E6-16992. Technical Correction of Two Anabolic Steroid Names

AGENCY:

Drug Enforcement Administration (DEA), U.S. Department of Justice.

ACTION:

Final rule.

SUMMARY:

The purpose of this final rule is to correct the chemical names of two anabolic steroids in the Drug Enforcement Administration's (DEA) regulations. The Anabolic Steroid Control Act of 2004 included typographical errors in the chemical names of two anabolic steroids designated as Schedule III substances. Section 1180 of the Violence Against Women and Department of Justice Reauthorization Act of 2005 corrects these typographical errors. This Final Rule amends DEA regulations to conform to the Act.

Effective Date:

October 13, 2006.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at [phone].

SUPPLEMENTARY INFORMATION:

Background

On October 22, 2004, the President signed into law the Anabolic Steroid Control Act of 2004 (Pub. L. 108-358), which became effective on January 20, 2005. Section 2(a) of the Anabolic Steroid Control Act of 2004 amended the Controlled Substances Act (CSA) by listing 59 specific substances as being Schedule III anabolic steroids (21 U.S.C. § 802(41)(A)). This list included two typographical errors in the chemical names of two anabolic steroids. Congress corrected this error under “Section 1180 of the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Pub. L. 109-162). Section 1180 amends the CSA (21 U.S.C. 802(41)(A)) by replacing the chemical names for the following anabolic steroids:13β-ethyl-17β -hydroxygon-4-en-3-one and stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole). By this Final Rule, DEA is amending its regulations to conform to statute. Consequently, public comments are not being solicited since they could not alter this rule.

Regulatory Certifications

Administrative Procedure Act

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (5 U.S.C. 553), including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest. The Violence Against Women and Department of Justice Reauthorization Act (Pub. L. 109-162) made two technical corrections to the CSA to correct typographical errors that were made in previous legislation. This Final Rule merely makes conforming amendments to DEA regulations implementing the Act to correct these typographical errors. Therefore, DEA finds it unnecessary to publish this rule for public notice and comment.

Further, the Administrative Procedure Act permits an agency to make this rule effective upon the date of publication if the agency finds good cause to do so (5 U.S.C. 553(d)(3)). As delaying the effective date of typographical corrections to the Code of Federal Regulations would serve no purpose and could, in fact, cause confusion were a person to misinterpret existing regulations, DEA finds good cause to make this rule effective upon publication.

Regulatory Flexibility Act

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and, by approving it, certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This Final Rule merely corrects typographical errors in the chemical names of two anabolic steroids.

Executive Order 12866

The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with Executive Order 12866, § 1(b). DEA has determined that this rule is not a significant regulatory action. Therefore, the Office of Management and Budget has not reviewed this action.

Executive Order 12988

This regulation meets the applicable standards set forth in §§ 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 $118,000,000 or more 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.

Small Business Regulatory Enforcement Fairness Act of 1996

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. 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 foreign-based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1300

• Chemicals
• Drug traffic control

For the reasons set out above, 21 CFR part 1300 is amended as follows:

PART 1300—DEFINITIONS

1. The authority citation for part 1300 continues to read as follows:

Authority: 21 U.S.C. 802, 871(b), 951, 958(f).

2. Section 1300.01 is amended by revising paragraphs (b)(4)(xxiii) and (b)(4)(liv) to read as follows:

§ 1300.01

Definitions relating to controlled substances.

* * * * *

(b) * * *

(4) * * *

(xxiii) 13β-ethyl-17β-hydroxygon-4-en-3-one

* * * * *

(liv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole)

* * * * *

Dated: September 29, 2006.

Michele M. Leonhart,

Deputy Administrator.