Federal
Register Notices > Rules
- 2006 > Final Rule -
Schedules of Controlled Substances: Exempt Anabolic Steroid Products
FR Doc E6-17522 [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]
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.
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
Trade name |
Company |
Form |
Ingredients |
Quantity |
EssianTM H.S |
Pharmaceutics International Inc. |
Tablets |
Esterfied Estrogens |
0.625mg/Tablet. |
|
|
|
Methyltestosterone |
1.25mg/Tablet. |
EssianTM |
Pharmaceutics International Inc. |
Tablets |
Esterfied Estrogens |
1.25mg/Tablet. |
|
|
|
Methyltestosterone |
2.5mg/Tablet. |
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
- 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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|