Manufacturer of Controlled Substances; Notice of Application, 73361 [E7-25114]
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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.
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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.’’
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]]>Agencies
[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Page 73361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25114]
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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 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
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)............... I
Cocaine (9041)............................. 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.
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]
BILLING CODE 4410-09-P
