Regulations & Codified CSA > CFR > Section 1308 > Section 1308.34 > Section 1308.34a

Code of Federal Regulations

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 160F]

EXEMPT ANABOLIC STEROID PRODUCTS

In accordance with the provisions of 21 U.S.C. 811(a) of the CSA, this action is a formal rulemaking "on the record after opportunity for a hearing." Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive order (E.O.) 12866, section 3(d)(1).

The Deputy Assistant Administrator, Office of Diversion Control, in accordance with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small-business entities. The inclusion of a product in 21 CFR 1308.34 relieves persons who handle the product in the course of legitimate business from the registration, records, reports, prescription, physical security, import and export requirements associated with Schedule III controlled substances under the CSA. Specifically, the products are exempted from application of sections 302 through 309 and 1002 through 1004 of the CSA (21 U.S.C. 822-829 and 952-954) and Sections 1301.11, 1301.13 and 1301.71 through 1301.76 of Title 21 Code of Federal Regulations.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

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 costs or prices; or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 12612, it is determined that this rule will not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Dated: September 8, 1997

John H. King,

Deputy Assistant Administrator, 
Office of Diversion Control, 
Drug Enforcement Administration