[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Notices]               
[Page 67178-67179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no05-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E-0020] (formerly Docket No. 02E-0020)

 
Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZOMETA; 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 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.

[[Page 67179]]


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.
[FR Doc. 05-22012 Filed 11-3-05; 8:45 am]

BILLING CODE 4160-01-S