[Federal Register Volume 71, Number 203 (Friday, October 20, 2006)]
[Rules and Regulations]
[Pages 61876-61877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17522]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-277F]
RIN 1117-AA98


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing an 
Interim Rule designating two pharmaceutical preparations as exempt 
anabolic steroid products under the Controlled Substances Act. This 
action is part of the ongoing implementation of the Anabolic Steroids 
Control Act of 1990.

DATES: Effective Date: This final rule is effective October 20, 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, Telephone: (202) 307-
7183.

SUPPLEMENTARY INFORMATION:

Background

    The Anabolic Steroids Control Act (ASCA) of 1990 (Title XIX of Pub. 
L. 101-647) placed anabolic steroids into Schedule III of the 
Controlled Substances Act (CSA). Section 1903 of the ASCA provides that 
the Attorney General may exempt products which contain anabolic 
steroids from all or any part of the Controlled Substances Act (CSA) 
(21 U.S.C. 801 et seq.) if the products have no significant potential 
for abuse. The authority to exempt these products was delegated from 
the Attorney General to the Administrator of the Drug Enforcement 
Administration (28 CFR 0.100(b)), who in turn, redelegated this 
authority to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration (28 CFR part 0, Appendix to 
Subpart R, Section 7(g)). The procedure for implementing this section 
of the ASCA is found in Sec.  1308.33 of Title 21 of the Code of 
Federal Regulations. An application which was in conformance with Sec.  
1308.33 of Title 21 of the Code of Federal Regulations was received and 
was forwarded to the Secretary of Health and Human Services for 
evaluation. The purpose of this rule is to finalize an interim rule 
regarding two products which the Deputy Assistant Administrator, Office 
of Diversion Control, finds meet the exempt anabolic steroid product 
criteria.

Anabolic Steroid Products Being Added to the List of Products Exempted 
From Application of the CSA

    DEA received a letter dated January 12, 2004, written to the DEA on 
behalf of Pharmaceutics International Inc. (PII), and an application to 
exempt from control under the CSA two products each containing 
esterified estrogens and methyltestosterone. In a letter dated April 1, 
2004, DEA provided a copy of this application to the Department of 
Health and Human Services (DHHS) along with a request for evaluation 
and a recommendation. In a letter dated September 22, 2005, the 
Assistant Secretary of Health for DHHS recommended that both 
EssianTM and EssianTM H.S. be exempted from 
control under the CSA based on their similarity to the products, 
Estratest[supreg] and Estratest[supreg] H.S., respectively, both of 
which have been exempted from control under the CSA.
    DEA agreed with DHHS regarding the similarity of these products to 
products which have already been exempted from the regulatory controls 
of the Controlled Substances Act. Further, after reviewing several law 
enforcement databases, DEA did not find evidence of significant abuse 
or trafficking of these types of products. Therefore, DEA published an 
Interim rule with request for comments (71 FR 10835, March 3, 2006).

Comments Received

    The DEA received no comments in response to the Interim Rule. Thus, 
the rule is being finalized without change. Accordingly, the Deputy 
Assistant Administrator hereby affirms his order that the following 
anabolic steroid products be added to the list of products excluded 
from application of certain controls of the Controlled Substances Act 
and referenced in 21 CFR 1308.34.

                                        Exempt Anabolic Steroid Products
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           Trade name                   Company              Form             Ingredients          Quantity
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EssianTM H.S....................  Pharmaceutics       Tablets...........  Esterfied           0.625mg/Tablet.
                                   International Inc                       Estrogens.         1.25mg/Tablet.
                                                                          Methyltestosterone
EssianTM........................  Pharmaceutics       Tablets...........  Esterfied           1.25mg/Tablet.
                                   International Inc.                      Estrogens.         2.5mg/Tablet.
                                                                          Methyltestosterone
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Regulatory Certifications

Regulatory Flexibility Act

    The granting of exemption status relieves persons who handle the 
exempted products in the course of legitimate business from the 
registration, recordkeeping, security, and other requirements imposed 
by the CSA. Accordingly, the Deputy Assistant Administrator certifies 
that this action will not have a significant economic impact upon a 
substantial number of small entities whose interests must be considered 
under the Regulatory Flexibility Act (5 U.S.C. 605(b)).

Executive Order 12866

    The Deputy Assistant Administrator has determined that this is not 
a ``significant rule,'' as that term is used in Executive Order 12866. 
This final rule exempts the identified steroid products from the 
regulatory controls that apply to controlled substances. Therefore, 
this rule has not been reviewed by the Office of Management and Budget.

[[Page 61877]]

Executive Order 12988

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This final rule 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 law. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This final rule will not result in the expenditure by State, local 
or tribal governments, in the aggregate, or by the private sector, of 
$115,000,000 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 final 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 United States-based companies to 
compete with foreign-based companies in domestic and export markets.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
Pursuant to the authority vested in the Attorney General by section 
1903 of the Anabolic Steroid Control Act of 1990, delegated to the 
Administrator of the Drug Enforcement Administration pursuant to 21 
U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy Assistant 
Administrator of the DEA Office of Diversion Control pursuant to 28 CFR 
part 0, Appendix to Subpart R, Section 7(g), the Deputy Assistant 
Administrator hereby adopts as a final rule, without change, the 
interim rule which was published at 71 FR 10835, on March 3, 2006 
amending the list described in 21 CFR 1308.34.

    Dated: October 10, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E6-17522 Filed 10-19-06; 8:45 am]
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