05-22012. Determination of Regulatory Review Period for Purposes of Patent Extension; ZOMETA; 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 February 28, 2003 (68 FR 9690). The document announced that FDA had determined the regulatory review period for ZOMETA. A Request for Revision of Regulatory Review Period was filed for the product on May 4, 2005. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect due to a clerical error. Therefore, FDA is revising the determination of the regulatory review period to reflect the correct effective date for the IND.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory Policy (HFD-13), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681.

SUPPLEMENTARY INFORMATION:

In FR Doc. 03-4691, appearing on page 9690 in the Federal Register of February 28, 2003, the following corrections are made:

1. On page 9690, in the third column, in the first complete paragraph, in the third line, “2,810” is corrected to read “2,901”; in the fourth line, “2,201” is corrected to read “2,292”.

2. On page 9690, in the third column, in the second complete paragraph, beginning in the fourth line, “December 12, 1993” is corrected to read “September 12, 1993”; in line 10, “December 12, 1993” is corrected to read “September 12, 1993”.

Dated: October 20, 2005.

Jane A. Axelrad,

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