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Carryover Balances in FY 2010

Back to Table of Contents: FY 2010 MDUFMA Financial Report


Under MDUFMA, fees collected, appropriated, and not obligated by the end of a fiscal year remain available to FDA for future fiscal years. They are referred to as carryover balances. Operations in FY 2010 resulted in an increase of carryover balances of $6,350,642, and increased the net carryover balance from $37,886,475 to $44,237,117 by the end of the year.
Table 3 captures FDA’s carryover balances at the beginning of each fiscal year since the beginning of MDUFMA in FY 2003.
Table 3
Statement of Cash, Obligations, and
Carryover Balances by Fiscal Year
As of September 30 of each Fiscal Year
Net Cash
The carryover balances in table 3 reflect the cumulative cash from the beginning to the end of each fiscal year, the net cash collected, and any refunds or other adjustments that occurred during each fiscal year. The net cash amount for FY 2010 is different from the fees credited to FY 2010, shown on page 3. The reason for this is that some of the cash collected in FY 2010 was for fees owed from previous years. Net cash also reflects all refunds processed in FY 2010 even if the fee was paid in a previous fiscal year.
Fee Amounts Appropriated, Fees Collected, and Differences
Under MDUFMA II, if cumulative collections through FY 2010 and estimated collections for FY 2011 exceed cumulative fees authorized to be appropriated for the same period, FDA will reduce fees when fees are set for FY 2012 by the cumulative amount by which fees collected over this period exceed fees authorized to be appropriated over the same period. Table 4 provides annual cumulative net collections, collection ceilings (appropriated amount of fees that may be collected each year), and differences through the end of FY 2010.
Table 4
Statement of Fees Appropriated, Fees Collected, and Differences
 As of September 30, 2010
Fees Appropriated
Fees Collected
As table 4 shows, the total amount of fees collected for each year of MDUFMA I fell short of the amount appropriated every year. In FY 2010, for the third consecutive year under MDUFMA II, fees collected exceeded the appropriation, by a total of $9,935,587. Amounts collected in excess of appropriations for FY 2008 through FY 2010 total $18,003,760. Cumulative excess collections from FY 2008 through 2010, and estimated collections for FY 2011, if positive, would offset (reduce) fee amounts when they are set for FY 2012.
Availability of Carryover Balances
The total amount that FDA has collected from 2008 through 2010 that exceeds the amounts appropriated in each year, as shown on the last line of table 4 is $18,003,760. Of this, $8,491,930 is considered unearned revenue, which FDA is unable to obligate or offset until applications are submitted pertaining to these funds. For this reason the total amount of funds collected in excess of appropriations that can be subject to the offset provision is $9,511,830. 
FDA also holds $1,000,000 in reserve for potential refunds in future years. In addition, MDUFMA requires FDA to have at least one month of operating funds from fees in reserve at the end of each fiscal year for use at the beginning of the next fiscal year. All three of these amounts must be held in reserve and are not available for allocation. Table 5 shows the amounts of carryover that must be held in reserve and the amount, $19,757,062, available for allocation in subsequent fiscal years. (MDUFMA II anticipated a growing carryover balance through FY 2010, which would then be drawn down in the final two years.)
Table 5
Medical Device Fee Revenue Carryover Balance
As of September 30, 2010
Status of Carryover Funds
Unearned Revenue/Excess Collections
Reserve for Future Refunds
1-Month Reserve for Next Fiscal Year
Available Cash for Allocation in future
Total Carryover Balance


Next Section: Total Cost of the Process for the Review of Medical Device Applications in FY 2010