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User Fees

MQSA Inspection Fees

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
Office of Financial Management, (HFA-120)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Ph. 301-827-5042.

Prescription Drug User Fees

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 Simms
Office of Financial Management, (HFA-120)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Ph. 301-827-5042.

Color Additive Certification Fees

The 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.

Current Schedule of Fees - Color

  1. Fees for Straight Colors Including Lakes
$.30 per pound of the batch covered but not less than $192
  1. Repacks of Certified Color, Color Additives and Color Additives mixtures.

(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 Dougherty
Office of Financial Management
Reports and Analysis Section
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Ph. 301-827-5032.

Export Certificate Fees

The 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
Office of Financial Management
CFO Liaison Branch (HFA-120)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Ph. 301-827-5042

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