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
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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 process Ivy Laboratories, Inc., Over- ...... Pail ...... Testosterone propionate ...... 25 mg/ pellets. land Parks, KS. Estradiol benzoate ...... 2.5 mg/pellet Component TE±S in process Ivy Laboratories, Inc., Over- ...... Pail or drum ... Trenbolone acetate ...... 5 parts granulation. land Park, KS. Estradiol USP ...... 1 part Component TE±S in process Ivy Laboratories, Inc., Over- ...... Pail ...... Trenbolone acetate ...... 120 mg/ pellets. land Parks, KS. Estradiol USP ...... 24 mg/pellet Testoderm with Adhesive 4 Alza Corp., Palo Alto,CA ...... Export only .... Patch ...... Testosterone ...... 10 mg mg/d. Testosterone Ophthalmic So- Allergan, Irvine, CA ...... Ophthalmic Testosterone ...... ≤0.6% w/v lutions. Solutions.
The interim rule became immediately has determined to be an unnecessary What Exempt Anabolic Steroid effective on publication in the Federal burden on the businesses manufacturing Products are Included in the List Register, January 20, 2000, in order to these products. Referred to in 21 CFR 1308.34? provide a health benefit to the public by What Comments to the Interim Rule more expeditiously increasing the With the publication of this final rule, Were Received? access to these anabolic steroid products the complete list of products referred to and to reduce regulatory restrictions Comments to the interim rule were in 21 CFR 1308.34 is as follows: that DEA (in consultation with HHS) requested, none were received.
EXEMPT ANABOLIC STEROID PRODUCTS
Trade Name Company NDC No. Form Ingredients Quantity
Andro-Estro 90±4 ...... Rugby Laboratories, Rock- 0536±1605 Vial ...... Testosterone enanthate ...... 90 mg/ml ville Centre, NY. Estradiol valerate ...... 4 mg/ml Androgyn L.A...... Forest Pharmaceuticals, St. 0456±1005 Vial ...... Testosterone enanthate ...... 90 mg/ml Louis, MO. Estradiol valerate ...... 4 mg/ml Component E±H in process Ivy Laboratories, Inc., Over- Pail or drum ... Testosterone propionate ...... 10 parts granulation. land Park, KS. Estradiol benzoate ...... 1 part Componenet E±H in process Ivy Laboratories, Inc., Over- Pail ...... Testosterone propionate ...... 25 mg/ pellets. land Park, KS. Estradiol benzoate ...... 2.5 mg/pellet Component TE±S in process Ivy Laboratories, Inc., Over- Pail or drum ... Trenbolone acetate ...... 5 parts granulation. land Park, KS. Estradiol USP ...... 1 part Component TE±S in process Ivy Laboratories, Inc., Over- Pail ...... Trenbolone acetate ...... 120 mg/ pellets. land Park, KS. Estradiol USP ...... 24 mg/pellet
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EXEMPT ANABOLIC STEROID PRODUCTSÐContinued
Trade Name Company NDC No. Form Ingredients Quantity depANDROGYN ...... Forest Pharmaceuticals, St. 0456±1020 Vial ...... Testosterone cypionate ...... 50 mg/ml Louis, MO. Estradiol cypionate ...... 2 mg/ml DEPTO±T.E...... Quality Research Pharm., 52765±257 Vial ...... Testosterone cypionate ...... 50 mg/ml Carmel, IN. Estradiol cypionate ...... 2 mg/ml Depo-Testadiol ...... The Upjohn Company, Kala- 0009±0253 Vial ...... Testosterone cypionate ...... 50 mg/ml mazoo, MI. Estradiol cypionate ...... 2 mg/ml depTESTROGEN ...... Martica Pharmaceuticals, 51698±257 Vial ...... Testosterone cypionate ...... 50 mg/ml Phoenix, AZ. Estradiol cypionate ...... 2 mg/ml Duomone ...... Wintec Pharmaceutical, Pa- 52047±360 Vial ...... Testosterone enanthate ...... 90 mg/ml cific, MO. Estradiol valerate ...... 4 mg/ml DUO±SPAN II ...... Primedics Laboratories, Gar- 0684±0102 Vial ...... Testosterone cypionate ...... 50 mg/ml dena, CA. Estradiol cypionate ...... 2 mg/ml DURATESTRIN ...... W. E. Hauck, Alpharetta, GA 43797±016 Vial ...... Testosterone cypionate ...... 50 mg/ml Estradiol cypionate ...... 2 mg/ml Estratest ...... Solvay Pharmaceuticals, 0032±1026 TB ...... Esterifield estrogens ...... 1.25 mg Marietta, GA. Methyltestosterone ...... 2.5 mg Estratest HS ...... Solvay Pharmaceuticals, 0032±1023 TB ...... Esterifield estrogens ...... 0.625 mg Marietta, GA. Methyltestosterone ...... 1.25 mg Menogen ...... Sage Pharmaceuticals, 59243±570 TB ...... Esterifield estrogens ...... 1.25 mg Shreveport, LA. Methyltestosterone ...... 2.5 mg Menogen HS ...... Sage Pharmaceutical, 59243±560 TB ...... Esterifield estrogens ...... 0625 mg Shreveport, LA. Methyltestosterone ...... 1.25 mg PAN ESTRA TEST ...... Pan American Labs., Cov- 0525±0175 Vial ...... Testosterone cypionate ...... 50 mg/ml ington, LA. Estradiol cypionate ...... 2 mg/ml Premarin with Ayerst Labs. Inc,. New York, 0046±0878 TB ...... Conjugated estrogens ...... 0.625 mg Methyltestosterone. NY. Methyltestosterone ...... 5.0 mg Premarin with Ayerst Labs. Inc., New York, 0046±0879 TB ...... Conjugated estrogens ...... 1.25 mg Methyltestosterone. NY. Methyltestosterone ...... 10.0 mg Synovex H in-process bulk pel- Syntex Animal health, Palo Drum ...... Testosterone propionate ...... 25 mg lets. Alto, CA. Estradiol benzoate ...... 2.5 mg/pellet Synovex H in-process granula- Syntex Animal Health, Palo Drum ...... Testosterone propionate ...... 10 part tion. Alto, CA. Estradiol benzoate ...... 1 part Synovex Plus in-process bulk Fort Dodge Animal Health, Drum ...... Trenbolone acetate ...... 25 mg/ pellets. Fort Dodge, IA. Estradiol benzoate ...... 3.50 mg/pel- let Synovex Plus in-process Fort Dodge Animal Health, Drum ...... Trenbolone acetate ...... 25 parts granulation. Fort Dodge, IA. Estradiol benzoate ...... 3.5 parts Testagen ...... Clint Pharmaceuticals, Nash- 55553±257 Vial ...... Testosterone cypionate ...... 50 mg/ml ville, TN. Estradiol cypionate ...... 2 mg/ml TEST±ESTRO Cypionates ...... Rugby Laboratories Rockvill 0536±9470 Vial ...... Testosterone cypionate ...... 50 mg/ml Centre, NY. Estradiol cypionate ...... 2 mg/ml Testoderm 4 mg/d ...... Alza Copr., Palo Alto, CA ..... 17314±4608 Patch ...... Testosterone ...... 10 mg Testoderm 6 mg/d ...... Alza Corp., Palo Alto, CA ..... 17314±4609 Patch ...... Testosterone ...... 15 mg Testoderm with Adhesive 4 Alza Corp., Palo Alto, CA ..... Export only Patch ...... Testosterone ...... 10 mg mg/d. Testoderm with Adhesive 6 Alza Corp., Palo Alto, CA ..... 17314±2836 Patch ...... Testosterone ...... 15 mg mg/d. Testoderm in-process film ...... Alza Corp, Palo Alto, CA ...... Sheet ...... Testosterone ...... 0.25 mg/cm2 Testoderm with Adhesive in- Alza Corp., Palo Alto, CA ..... Sheet ...... Testosterone ...... 0.25 mg/cm2 process film. Testosterone Cypionate/Estra- Best Generics, No. Miami 54274±530 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. Beach, FL. Estradiol cypionate ...... 2 mg/ml Testosterone Cypionate/Estra- Goldline Labs, Ft. Lauder- 0182±3069 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. dale, Fl. Estradiol cypionate ...... 2mg/ml Testosterone Cyp 50 Estradiol I.D.E.-Interstate, Amityville, 0814±7737 Vial ...... Testosterone cypionate ...... 50 mg/ml Cyp 2. NY. Estradiol cypionate ...... 2 mg/ml Testosterone Cypionate/Estra- Schein Pharmaceuticals, Port 0364±6611 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. Washington, NY. Estradiol cypionate ...... 2 mg/ml Testosterone Cypionate/Estra- Steris Labs. Inc., Phoenix, 0402±0257 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. AZ. Estradiol cypionate ...... 2 mg/ml Testosterone Enanthate/Estra- Goldline Labs, Ft. Lauder- 0182±3073 Vial ...... Testosterone enanthate ...... 90 mg/ml diol Valerate Injection. dale, Fl. Estradiol valerate ...... 4 mg/ml Testosterone Enanthate/Estra- Schein Pharmaceuticals, Port 0364±6618 Vial ...... Testosterone enanthate ...... 90 mg/ml diol Valerate Injection. Washington, NY. Estradiol valerate ...... 4 mg/ml Testosterone Enanthate/Estra- Steris Labs. Inc., Phoenix, 0402±0360 Vial ...... Testosterone enanthate ...... 90 mg/ml diol Valerate Injection. AZ. Estradiol valerate ...... 4 mg/ml Testosterone Ophthalmic Solu- Allergan, Irvine, CA ...... Ophthalmic Testosterone ...... ≤0.6% w/v tions. solutions. Tilapia Sex Reversal Feed (In- Rangen, Inc., Buhl, ID ...... Plastic bags ... Methyltestosterone ...... 60 mg/kg fish vestigational). feed
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EXEMPT ANABOLIC STEROID PRODUCTSÐContinued
Trade Name Company NDC No. Form Ingredients Quantity
Tilapia Sex Reversal Feed (In- Ziegler Brothers, Inc., Gard- Plastic bags ... Methyltestosterone ...... 60 mg/kg fish vestigational). ners, PA. feed
Additional copies of this list may be Unfunded Mandates Reform Act of 1995 DEPARTMENT OF JUSTICE obtained by submitting a written request to the Drug and Chemical Evaluation This rule will not result in the Drug Enforcement Administration Section, Office of Diversion Control, expenditure by State, local and tribal Drug Enforcement Administration, governments, in the aggregate, or by the 21 CFR Part 1310 Washington, D.C. 20537. private sector, of $100,000,000 or more in any one year, and it will not [DEA±156F] Plain Language Instructions significantly or uniquely affect small RIN # 1117±AA43 The Drug Enforcement governments. Therefore, no actions were Administration makes every effort to deemed necessary under provisions of Listed Chemicals; Final Establishment write clearly. If you have suggestions as the Unfunded Mandates Reform Act of of Thresholds for Iodine and to how to improve the clarity of this 1995. Hydrochloric Gas (Anhydrous regulation, call or write Patricia M. Small Business Regulatory Enforcement Hydrogen Chloride) Good, Chief, Liaison and Policy Section, Fairness Act of 1996 AGENCY: Drug Enforcement Office of Diversion Control, Drug Administration (DEA), Justice. Enforcement Administration, This rule is not a major rule as Washington, D.C. 20537, Telephone defined by Section 804 of the Small ACTION: Final Rule with request for (202) 307–7297. Business Regulatory Enforcement comment. Fairness Act of 1996. This rule will not Certifications result in an annual effect on the SUMMARY: Effective October 3, 1996, the Comprehensive Methamphetamine Regulatory Flexibility Act economy of $100,000,000 or more; a major increase in costs or prices; or Control Act of 1996 (MCA) established The Deputy Assistant Administrator, significant adverse effects on that iodine is a List II chemical; for the DEA Office of Diversion Control, competition, employment, investment, however, it was not made subject to in accordance with the Regulatory productivity, innovation, or on the import/export regulatory controls. Flexibility Act [5 U.S.C. 605(b)], has ability of United States-based While exports of the listed chemical reviewed this rule and by approving it, companies to compete with foreign- hydrochloric acid (including anhydrous certifies that it will not have significant based companies in domestic and hydrogen chloride, referred to in the economic impact on a substantial export markets. MCA as hydrochloric gas, which is a number of small business entities. The form of hydrogen chloride) were already granting of exempt status relieves PART 1308Ð[AMENDED] regulated pursuant to 21 CFR 1310, the persons who handle the exempt MCA had the practical effect of products in the course of legitimate Pursuant to the authority delegated to directing the DEA to place domestic business from the registration, labeling, the Administrator of the DEA pursuant controls on anhydrous hydrogen records, reports, prescription, physical to 21 U.S.C. 871(a) and 28 CFR 0.100 chloride. Since no domestic thresholds security, and import and export and redelegated to the Deputy Assistant for iodine or anhydrous hydrogen restrictions imposed by the CSA. Administrator of the Drug Enforcement chloride have been established prior to Administration Office of Diversion this Final Rule, all domestic Executive Order 12866 Control, pursuant to 28 CFR 0.104, transactions involving such chemicals The Deputy Assistant Administrator appendix to subpart R, section 7(g), the have been subject to recordkeeping and further certifies that this rulemaking has Deputy Assistant Administrator of the reporting requirements under the been drafted in accordance with the Office of Diversion Control hereby Controlled Substances Act since principles in Executive Order 12866, adopts as a final rule, without change, October 3, 1996. section 1(b). The Office of Management the interim rule which was published at This rule establishes a domestic and Budget (OMB) reviewed the interim 65 FR 3124 on Jan. 20, 2000 and threshold of zero (0.0 kilograms) for rule as a significant action; the DEA corrected at 65 FR 5024, on Feb. 2, 2000, anhydrous hydrogen chloride, and a received no comments regarding the amending the list described in 21 CFR domestic threshold of 0.4 kilograms for interim rule. This final rule falls into a 1308.34. iodine. Import and export transactions category of regulatory actions which Dated: July 3, 2000. in anhydrous chloride are unaffected by OMB has determined are exempt from this rule. Iodine transactions involving John H. King, regulatory review. Therefore, this action amounts below the threshold will not be has not been reviewed by the OMB. Deputy Assistant Administrator, Office of subject to recordkeeping and reporting Diversion Control. requirements except for reporting of any Executive Order 13132 [FR Doc. 00–17915 Filed 7–13–00; 8:45 am] unusual or excessive loss or This action has been analyzed in Editorial Note: Due to numerous printing disappearance as required by 21 U.S.C. accordance with the principles and errors, rule document FR Doc. 00-17915 830(b)(1)(C). criteria in Executive Order 13132 and it originally published at 65 FR 43690-43694, Although the threshold for anhydrous has been determined that this rule does Friday, July 14, 2000 is being reprinted in its hydrogen chloride is established at 0.0 entirety. not have sufficient federalism kilogram, DEA has concluded that implications to warrant the preparation [FR Doc. R0–17915 Filed 8–1–00; 8:45 am] certain transactions in anhydrous of a Federalism Assessment. BILLING CODE 1505±01±D hydrogen chloride are not sources for
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