[Federal Register Volume 65, Number 93 (Friday, May 12, 2000)]
[Rules and Regulations]
[Pages 30541-30542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11884]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[DEA-200S]


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.

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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

[[Page 30542]]

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 (202) 307-7297.

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 (202) 307-7297.

    Dated: May 5, 2000.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 00-11884 Filed 5-11-00; 8:45 am]
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