Date="03/19/93" Citation="58 FR 15088" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE" Subject="Schedules of Controlled Substances; Excluded Veterinary Anabolic Stero id Implant Products"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Excluded Veterinary Anabolic Steroid Implant Products AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Excluded Veterinary Anabolic Steroid Implant Products AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. + ------------------------------------------------------------ SUMMARY: The Drug Enforcement Administration (DEA) identifies the veterinary anabolic steroid implant product, Implus(TM)- H, as being excluded from the Controlled Substances Act. This action is part of the ongoing implementation of the Anabolic Steroid Control Act of 1990. EFFECTIVE DATE: March 19, 1993. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., (Chief, Drug and Chemical Evaluation Section), 202-307-7183. SUPPLEMENTARY INFORMATION: The Anabolic Steroids Control Act of 1990 (ASCA) (title XIX of Public Law 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)(1) 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. A procedure for designating products as being excluded from the CSA was published (56 FR 42935, August 30, 1991) and eight products were identified (57 FR 19533, July 22, 1992 and 57 FR 36372, August 13, 1992). Ivy Laboratories, Inc. notified the DEA in accordance with 21 CFR 1308.25 that Heifer-old, a product which they manufacture and which is identified as being an excluded veterinary anabolic steroid implant product, would be sold under an additional name. The purpose of this rule is to add that name, Implus(TM)-H, to 21 CFR 1308.26, the list of excluded veterinary anabolic steroid implant products. This action was not preceded by a proposal because it involves only a name change. The listing of a product in 21 CFR 1308.26 relieves persons who handle it from the registration, recordkeeping, security, and other requirements imposed by the CSA. Accordingly, the Deputy Assistant Administrator certifies that this action will not have an economic impact upon small entities whose interests must be considered under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.). This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this matter does not have sufficient federalism implications to require the preparation of a Federalism Assessment. 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 12291. 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 12291, and that it would otherwise meet the applicable standards of sections 2(a) and 2(b)(2) of Executive Order 12778. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Under the authority vested in the Attorney General by title XIX of Public Law 101-647, as delegated to the Administrator of the DEA pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy Assistant Administrator, Office of Diversion Control in 28 CFR 0.104, appendix to subpart R, section 7(g), the Deputy Assistant Administrator of the Office of Diversion Control hereby amends 21 CFR Part 1308 as set forth below: PART 1308-[AMENDED] 1. The authority citation for 21 CFR Part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted. 2. Section 1308.26(a) is amended by adding, in alphabetical order, one new entry to the Table of Excluded Veterinary Anabolic Steroid Implant Products, to read as follows: sec1308.26 Excluded veterinary anabolic steroid implant products. (a) * * * Table of Excluded Veterinary Anabolic Steroid Implant Product s ------------------------------------------------------------------------------- ------------------ Trade name Company NDC code Delivery Ingredients Quantity system ------------------------------------------------------------------------------- ------------------ * * * * * * * Implus(TM)-H . The Upjohn 0009-0434-01 20 implant testosterone 200 mg/implant, Company, belt 8 propionate 20 mg/implant Kalamazoo, MI pellets/ estradiol implant benzoate * * * * * * * ------------------------------------------------------------------------------- ------------------ Dated: March 12, 1993. Gene R. Haislip, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 93-6262 Filed 3-18-93; 8:45 am] BILLING CODE 4410-09-M