[Federal Register Volume 63, Number 244 (Monday, December 21, 1998)]
[Notices]
[Pages 70411-70412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0788]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Sucralose

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined

[[Page 70412]]

the regulatory review period for Sucralose 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 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)(2)(B).
    FDA recently approved for marketing the food additive Sucralose 
(sucralose). Sucralose is used as a nonnutritive sweetener in food 
where standards of identity do not preclude such use. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for Sucralose (U.S. Patent No. 4,435,440) from 
Tate & Lyle PLC, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated October 7, 1998, FDA advised the Patent 
and Trademark Office that this food additive had undergone a regulatory 
review period and that the approval of Sucralose 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 
Sucralose is 5,332 days. Of this time, 1,260 days occurred during the 
testing phase of the regulatory review period, while 4,072 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 additive product was begun: August 30, 
1983. FDA has verified the applicant's claim that the test was begun on 
August 30, 1983.
    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 additive product under section 409 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348): February 9, 1987. 
FDA has verified the applicant's claim that the petition was initially 
submitted on February 9, 1987.
    3. The date the petition became effective: April 3, 1998. FDA has 
verified the applicant's claim that the regulation for the additive 
became effective on April 3, 1998.
    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 730 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before February 19, 1999, 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 June 21, 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: December 4, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-33638 Filed 12-18-98; 8:45 am]
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