[Federal Register Volume 67, Number 42 (Monday, March 4, 2002)]
[Notices]
[Pages 9756-9757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0053]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Diphenylmethane Diisocyanate

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 diphenylmethane diisocyanate 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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-007), Food and Drug

[[Page 9757]]

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 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 
diphenylmethane diisocyanate. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
diphenylmethane diisocyanate (U.S. Patent No. 4,968,514) from BF 
Goodrich Co., 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 2, 2001, FDA advised the Patent 
and Trademark Office that this food additive had undergone a regulatory 
review period and that the approval of diphenylmethane diisocyanate 
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 
diphenylmethane diisocyanate is 1,326 days. Of this time, 739 days 
occurred during the testing phase of the regulatory review period, 587 
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: September 23, 
1996. FDA has verified the applicant's claim that the test was begun on 
September 23, 1996.
    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): October 1, 1998. 
The applicant claims September 9, 1998, as the date the petition for 
diphenylmethane diisocyanate was initially submitted. However, FDA 
records indicate that the petition was submitted on October 1, 1998.
    3. The date the petition became effective: May 9, 2000. FDA has 
verified the applicant's claim that the regulation for the additive 
became effective/commercial marketing was permitted on May 9, 2000.
    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 962 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 or electronic comments and ask for a redetermination by May 3, 
2002. 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 September 3, 2002. 
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: January 23, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-4965 Filed 3-1-02; 8:45 am]
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