[Federal Register Volume 65, Number 223 (Friday, November 17, 2000)]
[Rules and Regulations]
[Pages 69442-69443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29439]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308


Schedule II Control of Dihydroetorphine Under the Controlled 
Substances Act (CSA)

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: This is a final rule issued by the DEA that dihydroetorphine 
(7,8-dihydro-7-[1-(R)-hydroxy-1-methylbutyl]-6,14-endo-
ethanotetrahydrooripavine) is a Schedule II controlled substance. 
Although dihydroetorphine is not specifically listed in Schedule II of 
the Controlled Substances Act (CSA), it is a derivative of thebaine and 
as such is controlled under 21 U.S.C. 812 Schedule II(a)(1) which 
includes ``Opium and opiate, and any salt, compound, derivative, or 
preparation of opium or opiate.'' Dihydroetorphine is a derivative of 
thebaine, a natural constituent of opium, hence dihydroetorphine is, by 
virtue of 21 U.S.C. 812 and 21 CFR Part 1308.12(b)(1)(16), a Schedule 
II controlled substance. International control of dihydroetorphine in 
Schedule I of the Single Convention on Narcotic Drugs, 1961 in 1998 
prompted the DEA to specifically list dihydroetorphine as a controlled 
substance in Schedule II of the CSA.

EFFECTIVE DATE: November 17, 2000.

FOR FURTHER INFORMATION OR QUOTA REQUESTS CONTACT: Frank Sapienza, 
Chief, Drug and Chemical Evaluation Section, Office of Diversion 
Control, Drug Enforcement Administration, Washington, DC 20537, (202) 
307-7183.

SUPPLEMENTARY INFORMATION:

What Is Dihydroetorphine and Why Is It Controlled?

    Dihydroetorphine is the international non-proprietary name for a 
chemical substance which is chemically similar to etorphine. It is an 
opiate-like

[[Page 69443]]

substance that is 3-4 order of magnitude (1000 to 10,000 times) more 
potent than morphine but with a shorter duration of action. The effects 
of dihydroetorphine and its psychological dependence liability are 
similar to those produced by heroin. Animal studies demonstrate that it 
is a highly potent analgesic with effects that begin within 15 minutes 
of administration and the effects last from 60-90 minutes. 
Dihydroetorphine was registered in China in December of 1992 for the 
relief of acute severe pain. However, abuse of dihydroetorphine began 
soon after it was marketed in China in 1992. Dihydroetorphine is not 
marketed or used medically in the United States. As a thebaine 
derivative, dihydroetorphine is controlled in Schedule II of the CSA in 
the United States.

Under What Authority Is Dihydroetorphine Controlled?

    This order is prompted by a letter dated November 11, 1998, in 
which the United States Government was informed by the Secretary-
General of the United Nations that dihydroetorphine has been added to 
Schedule I of the Single Convention on Narcotic Drugs, 1961 (1961 
Convention). As a signatory Member State to the 1961 Convention, the 
United States is obligated to control dihydroetorphine under national 
drug control legislation, i.e., the CSA. Dihydroetorphine is currently 
controlled under Schedule II of the CSA as a thebaine derivative, and 
as such, all regulations and criminal sanctions applicable to Schedule 
II substances have been and are applicable to dihydroetorphine. 
Schedule II control under the CSA satisfies the requirements of 
Schedule II control under the 1961 Convention.

Executive Order 12866

    This regulation has been drafted and reviewed in accordance with 
Executive Order 12866, Section 1(b), Principles of Regulation. DEA has 
determined that this rule is not a significant regulatory action under 
Executive Order 12866, Section 3(f), Regulatory Planning and Review, 
and accordingly this rule has not been reviewed by the Office of 
Management and Budget.

Executive Order 12988--Civil Justice Reform

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Regulatory Flexibility Act

    This action will not have a significant economic impact on a 
substantial number of entities whose interests must be considered under 
the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). This action 
provides notification of control of dihydroetorphine in Schedule II of 
the CSA in order to comply with international treaty obligations. 
Although dihydroetorphine was not specifically listed in the CSA as a 
controlled substance, it was already controlled in Schedule II of the 
CSA as a derivative of thebaine.

Unfunded Mandate Reform Act

    This rule will not result in the expenditure of 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.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Sec. 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 the United States-based companies to compete with 
foreign-based companies in domestic and export markets.

Executive Order 13132 Federalism

    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. 13132, it is 
determined that this rule will not have sufficient federalism 
implications to warrant the preparation of a Federalism Assessment.

Plain English

    The DEA makes every effort to write clearly. If you have 
suggestions as to how to improve the clarity of this regulation please 
contact Patricia M. Good, Chief, Policy and Liaison Section, Office of 
Diversion Control, Drug Enforcement Administration, Washington, DC 
20537, phone (202) 307-7297.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

    Under the authority vested in the Attorney General by Section 
201(d)(1) of the CSA [21 U.S.C. 811(d)(1)], and delegated to the 
Administrator of the DEA by the Department of Justice regulations (28 
CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28 
CFR 0.104, Appendix to Subpart R, Section 12, the Deputy Administrator 
hereby amends 21 CFR part 1308 as follows:

PART 1308--[AMENDED]

    1. The authority citation for Part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. Section 1308.12 is amended by redesignating paragraphs (b)(1)(8) 
through (b)(1)(16) as (b)(1)(9) through (b)(1)(17) and adding a new 
paragraph (b)(1)(8) to read as follows:


Sec. 1308.12  Schedule II.

* * * * *
    (b) * * *
    (1) * * *

    (8) dihydroetorphine--9334
* * * * *

    Dated: November 7, 2000.
Julio F. Mercado,
Deputy Administrator.
[FR Doc. 00-29439 Filed 11-16-00; 8:45 am]
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