[Federal Register Volume 68, Number 10 (Wednesday, January 15, 2003)]
[Rules and Regulations]
[Pages 1964-1965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-772]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-2361


Schedules of Controlled Substances: Exempt Anabolic Steroid 
Products

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

ACTION: Interim rule and request for comments.

-----------------------------------------------------------------------

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

DATES: Effective date: January 15, 2003.
    Comment date: Comments must be received on or before March 17, 
2003.

ADDRESSES: Comments must be submitted to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537. Attention: DEA Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, 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) (21 U.S.C. 801 et seq.). 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 0.1009b)), who, in turn, 
redelegated this authority to the Deputy Assistant Administrator, 
Office of Diversion Control, Drug Enforcement Administration (28 CFR 
appendix to subpart R, section 7, paragraph (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 his evaluation. The purpose of this rule is to 
identify 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 June 18, 2002, written tot he DEA on 
behalf of Syntho Pharmaceuticals Inc., and two

[[Page 1965]]

petitions to exempt from control under the CSA a two products each 
containing esterified estrogens and methyltestosterone. In a letter 
dated July 16, 2002, DEA provided a copy of these petitions to the 
Department of Health and Human Services (HHS) along with a request for 
evaluation and recommendation. In a letter dated September 14, 2002, 
the Assistant Secretary of Health for HHS recommended that both Syntest 
H.S. and Syntest D.S. be exempted from controls under the CSA based on 
their similarity to the products, Estratest H.S. and Estratest, 
respectively, both of which have been exempted from control under the 
CSA. A subsequent examination of DEA databases did not reveal any 
evidence of abuse or diversion of Estratest H.S. and Estratest.
    The Deputy Assistant Administrator, having reviewed the 
application, recommendation of the Secretary, and other relevant 
information, finds that Syntest H.S. and Syntest D.S. have no 
significant potential for abuse. Information on these products is given 
below.

                                            Exempt Anabolic Products
----------------------------------------------------------------------------------------------------------------
           Trade name                   Company              Form             Ingredients          Quantity
----------------------------------------------------------------------------------------------------------------
Syntest H.S.....................  Syntho              Tablets...........  Esterfied           0.62mg/Tablet.
                                   Pharmaceuticals,                        Estrogrens.
                                   Farmingdale, NY.
                                                                          Methylestosterone.  1.25mg/Tablet.
Syntest D.S.....................  Syntho              Tablets...........  Esterfied           1.25mg/Tablet.
                                   Pharmaceuticals,                        Estrogrens.
                                   Farmingdale, NY.
                                                                          Methylestosterone.  2.5mg/Tablet.
----------------------------------------------------------------------------------------------------------------

    Therefore, the Deputy Assistant Administrator hereby orders that 
the above anabolic steroid products be added to the list of products 
excluded from application of the CSA and referenced in 21 CFR 1308.34
    Interested persons are invited to submit their comments in writing 
with regard to this interim rule. If any comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which this order is based, the Deputy Assistant Administrator 
shall immediately suspend the effectiveness of this order until she may 
reconsider the application in light of the comments and objections 
filed. Thereafter, the Deputy Assistant Administrator shall reinstate, 
revoke, or amend her original order as she determines appropriate.

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, record keeping, 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 interest must be considered 
under the Regulatory Flexibility Act. (5 U.S.C. 605(b)).

Executive Order 12866

    It has been determined that drug control matters are not subject to 
review by the Office of Management and Budget (OMB) pursuant to the 
provisions of Executive Order 12866. Accordingly, this action is not 
subject to those provisions of Executive Order 12l778 which are 
contingent upon review by OMB. Nevertheless, the Deputy Assistant 
Administrator has determined that this is not a ``major rule,'' as that 
term is used in Executive Order 12866, and that it would otherwise meet 
the applicable standards of sections 2(a) and 2(b)(2) of Executive 
Order 12788.

Executive Order 12988

    This interim 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 interim 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 interim rule will not result in the expenditure by State, 
local or 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 provisions of the Unfunded 
Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This interim 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.

    Dated: January 6, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-772 Filed 1-14-03; 8:45 am]
BILLING CODE 4410-09-M