Determination of Regulatory Review Period for Purposes of Patent Extension; CYDECTIN, 54993-54994 [06-7800]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Notices]
[Pages 54993-54994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7800]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0040]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for CYDECTIN 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 https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-7), Center for Drug Evaluation and Research, 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

[[Page 54994]]

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 
CYDECTIN (moxidectin). CYDECTIN is indicated for the treatment and 
control of certain internal and external parasites in cattle. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for CYDECTIN (U.S. Patent No. 
4,916,154) from American Cyanamid Company, and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated April 6, 
2004, FDA advised the Patent and Trademark Office that this animal drug 
product had undergone a regulatory review period and that the approval 
of CYDECTIN 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 
CYDECTIN is 2,857 days. Of this time, 2,841 days occurred during the 
testing phase of the regulatory review period, while 16 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 (the act) (21 U.S.C. 355(j)) involving this 
animal drug product became effective: April 5, 1990. The applicant 
claims April 9, 1990, as the date the investigational new animal drug 
application (INAD) became effective. However, FDA records indicate that 
the date of FDA's letter assigning a number to the INAD was April 5, 
1990, which is considered to be the effective date for the INAD.
    2. The date the application was initially submitted with respect to 
the animal drug product under section 512(b) of the act: January 13, 
1998. The applicant claims August 8, 1995, as the date the new animal 
drug application (NADA) for CYDECTIN (NADA 141-099) was initially 
submitted. The applicant claims this is the date it submitted the first 
component of NADA 141-099, which was submitted in several modules. It 
is FDA's position that the approval phase begins when the marketing 
application is complete. A review of FDA records reveals that the date 
of FDA's official acknowledgement letter assigning a number to NADA 
141-099 was January 13, 1998, which is considered to be the initially 
submitted date for NADA 141-099.
    3. The date the application was approved: January 28, 1998. FDA has 
verified the applicant's claim that NADA 141-099 was approved on 
January 28, 1998.
    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 1,754 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 November 20, 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 March 
19, 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 are to 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: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 06-7800 Filed 9-19-06; 8:45 am]
BILLING CODE 4160-01-S