[Federal Register Volume 67, Number 121 (Monday, June 24, 2002)]
[Rules and Regulations]
[Pages 42479-42481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15860]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-230I]


Schedules of Controlled Substances: Excluded Veterinary Anabolic 
Steroid Implant 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 three 
veterinary anabolic steroid implant products as being excluded from the 
Controlled Substances Act. This action is part of the ongoing 
implementation of the Anabolic Steroid Control Act.

DATES: Effective: June 24, 2002. Comments must be submitted on or 
before August 23, 2002.

ADDRESSES: Comments must be submitted to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537.

[[Page 42480]]

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 
1902(b)(41)(B)(i) of the ASCA provides for the exclusion of any 
anabolic steroid which the Secretary of Health and Human Services has 
approved for administration through implants to cattle or other 
nonhuman species. The procedure for implementing this section of the 
ASCA is described in Sec. 1308.25 of Title 21 Code of Federal 
Regulations. The purpose of this rule is to identify three products 
which the Deputy Assistant Administrator, Office of Diversion Control, 
finds meet the excluded veterinary anabolic steroid implant product 
criteria.

What Anabolic Steroid Veterinary Implant Products Are Being Added to 
the List of Products Excluded From Application of the CSA?

    The Deputy Assistant Administrator, having reviewed the 
applications which were made in conformance with 21 U.S.C. 
802(41)(B)(i) and 21 CFR 1308.25, finds that the anabolic steroid 
products, Revalor[reg]-IS, Revalor[reg]-IH and Revalor[reg]-200, are 
expressly intended for administration through implants to cattle and 
have been approved by the Secretary of Health and Human Services for 
such use. Therefore, pursuant to the authority vested in the Attorney 
General by Title XIX of Pub. L. 101-647 as delegated to the 
Administrator of DEA pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100, the 
Deputy Assistant Administrator hereby orders that the following 
anabolic steroid veterinary implant products be added to the list of 
products excluded from application of the CSA and referenced in 21 CFR 
1308.26(a).

                                                  Excluded Veterinary Anabolic Steroid Implant Products
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             Trade name                      Company             NDC code         Delivery system           Ingredients                Quantity
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Revalor-IS.........................  Intervet Inc.,             57926-022-01  10 implant cartridge..  Trenbolone Acetate....  20 mg/Pellet.
                                      Millsboro, DE.                          4 pellets/implant.....  Estradiol-17beta......  4 mg/Pellet.
Revalor-IH.........................  Intervet Inc.,             57926-025-01  10 implant cartridge..  Trenbolone Acetate....  20 mg/Pellet.
                                      Millsboro, DE.                          4 pellets/implant.....  Estradiol-17beta......  2 mg/Pellet.
Revalor-200........................  Intervet Inc.,             57926-024-01  10 implant cartridge..  Trenbolone Acetate....  20 mg/Pellet.
                                      Millsboro, DE.                          10 pellets/implant....  Estradiol-17beta......  2 mg/Pellet.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The exemption of these products relates to their production, 
distribution, and use in animals only. If any person distributes, 
dispenses or otherwise diverts these products to use in humans, he/she 
shall be deemed to have distributed a Schedule III controlled substance 
and may be prosecuted for CSA violations.
    Section 102(41)(b) of the CSA (21 U.S.C. 802(41)(B)(i)) states that 
the term ``anabolic steroid'' ``does not include an anabolic steroid 
which is expressly intended for administration through implants to 
cattle or other nonhuman species and which has been approved by the 
Secretary of Health and Human Services for such administration.'' Title 
21 CFR 1308.25(a) permits any person to apply for an exemption from any 
schedule of the CSA for any product meeting the above criteria. 
Therefore, in compliance with 21 CFR 1308.25, and having been presented 
with the proper documentation, DEA is issuing this order that the three 
identified products are excluded from the definition of anabolic 
steroid pursuant to 21 U.S.C. 802(41)(B)(i).
    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 excluded status relieves persons who handle the 
excluded 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 interests 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 12778 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 12778.

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.

[[Page 42481]]

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: June 14, 2002.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 02-15860 Filed 6-21-02; 8:45 am]
BILLING CODE 4410-09-M