69632 Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 / Notices withdraw approval of all new drug 15. NDA 9–402; Delestrogen Injection, for Drug Evaluation and Research (21 applications (NDA’s) for estrogen- Delestrogen 4X Injection, and CFR 5.82). containing drug products labeled for use Delestrogen 2X Injection containing Dated: November 30, 1998. in postpartum breast engorgement estradiol valerate; E. R. Squibb & Sons, Janet Woodcock, approved either before or after the Drug Inc. Director, Center for Drug Evaluation and Amendments of 1962 (Pub. L. 87–781). 16. NDA 9–545; Deladumone Research. The NOOH also applied to any Injection containing testosterone [FR Doc. 98–33455 Filed 12–16–98; 8:45 am] identical, similar, or related drug enanthate and estradiol valerate; E. R. product whether or not it was the Squibb & Sons, Inc. BILLING CODE 4160±01±F subject of an NDA. The NOOH listed the 17. NDA 10–597; Tace-Androgen following NDA’s: Capsules containing chlorotrianisene DEPARTMENT OF HEALTH AND 1. NDA 0–740; Di-Ovocylin Injection and methyltestosterone; Merrell- HUMAN SERVICES containing estradiol dipropionate; Ciba National Laboratories. Pharmaceutical Co., Division Ciba Giegy 18. NDA 11–444; Tace Capsules Food and Drug Administration Corp., 556 Morris Ave., Summit, NJ containing chlorotrianisene and Tace 07901. with Ergonovine Capsules containing [Docket No. 98E±0227] 2. NDA 4–039; Stilbestrol Ect. chlorotrianisene and ergonovine Determination of Regulatory Review containing diethylstilbestrol; Eli Lilly & maleate; Merrell-National Laboratories. Period for Purposes of Patent Co., Box 618, Indianapolis, IN 46206. 19. NDA 16–235; Tace 72-Milligram Extension; Silicone AMO ARRAY 3. NDA 4–041; Stilbestrol Tablets and Capsule containing chlorotrianisene; Multifocal IOL Injection containing diethylstilbestrol; Merrell-National Laboratories. Eli Lilly & Co. 20. NDA 16–768; Estrovis Tablets AGENCY: Food and Drug Administration, 4. NDA 4–056; Stilbestrol Tablets, containing quinestrol; Warner Chilcott HHS. Injection, and Suppositories containing Laboratories, Division Warner Lambert ACTION: Notice. diethylstilbestrol; E. R. Squibb & Sons, Co., 201 Tabor Rd., Box W, Morris Inc., Box 4000, Princeton, NJ 08540. Plains, NJ 07950. SUMMARY: The Food and Drug 5. NDA 4–073; Stilbestrol Perles, In response to the NOOH, Merrell- Administration (FDA) has determined Injection and Suppositories containing the regulatory review period for Silicone National Laboratories, Parke-Davis, E. R.   diethylstilbestrol; The Upjohn Co., 7171 Squibb & Sons, Inc., Byk-Gulden, Inc., AMO ARRAY multifocal IOL and is Portage Rd., Kalamazoo, MI 49002. and the American College of publishing this notice of that 6. NDA 4–782; Premarin Tablets Obstetricians and Gynecologists (the determination as required by law. FDA containing conjugated estrogens; Ayerst College) requested hearings, but the has made the determination because of Laboratories, Division of American firms voluntarily agreed to remove the the submission of an application to the Home Products Corp., 685 Third Ave., indication from their labeling. Since Commissioner of Patents and New York, NY 10017. then, the College and the firms, or their Trademarks, Department of Commerce, 7. NDA 4–823; Estrone Injection respective successors in interest, have for the extension of a patent which containing estrone; Abbott Laboratories, withdrawn their hearing requests. (The claims that medical device. 14th and Sheridan Rd., North Chicago, approvals of NDA 7–661, NDA 8–099, ADDRESSES: Written comments and IL 60064. and NDA 9–545 were withdrawn in a petitions should be directed to the 8. NDA 5–159; Diethylstilbestrol Federal Register notice of October 29, Dockets Management Branch (HFA– Dipropionate Tablets containing 1998 (63 FR 58053); the approval of 305), Food and Drug Administration, diethylstilbestrol dipropionate; Blueline NDA 10–597 was withdrawn in a 5630 Fishers Lane, rm. 1061, Rockville, Laboratories, Inc., 302 South Broadway, Federal Register notice of June 25, 1993 MD 20852. St. Louis, MO 63102. (58 FR 34466); the approval of NDA 16– FOR FURTHER INFORMATION CONTACT: 9. NDA 5–233; Diethylstilbestrol 768 was withdrawn in a Federal Brian J. Malkin, Office of Health Affairs Tablets containing diethylstilbestrol; Register notice of March 27, 1996 (61 (HFY–20), Food and Drug High Chemical Co., 1760 North Howard FR 13506).) Administration, 5600 Fishers Lane, St., Philadelphia, PA 19122. Therefore, for reasons stated in the Rockville, MD 20857, 301–827–6620. 10. NDA 5–292; Estinyl Tablets NOOH of October 24, 1978, as well as SUPPLEMENTARY INFORMATION: The Drug containing ethinyl estradiol; Schering the reasons discussed above, the Price Competition and Patent Term Corp., Galloping Hill Rd., Kenilworth, Director of the Center for Drug Restoration Act of 1984 (Pub. L. 98–417) NJ 07033. Evaluation and Research hereby and the Generic Animal Drug and Patent 11. NDA 7–661; AE Tablets and withdraws approval of any estrogen- Term Restoration Act (Pub. L. 100–670) Tylosterone Tablets containing containing drug product insofar as it is generally provide that a patent may be diethylstilbestrol and labeled for the suppression of extended for a period of up to 5 years methyltestosterone; Eli Lilly & Co. postpartum breast engorgement. (In the so long as the patented item (human 12. NDA 8–099; Tylosterone Injection Federal Register of January 17, 1995 (60 drug product, animal drug product, containing diethylstilbestrol and FR 3404), FDA withdrew approval of medical device, food additive, or color methyltestosterone; Eli Lilly & Co. bromocriptine mesylate for the additive) was subject to regulatory 13. NDA 8–102; Tace Tablets and indication of the prevention of review by FDA before the item was Capsules containing chlorotrianisene; physiological lactation, i.e., postpartum marketed. Under these acts, a product’s Merrell-National Laboratories, Division breast engorgement; today’s action regulatory review period forms the basis of Richardson-Merrell Inc., 110 East means, therefore, that no product is for determining the amount of extension Amity Rd., Cincinnati, OH 45215. currently approved for this indication.) an applicant may receive. 14. NDA 8–579; Vallestril Tablets This notice is issued under authority A regulatory review period consists of containing methallenestril; Searle delegated to the Commissioner of Food two periods of time: A testing phase and Laboratories, Division of G. D. Searle & and Drugs (21 CFR 5.10(a)(1)) and an approval phase. For medical devices, Co., Box 5100, Chicago, IL 60680. redelegated to the Director of the Center the testing phase begins with a clinical Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 / Notices 69633 investigation of the device and runs 360j(g)) for human tests to begin became DEPARTMENT OF HEALTH AND until the approval phase begins. The effective on June 15, 1989. However, HUMAN SERVICES approval phase starts with the initial FDA records indicate that the IDE was submission of an application to market determined substantially complete for Food and Drug Administration the device and continues until clinical studies to have begun on [Docket No. 98E±0849] permission to market the device is November 22, 1989, which represents granted. Although only a portion of a the IDE effective date. Determination of Regulatory Review regulatory review period may count 2. The date the application was Period for Purposes of Patent toward the actual amount of extension initially submitted with respect to the Extension; Vitreon that the Commissioner of Patents and device under section 515 of the act (21 Trademarks may award (half the testing U.S.C. 360e): September 3, 1996. The AGENCY: Food and Drug Administration, phase must be subtracted as well as any applicant claims August 30, 1996, as the HHS. time that may have occurred before the date the premarket approval application ACTION: Notice. patent was issued), FDA’s determination (PMA) for Silicone AMO ARRAY SUMMARY: The Food and Drug of the length of a regulatory review multifocal IOL (PMA P960028) was Administration (FDA) has determined period for a medical device will include initially submitted. However, FDA the regulatory review period for all of the testing phase and approval records indicate that PMA P960028 was Vitreon and is publishing this notice phase as specified in 35 U.S.C. submitted on September 3, 1996. of that determination as required by 156(g)(3)(B). 3. The date the application was FDA recently approved for marketing law. FDA has made the determination approved: September 5, 1997. FDA has the medical device Silicone AMO because of the submission of an verified the applicant’s claim that PMA ARRAY multifocal IOL. Silicone application to the Commissioner of P960028 was approved on September 5, AMO ARRAY multifocal IOL is Patents and Trademarks, Department of 1997. indicated for the visual correction of Commerce, for the extension of a patent aphakia in persons 60 years of age or This determination of the regulatory which claims that medical device. review period establishes the maximum older in whom a cataractous lens has ADDRESSES: Written comments and potential length of a patent extension. been removed and who may benefit petitions should be directed to the However, the U.S. Patent and from useful near vision without reading Dockets Management Branch (HFA– Trademark Office applies several aid and increased spectacle 305), Food and Drug Administration, statutory limitations in its calculations independence across a range of 5630 Fishers Lane, rm. 1061, Rockville, of the actual period for patent extension. distances where the potential visual MD 20852. In its application for patent extension, effects associated with multifocality are FOR FURTHER INFORMATION CONTACT: acceptable. Subsequent to this approval, this applicant seeks 1,533 days of patent term extension. Brian J. Malkin, Office of Health Affairs the Patent and Trademark Office (HFY–20), Food and Drug Anyone with knowledge that any of received a patent term restoration Administration, 5600 Fishers Lane,  the dates as published is incorrect may, application for Silicone AMO Rockville, MD 20857, 301–827–6620. ARRAY multifocal IOL (U.S. Patent on or before February 16, 1999, submit No. 4,898,461) from Vision to the Dockets Management Branch SUPPLEMENTARY INFORMATION: The Drug Pharmaceuticals, L.P., and the Patent (address above) written comments and Price Competition and Patent Term and Trademark Office requested FDA’s ask for a redetermination. Furthermore, Restoration Act of 1984 (Pub. L. 98–417) assistance in determining this patent’s any interested person may petition FDA, and the Generic Animal Drug and Patent eligibility for patent term restoration. In on or before July 15, 1999, for a Term Restoration Act (Pub. L. 100–670) a letter dated June 19, 1998, FDA determination regarding whether the generally provide that a patent may be advised the Patent and Trademark applicant for extension acted with due extended for a period of up to 5 years Office that this medical device had diligence during the regulatory review so long as the patented item (human undergone a regulatory review period period. To meet its burden, the petition drug product, animal drug product, and that the approval of Silicone AMO must contain sufficient facts to merit an medical device, food additive, or color ARRAY multifocal IOL represented FDA investigation. (See H. Rept. 857, additive) was subject to regulatory the first permitted commercial part 1, 98th Cong., 2d sess., pp. 41–42, review by FDA before the item was marketing or use of the product. Shortly 1984.) Petitions should be in the format marketed. Under these acts, a product’s thereafter, the Patent and Trademark specified in 21 CFR 10.30. regulatory review period forms the basis Office requested that FDA determine the Comments and petitions should be for determining the amount of extension product’s regulatory review period. submitted to the Dockets Management an applicant may receive. FDA has determined that the Branch (address above) in three copies A regulatory review period consists of applicable regulatory review period for (except that individuals may submit two periods of time: A testing phase and   Silicone AMO ARRAY multifocal single copies) and identified with the an approval phase. For medical devices, IOL is 2,846 days. Of this time, 2,478 docket number found in brackets in the the testing phase begins with a clinical days occurred during the testing phase heading of this document. Comments investigation of the device and runs of the regulatory review period, while and petitions may be seen in the until the approval phase begins. The 368 days occurred during the approval Dockets Management Branch between 9 approval phase starts with the initial phase. These periods of time were a.m. and 4 p.m., Monday through submission of an application to market derived from the following dates: Friday. the device and continues until 1. The date a clinical investigation permission to market the device is involving this device was begun: Dated: December 4, 1998. granted. Although only a portion of a November 22, 1989. The applicant Thomas J. McGinnis, regulatory review period may count claims that the investigational device Deputy Associate Commissioner for Health toward the actual amount of extension exemption (IDE) required under section Affairs. that the Commissioner of Patents and 520(g) of the Federal Food, Drug, and [FR Doc. 98–33453 Filed 12–16–98; 8:45 am] Trademarks may award (half the testing Cosmetic Act (the act) (21 U.S.C. BILLING CODE 4160±01±F phase must be subtracted as well as any