00-11884. Schedules of Controlled Substances: Addition of Gamma-Hydroxybutyric Acid to Schedule I; Extension of Application of Order Form Requirement for Certain Persons

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Supplementary statement to final rule.

SUMMARY:

On March 13, 2000, DEA published a final rule (65 FR 13235) implementing the provisions of Pub. L. 106-172 “The Samantha Reid and Hillory J. Farias Date-Rape Prevention Act of 1999”, placing gamma-hydroxybutyric acid (GHB) and its salts, isomers, and salts of isomers into Schedule I of the Controlled Substances Act (CSA). The final rule placed Food and Drug Administration (FDA) approved products containing GHB in Schedule III, if or when these products are approved. The final rule required that any person who manufactures, distributes, dispenses, imports or exports GHB or who engages in research or conducts instructional activities with GHB, or who proposes to engage in such activities, submit an application for Schedule I registration in accordance with Title 21, Code of Federal Regulations (CFR), Part 1301 by May 12, 2000. Persons wishing to handle GHB for any of the above listed purposes must conduct all transactions using DEA Form 222, U.S. Official Order Forms for Schedule I and II Controlled Substances. Since these forms are provided only to registrants, this notice is providing an extension in the application of the order form requirement for GHB for persons submitting a registration application by May 12, 2000.

FOR FURTHER INFORMATION CONTACT:

Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, Telephone [phone].

SUPPLEMENTARY INFORMATION:

What Did DEA's Final Rule Accomplish?

On March 13, 2000, DEA published a final rule (65 FR 13235) implementing the provisions of Pub. L. 106-172 “The Samantha Reid and Hillory J. Farias Date-Rape Prevention Act of 1999”, placing gamma-hydroxybutyric acid (GHB) and its salts, isomers, and salts of isomers into Schedule I of the Controlled Substances Act (CSA).

The final rule noted that, pursuant to 21 CFR Part 1301, any person who manufactures, distributes, dispenses, imports or exports GHB or who engages in research or conducts instructional activities with GHB, or who proposes to engage in such activities, must submit an application for Schedule I registration by May 12, 2000. This was the first scheduling action involving GHB, and DEA recognized that persons distributing GHB for legitimate purposes would need time to comply with the new regulations.

Why Is DEA Providing an Extension of the Application of the Order Form Requirement and to Whom Does This Extension Apply?

At the same time, DEA required that persons wishing to distribute GHB for any of the above listed purposes must conduct all transactions using DEA Form 222, U.S. Official Order Forms for Schedule I and II Controlled Substances, as required by 21 CFR 1305.03. Given the DEA does not provide order forms until registration is approved, it would not be possible for applicants to comply with the order form requirements of the final rule while their application for registration is pending. Therefore, DEA is providing and extension in the application of the order form requirement for GHB for persons submitting a registration application by May 12, 2000. Persons who have submitted a registration application by May 12, 2000 may continue to handle and conduct transactions involving GHB. These persons must keep records regarding each transaction containing information required on the order form. Distributions of GHB may occur without the order form while applications for registration are pending. However, once registration is approved, and order forms have been received, these registrants must complete order forms for the transactions which have been conducted and must distribute the order forms according to the requirements of the regulations.

To Whom Does This Extension Not Apply?

The extension of the application of the order form requirement for GHB does not apply to persons submitting an application for registration after May 12, 2000. Persons submitting an application for registration after May 12, 2000 may not handle or conduct transactions involving GHB until registration has been granted by the Administration.

Regulatory Certifications

Regulatory Flexibility Act

The Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted in a manner consistent with the principles of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). It will not have a significant financial impact on a substantial number of small business entities. This supplementary statement to the final rule provides an extension of the application of the order form requirement for GHB, permitting persons to distribute GHB without using an official order form until those persons have been registered by the Administration.

Executive Order 12866

The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). DEA has determined that this is not a significant rulemaking action. This supplementary statement to the final rule permits distributions of GHB to occur without the use of order forms until persons are registered with the Administration. Therefore, this action has not been reviewed by the Office of Management and Budget.

Executive Order 13132

This action has been analyzed in accordance with the principles and criteria in Executive Order 13132, and it has been determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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 $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provision 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 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 foreign-based companies in domestic and export markets.

Plain Language Instructions

The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone [phone].

Dated: May 5, 2000.

John H. King,

Deputy Assistant Administrator, Office of Diversion Control.