Treatment of Overall Foreign and Domestic Losses, 13679 [2010-6462]
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Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations
of the Chain Drug Consortium, Boca
Raton, Florida, and ‘‘The Kroger’’ label
by The Kroger Company of Cincinnati,
Ohio). Based on the application and
other information received, including
the quantitative composition of the
substance and labeling and packaging
information, DEA has determined that
this product (sold under various private
labels) may, under the Federal Food,
Drug, and Cosmetic Act, be lawfully
sold over the counter without a
prescription (21 U.S.C. 811(g)(1)).
The Deputy Assistant Administrator
finds that this product meets the criteria
for exclusion from the CSA in
accordance with 21 U.S.C. 811(g)(1).
Note that this exclusion only applies to
the finished drug product in the form of
an inhaler (in the exact formulation
detailed in the application for
exclusion), which is lawfully sold under
the Federal Food, Drug, and Cosmetic
Act. The extraction or removal of the
active ingredient (Levmetamfetamine)
from the inhaler shall negate this
exclusion and, depending on the
circumstances, result in the possession
or manufacture of a schedule II
controlled substance.
This rulemaking finalizes the addition
of Classic Pharmaceuticals, LLC product
containing 50 mg Levmetamfetamine in
a Nasal Decongestant Inhaler/Vapor
Inhaler and marketed under various
private labels to the list of excluded
nonnarcotic products contained in 21
CFR 1308.22. Therefore, this product is
excluded from CSA regulatory
provisions pursuant to 21 U.S.C.
811(g)(1).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator
hereby certifies that this rulemaking has
been drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612). This rule will not have a
significant economic impact on a
substantial number of small entities.
This rule adds a product to the list of
products excluded from the
requirements of the CSA.
wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Executive Order 12866
The Deputy Assistant Administrator
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866
Section 1(b). It has been determined that
this is not ‘‘a significant regulatory
action.’’ As discussed previously, based
on the information received by the
manufacturer of the product in question,
DEA has determined that this product
may, under the Federal Food, Drug, and
VerDate Nov<24>2008
11:33 Mar 22, 2010
Jkt 220001
Cosmetic Act, be lawfully sold over the
counter without a prescription.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988, Civil
Justice Reform.
Executive Order 13132
This rulemaking 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
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule 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.
Congressional Review Act
This rule is not a major rule as
defined by Section 804 of the
Congressional Review Act/Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
$100,000,000 or more; a major increase
in cost 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.
Administrative Procedure Act
The Administrative Procedure Act
permits an agency to make a rule
effective upon date of publication if it
is ‘‘a substantive rule which grants or
recognizes an exemption or relieves a
restriction’’ (5 U.S.C. 553(d)(1)). Since
this rule excludes a nonnarcotic drug
product from the provisions of the CSA,
and as this rule finalizes an interim rule
already in effect excluding this product
from CSA regulatory control, DEA finds
that it meets the criteria set forth in 5
U.S.C. 553(d)(1) for an exception to the
effective date requirement.
The Interim Rule with Request for
Comments amending part 1308 of title
21, Code of Federal Regulations,
published in the Federal Register
August 28, 2009, at 74 FR 44281, is
hereby adopted as a final rule without
change.
■
Dated: March 16, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 2010–6176 Filed 3–22–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
Determination of Interest Expense
Deduction of Foreign Corporations
CFR Correction
In Title 26 of the Code of Federal
Regulations, Part 1 (§§ 1.851 to 1.907),
revised as of April 1, 2009, in § 1.882–
5, move paragraph (d)(2)(ii)(B)
introductory text from the second
column on page 435 to the first column
on page 436, following paragraph (2)
through (3).
[FR Doc. 2010–6463 Filed 3–22–10; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
Treatment of Overall Foreign and
Domestic Losses
CFR Correction
In Title 26 of the Code of Federal
Regulations, Part 1 (§§ 1.851 to 1.907),
revised as of April 1, 2009, on page 808,
in § 1.904(f)–2, in paragraph (c)(5)
Example 4, following ‘‘§ 1.904(f)–
2T(c)(5)’’, add ‘‘Example 4.’’.
[FR Doc. 2010–6462 Filed 3–22–10; 8:45 am]
BILLING CODE 1505–01–D
List of Subjects in 21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Narcotics, Prescription drugs.
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[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Rules and Regulations]
[Page 13679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6462]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
Treatment of Overall Foreign and Domestic Losses
CFR Correction
In Title 26 of the Code of Federal Regulations, Part 1 (Sec. Sec.
1.851 to 1.907), revised as of April 1, 2009, on page 808, in Sec.
1.904(f)-2, in paragraph (c)(5) Example 4, following ``Sec. 1.904(f)-
2T(c)(5)'', add ``Example 4.''.
[FR Doc. 2010-6462 Filed 3-22-10; 8:45 am]
BILLING CODE 1505-01-D
