Drug Enforcement Administration (DEA), Department of Justice.
Interim rule and request for comments.
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.
Effective: June 24, 2002. Comments must be submitted on or before August 23, 2002.
Comments must be submitted to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537. Start Printed Page 42480Attention: DEA Federal Register Representative/CCRStart Further Info
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.End Further Info End Preamble Start Supplemental Information
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 § 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®-IS, Revalor®-IH and Revalor®-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).
|Trade name||Company||NDC code||Delivery system||Ingredients||Quantity|
|Revalor-IS||Intervet Inc., Millsboro, DE||57926-022-01||10 implant cartridge 4 pellets/implant||Trenbolone Acetate Estradiol-17beta||20 mg/Pellet. 4 mg/Pellet.|
|Revalor-IH||Intervet Inc., Millsboro, DE||57926-025-01||10 implant cartridge 4 pellets/implant||Trenbolone Acetate Estradiol-17beta||20 mg/Pellet. 2 mg/Pellet.|
|Revalor-200||Intervet Inc., Millsboro, DE||57926-024-01||10 implant cartridge 10 pellets/implant||Trenbolone Acetate Estradiol-17beta||20 mg/Pellet. 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 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.
This interim rule meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
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.Start Printed 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.Start Signature
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