 1301.34(b), (c), (d), (e), and (f). As
noted in a previous notice published in
the Federal Register on September 23,
1975, 40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substances in schedules
I or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
VerDate Mar<15>2010
16:47 Jan 28, 2013
Jkt 229001
DEPARTMENT OF JUSTICE
Importer of Controlled Substances;
Notice of Application; Alkermes
Gainesville, LLC
Pursuant to Title 21 Code of Federal
Regulations 1301.34(a), this is notice
that on October 11, 2012, Alkermes
Gainesville, LLC., 1300 Gould Drive,
Gainesville, Georgia 30504, made
application to the Drug Enforcement
Administration (DEA) for registration as
an importer of noroxymorphone (9668),
a basic class of controlled substance
listed in schedule II.
The company plans to import the
listed substance for analytical research
and testing.
The import of the above listed basic
class of controlled substance 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.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances listed in schedules I or II,
which fall under the authority of section
1002(a)(2)(B) of the Act 21 U.S.C. 952
(a)(2)(B) may, in the circumstances set
forth in 21 U.S.C. 958(i), file comments
or objections to the issuance of the
proposed registration and may, at the
same time, file a written request for a
hearing on such application pursuant to
21 CFR 1301.43 and in such form as
prescribed by 21 CFR 1316.47.
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than February 28, 2013.
This procedure is to be conducted
simultaneously with, and independent
of, the procedures described in 21 CFR
1301.34(b), (c), (d), (e), and (f). As noted
in a previous notice published in the
Federal Register on September 23, 1975,
40 FR 43745–46, all applicants for
registration to import a basic class of
any controlled substance in schedules I
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
or II are, and will continue to be,
required to demonstrate to the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, that the requirements
for such registration pursuant to 21
U.S.C. 958(a); 21 U.S.C. 823(a); and 21
CFR 1301.34(b), (c), (d), (e), and (f) are
satisfied.
Dated: January 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–01837 Filed 1–28–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Petition
Requirements and Investigative Data
Collection: Trade Act of 1974, as
Amended
ACTION:
Notice.
The Department of Labor
(DOL) is submitting the Employment
and Training Administration (ETA)
sponsored information collection
request (ICR) revision titled, ‘‘Petition
Requirements and Investigative Data
Collection: Trade Act of 1974, as
Amended,’’ to the Office of Management
and Budget (OMB) for review and
approval for use in accordance with the
Paperwork Reduction Act (PRA) of 1995
(44 U.S.C. 3501 et seq.).
DATES: Submit comments on or before
February 28, 2013.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained from the RegInfo.gov
Web site, https://www.reginfo.gov/
public/do/PRAMain, on the day
following publication of this notice or
by contacting Michel Smyth by
telephone at 202–693–4129 (this is not
a toll-free number) or sending an email
to DOL_PRA_PUBLIC@dol.gov.
Submit comments about this request
to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for DOL–ETA, Office of
Management and Budget, Room 10235,
725 17th Street NW., Washington, DC
20503, Fax: 202–395–6881 (this is not a
toll-free number), email:
OIRA_submission@omb.eop.gov.
SUMMARY:
E:\FR\FM\29JAN1.SGM
29JAN1
]]>Agencies
[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Page 6132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01837]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application;
Alkermes Gainesville, LLC
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on October 11, 2012, Alkermes Gainesville, LLC., 1300
Gould Drive, Gainesville, Georgia 30504, made application to the Drug
Enforcement Administration (DEA) for registration as an importer of
noroxymorphone (9668), a basic class of controlled substance listed in
schedule II.
The company plans to import the listed substance for analytical
research and testing.
The import of the above listed basic class of controlled substance
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.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances listed in schedules I or II, which fall under the authority
of section 1002(a)(2)(B) of the Act 21 U.S.C. 952 (a)(2)(B) may, in the
circumstances set forth in 21 U.S.C. 958(i), file comments or
objections to the issuance of the proposed registration and may, at the
same time, file a written request for a hearing on such application
pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR
1316.47.
Any such written comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than February 28, 2013.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR 1301.34(b), (c),
(d), (e), and (f). As noted in a previous notice published in the
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants
for registration to import a basic class of any controlled substance in
schedules I or II are, and will continue to be, required to demonstrate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, that the requirements for such
registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR
1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: January 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2013-01837 Filed 1-28-13; 8:45 am]
BILLING CODE 4410-09-P
