[Federal Register Volume 71, Number 78 (Monday, April 24, 2006)]
[Notices]
[Pages 21029-21030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E-0030]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; FASLODEX; 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 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

[[Page 21030]]

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.
[FR Doc. E6-6083 Filed 4-21-06; 8:45 am]
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