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Reserves and Balance Available for Allocation in FY 2011

Back to Table of Contents: FY 2011 MDUFMA Financial Report


Table 6 provides a summary of carryover balances as of September 30, 2011, and anticipated claims on those balances.


The total amount that FDA has collected from FY 2008 through FY 2011 that exceeds the amounts appropriated in each year, as shown on the last line of Table 5 is $24,067,861.  Of this, $11,297,946 is considered unearned revenue, which FDA is unable to obligate or offset until applications are submitted pertaining to these funds.  When setting fees for FY 2012, FDA offset $9,511,830 which was the projected excess collected by the end of FY 2011.  At the end of  FY 2011 the total cumulative amount of funds that were unappropriated, with the exception of unearned revenue, was $3,258,085. 


FDA performed the offset for the excess collections of $9,511,830 but those funds are not available as they have not been appropriated by Congress.  As a result FDA cannot obligate these funds until they have been deemed appropriated, and will continue to hold them in reserve until such time.


FDA also holds unearned revenue in reserve until those funds are either refunded or applied to a valid coversheet.  The total amount of unearned revenue being held by FDA is $12,930,959, which is different from the number in table 5 because it includes all unearned revenue and not just unearned revenue collected between FY 2008 and FY 2011.  FDA 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.  At the end of FY 2011 this was projected to be $6,500,000.  All five of these amounts are held in reserve and are not available for allocation.  Table 6 shows the amounts of carryover that must be held in reserve and the amount, $20,786,961, available for allocation in subsequent fiscal years.  (FDA’s financial plan for MDUFMA II anticipated a growing available carryover balance through FY 2010, which would then be drawn down in the final two years.)


Table 6

Summary Statement of Medical Device User Fee

Carryover Balance

As Of September 30, 2011 


 Unearned Revenue (FY 2006 – FY 2011) $12,930,959
 Unappropriated Collections that have been Offset $9,511,830
 Other Unappropriated Collections $3,258,085
 Reserve for Future Refunds $1,000,000
 1-Month Reserve for Next Fiscal Year $6,500,000
 Available Cash for Allocation in Future $20,786,961


Next Section: Total Costs of the Process for the Review of Medical Device Applications in FY 2011