|
Location |
Activities |
|---|---|
Washington, D.C. area: |
|
| Rockville, MD | FDA Headquarters and headquarters operations of the Human Drugs, Biologics, Animal Drugs, Device and Radiological Health products programs and laboratories. |
| Washington, D.C. | Foods program headquarters and laboratories |
| Bethesda, MD | Human Drugs and Biologics laboratories |
| Beltsville, MD | Foods and Animal Drugs Research facilities |
Field Operations Facilities: |
|
| Jefferson, AR | Arkansas Regional Laboratory |
| Oakland, CA | Pacific Regional Office |
| Alameda, CA | San Francisco District Office and laboratory |
| Los Angeles, CA | Pacific Regional Laboratory Southwest |
| Irvine, CA | Los Angeles District Office |
| Denver, CO | Denver District Office and laboratory (special emphasis in animal drugs residue testing) |
| Maitland, FL | Florida District Office |
| Atlanta, GA | Southeast Regional Office, Southeast Regional Laboratory, and Atlanta District Office |
| Chicago, IL | Chicago District Office |
| Lenexa, KS | Kansas City District Office and laboratory (special emphasis in pesticides and total diet analysis) |
| New Orleans, LA | New Orleans District Office |
| Stoneham, MA | New England District Office |
| Winchester, MA | Winchester Engineering and Analytical Center (testing of Medical Devices and Radiological Health Research products)- Testing facility for Radionuclides and Radiopharmaceutics. |
| Baltimore, MD | Baltimore District Office |
| Detroit, MI | Detroit District Office and laboratory |
| Minneapolis, MN | Minneapolis District Office |
| Parsippany, NJ | New Jersey District Office |
| Jamaica, NY | Northeast Regional Office, Regional laboratory and New York District Office |
| Cincinnati, OH | Cincinnati District Office and Forensic Chemistry Center (elemental analysis) |
| Philadelphia, PA | Central Regional Office, Philadelphia District Office and laboratory (special emphasis on Human Drugs) |
| San Juan, PR | San Juan District Office and laboratory (special emphasis on human drugs products testing) |
| Dallas, TX | Southwest Regional Office and Dallas District Office |
| Bothell, WA | Seattle District Office and Pacific Regional Laboratory Northwest (special emphasis on seafood products testing) |
Other Specialized facilities: |
|
| Dauphin Island, AL | Fishery research (CFSAN) |
| Jefferson, AR | National Center for Toxicological Research (NCTR) |
| St. Louis, MO | Specialized human drugs product testing laboratory (CDER) |
PDUFA, as amended, contains three legal conditions or "triggers" that must be satisfied each year before FDA can collect and spend user fees. As an example, the following calculations summarize how those conditions were met for FY 2000. All of the conditions for FY 2001 will not be known until after the end of the fiscal year in October 2001.
The first condition is that FDA's Salaries and Expenses Appropriation (excluding user fees) must meet or exceed FDA's FY 1997 Salaries and Expenses Appropriation (excluding user fees and adjusted for inflation). In FY 2000, FDA's Salaries and Expenses Appropriation (excluding user fees and rent to GSA, both of which were not included in the FY 1997 Appropriated amount) totaled $940,458,000. FDA's FY 1997 total Salaries and Expenses appropriation, excluding user fees, and adjusted as required by the statute, was $850,719,913. Therefore, since the FY 2000 amount is greater, the first condition was met.
The second condition is that the amount of user fees collected each year must be specifically included in FDA's appropriations. For FY 2000, FDA's appropriation acts specified that $145,434,000 would come from PDUFA fees, in addition to sums provided in regular appropriations. The appropriation act specified that the fees collected could remain available until expended. Thus, the second condition was met.
The third condition is that user fees may be collected and used only in years when FDA also uses a specified minimum amount of appropriated funds for the drug review process. The specified minimum is the amount FDA spent on the drug review process from appropriations (exclusive of user fees) in FY 1997, and adjusted for inflation. In FY 1997, FDA's actual obligations for the process for the review of human drug applications, excluding obligations paid from user fees, was $147,959,689, as reported in the FY 1997 Financial Report to Congress. Multiplying this amount by the adjustment factor of 1.0375, FDA's 1997 adjusted costs for the process for the review of human drug applications paid from appropriations exclusive of fees, is $153,508,177. As shown in the FY 2000 PDUFA Financial Report, FDA obligated $167,646,122 from appropriated funds in FY 2000 for the drug review process, which exceeded the specified minimum amount. Thus, the third condition was met.
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