Document ID: FDA-2009-N-0339-0002
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Rates for Fiscal Year 2010; Correction
Posted Date: 2009-10-27T04:00Z

[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Notices]               
[Page 55244]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc09-67]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0339]

 
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.
[FR Doc. E9-25804 Filed 10-26-09; 8:45 am]

BILLING CODE 4160-01-S