[Federal Register Volume 66, Number 95 (Wednesday, May 16, 2001)]
[Notices]
[Pages 27149-27150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1412]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Uvasorb HA88

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for Uvasorb HA88 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 that claims that food additive.

ADDRESSES: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Regulatory Policy 
Staff (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 100-670) generally provide 
that a patent may be extended for a period of up to 5 years as 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. section 
156(g)(2)(B).
    FDA recently approved for marketing the food additive Uvasorb HA88. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Uvasorb HA88 (U.S. Patent No. 
4,477,615) from 3V Partecipazioni Industriali S.p.A., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
August 4, 2000, FDA advised the Patent and Trademark Office that this 
food additive had undergone a regulatory review period and that the 
approval of Uvasorb HA88 represented the first permitted commercial 
marketing or use of the product. Subsequently, 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 
Uvasorb HA88 is 3,482 days. Of this time, 684 days occurred during the 
testing phase of the regulatory review period, and 2,798 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: November 2, 
1989. FDA has verified the applicant's claim that the test was begun on 
November 2, 1989.
    2. The date the petition requesting the issuance of a regulation 
for use of the additive (petition) was initially

[[Page 27150]]

submitted with respect to the food additive product under section 409 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348): September 
16, 1991. FDA has verified the applicant's claim that the petition was 
initially submitted on September 16, 1991.
    3. The date the petition became effective: May 14, 1999. FDA has 
verified the applicant's claim that the regulation for the additive 
became effective/commercial marketing was permitted on May 14, 1999.
    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 1,827 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written comments and ask for a redetermination by July 16, 2001. 
Furthermore, any interested person may petition FDA for a determination 
regarding whether the applicant for extension acted with due diligence 
during the regulatory review period by November 12, 2001. 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. Three copies of any information are to be submitted 
except that individuals may submit one copy. Comments are to be 
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: March 2, 2001.
Jane A Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 01-12228 Filed 5-15-01; 8:45 am]
BILLING CODE 4160-01-S