Document ID: FDA-2010-E-0334-0008
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction
Posted Date: 2012-06-08T04:00Z

[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Page 34051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13902]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0333 and FDA-2010-E-0334]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; KALBITOR; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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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.
[FR Doc. 2012-13902 Filed 6-7-12; 8:45 am]
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