John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated New Drug Applications; Opportunity for a Hearing

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1198]

John J. Ferrante et al.; Proposal to Withdraw Approval of 158 Abbreviated New Drug Applications; Opportunity for a Hearing

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 158 abbreviated new drug applications (ANDA's). The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.

DATES:

Submit written requests for a hearing by April 27, 2000; submit data and information in support of the hearing request by May 30, 2000.

ADDRESSES:

Requests for a hearing, supporting data, and other comments are to be identified with Docket No. 00N-1198 and submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Pritzlaff, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

The holders of approved applications to market new drugs for human use are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 314.81 (21 CFR 314.81). The holders of the applications listed in the following table have failed to submit the required annual reports and have not responded to the agency's request by certified mail for submission of the reports.

ANDA No.

Drug

Applicant

60-058

Chloramphenicol Capsules, 250 milligrams (mg).

John J. Ferrante, c/o Operations Management Consulting, 11 Fairway Lane, Trumbull, CT 06611.

60-062

Penicillin G Potassium.

The Upjohn Co., 700 Portage Rd., Kalamazoo, MI 49001.

60-094

Sterile Penicillin G Procaine Suspension USP.

Do.

60-110

Sterile Dihydrostreptomycin Sulfate USP.

Pfizer Central Research, Pfizer, Inc., Eastern Point Rd., Groton, CT 06340.

60-170

Penicillin G Potassium Tablets, 200,000, 250,000, and 400,000 units.

John J. Ferrante.

60-173

Tetracycline Hydrochloride (HCl) Capsules, 250 mg.

Do.

60-174

Tetracycline Oral Suspension, 125 mg/5 milliliters (mL).

Do.

60-177

Bacitracin-Neomycin Sulfate Polymyxin B Sulfate Ointment.

Do.

60-178

Bacitracin-Neomycin Sulfate Ointment.

Do.

60-179

Oxytetracycline HCl Capsules, 250 mg.

Do.

60-188

Neomycin Sulfate and Hydrocortisone Actetate Ophthalmic Suspension USP.

Akorn, Inc., c/o Walnut Pharmaceuticals, Inc., 1340 North Jefferson St., Anaheim, CA 92807.

60-360

Neomycin and Polymyxin B Sulfate and Bacitracin Ointment with Benzocaine.

Ambix Laboratories, 210 Orchard St., East Rutherford, NJ 07073.

60-435

Tetracycline HCl Tablets USP, 250 mg.

Farmitalia Carlo Erba S.p.A., c/o Montedison, USA, Inc., 1114 Avenue of the Americas, New York, NY 10036.

60-453

Neomycin and Polymyxin B Sulfate and Bacitracin Ointment with Diperodon HCl.

Ambix Laboratories.

60-464

Neomycin Sulfate and Prednisolone.

The Upjohn Co.

60-647

Neo-Polycin Opthalmic Ointment.

Merrell Dow Pharmaceuticals, Inc., P.O. Box 68511, Indianapolis, IN 46268.

60-666

Ampicillin Tihydrate for Oral Suspension.

Beecham Laboratories, 501 Fifth St., Bristol, TN 37620.

60-690

Oxytetracycline HCl.

Pierrel America, Inc., 576 Fifth Ave., New York, NY 10036.

60-720

Tetracycline HCl Capsules, 250 mg.

Towne Paulsen & Co., Inc., 140 East Duarte Rd., Monrovia, CA 91016.

60-757

Polymyxin B Sulfate, 500,000 units.

Burroughs Wellcome Co., 3030 Cornwallis Rd., Research Triangle Park, NC 27709.

60-774

Griseofulvin Tablets, 500 mg.

McNeil Consumer, Inc., Camp Hill Rd., Fort Washington, PA 19034.

60-809

Penicillin G Potassium Tablets USP, 100,000, 200,000, 250,000, 400,000, and 500,000 units.

Consolidated Pharmaceutical Group, 6110 Robinwood Rd., Baltimore, MD 21225.

60-855

Oxytetracycline HCl Capsules, 250 mg.

Rachelle Laboratories, Inc., 700 Henry Ford Ave., P.O. Box 2029, Long Beach, CA 90801.

60-869

Oxytetracycline HCl Capsule, 250 mg.

Proter S.p.A., c/o Arnold Buhl Christen, 1000 Connecticut Ave., Washington, DC 20086.

61-174

Candicidin.

Penick Corp., 1050 Wall St. West, Lyndhurst, NJ 07071.

61-396

Hetacillin Capsules.

Bristol-Myers, U.S. Pharmaceutical Group, Evansville, IN 47721-0001.

61-523

Tetracycline HCl Susceptibility Power, 20 mg.

Lederle Laboratories, Division of American Cyanamid Co., Pearl River, NY 10965.

61-676

Ampicillin Trihydrate Capsules, 250 mg and 500 mg.

Public Health Service, Health Service Administration, Perry Point, MD 21902.

61-700

Bacitracin Zinc USP for Compounding.

Alpharma A.S., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024.

61-718

Nystatin Vaginal Tablets USP, 100,000 units.

Holland-Rantos Co., Inc., 310 Enterprise Ave., Trenton, NJ 08638.

61-720

Doxycycline Oral Suspension USP.

Rachelle Laboratories, Inc.

61-933

Penicillin G Potassium for Injection USP.

E.R. Squibb & Sons, P.O. Box 191, New Brunswick, NJ 08903-0191.

61-953

Doxycycline Hyclate Injection.

Rachelle Laboratories, Inc., P.O. Box 187, Culver, IN 46511.

61-957

Benzylpenicilloyl Polylysine Injection.

Kremers-Urban Co., 5600 West County Line Rd., P.O. Box 2038, Milwaukee, WI 53201.

61-961

Bacitracin Ointment USP.

Clay-Park Labs, Inc., 1700 Bathgate Ave., Bronx, NY 10457.

61-994

Kanamycin Sulfate Injection USP.

Bristol Laboratories, Division of Bristol-Myers Co., P.O. Box 657, Syracuse, NY 13201.

62-007

Bacitracin USP, 50,000 and 10,000 units/vial.

Alpharma A.S., c/o Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024.

62-042

Chloramphenicol Ophthalmic Solution, 0.5%.

Akorn, Inc.

62-138

Cefoxitin Solution.

Pfizer Pharmaceuticals, Inc., 235 East 42d St., New York, NY 10017.

62-224

Neomycin Sulfate Ointment.

Clay-Park Labs, Inc.

62-236

Bacitracin Ointment USP.

Denison Laboratories, Inc., 60 Dunnell Lane, P.O. Box 1305, Pawtucket, RI 02862.

62-248

Gentamicin Sulfate Injection USP.

The Upjohn Co.

62-345

Tetracycline HCl Capsules, 250 mg.

Public Health Service, HAS Supply Service Center, Perry Point, MD 21902.

62-354

Gentamicin Sulfate Injection USP.

Kalapharm, Inc., 145 East 27th St., New York, NY 10016.

62-357

Amoxicillin Trihydrate Capsules, 250 mg and 500 mg.

Public Health Service, HAS Supply Service Center.

62-359

Bacitracin Topical Ointment, 500 units/gram.

NMC Laboratories, Inc., 70-36 83d St., Glendale, NY 11385.

62-361

Bacitracin-Neomycin-Polymyxin B Sulfate.

Do.

62-528

Amoxicillin Capsules USP, 250 mg and 500 mg.

Laboratories Atral, S.A., c/o Louie F. Turner, P.O. Box 331044, Fort Worth, TX 76133-2924.

62-538

Doxycycline Hyclate Tablets USP, 100 mg.

Vintage Pharmaceuticals, Inc., 3241 Woodpark Blvd., Charlotte, NC 28206.

71-278

PEG 3350 and Electrolytes for Oral Solution USP.

E-Z-EM, Inc., 717 Main St., Westbury, NY 11590.

71-320

PEG 3350 and Electrolytes for Oral Solution USP.

DynaPharm, Inc., P.O. Box 2141, Del Mar, CA 92014.

71-419

Chlorhexidine Gluconate Topical Solution 4%.

Hygenics Pharmaceuticals, Inc., 26941 Cabot Rd., suite 128, Laguna Hills, CA 92653.

71-639

Ibuprofen Tablets USP, 200 mg.

Vintage Pharmaceuticals, Inc.

71-644

Ibuprofen Tablets USP, 400 mg.

Do.

71-777

Clorazepate Dipotassium Capsules, 3.75 mg.

Able Laboratories, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.

71-778

Clorazepate Dipotassium Capsules, 7.5 mg.

Do.

71-779

Clorazepate Dipotassium Capsules, 15 mg.

Do.

72-319

Glycoprep (PEG 3350 and Electrolytes for Oral Solution).

Goldline Laboratories, 1900 West Commerical Blvd., Ft. Lauderdale, FL 33309.

72-399

Sulfamethoxazole and Trimethorprim Oral Suspension USP.

NASKA Pharmacal Co., Inc., P.O. Box 898 Riverview Rd., Lincolnton, NC 28093.

72-409

Nifedipine Capsules USP, 10 mg.

Chase Laboratories, Inc., 280 Chestnut St., Newark, NJ 07105.

73-421

Nifedipine Capsules USP, 20 mg.

Do.

74-080

Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg.

SCS Pharmaceuticals, 4901 Searle Pkwy., Skokie, IL 60077.

80-094

Triple Sulfoid Tablets.

Pal-Pak, Inc., 1201 Liberty St., Allentown, PA 18102.

80-117

Nitrofurantoin Tablets, 50 mg.

Rachelle Laboratories, Inc., 700 Henry Ford Ave., P.O. Box 2029, Long Beach, CA 90801.

80-118

Nitrofurantoin Tablets, 100 mg.

Do.

80-335

Prednisolone Tablets, 5 mg.

Central Pharmaceutical, Inc., 110-128 East Third St., Seymour, IN 47274.

80-375

Lidocaine HCl Injection USP, 2%.

Rachelle Laboratories, Inc.

80-376

Lidocaine HCl Injection USP, 1%.

Do.

80-481

Hydrocortisone Ointment USP.

C & M Pharmacal, Inc., 1721 Maple Lane, Hazel Park, MI 48030-1215.

80-482

Hydrocortisone Cream USP.

Do.

80-562

Prednisolone Tablets, 2.5 mg and 5 mg.

John J. Ferrante.

80-568

Hydrocortisone Tablets, 10 mg and 20 mg.

Do.

80-967

Vitamin A Capsules USP.

West-Ward, Inc., 465 Industrial Lane, Eatontown, NJ 07724.

81-008

Chlorzoxazone Tablets USP, 500 mg.

Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220.

83-102

Vitamin D Capsules, 50,000 units.

West-Ward, Inc.

83-156

Hydrocortisone Acetate Cream, 1.0%.

Parke-Davis, Div. of Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950.

83-161

Dexamethasone Sodium Phosphate Injection.

Dell Laboratories, Inc., 668 Front St., Teaneck, NJ 07666.

83-358

Prednisolone Sodium Phosphate Ophthalmic Solution USP.

Akorn, Inc.

83-400

Propoxyphene HCl Capsules USP, 65 mg.

Rachelle Laboratories, Inc.

83-643

Acetaminophen and Codeine Phosphate Tablets, 325 mg/30 mg.

Carnrick Laboratories, Inc., 65 Horse Hill Rd., Cedar Knolls, NJ 07927.

83-682

Phendimetrazine Tartrate Tablets USP, 35 mg (yellow).

Zenith Laboratories, Inc., 140 Legrand Ave., Northvale, NJ 07647.

83-787

Chlorpheniramine Maleate Tablets, 4 mg.

West-Ward, Inc.

83-790

Phendimetrazine Tartrate Tablets USP, 35 mg.

Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837.

83-791

Nitrofurazone Powder.

Roberts Laboratories, Inc., 4 Industrial Way West, Eatontown, NJ 07724.

83-829

Chlorpromazine HCl Tablets USP.

Rachelle Laboratories, Inc.

83-977

Selenium Sulfide.

USV Pharmaceutical Corp., One Scarsdale Rd., Tuckahoe, NY 10707.

84-030

Meprobamate Tablets, 400 mg

Ferndale Laboratories, Inc.

84-185

Bethanechol Chloride Tablets, 10 mg.

Wendt Laboratories, Inc., 100 Nancy Dr., P.O. Box 128, Belle Plaine, MN 56011.

84-186

Bethanechol Chloride Tablets, 25 mg.

Do.

84-255

Sulfasalazine Tablets, 500 mg.

William H. Rorer, Inc., 500 Virginia Dr., Fort Washington, PA 19034.

84-337

Sulfisoxasole Tablets, 500 mg.

Rachelle Laboratories, Inc.

84-377

Prednisone Capsules, 50 mg.

R. P. Scherer Corp., 2725 Scherer Dr., St. Petersburg, FL 33702.

84-492

Prednisolone Acetate Injection.

Akorn, Inc.

84-563

Aminophylline Tablets, 200 mg.

ICN Pharmaceuticals, Inc., 5040 Lester Rd., Cincinnati, OH 45213.

84-639

Chlordiazepoxide HCl Capsules USP, 10 mg.

Rachelle Laboratories, Inc.

84-727

Lidocaine HCl Injection 2%.

Pharmaton, Inc., 150 East 58th St., New York, NY 19155.

84-728

Lidocaine HCl Injection, 2% with Epinephrine 1:50,000.

Pharmaton, Inc., c/o Bass, Ullman & Lustrigman, 747 Third Ave., New York, NY 10017.

84-855

Dexamethasone Sodium Phosphate Ophthalmic Solution USP, 0.1%.

Akorn, Inc.

85-039

Folic Acid Tablets USP, 1 mg.

Wendt Laboratories, Inc.

85-040

Isoniazed Tablets USP, 100 mg.

Do.

85-041

Meclizine HCl Tablets, 25 mg.

Do.

85-042

Methocarbamol Tablets USP, 500 mg.

Do.

85-044

Reserpine Tablets USP, 0.25 mg.

Do.

85-086

Chlordiazepoxide HCl Capsules, 5 mg.

Rachelle Laboratories, Inc.

85-087

Chlordiazepoxide HCl Capsules USP, 25 mg.

Do.

85-091

Isoniazid Tablets USP, 100 mg.

Pharmavite Corp., 15451 San Fernando Mission Blvd., P.O. Box 9606, Mission Hills, CA 91346-9606.

85-104

Chlorpheniramine Maleate Tablets USP, 4 mg.

Do.

85-118

Chlordiazepoxide HCl Capsules, 5 mg.

John J. Ferrante.

85-119

Chlordiazepoxide HCl Capsules, 10 mg.

Do.

85-120

Chlordiazepoxide HCl Capsules, 25 mg.

Do.

85-341

Butabartital Sodium Tablets USP, 30 mg.

Vale Chemical Co., Inc., 1201 Liberty St., Allentown, PA 18102.

85-345

Butabartital Sodium Tablets USP, 15 mg.

Do.

85-477

Secobarbital Sodium Capsules, 100 mg.

ICN Pharmaceuticals, Inc., 222 North Vincent Ave., Covina, CA 91722.

85-509

Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg/0.025 mg.

Inwood Laboratories, Inc., Subsidiary of Forest Labs, Inc., 150 East 58th St., New York, NY 10155.

85-539

Triamcinolone Acetonide Cream USP, 0.1%, 0.5%, and 0.025%.

Zenith Goldline Pharmaceuticals, Inc.,

85-630

Trichlormethiazide Tablets, 4 mg.

Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136.

85-733

Hydrocortisone Cream USP, 1%.

Zenith Goldine Pharmaceuticals, Inc.

85-777

Selenium Sulfide USP.

Do.

85-851

Imipramine HCl Tablets USP, 25 mg.

A. H. Robins Co., 1407 Cummings Dr., P.O. Box 26609, Richmond, VA 23261-6609.

86-116

Phendimetrazine Tartrate Tablets, 17.5 mg.

Camall Co., P.O. Box 218, Washington, MI 48094.

86-129

Heparin Sodium Injection USP, 1,000 units/mL.

Pharma-Serve, Inc., 218-20 98th Ave., Queens Village, NY 11429.

86-543

Diphenhydramine HCl Capsules, 25 mg.

Newtron Pharmaceuticals, Inc., 155 Knickerbocker Ave., Bohemia, NY 11716.

86-544

Diphenhydramine HCl Capsules, 50 mg.

Do.

86-766

Nitrofurazone Ointment 0.2%.

Wendt Laboratories, Inc.

87-081

Nitrofurazone Solution 0.2%.

Do.

87-328

Trifluoperazine HCl Tablets USP, 5 mg.

Zenith Goldline Pharmaceuticals, Inc.

87-375

Triamcinolone Acetonide Ointment USP, 0.025%.

Do.

87-376

Triamcinolone Acetonide Ointment USP, 0.5%.

Do.

87-377

Triamcinolone Acetonide Ointment USP, 0.1%.

Do.

87-427

Hydrocortisone Cream USP, 1%.

Do.

87-428

Triamcinolone Acetonide Cream USP, 0.5%.

Do.

87-429

Triamcinolone Acetonide Cream USP, 0.1%.

Do.

87-430

Triamcinolone Acetonide Cream USP, 0.025%.

Do.

87-489

Hydrocortisone Lotion USP, 1%.

Heran Pharmaceutical, Inc., 7215 Eckhert Rd., San Antonio, TX 78238.

87-612

Trifluoperazine HCl Tablets USP, 1 mg.

Zenith Goldline Pharmaceuticals, Inc.

87-613

Trifluoperazine HCl Tablets USP, 2 mg.

Do.

87-614

Trifluoperazine HCl Tablets USP, 10 mg.

Do.

87-628

Butalbital, Acetaminophen, and Caffeine Capsules, 50 mg/325 mg/40 mg.

Roberts/Hauck Pharmaceuticals, Inc., Six Industrial Way West, Eatontown, NJ 07724.

87-818

Sulfacetamide Sodium Ophthalmic Solution, 10%.

Bausch & Lomb Pharmaceuticals, 8500 Hidden River Pkwy., Tampa, FL 33637.

87-834

Hydrocortisone USP (micronized powder).

Torch Laboratories, Inc., P.O. Box 248, Reisterstown, MD 21136.

87-865

Chlorpromazine HCl Tablets, 25 mg.

West-Ward, Inc.

88-024

Phendimetrazine Tartrate Extended-Release Capsules, 105 mg.

Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837.

88-059

Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension USP, 10%/0.5%.

Akorn, Inc.

88-089

Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension USP, 10%/0.5%.

Bausch & Lomb Pharmaceuticals.

88-189

Reserpine and Hydrochlorthiazide Tablets USP, 0.125 mg/50 mg.

West-Ward, Inc.

88-255

Theophylline Sustained-Release Capsules, 300 mg.

R. P. Scherer North America, P.O. Box 5600, Clearwater, FL 33518.

88-393

Hydroxyzine Pamoate Capsules, 50 mg.

Vanguard Labs, Packaging Div. of MWM Corp., 101-107 Samson St., P.O. Box K, Glasgow, KY 42141.

88-447

Tropicamide Ophthalmic Solution USP, 1%.

Akorn, Inc.

88-474

Triprolidine HCl and Pseudoephedrine HCl, 1.25 mg/5 mL and 30 mg/5 mL.

Newtron Pharmaceuticals, Inc.

89-268

Butalbital and Acetaminophen Capsules, 50 mg/325 mg.

Dunhall Pharmaceuticals, Inc., P.O. Box 100, Gravette, AR 72736.

89-273

Hydrocortisone Cream USP, 1.0%.

Topiderm, Inc., 155 Knickerbocker Ave., Bohemia, NY 11716.

89-274

Triamcinolone Acetonide Cream USP, 0.025%.

Do.

89-275

Triamcinolone Acetonide Cream USP, 0.1%.

Do.

89-276

Triamcinolone Acetonide Cream USP, 0.5%.

Do.

89-495

Hydrocortisone Lotion USP, 1%.

Beta Dermaceuticals, Inc., 5419 Bandera Rd., suite 708, San Antonio, TX 78238.

89-805

Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg.

Vintage Pharmaceuticals, Inc.

89-828

Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg.

Do.

89-990

Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg.

Do.

Therefore, notice is given to the holders of the applications listed in the table and to all other interested persons that the Director of the Center for Drug Evaluation and Research proposes to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing approval of the applications and all amendments and supplements thereto on the ground that the applicants have failed to submit reports required under § 314.81.

In accordance with section 505 of the act and 21 CFR part 314, the applicants are hereby provided an opportunity for a hearing to show why the applications listed previously should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug products covered by these applications.

An applicant who decides to seek a hearing shall file: (1) On or before April 27, 2000, a written notice of participation and request for a hearing, and (2) on or before May 30, 2000, the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing. Any other interested person may also submit comments on this notice. The procedures and requirements governing this notice of opportunity for a hearing, notice of participation and request for a hearing, information and analyses to justify a hearing, other comments, and a grant or denial of a hearing are contained in § 314.200 and in 21 CFR part 12.

The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and constitutes a waiver of any contentions concerning the legal status of the drug products. FDA will then withdraw approval of the applications and the drug products may not thereafter lawfully be marketed, and FDA will begin appropriate regulatory action to remove the products from the market. Any new drug product marketed without an approved new drug application is subject to regulatory action at any time.

A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. Reports submitted to remedy the deficiencies must be complete in all respects in accordance with § 314.81. If the submission is not complete or if a request for a hearing is not made in the required format or with the required reports, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing.

All submissions under this notice of opportunity for a hearing must be filed in four copies. Except for data and information prohibited from public disclosure under section 301 of the act (21 U.S.C. 331(j)) or 18 U.S.C. 1905, the submissions may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

This notice is issued under the Federal Food, Drug, and Cosmetic Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the Director,

Center for Drug Evaluation and Research (21 CFR 5.82).

Dated: March 13, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 00-7589 Filed 3-27-00; 8:45 am]

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