# Presentation: 755310

## Financial Aspects of MDUFMA 

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**Financial Aspects of MDUFMA **

- Presentation at Public Meeting by
- Frank Claunts
- December 3, 2003

## MDUFMA

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-   FY 2003 Accomplishments
-   FY 2003 Final Results

## MDUFMAFY 2003 Accomplishments

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**MDUFMA**FY 2003 Accomplishments

## FY 2003 Accomplishments

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- 10/26/02—MDUFMA enacted
- 11/21/02—FR Notice of FY 2003 fees and interim procedures
- 2/20/03—Enabling appropriations enacted
- 2/25/03—FR Notice with detailed payment procedures
- Lock Box at USBank
- Unique Payment ID numbers and Cover Sheets to track/link payments & applications
- Guidance on qualifying as a small business, applications subject to fees, bundling, and other MDUFMA topics

## FY 2003 Accomplishments Continued

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- FY 2003 Accomplishments Continued

- Website for MDUFMA information
- March-April—Invoiced for applications received between October 1 and March 31
- April—Webcast to explain invoice/payment process and answer questions
- Develop internal plans for fee allocation and use
- Creation of internal daily reports on fees received, discrepancies, and firms in arrears
- Developed and implemented modified time reporting systems for accounting for device review process costs

## FY 2003 Accomplishments Continued

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- FY 2003 Accomplishments Continued

- 8/1/03—Published FR Notice of FY 2004 MDUFMA fees and supporting information
- 8/25/03—Automated Cover Sheet transmission
- 10/29/03—Secured assurances of adequate appropriations for FY 2005 and beyond
- Working on FY 2003 Financial Report to Congress—due end of January, 2004—and 5-Year Financial Plan

## FY 2003 Accomplishments Continued

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- FY 2003 Accomplishments Continued

| Fiscal Year | 2003 |  | 2004 |  |
| --- | --- | --- | --- | --- |
| Fee Type | Full | S.B. | Full | S.B. |
| Full Fees | $154,000 | $58,520 | $206,811 | $78,588 |
| 180-Day Supps | $33,110 | $12,582 | $44,464 | $16,896 |
| Real Time Supps | $11,088 | $4,213 | $14,890 | $5,658 |
| 510(k)’s | $2,187 | $2,187 | $3,480 | $2,784 |

## MDUFMAActual FY 2003 Results SummaryMore Details Will be In Financial Report to Congress due January 30

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**MDUFMA**Actual FY 2003 Results SummaryMore Details Will be In Financial Report to Congress due January 30

## Actual Collections Realized

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- Actual Collections Realized

- Collections were much higher in September than predicted—perhaps due to higher fees starting October 1
- Total FY 2003 collections--$21.9 million
- $2.3 million more that estimated based on collections through June 30
- $3.2 million less than $25.1 million revenue target for FY 2003

## Revised FY 2004 Revenue Amount

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|  | 2004 Orig. | 2004 Rev. |
| --- | --- | --- |
| Statutory Revenue Amount | $27,255,000 | $27,255,000 |
| Inflation Adjustment | $1,163,789 | $1,163,789 |
| Compensating Adjustment | $5,478,000 | $3,235,418 |
| FY 2004 Total | $33,896,789 | $31,654,207 |

## Actual Collections Realizedcontinued

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- Actual Collections Realizedcontinued

- We have informed appropriation committees
- They will lower the collection ceiling in the FY 2004 appropriation act to $ 31,654,207
- Collections unlikely to exceed this amount because of lower numbers of fee-paying applications
- Should FDA collect more than this in FY 2004, the excess collections will cause the  FY 2005 fees to be lowered to offset any surplus collections

## FY 2003 Results Summary

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- FDA spent $14.9 million of fees collected and carried over the balance
- FDA used 22 more staff years on the device review process in 2003 than in 2002
- Most were hired near the end of the year
- CDRH actually hired 67 new staff late in the year, but because they were hired late only used a few more staff years in FY 2003
- Expect to utilize over 100 more staff years on device review process in FY 2004 than in FY 2002

## FY 2003 Results Summary

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- These additional funds give FDA the resources needed to meet the MDUFMA performance goals
- More FY 2003 financial details will be included in the report to Congress at the end of January

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