FR Doc E6-14516

[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Rules and Regulations]
[Page 51996-51998]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se06-9]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-289I]
RIN 1117-AB04

Schedules of Controlled Substances: Exempt Anabolic Steroid
Products

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

ACTION: Interim rule and request for comments.

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SUMMARY: The Drug Enforcement Administration (DEA) is designating six
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: This rule is effective September 1, 2006. Written comments must
be postmarked, and electronic comments must be sent, on or before
October 31, 2006.

ADDRESSES: To ensure proper handling of comments, please reference
Docket No. DEA-289 on all written and electronic correspondence.
Written comments sent via regular mail should be sent to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: DEA Federal Register
Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
Comments may be sent electronically to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided at that

site. DEA will accept attachments to electronic comments in Microsoft
Word, Word Perfect, Adobe PDF, or Excel file formats only. DEA will not
accept any file formats other than those specifically listed here.

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) (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 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. Three
applications which were in conformance with 21 CFR 1308.33 were
received and forwarded to the Secretary of Health and Human Services
for evaluation. The purpose of this rule is to identify six 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 three letters dated June 8, 2005, July 1, 2005 and
August 22, 2005, written to the DEA on behalf of Interpharm Inc.,
Lannett Company Inc., and ANDAPharm, LLC, respectively. Each of these
three letters contained an application to exempt from control under the
CSA two products, each containing esterified estrogens and
methyltestosterone. In two letters dated November 14, 2005, DEA
provided a copy of the Lannett and ANDAPharm applications to the
Department of Health and Human Services (DHHS) along with a request for
evaluation and a recommendation. In a letter dated November 15, 2005,
DEA provided a copy of the Interpharm application to DHHS along with a
request for evaluation and recommendation. In three separate letters
dated March 30, 2006, the Assistant Secretary of Health for DHHS
recommended that all six products, two products of esterified estrogen
and methyltestosterone from each of the three applications, be exempted
from control under the CSA based on their similarity to the products
Estratest^[reg], Estratest^[reg] H.S.,
Essian^TM and Essian^TM H.S., which have been
exempted from control under the CSA.
DEA agrees 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 has not found evidence of significant abuse
or trafficking of these types of products.
The Deputy Assistant Administrator, having reviewed the
applications, recommendations of the Secretary, and other relevant
information, finds that the following six products have no significant
potential for abuse: Esterified Estrogens and Methyltestosterone, USP
(1.25 mg/2.5 mg); Esterified Estrogens and Methyltestosterone, USP
(0.625 mg/ 1.25 mg); Methyltestosterone and Esterified Estrogens (2.5
mg/1.25 mg); Methyltestosterone and Esterified

[[Page 51997]]

Estrogens (1.25 mg/0.625 mg); Esterified Estrogens/Methyltestosterone
(1.25 mg/2.5 mg) Tablet; and Esterified Estrogens/Methyltestosterone
(0.625 mg/1.25 mg) Tablet H.S. Information on these products is given
below.

Exempt Anabolic Steroid Products
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Trade name Company Form Ingredients Quantity
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Esterified Estrogens and Interpharm, Inc.................... Tablets......... Esterfied Estrogens................ 1.25 mg/Tablet.
Methyltestosterone, USP (1.25 Methyltestosterone................. 2.5 mg/Tablet.
mg/2.5 mg).
Esterified Estrogens and Interpharm, Inc.................... Tablets......... Esterfied Estrogens................ 0.625 mg/Tablet.
Methyltestosterone, USP (0.625 Methyltestosterone................. 1.25 mg/Tablet.
mg/1.25 mg).
Methyltestosterone and Lannett Company, Inc............... Tablets......... Esterfied Estrogens................ 1.25 mg/Tablet.
Esterified Estrogens (2.5 mg/ Methyltestosterone................. 2.5 mg/Tablet.
1.25 mg).
Methyltestosterone and Lannett Company, Inc............... Tablets......... Esterfied Estrogens................ 0.625 mg/Tablet.
Esterified Estrogens (Half Methyltestosterone................. 1.25 mg/Tablet.
Strength) (1.25 mg/0.625 mg).
Esterified Estrogens/ ANDAPharm, LLC..................... Tablets......... Esterfied Estrogens................ 1.25 mg/Tablet.
Methyltestosterone, (1.25 mg/ Methyltestosterone................. 2.5 mg/Tablet.
2.5 mg) Tablet.
Esterified Estrogens/ ANDAPharm, LLC..................... Tablets......... Esterfied Estrogens................ 0.625 mg/Tablet.
Methyltestosterone, (0.625 mg/ Methyltestosterone................. 1.25 mg/Tablet.
1.25 mg) Tablet.
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Therefore, the Deputy Assistant Administrator hereby orders that
the above anabolic steroid products be added to the list of products
excluded from application of certain controls of the CSA and referenced
in 21 CFR 1308.34.
Interested persons are invited to submit their comments 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 he may reconsider the
application in light of the comments and objections filed. Thereafter,
the Deputy Assistant Administrator shall reinstate, revoke, or amend
his original order as he 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, 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 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.

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 $117,000,000 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.

Administrative Procedure Act

An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including Notice of Proposed Rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest (5 U.S.C. 553(b)(3)(B). Further, the
Administrative Procedure Act permits an agency to make this rule
effective upon the date of publication if the rule is ``a substantive
rule which grants or recognizes an exemption or relieves a
restriction'' (5 U.S.C. 553(d)(1)). As the rule adds six anabolic
steroid products to the list of products exempted from regulatory
control under the Controlled Substances Act and provides a benefit to
the affected public, DEA finds that this rule meets the criteria set
forth in 5 U.S.C. 553(b)(3)(B) and 5 U.S.C. 553(d)(1) for an exception
to the usual notice and comment process.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

Pursuant to the authority vested in the Attorney General by section
1903 of the Anabolic Steroids 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 orders that the following compounds, mixtures, or
preparations containing anabolic steroids be exempted from application
of sections 302 through 309 and sections 1002 through 1004 of the
Controlled Substances Act (21 U.S.C. 822-829 and 21 U.S.C. 952-954) and
21 CFR 1301.13, 1301.22, 1301.71 through 1301.76 for administrative
purposes only and be

[[Page 51998]]

included in the list of products described in 21 CFR 1308.34.

New Exempt Anabolic Steroid Products
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Trade name Company Form Ingredients Quantity
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Esterified Estrogens and Interpharm, Inc.............. Tablets........... Esterfied Estrogens................. 1.25 mg/Tablet.
Methyltestosterone, USP (1.25 mg/ Methyltestosterone.................. 2.5 mg/Tablet.
2.5 mg).
Esterified Estrogens and Interpharm, Inc.............. Tablets........... Esterfied Estrogens................. 0.625 mg/Tablet.
Methyltestosterone, USP (0.625 Methyltestosterone.................. 1.25 mg/Tablet.
mg/1.25 mg).
Methyltestosterone and Esterified Lannett Company, Inc......... Tablets........... Esterfied Estrogens................. 1.25 mg/Tablet.
Estrogens (2.5 mg/1.25 mg). Methyltestosterone.................. 2.5 mg/Tablet.
Methyltestosterone and Esterified Lannett Company, Inc......... Tablets........... Esterfied Estrogens................. 0.625 mg/Tablet.
Estrogens (Half Strength) (1.25 Methyltestosterone.................. 1.25 mg/Tablet.
mg/0.625 mg).
Esterified Estrogens/ ANDAPharm, LLC............... Tablets........... Esterfied Estrogens................. 1.25 mg/Tablet.
Methyltestosterone, (1.25 mg/2.5 Methyltestosterone.................. 2.5 mg/Tablet.
mg) Tablet.
Esterified Estrogens/ ANDAPharm, LLC............... Tablets........... Esterfied Estrogens................. 0.625 mg/Tablet.
Methyltestosterone, (0.625 mg/ Methyltestosterone.................. 1.25 mg/Tablet.
1.25 mg) Tablet.
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Dated: August 24, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E6-14516 Filed 8-31-06; 8:45 am]

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