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

###### Food and Drug Administration

          - [Docket No. FDA-2009-E-0583]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) has determined the regulatory review period for BRYAN CERVICAL DISC SYSTEM 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 (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 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).

FDA recently approved for marketing the medical device BRYAN CERVICAL DISC SYSTEM. BRYAN CERVICAL DISC SYSTEM is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BRYAN CERVICAL DISC SYSTEM (U.S. Patent No. 6,156,067) from Medtronic Sofamor Danek, 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 BRYAN CERVICAL DISC SYSTEM represented the first permitted commercial marketing or use of the product. 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 BRYAN CERVICAL DISC SYSTEM is 2,702 days. Of this time, 1,653 days occurred during the testing phase of the regulatory review period, while 1,049 days occurred during the approval phase. These periods of time were derived from the following dates:

                    1.                     *The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective*: December 20, 2001. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the act for human tests to begin became effective December 20, 2001.                

                    2.                     *The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e)*: June 29, 2006. The applicant claims June 28, 2006, as the date the premarket approval application (PMA) for BRYAN CERVICAL DISC SYSTEM (PMA P060023) was initially submitted. However, FDA records indicate that PMA P060023 was submitted on June 29, 2006.                

                    3.                     *The date the application was approved*: May 12, 2009. FDA has verified the applicant's claim that PMA P060023 was approved on May 12, 2009.                

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 November 8, 2010. 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 7, 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: August 13, 2010.

Jane A. Axelrad,

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

[FR Doc. 2010-22177 Filed 9-3-10; 8:45 am]

BILLING CODE 4160-01-S