[Federal Register Volume 72, Number 105 (Friday, June 1, 2007)]
[Notices]
[Pages 30594-30595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007E-0046]


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

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 ZILMAX 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 Director 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 Division of 
Dockets Management (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: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 on the earlier date when either a major 
environmental effects test was initiated for the drug or when an 
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360b(j)) became 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

[[Page 30595]]

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 Director 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 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 ZILMAX 
(zilpaterol hydrochloride). ZILMAX is indicated for increased rate of 
weight gain, improved feed efficiency, and increased carcass leanness 
in cattle fed in confinement for slaughter during the last 20 to 40 
days on feed. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for ZILMAX (U.S. 
Patent No. 4,900,735) from Intervet International B.V., 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 5, 2007, FDA advised the Patent and Trademark Office that this 
animal drug product had undergone a regulatory review period and that 
the approval of ZILMAX 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 
ZILMAX is 4,720 days. Of this time, 4,674 days occurred during the 
testing phase of the regulatory review period, while 46 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 act involving 
this animal drug product became effective: September 9, 1993. FDA has 
verified the applicant's claim that the date the investigational new 
animal drug application (INAD) became effective was on September 9, 
1993.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the act: June 26, 2006. 
FDA has verified the applicant's claim that the new animal drug 
application (NADA) for ZILMAX (NADA 141-258) was initially submitted on 
June 26, 2006.
    3. The date the application was approved: August 10, 2006. FDA has 
verified the applicant's claim that NADA 141-258 was approved on August 
10, 2006.
    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 5 years of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by July 31, 2007. 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 28, 
2007. 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 Division of 
Dockets Management. Three copies of any mailed 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 7, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-10602 Filed 5-31-07; 8:45 am]
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