E6-6083. Determination of Regulatory Review Period for Purposes of Patent Extension; FASLODEX; 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 April 17, 2003 (68 FR 18992). The document announced that FDA had determined the regulatory review period for FASLODEX. A request for revision of regulatory review period was filed for the product on June 16, 2003. 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. 03-9536, appearing on page 18992 in the Federal Register of April 17, 2003, the following corrections are made:

1. On page 18992, in the second column, in the second complete paragraph, in the third line, “1,935” is corrected to read “1,938”; in the fourth line, “1,541” is corrected to read “1,544”.

2. On page 18992, in the second column, in the third complete paragraph, beginning in the fourth line, “January 8, 1997” is corrected to read “January 5, 1997”; and the last two sentences are corrected to read: “FDA has verified the applicant's claim that the date the investigational new drug application became effective was on January 5, 1997.”

Dated: March 22, 2006.

Jane A. Axelrad,

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