[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Notices]
[Pages 9298-9299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0229]


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

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 PAYLEAN 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 animal drug product.

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 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 animal drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the animal drug product and 
continues until FDA grants permission to market the drug 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 an animal drug product will include all

[[Page 9299]]

of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(4)(B).
    FDA recently approved for marketing the animal drug product PAYLEAN 
(ractopamine hydrochloride). PAYLEAN is indicated for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness 
in finishing swine fed a complete ration containing at least 16 percent 
crude protein from 150 pounds (lb) (68 kilograms (kg)) to 240 lb (109 
kg) body weight. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for PAYLEAN (U.S. 
Patent No. 4,690,951) from Eli Lilly & 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 
animal drug product had undergone a regulatory review period and that 
the approval of PAYLEAN 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 
PAYLEAN is 5,707 days. Of this time, 1,211 days occurred during the 
testing phase of the regulatory review period, while 4,496 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 512(j) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective: May 9, 
1984. FDA has verified the applicant's claim that the date the 
investigational new animal drug application (INAD) became effective was 
on May 9, 1984.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the Federal Food, Drug, 
and Cosmetic Act: September 1, 1987. FDA has verified the applicant's 
claim that the new animal drug application (NADA) for PAYLEAN (NADA 
140-863) was initially submitted on September 1, 1987.
    3. The date the application was approved: December 22, 1999. FDA 
has verified the applicant's claim that NADA 140-863 was approved on 
December 22, 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 1,095 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 April 
29, 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 August 27, 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 (address above). 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 24, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-4747 Filed 2-27-02; 8:45 am]
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