Importer of Controlled Substances; Notice of Application, 63155-63156 [E9-28824]
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63155
Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices
of the standard that was not met, (2)
improvements needed to meet the
program element or documentation
requirement of the standard, and (3)
projected completion dates for each
task.
II. Electronic Access
Persons with access to the Internet
may obtain the draft program standards
at https://www.fda.gov/downloads/
RegulatoryInformation/Guidances/
UCM125448.pdf.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per Response
No. of Respondents
44
1There
Total Annual
Responses
1
Hours per
Response
44
Total Hours
40
1,760
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED FIRST-YEAR BASELINE SELF-ASSESSMENT BURDEN1
Five-Year Frequency
per Response
No. of Respondents
17
1There
1
Hours
per Response
17
Total Hours
200
3,400
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–28834 Filed 12–1–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[LLCAC069000 L17110000 AL0000]
Notice of Public Meeting of the Carrizo
Plain National Monument Advisory
Council
AGENCY: Bureau of Land Management,
Interior.
ACTION: Notice of Public Meeting.
mstockstill on DSKH9S0YB1PROD with NOTICES
Total First-Year
Responses
SUMMARY: In accordance with the
Federal Land Policy and Management
Act and the Federal Advisory
Committee Act of 1972, the U.S.
Department of the Interior, Bureau of
Land Management (BLM) Carrizo Plain
National Monument Advisory Council
(MAC) will meet as indicated below.
DATES: The meeting will be held on
Saturday, January 23, 2010, at the
Carissa Plain Elementary School,
located approximately 2 miles
northwest of Soda Lake Road on
Highway 58. The meeting will begin at
10 a.m. and finish at 3 p.m. The meeting
will focus on the Resource Management
Plan/Environmental Impact Statement
(RMP/EIS) being developed for the
Carrizo Plain National Monument.
There will be a public comment period
from 2 p.m. to 3 p.m.
FOR FURTHER INFORMATION CONTACT: The
BLM, attention: Johna Hurl, Monument
Manager, 3801 Pegasus Drive,
VerDate Nov<24>2008
18:28 Dec 01, 2009
Jkt 220001
Bakersfield, CA 93308. Phone (661)
391–6093 or e-mail: jhurl@blm.gov.
SUPPLEMENTARY INFORMATION: The ninemember MAC advises the Secretary of
the Interior, through the BLM, on a
variety of public land issues associated
with the public land management of the
Carrizo Plain National Monument in
Central California. At this meeting,
monument staff will present updated
information on the progress of the RMP/
EIS. Draft alternatives being developed
by the Carrizo managing partners—the
BLM, the California Department of Fish
and Game and The Nature
Conservancy—will be the focus of this
meeting. This meeting is open to the
public. Depending on the number of
persons wishing to comment, and the
time available, the time allotted for
individual oral comments may be
limited. Individuals who plan to attend
and need special assistance such as sign
language interpretation or other
reasonable accommodations should
contact the BLM as indicated below.
Dated: November 25, 2009.
Janet Bedrosian,
Deputy State Director, External Affairs,
California State Office.
[FR Doc. E9–28808 Filed 12–1–09; 8:45 am]
BILLING CODE 4310–40–P
JUDICIAL CONFERENCE OF THE
UNITED STATES
Meeting of the Judicial Conference
Advisory Committee on Rules of Civil
Procedure
Judicial Conference of the
United States Advisory Committee on
Rules of Civil Procedure.
AGENCY:
PO 00000
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ACTION:
Notice of open meeting.
SUMMARY: The Advisory Committee on
Rules of Civil Procedure will hold a
two-day meeting. The meeting will be
open to public observation but not
participation.
March 18–19, 2010.
Time: 8:30 a.m. to 5 p.m.
ADDRESSES: Emory Law School, 1301
Clifton Road, Atlanta, GA 30322.
FOR FURTHER INFORMATION CONTACT: John
K. Rabiej, Chief, Rules Committee
Support Office, Administrative Office of
the United States Courts, Washington,
DC 20544, telephone (202) 502–1820.
DATES:
Dated: November 23, 2009.
John K. Rabiej,
Chief, Rules Committee Support Office.
[FR Doc. E9–28531 Filed 12–1–09; 8:45 am]
BILLING CODE 2210–55–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
This is notice that on July 1, 2009,
Cambrex Charles City, Inc., 1205 11th
Street, Charles City, Iowa 50616, made
application by renewal to the Drug
Enforcement Administration (DEA) for
registration as an importer of the basic
classes of controlled substances listed in
schedule II:
Drug
Opium, raw (9600) ........................
Poppy Straw Concentrate (9670)
E:\FR\FM\02DEN1.SGM
02DEN1
Schedule
II
II
63156
Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices
The company plans to import the
basic classes of controlled substances
for manufacture of active
pharmaceutical ingredients for sale to
its customers.
As explained in the Correction to
Notice of Application pertaining to
Rhodes Technologies, 72 FR 3417
(2007), comments and requests for
hearings on applications to import
narcotic raw material are not
appropriate.
As noted in a previous notice
published in the Federal Register on
September 23, 1975, (40 FR 43745), all
applicants for registration to import a
basic class of any controlled substances
in schedule 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: November 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–28824 Filed 12–1–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2), authorizing the importation of
such a substance, provide
manufacturers holding registrations for
the bulk manufacture of the substance
an opportunity for a hearing.
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on October
8, 2009, Mylan Pharmaceuticals Inc.,
781 Chestnut Ridge Road, Morgantown,
West Virginia 26505, made application
by letter to the Drug Enforcement
Administration (DEA) to be registered as
an importer of the basic classes of
controlled substances listed in schedule
II:
Drug
Oxycodone (9143) ........................
Hydromorphone (9150) ................
VerDate Nov<24>2008
18:28 Dec 01, 2009
The company plans to import the
listed controlled substances as finished
dosage forms (FDF) for analytical testing
and distribution for clinical trials.
Any bulk manufacturer who is
presently, or is applying to be,
registered with DEA to manufacture
such basic classes of controlled
substances may 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 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 January 4, 2010.
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 schedule 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: November 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–28827 Filed 12–1–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
Pursuant to 21 U.S.C. 958(i), the
Attorney General shall, prior to issuing
a registration under this Section to a
bulk manufacturer of a controlled
substance in schedule I or II, and prior
to issuing a regulation under 21 U.S.C.
952(a)(2) authorizing the importation of
Schedule such a substance, provide
manufacturers holding registrations for
II
the bulk manufacture of the substance
II
an opportunity for a hearing.
Jkt 220001
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Therefore, in accordance with 21 CFR
1301.34(a), this is notice that on
September 22, 2009, ISP Freetown Fine
Chemicals, 238 South Main Street,
Assonet, Massachusetts 02702, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of
Phenylacetone (8501), a basic class of
controlled substance listed in schedule
II.
The company plans to import the
controlled substance to manufacture
amphetamine.
Any bulk manufacturers who are
presently, or are applying to be,
registered with DEA to manufacture
such basic class of controlled substance
may 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 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 January 4, 2010.
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 schedule 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: November 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E9–28825 Filed 12–1–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated August 21, 2009, and
published in the Federal Register on
E:\FR\FM\02DEN1.SGM
02DEN1
Agencies
[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Pages 63155-63156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28824]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application
This is notice that on July 1, 2009, Cambrex Charles City, Inc.,
1205 11th Street, Charles City, Iowa 50616, made application by renewal
to the Drug Enforcement Administration (DEA) for registration as an
importer of the basic classes of controlled substances listed in
schedule II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Opium, raw (9600)............................................ II
Poppy Straw Concentrate (9670)............................... II
------------------------------------------------------------------------
[[Page 63156]]
The company plans to import the basic classes of controlled
substances for manufacture of active pharmaceutical ingredients for
sale to its customers.
As explained in the Correction to Notice of Application pertaining
to Rhodes Technologies, 72 FR 3417 (2007), comments and requests for
hearings on applications to import narcotic raw material are not
appropriate.
As noted in a previous notice published in the Federal Register on
September 23, 1975, (40 FR 43745), all applicants for registration to
import a basic class of any controlled substances in schedule 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: November 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E9-28824 Filed 12-1-09; 8:45 am]
BILLING CODE 4410-09-P