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U.S. Department of Health and Human Services

Medical Devices

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FY 2009 and FY 2008 Medical Device User Fee Collections

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FY 2009 Medical Device User Fee Collections As of December 31, 2008
Source FY 2009
Expected
FY2009 Fee Revenues FY 2009 Surplus
Receipts Refunds Net % of Expected
Establishment Registration Fees $23,600,378 $26,887,381 $23,900 $26,863,481 113.8% $3,263,104
Application / Reporting Fees2 $28,946,623 $11,239,334   $11,239,334 38.8% (Deficit) $17,707,289 (Deficit)
Uncategorized3   $308,299   $308,299   308,299
Total4 $52,547,000 $38,126,715 $23,900 $38,411,114 73.1% (Deficit) $14,135,886 (Deficit)

Notes:

  1. The Authorized revenues shown for Establishment Registration fees assume 12,750 establishments will register and pay the fee of $1,851.
  2. The Authorized revenues shown for Application / Reporting Fees represents the difference between total authorized fee revenues and the
    amount shown for authorized Establishment Registration revenues.
  3. Nearly all of these amounts are believed to be attributable to establishment registration fees.
  4. Total FY 2008 authorized fee revenues are specified in section 738(h)(3) of the FD&C Act.
Comparison:
Medical Device User Fee Collection in Prior Years

Excludes Unearned Fees, Includes Refunds
FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 FY 2008
$21,620,549 $25,309,853 $31,801,091 $34,567,188 $26,893,394 $48,635,387

 

FY 2008 Medical Device User Fee Collections As Reconciled through December 31, 2008
Source FY 2008
Expected
FY2008 Fee Revenues FY 2008 Surplus
Receipts Refunds Net % of Expected
Establishment Registration Fees $21,751,500 $23,788,141 $127,205 $23,660,936 108.8% $1,909,436
Application / Reporting Fees2 $26,679,500 $26,037,989 $1,305,961 $24,732,028 92.7% (Deficit) $1,947,472 (Deficit)
Uncategorized3   $242,423 $- $242,423   $242,423
Total4 $48,431,000 $49,826,130 $1,433,166 $48,635,387 100.4% $204,387

Notes:

  1. The Authorized revenues shown for Establishment Registration fees assume 12,750 establishments will register and pay the fee of $1,706.
    During FY 2008, 13,869 establishments registered and paid the fee.
  2. The Authorized revenues shown for Application / Reporting Fees represents the difference between total authorized fee revenues and the
    amount shown for authorized Establishment Registration revenues.
  3. Nearly all of these amounts are believed to be attributable to establishment registration fees.
  4. Total FY 2008 authorized fee revenues are specified in section 738(h)(3) of the FD&C Act.
Comparison:
Medical Device User Fee Collection in Prior Years

Excludes Unearned Fees, Includes Refunds
FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
$21,620,549 $25,309,853 $31,801,091 $34,567,188 $26,893,394