[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57978-57979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0008]


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

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 DRAXXIN 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-7), 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 (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 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 a 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 DRAXXIN 
(tulathromycin). DRAXXIN is indicated for control of respiratory 
disease in cattle at high risk of developing bovine respiratory disease 
(BRD) and for treatment of BRD associated with Mannheimia haemolytica, 
Pasteurella multocida, and Histophilus somni. It is also indicated for 
the treatment of swine respiratory disease associated with 
Actinobacillus pleuropneumoniae, P. multocida, Bordetella 
bronchiseptica, and Haemophilus parasuis. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for DRAXXIN (U.S. Patent No. 6,420,536) from Pfizer, Inc., 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated February 24, 2006, FDA advised the Patent and Trademark 
Office that this animal drug product had undergone a regulatory review 
period and that the approval of DRAXXIN 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 
DRAXXIN is 2,451 days. Of this time, 2,414 days occurred during the 
testing phase of the regulatory review period, while 37 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: September 
9, 1998. FDA has verified the applicant's claim that the date the 
investigational new animal drug application (INADA) became effective 
was on September 9, 1998.
    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: April 18, 2005. FDA has verified the applicant's 
claim that the new animal drug application (NADA) for DRAXXIN (NADA 
141-244) was initially submitted on April 18, 2005.
    3. The date the application was approved: May 24, 2005. FDA has 
verified the applicant's claim that NADA 141-244 was approved on May 
24, 2005.
    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 360 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by December 1, 2006. 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 April 
2, 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

[[Page 57979]]

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: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-16087 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S