[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42405-42406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21130]


-----------------------------------------------------------------------

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