[Federal Register: August 7, 1998 (Volume 63, Number 152)] [Notices] [Page 42405-42406] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07au98-119] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97E-0290] Determination of Regulatory Review Period for Purposes of Patent Extension; Aqueous Aryl Fluorophosphite Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for Aqueous Aryl Fluorophosphite Suspension and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that food additive. ADDRESSES: Written comments and petitions should be directed to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6620. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For food additives, the testing phase begins when a major health or environmental effects test involving the food additive begins and runs until the approval phase begins. The approval phase starts with the initial submission of a petition requesting the issuance of a regulation for use of the food additive and continues until FDA grants permission to market the food additive product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Commissioner of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may [[Page 42406]] have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a food additive will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the food additive Aqueous Aryl Fluorophosphite Suspension (2,2'-ethylidenebis(4,6-di- tertbutylphenyl)fluorophosphonite). Aqueous Aryl Fluorophosphite Suspension is used as an antioxidant used in adhesives and in the preparation of polymers intended for contact with food. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for Aqueous Aryl Fluorophosphite Suspension (U.S. Patent No. 4,912,155) from Albemarle Corp., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 3, 1998, FDA advised the Patent and Trademark Office that this food additive had undergone a regulatory review period and that the approval of Aqueous Aryl Fluorophosphite Suspension represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for Aqueous Aryl Fluorophosphite Suspension is 2,930 days. Of this time, 935 days occurred during the testing phase of the regulatory review period, 1,995 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date a major health or environmental effects test (``test'') involving this food additive product was begun: January 9, 1989. The applicant claims July 21, 1986, as the date the test was begun. However, FDA records indicate that the test was begun on January 9, 1989. 2. The date the petition requesting the issuance of a regulation for use of the additive (``petition'') was initially submitted with respect to the food additive product under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348): August 1, 1991. FDA has verified the applicant's claim that the petition was initially submitted on August 1, 1991. 3. The date the petition became effective: January 15, 1997. FDA has verified the applicant's claim that the regulation for the additive became effective/commercial marketing was permitted on January 15, 1997. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,390 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may, on or before October 6, 1998, submit to the Dockets Management Branch (address above) written comments and ask for a redetermination. Furthermore, any interested person may petition FDA, on or before February 3, 1999, for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Dockets Management Branch (address above) in three copies (except that individuals may submit single copies) and identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Dated: July 8, 1998. Thomas J. McGinnis, Deputy Associate Commissioner for Health Affairs. [FR Doc. 98-21130 Filed 8-7-98; 8:45 am] BILLING CODE 4160-01-F