[Federal Register Volume 59, Number 72 (Thursday, April 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9047]


[[Page Unknown]]

[Federal Register: April 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 92E-0133]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; Supprelin; 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 June 2, 1992 (57 FR 23237), 
that announced its determination of the regulatory review period for 
purposes of patent extension for Supprelin (histrelin 
acetate). The document was published with some mathematical errors. The 
document incorrectly stated, ``FDA has determined that the applicable 
regulatory review period for Supprelin is 2,876 days. Of this 
time, 1,930 days occurred during the testing phase of the regulatory 
review period, while 946 days occurred during the approval phase.'' It 
should have stated, ``FDA has determined that the applicable regulatory 
review period for Supprelin is 2,878 days. Of this time, 
1,931 days occurred during the testing phase of the regulatory review 
period, while 947 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. 92-12846, appearing on page 23237 in the Federal 
Register of June 2, 1992, the following corrections are made: On the 
same page, in the second column, in the second line from the bottom, 
``2,876'' is corrected to read ``2,878''; and in the last line, 
``1,930'' is corrected to read ``1,931''; and in the third column, in 
line 2, ``946'' is corrected to read ``947''.

    Dated: April 6, 1994.
 Stuart L. Nightingale,
 Associate Commissioner for Health Affairs.
[FR Doc. 94-9047 Filed 4-13-94; 8:45 am]
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