E9-25804. Prescription Drug User Fee Rates for Fiscal Year 2010; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT:

David Miller, Office of Financial Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3917.

SUPPLEMENTARY INFORMATION:

In FR Doc. E9-18457, appearing on page 38451, in the Federal Register of Monday, August 3, 2009, the following corrections are made:

1. On page 38451, in the first column, in the Summary section, the fifth sentence “This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720).” is corrected to read “This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($79,720).”

2. On page 38452, the title of table 2 is corrected to read “Table 2.—FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change (Dollars in Thousands)”.

3. On page 38452, in table 2, in the fourth column that begins “PC&B per FTE”, remove “,” everywhere it appears and replace it with “.”.

4. On page 38454, footnote 1 to table 3 is corrected to read “¹ Table 3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years of 2002-2007 as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has been corrected in the revised number of 5,528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY 2009 would have been 3.76 percent rather than the 2.98 percent published in the Federal Register last year.”

Dated: October 22, 2009.

David Horowitz,

Assistant Commissioner for Policy.