51776 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations

EXCLUDED VETERINARY ANABOLIC IMPLANT PRODUCTSÐContinued

NDC or DIN Trade name Company No. Delivery system Ingredients Quantity

Revalor-H ...... Hoechst Roussel Vet, 12799±810 10 implant cartridge, 7 acetate ...... 140 mg/implant Somerville, NJ. pellets/implant. (20 mg/pellet) ...... 14 mg/implant (2 mg/pellet) Revalor-S ...... Hoechst Roussel Vet, 12799±809 10 implant cartridge, 6 ...... 120 mg/implant Somerville, NJ. pellets/implant. (20 mg/pellet) Estradiol ...... 24 mg/implant 4 mg/pellet) Synovex H ...... Fort Dodge Labs, Fort 0856±3901 10 implant clip, 8 pellets/ propionate ...... 200 mg/implant Dodge, IA. implant. (25 mg/pellet) ...... 20 mg/implant (2.5 mg/pellet) Synovex H ...... Syntex Laboratories, Palo ...... 10 implant clip, 8 pellets/ ...... 200 mg/implant Alto, CA. implant. (25 mg/pellet) Estradiol benzoate ...... 20 mg/implant (2.5 mg/pellet) Synovex Plus ..... Fort Dodge Labs, Fort 0856±3904 10 implant clip, 8 pellets/ Trenbolone acetate ...... 200 mg/implant Dodge, IA. implant. (25 mg/pellet) Estradiol ...... 28 mg/implant (3.5 mg/pellet)

In accordance with the provisions of ability of the -based provisions of the Controlled Substances 21 U.S.C. 811(a) of the CSA, this action companies to complete with foreign- Act (CSA) (21 U.S.C. 801 et seq.) is is a formal rulemaking ‘‘on the record based companies in domestic and adopted without change. after opportunity for a hearing.’’ Such export markets. proceedings are conducted pursuant to This rule will not have substantial DATES: Effective Date: October 3, 1997. the provisions of 5 U.S.C. 556 and 557 direct effects on the States, on the FOR FURTHER INFORMATION CONTACT: and, as such, are exempt from review by relationship between the national Frank L. Sapienza, Chief, Drug and the Office of Management and Budget government and the States, or on the Chemical Evaluation Section, 202–307– pursuant to Executive Order (E.O.) distribution of power and 7183. 12866, section 3(d)(1). responsibilities among the various The Deputy Assistant Administrator, levels of government. Therefore, in SUPPLEMENTARY INFORMATION: The Office of Diversion Control, in accordance with E.O. 12612, it is Acting Deputy Assistant Administrator, accordance with the Regulatory determined that this rule will not have Office of Diversion Control, Drug Flexibility Act [5 U.S.C. 605(b)], has sufficient federalism implications to Enforcement Administration (DEA), reviewed this rule and by approving it warrant the preparation of a Federalism published in the Federal Register, an certifies that it will not have a Assessment. interim rule which identified ten significant economic impact on a Dated: September 8, 1997. products as being exempt anabolic substantial number of small-business John H. King, steroid products (62 FR 29288, May 30, entities. The inclusion of a product in 1997). Comments were requested, none 21 CFR 1308.26 relieves persons who Deputy Assistant Administrator, Office of were received. handle the product in the course of Diversion Control, Drug Enforcement Administration. legitimate business from the Therefore, pursuant to the authority requirements imposed by the CSA. [FR Doc. 97–25973 Filed 10–2–97; 8:45 am] delegated to the Administrator of the This rule will not result in the BILLING CODE 4410±09±M DEA pursuant to 21 U.S.C. 871(a) and expenditure by State, local and tribal 28 CFR 0.100 and redelegated to the governments, in the aggregate, or by the DEPARTMENT OF JUSTICE Deputy Assistant Administrator of the private sector, of $100,000,000 or more Drug Enforcement Administration in any one year, and it will not Drug Enforcement Administration Office of Diversion Control, pursuant to significantly or uniquely affect small 28 CFR 0.104, appendix to subpart R, governments. Therefore, no actions were 21 CFR Part 1308 section 7(g)9, the Deputy Assistant deemed necessary under provisions of [DEA No. 160F] Administrator of the Office of Diversion the Unfunded Mandates Reform Act of Control, hereby adopts as a final rule, 1995. Schedules of Controlled Substances: without change, the interim rule This rule is not a major rule as Exempt Products amending 21 CFR 1308.34 which was defined by section 804 of the Small published at 62 FR 29288 on May 30, Business Regulatory Enforcement AGENCY: Drug Enforcement 1997. Fairness Act of 1996. This rule will not Administration, Department of Justice. The anabolic steroid containing result in an annual effect on the ACTION: Final rule. economy of $100,000,000 or more; a compounds, mixtures, or preparations major increase in costs or prices; or have SUMMARY: The interim rule (62 FR which are described in 21 CFR 1308.34 significant adverse effects on 29288, May 30, 1997) which identified are as follows: competition, employment, investment, ten anabolic steroid products as being productivity, innovation, or on the exempt from certain regulatory Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations 51777

EXEMPT ANABOLIC STEROID PRODUCTS

Trade name Company NDC No. Form Ingredients Quantity

Andro-Estro 90±4 ...... Rugby Laboratories, Rockville 0536±1605 Vial ...... ...... 90 mg/ml Centre, NY. ...... 4 mg/ml Androgyn L.A...... Forest Pharmaceuticals, St. 0456±1005 Vial ...... Testosterone enanthate ...... 90 mg/ml Louis, MO. Estradiol valerate ...... 4 mg/ml depANDROGYN ...... Forest Pharmaceuticals, St. 0456±1020 Vial ...... ...... 50 mg/ml Louis, MO. ...... 2 mg/ml DEPO-T.E...... Quality Research Pharm., 52765±257 Vial ...... Testosterone cypionate ...... 50 mg/ml Carmel, IN. 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, Mari- 0032±1026 TB ...... Esterified ...... 1.25 mg etta, GA. ...... 2.5 mg Estratest HS ...... Solvay Pharmaceuticals, Mari- 0032±1023 TB ...... ...... 0.625 mg etta, GA. Methyltestosterone ...... 1.25 mg Menogen ...... Sage Pharmaceuticals, 59243±570 TB ...... Esterified estrogens ...... 1.25 mg Shreveport, LA. Methyltestosterone ...... 2.5 mg Menogen HS ...... Sage Pharmaceuticals, 59243±560 TB ...... Esterified estrogens ...... 0.625 mg Shreveport, LA. Mrethyltestosterone ...... 1.25 mg PAN ESTRA TEST ...... Pan American Labs., Coving- 0525±0175 Vial ...... Testosterone cypionate ...... 50 mg/ml ton, LA. Estradiol cypionate ...... 2 mg/ml Premarin with Ayerst Labs. Inc., New York, 0046±0879 TB ...... ...... 1.25 mg Methyltestosterone. NY. Methyltestosterone ...... 10.0 mg Premarin with Ayerst Labs. Inc., New York, 0046±0878 TB ...... Conjugated estrogens ...... 0.625 mg Methyltestosterone. NY. Methyltestosterone ...... 5.0 mg Synovex H in-process bulk Syntex Animal Health, Palo ...... Drum ...... Testosterone propionate ...... 25 mg/ pellets. Alto, CA. Estradiol benzoate ...... 2.5 mg/pellet Synovex H in-process granu- Syntex Animal Health, Palo ...... Drum ...... Testosterone propionate ...... 10 parts lation. Alto, CA. Estradiol benzoate ...... 1 part Synovex Plus in-process Fort Dodge Animal Health, ...... Drum ...... Trenbolone acetate ...... 25 parts granulation. Fort Dodge, IA. Estradiol benzoate ...... 3.5 parts Synovex Plus in-process bulk Fort Dodge Animal Health, ...... Drum ...... Trenbolone acetate ...... 25 mg/ pellets. Fort Dodge, IA. Estradiol benzoate ...... 3.50 mg/pellet Testagen ...... Clint Pharmaceuticals, Nash- 55553±257 Vial ...... Testosterone cypionate ...... 50 mg/ml ville, TN. Estradiol cypionate ...... 2 mg/ml TEST-ESTRO Cypionates ..... Rugby Laboratories, Rockville 0536±9470 Vial ...... Testosterone cypionate ...... 50 mg/ml Centre, NY. Estradiol cypionate ...... 2 mg/ml Testoderm 4 mg/d ...... Alza Corp., 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 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 . Beach, FL. Estradiol cypionate ...... 2 mg/ml Testosterone Cypionate/Estra- Goldline Labs, Ft. Lauderdale, 0182±3069 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. FL. Estradiol cypionate ...... 2 mg/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, AZ 0402±0257 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. Estradiol cypionate ...... 2 mg/ml Testosterone Cypionate/Estra- The Upjohn Co., kalamazoo, 0009±0253 Vial ...... Testosterone cypionate ...... 50 mg/ml diol Cypionate Injection. MI. Estradiol cypionate ...... 2 mg/ml Testosterone Enanthate/Es- Goldline Labs, Ft. Lauderdale, 0182±3073 Vial ...... Testosterone enanthate ...... 90 mg/ml tradiol Valerate Injection. FL. Estradiol valerate ...... 4 mg/ml Testosterone Enanthate/Es- Schein Pharmaceuticals, Port 0364±6618 Vial ...... Testosterone enanthate ...... 90 mg/ml tradiol Valerate Injection. Washington, NY. Estradiol valerate ...... 4 mg/ml Testosterone Enanthate/Es- Steris Labs. Inc., Phoenix, AZ 0402±0360 Vial ...... Testosterone enanthate ...... 90 mg/ml tradiol Valerate Injection. Estradiol valerate ...... 4 mg/ml Tilapia Sex Reversal Feed Rangen, Inc., Buhl, ID ...... Plastic Methyltestosterone ...... 60 mg/kg fish (Investigational). Bags. feed Tilapia Sex Reversal Feed Zeigler Brothers, Inc., Gard- ...... Plastic Methyltestosterone ...... 60 mg/kg fish (Investigational. ners, PA. Bags. feed 51778 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations

In accordance with the provisions of Dated: September 8, 1997. in advance of the event or to provide a 21 U.S.C. 811(a) of the CSA, this action John H. King, delayed effective date. Following is a formal rulemaking ‘‘on the record Deputy Assistant Administrator, Office of normal rulemaking procedures in this after opportunity for a hearing.’’ Such Diversion Control, Drug Enforcement case would be impracticable. proceedings are conducted pursuant to Administration. Drafting Information: The drafters of the provisions of 5 U.S.C. 556 and 557 [FR Doc. 97–25972 Filed 10–2–97; 8:45 am] this regulation are LT T.G. Allan, Project and, as such, are exempt from review by BILLING CODE 4410±09±M Manager for the Captain of the Port, and the Office of Management and Budget LT K.A. Boodell, Project Counsel, pursuant to Executive order (E.O.) Thirteenth Coast Guard District Legal 12866, section 3(d)(1). DEPARTMENT OF TRANSPORTATION Office. The Deputy Assistant Administrator, Background and Purpose Office of Diversion Control, in Coast Guard accordance with the Regulatory The event requiring this regulation is Flexibility Act [5 U.S.C. 605(b)], has 33 CFR Part 165 the Oregon Department of Transportation’s Interstate 5 bridge reviewed this rule and by approving it [CGD13±97±023] certifies that it will not have a repair project. The repair project is significant economic impact on a Safety Zone Regulations; Interstate 5 scheduled to begin on September 16, substantial number of small-business Bridge Repair Project, Columbia River, 1997, at 5 a.m. (PDT) with work to entities. The inclusion of a product in Vancouver, WA continue twenty-four hours a day until 21 CFR 1308.34 relieves persons who the project is complete on or about handle the product in the course of AGENCY: Coast Guard, DOT. October 8, 1997. This event may result legitimate business from the ACTION: Temporary final rule. in a large number of vessels registration, records, reports, congregating near the bridge and prescription, physical security, import SUMMARY: The Coast Guard is construction barges. To promote the and export requirements associated with establishing a safety zone for the safety of both spectators and workers, a Schedule III controlled substances Interstate 5 bridge repair project on the safety zone is being established on the under the CSA. Specifically, the Columbia River in Vancouver, waters of the Columbia River around the products are exempted from application Washington. This project will run from repair project, and entry into this safety of sections 302 through 309 and 1002 Tuesday, September 16, 1997, from 5 zone is prohibited unless authorized by through 1004 of the CSA (21 U.S.C. a.m. (PDT) through Wednesday, October the Captain of the Port. This action is 822–829 and 952–954) and §§ 1301.11, 8, 1997, at 1 p.m. (PDT). The Coast necessary due to hazards associated 1301.13, and 1301.71 through 1301.76 Guard, through this action, intends to with heavy equipment and possible of Title 21 Code of Federal Regulations. protect persons, facilities, and vessels debris falling into the Columbia River in This rule will not result in the from safety hazards associated with the vicinity of the repair project. This expenditure by State, local and tribal heavy equipment and falling debris in safety zone will be enforced by governments, in the aggregate, or by the the vicinity of the repair project. Entry representatives of the Captain of the private sector, of $100,000,000 or more into this safety zone is prohibited unless Port, Portland, Oregon. The Captain of in any one year, and it will not authorized by the Captain of the Port. the Port may be assisted by other federal significantly or uniquely affect small EFFECTIVE DATES: This regulation agencies. governments. Therefore, no actions were becomes effective on September 16, Regulatory Evaluation deemed necessary under provisions of 1997, at 5 a.m. (PDT) and terminates on This temporary final rule is not a the Unfunded Mandates Reform Act of October 8, 1997, at 1 p.m. (PDT). 1995. significant regulatory action under FOR FURTHER INFORMATION CONTACT: This rule is not a major rule as section 3(f) of Executive Order 12866 defined by section 804 of the Small Lt. T.G. Allan, c/o Captain of the Port, and does not require an assessment of Business Regulatory Enforcement Portland, 6767 N. Basin Ave., Portland, potential costs and benefits under Fairness Act of 1996. This rule will not Oregon 97217–3992, (503) 240–9327. section 6(a)(3) of that order. It has been result in an annual effect on the SUPPLEMENTARY INFORMATION: exempted from review by the Office of economy of $100,000,000 or more; a Management and Budget under that Regulatory History major increase in costs or prices; or have order. It is not significant under the significant adverse effects on Pursuant to 5 U.S.C. 553, a notice of regulatory policies and procedures of competition, employment, investment, proposed rulemaking was not published the Department of Transportation (DOT) productivity, innovation, or on the for this regulation and good cause exists (44 CFR 11040, February 26, 1979). The ability of the United States-based for making it effective less than 30 days Coast Guard expects the economic companies to compete with foreign- from the date of publication in the impact of this proposal to be so minimal based companies in domestic and Federal Register. Publishing a NPRM that a full Regulatory Evaluation under export markets. and delaying its effective date would be paragraph 10e of the regulatory policies This rule will not have substantial contrary to the public interest since and procedures of DOT is unnecessary. direct effects on the States, on the immediate action is necessary to ensure This expectation is based on the fact relationship between the national the safety of structures and vessels that the safety zone will restrict less government and the States, or on the operating in the area of the bridge than a quarter of a square mile of the distribution of power and repair. Due to the complex planning and waterway. The entities most likely to be responsibilities among the various coordination involved, the event affected by this action are commercial levels of government. Therefore, in sponsor, the Oregon Department of ship, and tug and barge operators on the accordance with E.O. 12612, it is Transportation, was unable to provide Columbia River. These entities are determined that this rule will not have the Coast Guard with notice of the final aware of the Interstate bridge repair sufficient federalism implications to details until 30 days prior to the date of project and the safety zone, and they warrant the preparation of a Federalism the event. Therefore, sufficient time was can schedule their transits accordingly. Assessment. not available to publish a proposed rule If safe to do so, the representative of the