Manufacturer of Controlled Substances; Notice of Registration, 73367-73368 [E7-25044]
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73367
Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices
mstockstill on PROD1PC66 with NOTICES
manufacturing, and procurement
quotas. DEA is required to complete the
process of issuing individual import,
manufacturing, and procurement quotas
prior to January 1, 2008, as quotas are
issued for a calendar year. DEA believes
that a shorter comment period was
necessary to review and consider the
comments received from the public and
then establish the 2008 Assessment of
Annual Needs prior to the end of the
2007 calendar year.
DEA also believes that a 21-day
comment period was sufficient given
that its proposal was neither complex
nor technical. DEA notes that two of the
2008 assessments proposed were values
initially proposed on October 19, 2006,
when DEA proposed the 2007
Assessment of Annual Needs, and the
other three values were values
significantly higher than the values
proposed on October 19, 2006.
Additionally, DEA notes that interested
persons directly impacted by these
quotas (i.e., DEA-registered
manufacturers and importers) learned of
the factors DEA would consider in the
establishment of individual quotas in
July when the Interim Final Rule was
published. Many of these factors are set
forth by statute; any remaining factors
parallel the current system which has
existed for individual quotas for
controlled substances essentially since
the inception of the Controlled
Substances Act. For these reasons, DEA
believes that DEA registrants had ample
time to gather the necessary scientific
and technical information that would be
required to submit substantive
comments to the proposed 2008
Assessment of Annual Needs.
Finally, DEA believes that the
commenter did not proffer any specific
information beyond that which it
submitted in its written comments that
would be brought to light if the DEA
were to extend the comment period.
Withdrawal of 2008 Proposed
Assessment of Annual Needs
The commenter requested that the
proposed 2008 Assessment of Annual
Needs be withdrawn and reproposed,
presumably based on its comments.
DEA Response: After considering the
commenter’s comments, the DEA has
determined that the request for a
withdrawal of the proposed 2008
Assessment of Annual Needs is
unnecessary for the reasons discussed
above.
Conclusion
DEA has carefully considered the
comment received from the lone
commenter in connection with the
proposed 2008 Assessment of Annual
VerDate Aug<31>2005
18:00 Dec 26, 2007
Jkt 214001
Needs. Based on information provided
in the comment, along with information
provided by DEA-registered
manufacturers and importers of these
List I chemicals on applications for
individual import, manufacturing, and
procurement quotas pursuant to DEA
regulations, DEA has fully addressed the
relevant issues set forth in the comment.
Therefore, under the authority vested in
the Attorney General by section 306 of
the CSA (21 U.S.C. 826), and delegated
to the Administrator of the DEA by 28
CFR 0.100, and redelegated to the
Deputy Administrator pursuant to 28
CFR 0.104, the Deputy Administrator
hereby orders that the 2008 Assessment
of Annual Needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, be
established as follows:
Established
2008
assessment
of
annual
needs
(kg)
List I Chemical
Ephedrine (for sale) ..................
Ephedrine (for conversion) .......
Pseudoephedrine (for sale) ......
Phenylpropanolamine (for sale)
Phenylpropanolamine (for conversion) .................................
11,500
128,760
511,100
5,545
Frm 00058
Fmt 4703
Sfmt 4703
Dated: December 18, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 07–6218 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
85,470
The Office of Management and Budget
has determined that notices of quotas
are not subject to centralized review
under Executive Order 12866.
This action does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
action does not have any federalism
implications warranting the application
of Executive Order 13132.
The Deputy Administrator hereby
certifies that this action will not have a
significant economic impact upon a
substantial number of small entities
whose interests must be considered
under the Regulatory Flexibility Act, 5
U.S.C. 601–612. The establishment of
Assessment of Annual Needs for
ephedrine, pseudoephedrine, and
phenylpropanolamine is mandated by
law. The assessments are necessary to
provide for the estimated medical,
scientific, research and industrial needs
of the United States; for lawful export
requirements; and the establishment
and maintenance of reserve stocks.
Accordingly, the Deputy Administrator
has determined that this action does not
require a regulatory flexibility analysis.
PO 00000
This action meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
This action will not result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
This action is not a major rule as
defined by section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This action will not result
in an annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated September 21, 2007,
and published in the Federal Register
on September 27, 2007, (72 FR 54929–
54930), Cedarburg Pharmaceuticals,
Inc., 870 Badger Circle, Grafton,
Wisconsin 53024, 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:
Drug
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
Remifentanil (9739) ......................
Schedule
I
I
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
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73368
Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Notices
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Cedarburg Pharmaceuticals, Inc. to
manufacture the listed basic classes of
controlled substances is consistent with
the public interest at this time. DEA has
investigated Cedarburg Pharmaceuticals,
Inc. to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with state
and local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25044 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated August 16, 2007, and
published in the Federal Register on
August 27, 2007, (72 FR 49020),
Chattem Chemicals, Inc., 3801 St. Elmo
Avenue, Building 18, Chattanooga,
Tennessee 37409, 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
4–Methoxyamphetamine
(7411).
Dihydromorphine (9145)
Difenoxin (9168) .............
Amphetamine (1100) ......
Methamphetamine (1105)
Methylphenidate (1724) ..
Pentobarbital (2270) .......
Codeine (9050) ...............
Dihydrocodeine (9120) ...
Oxycodone (9143) ..........
Hydromorphone (9150) ...
Hydrocodone (9193) .......
Meperidine (9230) ...........
Dextropropoxyphene,
bulk (non-dosage
forms) (9273).
Morphine (9300) .............
VerDate Aug<31>2005
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
18:00 Dec 26, 2007
Jkt 214001
Drug
Schedule
Thebaine (9333) .............
Oxymorphone (9652) ......
Noroxymorphone (9668)
Alfentanil (9737) ..............
Sufentanil (9740) ............
Fentanyl (9801) ...............
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Chattem Chemicals, Inc. to manufacture
the listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated Chattem Chemicals, Inc. to
ensure that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25040 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971, at
this time. DEA has investigated CIMA
Labs, Inc. to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with state
and local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 952(a)
and 958(a), and in accordance with 21
CFR 1301.34, the above named company
is granted registration as an importer of
the basic class of controlled substance
listed.
Dated: December 18, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–25038 Filed 12–26–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled
Substances; Notice of Registration
By Notice dated August 16, 2007, and
published in the FEDERAL REGISTER on
August 27, 2007, (72 FR 49021), Cody
Laboratories, 601 Yellowstone Avenue,
Cody, Wyoming 82414, 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 Enforcement Administration
Importer of Controlled Substances;
Notice of Registration
By Notice dated August 28, 2007 and
published in the Federal Register on
September 10, 2007, (72 FR 51664),
CIMA Labs, Inc., 7325 Aspen Lane,
Brooklyn Park, Minnesota 55428 made
application by letter to the Drug
Enforcement Administration (DEA) to
be registered as an importer of Nabilone
(7379), a basic class of controlled
substance listed in schedule II.
The company plans to import the
basic class of controlled substance for
clinical trials and research.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a)
and determined that the registration of
CIMA Labs, Inc. to import the basic
class of controlled substance is
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Drug
Dihydromorphine (9145)
Amphetamine (1100) ......
Methamphetamine (1105)
Amobarbital (2125) .........
Pentobarbital (2270) .......
Secobarbital (2315) ........
Phenylacetone (8501) .....
Cocaine (9041) ...............
Codeine (9050) ...............
Dihydrocodeine (9120) ...
Oxycodone (9143) ..........
Hydromorphone (9150) ...
Diphenoxylate (9170) ......
Meperidine (9230) ...........
Methadone (9250) ..........
Oxymorphone (9652) ......
Alfentanil (9737) ..............
Sufentanil (9740) ............
Fentanyl (9801) ...............
Schedule
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans on manufacturing
the listed controlled substances in bulk
for sale to its customers.
E:\FR\FM\27DEN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Pages 73367-73368]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25044]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated September 21, 2007, and published in the Federal
Register on September 27, 2007, (72 FR 54929-54930), Cedarburg
Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024,
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:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)............... I
Dihydromorphine (9145)..................... I
Dihydrocodeine (9120)...................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Sufentanil (9740).......................... II
Fentanyl (9801)............................ II
Remifentanil (9739)........................ II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution to its customers.
[[Page 73368]]
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and determined that the registration of
Cedarburg Pharmaceuticals, Inc. to manufacture the listed basic classes
of controlled substances is consistent with the public interest at this
time. DEA has investigated Cedarburg Pharmaceuticals, Inc. to ensure
that the company's registration is consistent with the public interest.
The investigation has included inspection and testing of the company's
physical security systems, verification of the company's compliance
with state and local laws, and a review of the company's background and
history. Therefore, pursuant to 21 U.S.C. 823, and in accordance with
21 CFR 1301.33, the above named company is granted registration as a
bulk manufacturer of the basic classes of controlled substances listed.
Dated: December 17, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. E7-25044 Filed 12-26-07; 8:45 am]
BILLING CODE 4410-09-P
