|
FY 2002 |
FY 2003 Current Estimate |
FY 2004 Request |
Increase or Decrease |
|
|---|---|---|---|---|
|
Total Program Level |
$138,111,000 |
|||
|
$145,183,000 |
$163,133,000 |
+$17,950,000 |
||
| Budget Authority | $137,071,000 |
$135,374,000 |
$151,374,000 |
+$16,000,000 |
| User Fees | $1,040,000 |
$9,809,000 |
$ 11,759,000 |
+$1,950,000 |
| GSA Rent
Program Level |
||||
|
$99,916,000 |
$108,269,000 |
$120,045,000 |
+$11,776,000 |
|
|
Budget Authority |
$98,876,000 |
$98,876,000 |
$108,876,000 |
+$10,000,000 |
| Improving Management | $10,000,000 |
+$10,000,000 |
||
| Current Law User Fees | $1,040,000 |
$9,393,000 |
$10,919,000 |
+$1,526,000 |
|
PDUFA |
$1,040,000 |
$7,802,000 |
$8,646,000 |
+$844,000 |
|
MDUFMA |
$1,591,000 |
$2,273,000 |
+$682,000 |
|
|
Proposed Law User Fees |
$250,000 |
+$250,000 |
||
| ADUFA | ||||
|
Other Rent and Rent- |
||||
|
$38,195,000 |
$36,914,000 |
$43,088,000 |
+$6,174,000 |
|
Budget Authority |
$38,195,000 |
$36,498,000 |
$42,498,000 |
+$6,000,000 |
|
CDER Move |
$6,000,000 |
+$6,000,000 |
||
Current Law User Fees |
$416,000 |
$590,000 |
+$174,000 |
|
| MDUFMA | ||||
|
Fiscal Year |
Program Level |
Budget Authority |
User Fee |
|---|---|---|---|
|
2000 Actuals |
$93,340,000 |
$87,697,000 |
$5,643,000 |
|
2001 Actuals |
$93,136,000 |
$87,276,000 |
$5,860,000 |
|
2002 Actuals1/ |
$99,916,000 |
$98,876,000 |
$1,040,000 |
|
2003 Estimate |
$108,269,000 |
$98,876,000 |
$9,393,000 |
|
2004 Estimate |
$120,045,000 |
$108,876,000 |
$11,169,000 |
1 Includes FDA's FY 2002 Appropriation and the Counterterrorism Supplemental.
|
Fiscal Year |
Program Level |
Budget Authority |
User Fee |
|---|---|---|---|
|
2000 Actuals |
$32,452,000 |
$32,452,000 |
$0 |
|
2001 Actuals |
$30,897,000 |
$30,897,000 |
$0 |
|
2002 Actuals1/ 2/ |
$38,195,000 |
$38,195,000 |
$0 |
|
2003 Estimate |
$36,914,000 |
$36,498,000 |
$416,000 |
|
2004 Estimate |
$43,088,000 |
$42,498,000 |
$590,000 |
1 Includes FDA's FY 2002 Appropriation and the Counterterrorism Supplemental.
2 Includes $862,000 obligated during FY 2002 of the $4,000,000 provided for FDA’s initial move of staff to White Oak, MD.
Rent is part of the Salaries and Expenses Appropriation and includes Rental Payments to GSA and other Rent and Rent Related Activities. GSA Rental Payments includes charges for all of FDA's GSA space, both government-owned and GSA-leased. The Other Rent and Rent-Related account includes rent and rent-related charges that are not part of the GSA account.
FDA recently completed estimates of total FDA GSA Rent costs for FY 2004. Because of the substantial amount of additional space currently being requested or acquired, we expect fairly significant cost increases. Thus, because of changes in the amount of time it takes to acquire new space, and because variations in the rent rates always occur, FDA expects its GSA Rent costs to increase by at least $10,000,000 in FY 2004. FDA is working with GSA to obtain space around the county for field offices and additional space for Headquarters Centers at existing or new locations to accommodate the many Bioterrorism Personnel hired with Supplemental funds. FDA intends to redirect funds from the programs, including the Field component of those programs to cover the space costs for these personnel. FDA anticipates having to redistribute some funds in FY 2003 for GSA rent costs but has not yet determined the amount of this redistribution.
FDA is requesting an increase of $6,000,000 for facility-related costs not covered by GSA. FDA requests funds for costs to equip and occupy the CDER facility located at White Oak. These funds will be used for telecommunication and data cabling requirements and other infrastructure and moving costs. The funds represent the second installment to relocate and consolidate most of CDER’s Headquarters activities in one location, resulting in more effective and efficient operations. In FY 2002, Congress provided $4,000,000 to begin this move. FDA proposes to occupy its White Oak facility over a period of seven years, and, thus, will require additional future year funding to support the phased-in relocation strategy.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products. The PDUFA amendments of 2002 are effective for a five-year period with certain technical improvements. Specifically, Congress directed FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and develop principles for improving first-cycle reviews.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes the Agency to collect and spend user fees for the review of medical device applications. The law is patterned after the PDUFA that has enabled FDA to add over 1,000 employees to the drug review process over the last ten years.
MDUFMA is a multi-year enhancement effort to improve the quality and timeliness of the medical device review process. It authorizes the collection of user fees for the review of medical device applications of $25,125,000 in the first year. Those who submit premarket applications, certain supplements to those applications, and premarket notifications would pay the user fees. The revenues would be used by FDA to expedite the review of such applications. In FY 2004, user fee revenues are estimated at $29,190,000. Of this $29,190,000, $2,273,000 will be used for GSA rent.
In FY 2004, FDA is proposing a new user fee for Animal Drug and Feed Reviews that has strong industry interest and support. Animal drug and certain feed and food additive applicants, sponsors, and manufacturers would incur this fee to expedite their respective applications.
The FY 2004 budget includes $5,000,000 in user fees to provide a cost efficient, high quality review process that is predictable and performance driven much as the Agency has been able to do under PDUFA. The user fee will facilitate meeting the aggressive goal of 90 percent of specific review types completed within statutory (or lesser) time frames by the fifth year. Of this $5,000,000, $250,000 will be used for GSA rent.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes the Agency to collect and spend user fees for the review of medical device applications. The law is patterned after the PDUFA that has enabled FDA to add over 1,000 employees to the drug review process over the last ten years.
MDUFA is a multi-year enhancement effort to improve the quality and timeliness of the medical device review process. It authorizes the collection of user fees for the review of medical device applications of $25,125,000 in the first year. Those who submit premarket applications, certain supplements to those applications, and premarket notifications would pay the user fees. The revenues would be used by FDA to expedite the review of such applications. In FY 2004, user fee revenues are estimated at $29,190,000. Of this $29,190,000, $590,000 will be used for other rent and rent-related activities.