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The current (FY 2002) fee schedule went into effect February 13, 1998 for facility inspections conducted on or after that date. The fees allow FDA to recover the costs of the annual inspection program. The annual inspection fee is divided into two portions - the facility and unit. The facility portion of the fee is $1,345 and the unit portion is $204. The total fee is determined based upon the number of units at each facility. The fees were based on FY 1998 program budget projections, and encompasses all recoverable operating and personnel costs associated with the inspection program, excluding the cost of inspecting government entities.
Annual MQSA Inspection Fee by Schedule | |||||||
---|---|---|---|---|---|---|---|
Number of Units | 1
|
2
|
3
|
4
|
5
|
6
|
7
|
Fee | $1,549 | $1,753 | $1,957 | $2,161 | $2,365 | $2,569 | $2773 |
Follow-up Inspection Fee | |
---|---|
Fee
|
$878
|
For more information, contact:
Donna Simms
Fee Category |
Fee Rates for FY 1998 | Fee Rates for FY 1999 | Fee Rates for FY 2000 | Fee Rates for FY 2001 | Fee Rates for FY 2002 |
---|---|---|---|---|---|
Applications requiring clinical data |
$256,846 |
$272,282
|
$285,740
|
$309,647
|
$313,320
|
Applications not requiring clinical data |
$128,423
|
$136,141
|
$142,870
|
$154,823
|
$156,660
|
Supplements requiring clinical data |
$128,423
|
$136,141
|
$142,870
|
$154,823
|
$156,660
|
Establishments |
$141,966
|
$128,435
|
$141,971
|
$145,989
|
$140,109
|
Products |
$18,591
|
$18,364
|
$19,959
|
$21,892
|
$21,630
|
More Information About Prescription Drug User Fees
For more information, contact:
Donna SimmsThe fee for straight colors, including lakes, repacks and mixtures, is $.30 per pound. The fees, intended to recover the full costs of FDA's Color Certification Program, have been in effect since March 4, 1996.
|
$.30 per pound of the batch covered but not less than $192 |
---|---|
|
(1) 100 lbs. or less - $30 (2) over 100 lbs. - $30 plus $.06 for each pound over 100 lbs., but not over 1000 lbs. (3) over 1000 lbs. - $84 plus $.02 for each pound over 1000 lbs. |
For more information, contact:
Ted DoughertyThe fees, authorized under the FDA Export Reform and Enhancement Act of 1996, allow the agency to partially recover its costs for personnel, equipment, supplies, printing and overhead. The legislation caps the fee at $175 per certificate.
CBER
CVM
CDER
CDRH
For more information, contact:
Donna Simms