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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2009-E-0014]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) has determined the regulatory review period for FREESTYLE NAVIGATOR 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 medical device.

# ADDRESSES:

                        Submit electronic comments to                         *http://www.regulations.gov.*                         Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.                    

# FOR FURTHER INFORMATION CONTACT:

Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

# 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. 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 (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).                          ( print page 77879)    

FDA recently approved for marketing the medical device, FREESTYLE NAVIGATOR. FREESTYLE NAVIGATOR is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for FREESTYLE NAVIGATOR (U.S. Patent No. 5,262,035) from Abbott Diabetes Care 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 17, 2010, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of FREESTYLE NAVIGATOR represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that the FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for FREESTYLE NAVIGATOR is 2,320 days. Of this time, 750 days occurred during the testing phase of the regulatory review period, while 1,570 days occurred during the approval phase. These periods of time were derived from the following dates:

                    1.                     *The date clinical investigation on humans is begun as approved by an institutional review board (IRB) under section 520(g)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and when no investigational device exemption (IDE) is required:*                     November 6, 2001. The applicant claims that investigation of the device qualified for a non-significant risk study for the purpose of establishing clinical data necessary to support a subsequent premarket approval under section 515 of the FD&C Act. FDA has verified the applicant's claim that the device did not require an IDE under section 520(g) of the FD&C act, but did require IRB approval, granted November 6, 2001, for human tests to begin. This date represents the beginning of the testing phase of the regulatory review period.                

                    2.                     *The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e):*                     November 25, 2003. The applicant claims November 24, 2003, as the date the first premarket approval application (PMA) for FREESTYLE NAVIGATOR (PMA P030048) was initially submitted. However, FDA records indicate that PMA P030048 was submitted on November 25, 2003.                

                    3.                     *The date the application was approved:*                     March 12, 2008. FDA has verified the applicant's claim that PMA P050020 was approved on March 12, 2008.                

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 1,826 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**                    ) either electronic or written comments and ask for a redetermination by February 14, 2011. 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 June 13, 2011. 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.                

                    Interested persons may submit to the Division of Dockets Management (                    *see***ADDRESSES**                    ) electronic or written comments and written petitions. It is only necessary to send one set of comments. It is no longer necessary to send three copies of mailed comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.                

Dated: October 22, 2010.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug Evaluation and Research.

[FR Doc. 2010-31240 Filed 12-13-10; 8:45 am]

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