13678 Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations 

Approved: March 10, 2010. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

David V. Aguilar, 

Acting Deputy Commissioner, U.S. Customs 

and Border Protection. 

[FR Doc. 2010–6387 Filed 3–22–10; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 3 

[Docket No. FDA–2010–N–0010] 

Product Jurisdiction; Change of 

Address and Telephone Number; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to reflect a change in the 

address and telephone number for the 

Office of Combination Products (OCP). 

This action is editorial in nature and is 

intended to improve the accuracy of the 

agency’s regulations. 

DATES: Effective Date: April 19, 2010. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5130, Silver Spring, 

MD 20993–0002, 301–796–8930. To 

confirm that this change of address and 

telephone number has occurred, please 

see our Web site at www.fda.gov/ 

CombinationProducts/default.htm. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in 21 CFR part 

3 to reflect a change in the address and 

telephone number for OCP. Publication 

of this document constitutes final action 

on this change under the Administrative 

Procedure Act (5 U.S.C. 553). Notice 

and public procedures are unnecessary 

because FDA is merely updating 

nonsubstantive content. 

List of Subjects in 21 CFR Part 3 

Administrative practice and 

procedure, Biologics, Combination 

products, Drugs, Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 3 is 

amended as follows: 

PART 3—PRODUCT JURISDICTION 

■ 1. The authority citation for 21 CFR 

part 3 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 353, 355, 

360, 360c–360f, 360h–360j, 360gg–360ss, 

360bbb–2, 371(a), 379e, 381, 394; 42 U.S.C. 

216, 262, 264. 

§ 3.6 [Amended] 

■ 2. Section 3.6 is amended by 

removing ‘‘(HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, suite 200, Rockville, MD 20855, 

301–427–1934’’and by adding in its 

place ‘‘Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

rm. 5129, Silver Spring, MD 20993– 

0002, 301–796–8930,’’. 

Dated: March 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–6246 Filed 3–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–329F] 

RIN 1117–AB23 

Schedules of Controlled Substances; 

Table of Excluded Nonnarcotic 

Products: Nasal Decongestant Inhalers 

Manufactured by Classic 

Pharmaceuticals, LLC 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: Under this Final Rule, the 

Drug Enforcement Administration 

(DEA) is updating the Table of Excluded 

Nonnarcotic Products found in 21 CFR 

1308.22 to include the Nasal 

Decongestant Inhaler/Vapor Inhaler 

(containing 50 mg Levmetamfetamine) 

manufactured by Classic 

Pharmaceuticals, LLC and marketed 

under various private labels (to include 

the ‘‘Premier Value’’ and ‘‘Kroger’’ 

labels). This nonnarcotic drug product, 

which may be lawfully sold over the 

counter without a prescription under 

the Federal Food, Drug, and Cosmetic 

Act, is excluded from provisions of the 

Controlled Substances Act (CSA) 

pursuant to 21 U.S.C. 811(g)(1). 

DATES: This rulemaking shall become 

effective on March 23, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152; telephone: (202) 

307–7183. 

SUPPLEMENTARY INFORMATION: On August 

28, 2009, the DEA published an interim 

rule with request for comments [74 FR 

44281]. This interim rule updated the 

Table of Excluded Nonnarcotic Products 

found in 21 CFR 1308.22 to include the 

Nasal Decongestant Inhaler/Vapor 

Inhaler (containing 50 mg 

Levmetamfetamine) manufactured by 

Classic Pharmaceuticals, LLC and 

marketed under various private labels 

(to include the ‘‘Premier Value’’ and 

‘‘Kroger’’ labels). This nonnarcotic drug 

product, which may be lawfully sold 

over the counter without a prescription 

under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.), is 

excluded from provisions of the 

Controlled Substances Act (CSA) 

pursuant to 21 U.S.C. 811(g)(1). 

Comments Received 

DEA did not receive any comments to 

its interim rule published August 28, 

2009, regarding this exemption. 

Therefore, DEA is issuing this 

rulemaking to finalize the interim rule 

without change. 

Background 

The CSA, specifically 21 U.S.C. 

811(g)(1), states that the Attorney 

General shall by regulation exclude any 

nonnarcotic drug which contains a 

controlled substance from the 

application of the CSA, if such drug 

may, under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.), be 

lawfully sold over the counter without 

a prescription. This authority has been 

delegated to the Administrator of DEA 

and redelegated to the Deputy Assistant 

Administrator of the Office of Diversion 

Control pursuant to 28 CFR 0.100 and 

title 28, part 0, appendix to subpart R, 

7(g), respectively. 

Such exclusions apply only to 

nonnarcotic products and are only 

granted following suitable application to 

the DEA per the provisions of 21 CFR 

1308.21. The current Table of Excluded 

Nonnarcotic Products found in 21 CFR 

1308.22 lists those products that have 

been granted excluded status. 

Pursuant to the application process of 

21 CFR 1308.21, DEA received 

application for exclusion from Classic 

Pharmaceuticals, LLC, the manufacturer 

of a Nasal Decongestant Inhaler/Vapor 

Inhaler which contains the schedule II 

controlled substance 

Levmetamfetamine. This inhaler is sold 

over the counter under various private 

labels (such as the ‘‘Premier Value’’ label 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations 13679 

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. 

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 

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. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ 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 


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