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 |
---|---|---|
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]
BILLING CODE 4160-01-F