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MDUFA: FY 2009 and FY 2008 Medical Device User Fee Collections

MDUFA: 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
SourceFY 2009
Expected
FY2009 Fee RevenuesFY 2009 Surplus
ReceiptsRefundsNet% of Expected
Establishment Registration Fees$23,600,378$26,887,381$23,900$26,863,481113.8%$3,263,104
Application / Reporting Fees2$28,946,623$11,239,334 $11,239,33438.8% (Deficit)$17,707,289 (Deficit)
Uncategorized3 $308,299 $308,299 308,299
Total4$52,547,000$38,126,715$23,900$38,411,11473.1% (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 2003FY 2004FY 2005FY 2006FY 2007FY 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
SourceFY 2008
Expected
FY2008 Fee RevenuesFY 2008 Surplus
ReceiptsRefundsNet% of Expected
Establishment Registration Fees$21,751,500$23,788,141$127,205$23,660,936108.8%$1,909,436
Application / Reporting Fees2$26,679,500$26,037,989$1,305,961$24,732,02892.7% (Deficit)$1,947,472 (Deficit)
Uncategorized3 $242,423$-$242,423 $242,423
Total4$48,431,000$49,826,130$1,433,166$48,635,387100.4%$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 2003FY 2004FY 2005FY 2006FY 2007
$21,620,549$25,309,853$31,801,091$34,567,188$26,893,394