2012-13902. Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 2, 2012 (77 FR 26017). The document concerned FDA's determination of the regulatory review period for KALBITOR. The document published with an incorrect patent number for KALBITOR. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION:

In FR Doc. 2012-26017 in the Federal Register of Wednesday, May 2, 2012, the following correction is made:

1. On page 26017, in the third column, in the last paragraph, “U.S. Patent Nos. 5,795,685 and 7,276,480” is corrected to read “U.S. Patent Nos. 5,795,865 and 7,276,480.”

Dated: May 29, 2012.

Jane A. Axelrad,

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