FY 1998 PDUFA Financial Report: Appendix A
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CONDITIONS FOR ASSESSMENT AND USE OF FEES
The Food, Drug and Cosmetic Act (the Act), as amended by PDUFA and FDAMA, specifies three major conditions that must be met each year before user fees can be collected and spent. A summary of these conditions and how they were met was provided earlier on page 2. A more detailed presentation of each of these conditions is provided below, along with an explanation of how the condition was met in FY 1998.
The first condition comes from section 736(f)(1) of the Act. It states:
Fees may not be assessed under subsection (a) for a fiscal year beginning after FY 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
This requires that FDA's total Salaries and Expenses appropriation (excluding user fees) each year must be greater than or equal to FDA's FY 1997 Salaries and Expenses appropriation (excluding user fees). For making this comparison, FDA's 1997 Salaries and Expenses appropriation must be adjusted each year by an adjustment factor, which is defined in section 735(8) of the Act. It states:
The term 'adjustment factor' applicable to a fiscal year is the lower of --(A) the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 1997, or
(B) the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year (as reported in the Office of Management and Budget sequestration preview report, if available, required under section 254(c) of the Balanced Budget and Emergency Deficit Control Act of 1985) divided by such budget authority for fiscal year 1997 (as reported in the Office of Management and Budget final sequestration report submitted after the end of the 105th Congress, 1st Session).
The first calculated factor is the consumer price index of April 1997 (160.2) divided by the consumer price index of April of the fiscal year immediately preceding FY 1998 (which is also April 1997). The result of this division is a factor of one. The second calculated factor, domestic discretionary budget authority for FY 1997, as reported in the final sequestration report submitted after the end of the 105th Congress, 1st Session ($253.5 billion), divided by the domestic discretionary budget authority for the fiscal year immediately preceding FY 1998. Since this is the same number, this factor is also one. Since these two numbers both equal one, the lower of these two numbers is also one. Accordingly, the adjustment factor for FY 1998 is one.
FDA's total FY 1997 Salaries and Expenses appropriation, excluding fees, was $819,971,000. For FY 1998, FDA's total Salaries and Expenses appropriation, excluding user fees, was $857,501,000. Since the FY 1998 amount exceeds the FY 1997 amount, the first condition was met.
The second condition comes from Section 736(g)(2)(A). It states that fees "shall be collected in each fiscal year in an amount specified in appropriation acts , or otherwise made available for obligation, for such fiscal year…." Without a specific appropriation, no fees may be collected.
The first appropriation act (Public Law 105-86) specifying amounts collectable from fees during FY 1998 was signed by the President on November 18, 1997. It provided $91,204,000 to come from fees collected. A supplemental appropriation (Public Law 105-174) signed by the President on May 1, 1998 provided an additional $25,918,000 that was to come from fees collected. Combining these two amounts, a total of $117,122,000 was provided in appropriation acts to come from user fees. Thus, the second condition was met, and fees may be collected.
The third condition in the Act, in Section 736 (g) (2) (B), states:
fees shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor.
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. Applying the adjustment factor of one derived above, FDA's 1997 adjusted costs for the process for the review of human drug applications is $147,959,689.
The following table shows the FDA costs (obligations) for the process for the review of human drug applications for FY's 1997 and 1998. It also shows the amount of these costs that was met from appropriations and the amount met from user fee revenues. Since the 1998 amount spent from base appropriations exceeded the 1997 adjusted amount, the third condition was met.
FOOD AND DRUG ADMINISTRATION
OBLIGATIONS FOR THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS
as of September 30, 1998
|Adjusted FY 1997||FY 1998|
|From User Fee Revenues||$84,289,046||$101,615,000|
Next Section: Appendix B: Exemptions and Waivers