[Federal Register Volume 61, Number 229 (Tuesday, November 26, 1996)]
[Notices]
[Pages 60106-60107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96E-0315]


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

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 Nuflor 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: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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

[[Page 60107]]

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 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 
Nuflor (florfenicol). Nuflor is indicated for 
treatment of bovine respiratory disease (BRD), associated with 
Pasteurella haemolytica, P. multocida, and Haemophilus somnus. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Nuflor (U.S. Patent 
No. 4,235,892) from Schering Corp. and the Patent and Trademark Office 
requested FDA's assistance in determining the patent's eligibility for 
patent term restoration. In a letter dated September 17, 1996, FDA 
advised the Patent and Trademark Office that this animal drug product 
had undergone a regulatory review period and that the approval of 
Nuflor represented the first commercial marketing 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 
Nuflor is 4,209 days. Of this time, 4,205 days occurred 
during the testing phase of the regulatory review period, while 4 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 became effective: November 23, 1984. FDA has 
verified the applicant's claim that November 23, 1984, was the date 
that the investigational new animal drug application became effective.
    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: May 28, 1996. FDA has verified the applicant's claim 
that May 28, 1996, was the date that the new animal drug application 
(NADA) for Nuflor (NADA 141-063) was initially submitted.
    3. The date the animal drug was approved: May 31, 1996. FDA has 
verified the applicant's claim that NADA 141-063 was approved on May 
31, 1996.
    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 1,096 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before January 27, 1997, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before May 27, 1997, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. 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) in three copies (except that 
individuals may submit single copies) and 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: November 18, 1996.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 96-30196 Filed 11-25-96; 8:45 am]
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