Date="12/18/92" Citation="57 FR 60148" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Registration and Reregistration Application Fees"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1301 and 1311 Registration and Reregistration Application Fees AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed rulemaking.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1301 and 1311 Registration and Reregistration Application Fees AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed rulemaking. ------------------------------------------------------------ SUMMARY: The DEA proposes to adjust the current application fee schedule for DEA registration to adequately recover the Federal costs associated with the Diversion Control Program as mandated in the Department of Justice and Related Agencies Appropriations Act, 1993 (section 111 (b), Pub. L. 102-395). DATES: Comments and objections must be submitted by January 19, 1993. ADDRESSES: Comments and objections should be submitted in quintuplicate to the Administrator, Drug Enforcement Administration, Washington, DC 20537 Attention: Federal Register Representative/CCR. FOR FURTHER INFORMATION CONTACT: Mr. Terrance Woodworth, Chief, Drug Operations Section, Office of Diversion Control, Washington, DC 20537, Telephone (202) 307-8569. SUPPLEMENTARY INFORMATION: The Department of Justice and Related Agencies Appropriations Act, 1993 (Pub. L. 102-395) requires that the Drug Enforcement Administration (DEA) collect fees to ensure the recovery of the full costs of operating the Diversion Control Program. Section 111 (b) of that Act requires that there be established an account in the general fund of the Treasury, and in section 111 (b)(1) "there shall be deposited as offsetting receipts into that account all fees collected by the Drug Enforcement Administration, in excess of $15,000,000, for the operation of its diversion control program." In addition, section 111 (b)(3) requires "fees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program." The Controlled Substances Act of 1970 (CSA) has, for 22 years, required the registration of any person who manufactures, distributes or dispenses a controlled substance. Section 301 of the CSA (21 U.S.C. 821) authorizes the charging of "reasonable fees relating to the registration and control of the manufacture, distribution and dispensing of controlled substances." This is the only fee collection made by DEA and the administrative mechanisms for its collection and processing are well established and efficient. The fee schedule under the CSA was established in 1971 and was adjusted in 1984. The fees have remained unchanged since that time. Modifications to the fee structure have been applied equitably across all registration categories in accordance with the existing structure. The legislation (Pub. L. 102-395) requires that the established fee recover costs during fiscal year 1993 and thereafter. The amount to be recovered is established by the Congressional appropriations process. This announcement establishes the fee structure under the existing registration system to recover the legislated appropriation. This appropriated amount required to be recovered for fiscal year 1993 will be $12 million above the fees currently set, and a total of $65.6 million will be required for fiscal year 1994. A correction is also being made to Section 1301.11(d) to include reregistration which was inadvertently omitted in a previous change to the section. Pursuant to section 3(c)(3) and 3(e)(2)(C) of E.O. 12291, this proposed action has been submitted for review to the Office of Management and Budget, and approval of that office has been requested pursuant to the provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. et seq. This rule is not a major rule for purposes of Executive Order (E.O.) 12291 of February 17, 1981. The vast majority of DEA registrants are considered to be small entities whose interests are to be considered under the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. However, these registrants are predominantly practitioners and pharmacies whose individual registration fees would be increased by $180 once every three years. Therefore, the Administrator has concluded that the fee increase will have no significant impact on small entities. This action has been analyzed in accordance with the principles and criteria contained in E.O. 12612, and it has been determined that the proposed rule has no implications which would warrant the preparation of a Federalism Assessment. List of Subjects 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. 21 CFR Part 1311 Administrative practice and procedure, Drug traffic control, Exports, Imports. For reasons set out above, 21 CFR part 1301 and 21 CFR part 1311 are proposed to be amended as follows: PART 1301-[AMENDED] 1. The authority citation for part 1301 continues to read as follows: Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877. 2. Section 1301.11 is proposed to be revised as follows: sec1301.11 Fee amounts. (a) For each registration or reregistration to manufacture controlled substances, the registrant shall pay an application fee of $1,000. (b) For each registration or reregistration to distribute controlled substances, the registrant shall pay an application fee of $500. (c) For each registration or reregistration to dispense, or to conduct instructional activities with, controlled substances listed in Schedules II through V, the registrant shall pay an application fee of $240 for a three-year registration equating to an annualized fee of $80 per annum. (d) For each registration or reregistration to conduct research or instructional activities with a controlled substance listed in Schedule I, or to conduct research with a controlled substance in Schedules II through V, the registrant shall pay an application fee of $80. (e) For each registration or reregistration to conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay an application fee of $80. (f) For each registration or reregistration to engage in a narcotic treatment program, including a compounder, the registrant shall pay an application fee of $80. PART 1311-[AMENDED] 1. The authority citation for part 1311 continues to read as follows: Authority: 21 U.S.C. 952, 956, 957, 958, unless otherwise noted. 2. Section 1311.11 is proposed to be revised as follows: sec1311.11 Fee amounts. (a) For each registration or reregistration to import controlled substances, the registrant shall pay an application fee of $500. (b) For each registration or reregistration to export controlled substances, the registrant shall pay an application fee of $500. Dated: November 20, 1992. Robert C. Bonner, Administrator, Drug Enforcement Administration. [FR Doc. 92-30643 Filed 12-17-92; 8:45 am] BILLING CODE 4410-09-M