[Federal Register: October 20, 2006 (Volume 71, Number 203)]
[Rules and Regulations]
[Page 61876-61877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc06-5]
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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]
BILLING CODE 4410-09-P