47306 Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations bench studies and clinical trials, other The Regulatory Flexibility Act PART 884ÐOBSTETRICAL AND relevant performance data, and labeling requires agencies to analyze regulatory GYNECOLOGICAL DEVICES will ensure that minimum levels of options that would minimize any performance, for both safety and significant impact of a rule on small 1. The authority citation for 21 CFR effectiveness, are addressed before entities. FDA knows of only one part 884 continues to read as follows: marketing clearance. Thus, persons who manufacturer of this type of device. Authority: 21 U.S.C. 351, 360, 360c, 360e, intend to market this device must Classification of these devices from 360j, 371. submit to FDA a premarket notification class III to class II will relieve this 2. Section 884.5970 is added to submission containing information on manufacturer of the device of the cost of subpart F to read as follows: the clitoral engorgement device before complying with the premarket approval marketing the device. requirements of section 515 of the act § 884.5970 Clitoral engorgement device. On April 28, 2000, FDA issued an (21 U.S.C. 360e) and may permit small (a) Identification. A clitoral order to the petitioner classifying potential competitors to enter the engorgement device is designed to apply Urometrics EROS±Clitoral Therapy marketplace by lowering their costs. The a vacuum to the clitoris. It is intended Device and substantially equivalent agency, therefore, certifies that the final for use in the treatment of female sexual devices of this generic type into class II rule will not have a significant impact arousal disorder. under the generic name, clitoral on a substantial number of small (b) Classification. Class II (special engorgement device. FDA identifies this entities. controls). The special control is a generic type of device as a device Section 202(a) of the Unfunded guidance document entitled: ``Guidance designed to apply a vacuum to the Mandates Reform Act of 1995 requires for Industry and FDA Reviewers: Class clitoris. It is intended for use in the that agencies prepare a written II Special Controls Guidance Document treatment of female sexual arousal statement of anticipated costs and for Clitoral Engorgement Devices.'' disorder. FDA is codifying this device benefits before proposing any rule that Dated: July 17, 2000. by adding 21 CFR 884.5970. This order may result in an expenditure by State, Linda S. Kahan, also identifies the following special local, and tribal governments, in the Deputy Director for Regulations Policy, Center control applicable to this device: A aggregate, or by the private sector, of for Devices and Radiological Health. special controls guidance document $100 million in any one year (adjusted [FR Doc. 00±19489 Filed 8±1±00; 8:45 am] entitled ``Guidance for Industry and annually for inflation). The Unfunded BILLING CODE 4160±01±F FDA Reviewers: Class II Special Mandates Reform Act does not require Controls Guidance for Clitoral FDA to prepare a statement of costs and benefits for the final rule, because the Engorgement Devices.'' DEPARTMENT OF JUSTICE final rule is not expected to result in any II. Environmental Impact 1-year expenditure that would exceed Drug Enforcement Administration The agency has determined under 21 $100 million. CFR 25.34(b) that this action is of a type IV. Federalism 21 CFR Part 1308 that does not individually or cumulatively have a significant effect on FDA has analyzed this final rule in [DEA±187F] the human environment. Therefore, accordance with the principles set forth RIN 1117±AA51 neither an environmental assessment in Executive Order 13132. FDA has nor an environmental impact statement determined that the rule does not Schedules of Controlled Substances: is required. contain policies that have substantial Exempt Anabolic Steroids Products; direct effects on the States, on the Republication III. Analysis of Impacts relationship between the National FDA has examined the impacts of the Government and the States, or on the Editorial Note: Due to numerous printing final rule under Executive Order 12866 distribution of power and errors, rule document FR Doc. 00-17915 and the Regulatory Flexibility Act (5 responsibilities among the various originally published at 65 FR 43690-43694, U.S.C. 601±612) (as amended by subtitle levels of government. Accordingly, the Friday, July 14, 2000 is being reprinted in its entirety. D of the Small Business Regulatory agency has concluded that the rule does AGENCY: Drug Enforcement Fairness Act of 1996 (Public Law 104± not contain policies that have Administration, Department of Justice. 121)), and the Unfunded Mandates federalism implications as defined in Reform Act of 1995 (Public Law 104±4). the order and, consequently, a ACTION: Final rule. federalism summary impact statement is Executive Order 12866 directs agencies SUMMARY: The Drug Enforcement not required. to assess all costs and benefits of Administration (DEA) published an available regulatory alternatives and, V. Paperwork Reduction Act of 1995 interim rule with request for comments when regulation is necessary, to select (65 FR 3124, Jan. 20, 2000, as corrected This final rule contains no collections regulatory approaches that maximize at 65 FR 5024, Feb. 2, 2000) which of information. Therefore, clearance by net benefits (including potential identified six anabolic steroid products the Office of Management and Budget economic, environmental, public health as being exempt from certain regulatory under the Paperwork Reduction Act of and safety, and other advantages; provisions of the Controlled Substances 1995 is not required. distributive impacts; and equity). The Act (21 U.S.C. 801 et seq.) (CSA). No agency believes that this final rule is Therefore, under the Federal Food, comments were received. Therefore, the consistent with the regulatory Drug, and Cosmetic Act and under interim rule is being adopted without philosophy and principles identified in authority delegated to the Commissioner change. the Executive Order. In addition, the of Food and Drugs, 21 CFR part 884 is final rule is not a significant regulatory amended as follows: EFFECTIVE DATE: July 14, 2000. action as defined by the Executive Order FOR FURTHER INFORMATION CONTACT: List of Subjects in 21 CFR Part 884 and so it is not subject to review under Frank L. Sapienza, Chief, Drug and the Executive Order. Medical devices. Chemical Evaluation Section, Drug VerDate 11<MAY>2000 18:25 Aug 01, 2000 Jkt 190000 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 E:\FR\FM\02AUR1.SGM pfrm01 PsN: 02AUR1 Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations 47307 Enforcement Administration, records, reports, prescription, physical for Health, Department of Health and Washington, D.C. 20537; Telephone security, and import and export Human Services (HHS) a (202) 307±7183. restrictions associated with Schedule III recommendation as to whether these substances. SUPPLEMENTARY INFORMATION: products should be considered for Why Did DEA Add Six Products to the exemption from certain portions of the What Does This Rule Accomplish and List of Exempt Anabolic Steroids CSA. The Deputy Assistant by What Authority Is It Being Issued? Products? Administrator received the determination and recommendation of This rule finalizes an interim rule (65 Manufacturers of six anabolic steroid the Assistant Secretary for Health and FR 3124, Jan. 20, 2000, as corrected at products submitted exempt status Surgeon General that there was 65 FR 5024, Feb. 2, 2000) which applications to the Deputy Assistant sufficient evidence to establish that each identified six products as being exempt Administrator for the DEA Office of product does not possess a significant from certain portions of the Controlled Diversion Control in accordance with 21 potential for abuse. Substances Act (21 U.S.C. 801 et seq.) CFR 1308.33. Each application (CSA). Section 1903 of the Anabolic delineated a set of facts which the Which Anabolic Steroid Products Are Steroids Control Act of 1990 (title XIX applicant believed justified the exempt Affected and When Does the Rule of Pub. L. 101±647) (ASCA) provides status of its product. The applicants Become Effective? that the Attorney General may exempt provided information which they products which contain anabolic believed showed that because of the In the interim rule, the Deputy steroids from all or any part of the CSA specific product preparation, Assistant Administrator identified the if the products have no significant concentration, mixture, or delivery following six products as being exempt potential for abuse. The procedure for system these products had no from application of sections 302 and implementing this section of the ASCA significant potential for abuse. Upon through 309 and 1002 through 1004 of is described in 21 CFR 1308.33. Exempt acceptance of the applications, the the CSA (21 U.S.C. 822±829 and 952± status removes each product from Deputy Assistant Administrator 954) and 21 CFR 1301.13, 1301.22, and application of the registration, labeling, requested from the Assistant Secretary 1301.71 through 1301.76: EXEMPT ANABOLIC STEROID PRODUCTS Trade name Company NDC No. Form Ingredients Quantity Component E±H in process Ivy Laboratories, Inc., Over- ........................ Pail or drum ... Testosterone propionate ....... 10 parts granulation. land Park, KS. Estradiol benzoate ................ 1 part Component E±H in