[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14446]


[[Page Unknown]]

[Federal Register: June 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93E-0099]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; MycobutinTM; 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 15, 1994 (59 FR 18133), 
that announced its determination of the regulatory review period for 
purposes of patent extension for MycobutinTM (rifabutin). The 
document was published with some mathematical errors. The document 
incorrectly stated, ``FDA has determined that the applicable regulatory 
review period for MycobutinTM is 2,831 days. Of this time, 2,124 
days occurred during the testing phase of the regulatory review period, 
while 707 days occurred during the approval phase.'' It should have 
stated, ``FDA has determined that the applicable regulatory review 
period for MycobutinTM is 2,469 days. Of this time, 2,127 days 
occurred during the testing phase of the regulatory review period, 
while 342 days occurred during the approval phase.'' This document 
corrects those errors.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

    In FR Doc. 94-9099, appearing on page 18133 in the Federal Register 
of April 15, 1994, the following corrections are made: On page 18134, 
in the first column, in the second complete paragraph, in line 3, 
``2,831'' is corrected to read ``2,469''; in line 4, ``2,124'' is 
corrected to read ``2,127''; and in line 6, ``707'' is corrected to 
read ``342''.

    Dated: June 8, 1994.
 Stuart L. Nightingale,
 Associate Commissioner for Health Affairs.
[FR Doc. 94-14446 Filed 6-13-94; 8:45 am]
BILLING CODE 4160-01-F