Manufacturer of Controlled Substances; Notice of Application, 73360-73361 [E7-25048]
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73360
Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such substances
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement Administrator,
Office of Diversion Control, Federal
Register Representative (ODL),
Washington, DC 20537, or any being
sent via express mail should be sent to
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 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25049 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer Of Controlled
Substances; Notice Of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 6, 2007,
Noramco Inc., Division of Ortho,
McNeil, Inc., 500 Swedes Landing Road,
Wilmington, Delaware 19801, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances listed in schedules I and II:
mstockstill on PROD1PC66 with NOTICES
Drug
Schedule
Codeine-N-oxide (9053)
Morphine-N-oxide (9307)
Dihydromorphine (9145)
Codeine (9050) ...............
Dihydrocodeine (9120) ...
Oxycodone (9143) ..........
Hydromorphone (9150) ...
Hydrocodone (9193) .......
Morphine (9300) .............
Thebaine (9333) .............
Opium, raw (9600) ..........
Opium extracts (9610) ....
Opium fluid extract
(9620).
Opium tincture (9630) .....
Opium, powdered (9639)
Opium, granulated (9640)
Poppy Staw (9650) .........
VerDate Aug<31>2005
I
I
II
II
II
II
II
II
II
II
II
II
II
Schedule
Oxymorphone (9652) ......
Alfentanil (9737) ..............
Sufentanil (9740) ............
Carfentanil (9743) ...........
Fentanyl (9801) ...............
II
II
II
II
II
The company plans to bulk
manufacture the above listed controlled
substances for sale and distribution to
manufacturers for product development
and formulation.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such substance
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement Administrator,
Office of Diversion Control, Federal
Register Representative (ODL),
Washington, DC 20537, or any being
sent via express mail should be sent to
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 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25045 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application
This is notice that on November 6,
2007, Noramco Inc., 500 Swedes
Landing Road, Wilmington, Delaware
19801, 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:
Schedule
Raw Opium (9600) .........
Concentrate of Poppy
Straw (9670).
II
II
The company plans to import the
listed controlled substances to
manufacture other controlled
substances.
As noted in a previous notice
published in the Federal Register on
Jkt 214001
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: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25054 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 12,
2007, Orasure Technologies, Inc.,
Lehigh University, Seeley G MuddBuilding 6, 220 East First Street,
Bethlehem, Pennsylvania 18015, made
application by renewal to the Drug
Enforcement Administration (DEA) as a
bulk manufacturer of the basic classes of
controlled substances listed in
schedules I and II:
Drug
DEPARTMENT OF JUSTICE
Drug
II
II
II
II
19:40 Dec 26, 2007
Drug
PO 00000
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Fmt 4703
Sfmt 4703
Tetrahydrocannabinols
(THC) (7370).
4–Methoxyamphetamine
(7411).
Normorphine (9313) ........
Amphetamine (1100) ......
Methamphetamine (1105)
Cocaine (9041) ...............
Oxycodone (9143) ..........
Hydromorphone (9150) ...
Benzoylecgonine (9180)
Hydrocodone (9193) .......
Meperidine (9230) ...........
Methadone (9250) ..........
Morphine (9300) .............
Schedule
I
I
I
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
to manufacture controlled substance
derivatives. These derivatives will be
used in diagnostic products created
specifically for internal use only.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such substances
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
E:\FR\FM\27DEN1.SGM
27DEN1
Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), Washington, DC 20537, or any
being sent via express mail should be
sent to 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 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25114 Filed 12–26–07; 8:45 am]
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25048 Filed 12–26–07; 8:45 am]
Established Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2008
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) of Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on November 15,
2007, Organix Inc., 240 Salem Street,
Woburn, Massachusetts 01801, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as a bulk manufacturer of
the basic classes of controlled
substances listed in schedule I and II:
Drug
Schedule
mstockstill on PROD1PC66 with NOTICES
Tetrahydrocannabinols (7370) .....
Cocaine (9041) .............................
I
II
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers for research
purposes.
Any other such applicant and any
person who is presently registered with
DEA to manufacture such substances
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections being sent via regular mail
should be addressed, in quintuplicate,
to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), Washington, DC 20537, or any
being sent via express mail should be
sent to 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 25, 2008.
VerDate Aug<31>2005
19:40 Dec 26, 2007
Jkt 214001
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–306E]
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of Assessment of Annual
Needs for 2008.
AGENCY:
SUMMARY: This notice establishes the
initial year 2008 Assessment of Annual
Needs for certain List I chemicals in
accordance with the Combat
Methamphetamine Epidemic Act of
2005 (CMEA), enacted on March 9,
2006.
EFFECTIVE DATE:
December 27, 2007.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
& Chemical Evaluation Section, Drug
Enforcement Administration,
Washington, DC 20537, Telephone:
(202) 307–7183.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
Section 713 of the Combat
Methamphetamine Epidemic Act of
2005 (CMEA) (Title VII of Pub. L. 109–
177) amended section 306 of the
Controlled Substances Act (CSA) (21
U.S.C. 826) requiring that the Attorney
General establish quotas to provide for
the annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine. Section 715 of
the CMEA amended 21 U.S.C. 952 by
adding ephedrine, pseudoephedrine and
phenylpropanolamine to the existing
language concerning importation of
controlled substances.
The 2008 Assessment of Annual
Needs represents those quantities of
ephedrine, pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and/or
imported into the United States in 2008
to provide adequate supplies of each
chemical for: The estimated medical,
scientific, research, and industrial needs
of the United States; lawful export
requirements; and the establishment
and maintenance of reserve stocks.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
73361
The responsibility for establishing the
assessment has been delegated to the
Administrator of the DEA by 28 CFR
0.100. The Administrator, in turn, has
redelegated this function to the Deputy
Administrator, pursuant to 28 CFR
0.104.
On September 20, 2007, a notice
entitled, ‘‘Assessment of Annual Needs
for the List I Chemicals Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine for 2008:
Proposed’’ was published in the Federal
Register (72 FR 53911). This notice
proposed the initial 2008 Assessment of
Annual Needs for ephedrine (for sale),
ephedrine (for conversion),
pseudoephedrine (for sale),
phenylpropanolamine (for sale) and
phenylpropanolamine (for conversion).
All interested persons were invited to
comment on or object to the proposed
assessments on or before October 11,
2007.
Comments Received
DEA did not receive any comments or
objections from the more than 1,050
DEA-registered manufacturers and
importers directly impacted by this
notice. However, DEA did receive one
comment from a law firm representing
a DEA-registered distributor of
nonprescription (over-the-counter
(OTC)) products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine. When sold at
retail, these products are referred to as
scheduled listed chemical products.1
This same commenter commented to
DEA’s proposed 2007 Assessment of
Annual Needs which was published in
the Federal Register on October 19,
2006 (71 FR 61801). The comment
submitted to this notice is virtually
identical to that previously considered
by DEA in that the comment included
the same reports. However, DEA notes
that the current comment includes one
new report and one new letter. The new
report was prepared by an economist
who was retained by the DEA-registered
distributor being represented by the law
firm. The letter was prepared by the
statistician whose report was submitted
as part of this commenter’s comments to
the 2007 proposed assessment.
The commenter’s comments related to
DEA’s proposed assessments for
ephedrine (for sale) and
pseudoephedrine (for sale). These
assessments are discussed below within
1 Title 21 U.S.C. 802(45) defines a scheduled
listed chemical product as ‘‘a product that contains
ephedrine, pseudoephedrine, or
phenylpropanolamine; and * * * may be marketed
or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act as a
nonprescription drug.’’
E:\FR\FM\27DEN1.SGM
27DEN1
]]>Agencies
[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Pages 73360-73361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25048]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Application
Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal
Regulations (CFR), this is notice that on November 12, 2007, Orasure
Technologies, Inc., Lehigh University, Seeley G Mudd-Building 6, 220
East First Street, Bethlehem, Pennsylvania 18015, made application by
renewal to the Drug Enforcement Administration (DEA) as a bulk
manufacturer of the basic classes of controlled substances listed in
schedules I and II:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (THC) (7370)......... I
4-Methoxyamphetamine (7411)................ I
Normorphine (9313)......................... I
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Cocaine (9041)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Benzoylecgonine (9180)..................... II
Hydrocodone (9193)......................... II
Meperidine (9230).......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk to manufacture controlled substance derivatives. These
derivatives will be used in diagnostic products created specifically
for internal use only.
Any other such applicant and any person who is presently registered
with DEA to manufacture such substances may file comments or objections
to the issuance of the proposed registration pursuant to 21 CFR
1301.33(a).
[[Page 73361]]
Any such written comments or objections being sent via regular mail
should be addressed, in quintuplicate, to the Drug Enforcement
Administration, Office of Diversion Control, Federal Register
Representative (ODL), Washington, DC 20537, or any being sent via
express mail should be sent to 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 25, 2008.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E7-25048 Filed 12-26-07; 8:45 am]
BILLING CODE 4410-09-P
