Appendix C: Waivers and Reductions Granted in FY 2011
MDUFMA directs FDA to waive the first premarket application fee from a qualified small business and the fee for an application submitted solely for pediatric indications. It also directs FDA to reduce fees for subsequent applications from qualified small businesses in all categories except the annual establishment registration fee. In addition, FDA does not collect fees for the following application types:
• applications for Humanitarian Device Exemptions (HDE) submitted under section 520(m) of
the FD&C Act;
• applications submitted under section 351 of the Public Health Service (PHS) Act for a product
licensed for further manufacturing use only;
• applications submitted by a state or federal government entity for devices that are not
intended for commercial distribution; and
• 510(k)s submitted to certified third-party reviewers, rather than to FDA.
Table 12 summarizes the waivers and reductions granted by FDA for MDUFMA fees payable in FY 2011, as well as the total value of each. Please note that the waivers and reductions listed below are for cohort year FY 2011 only.
FY 2011 Small Business Fee Waivers And Reductions Granted
As Of September 30, 2011
AMOUNT REDUCED PER FEE
CATEGORY NUMBER TOTAL VALUE Full Fees Waived 11 $236,298 $2,599,278 Full Fees Reduced 7 $177,223 $1,240,561 Panel Track Supplements Reduced 1 $132,918 $132,918 180-Day Supplements Reduced 15 $26,584 $398,760 Real-Time Supplements Reduced 17 $12,406 $210,902 510(k)s Fees Reduced 938 $2,174 $2,039,212 30-day Notice Fees Reduced 67 $1,891 $126,697 513(g)s Fees Reduced 35 $1,595 $55,825 Annual Periodic Report Fees Reduced 52 $6,202 $322,504 TOTAL 1,143 $7,126,657
Note: Amount of reduction per fee type = full fee rate - small business fee rate
In FY 2011 FDA waived 11 fees for first-time submissions of PMAs or BLAs, and reduced a total of 1,143 fees.
FDA collected $68,372,642 in fee revenue during FY 2011. Had there been no small-business waivers or reductions, FDA would have collected an additional $7,126,657, or an additional 10.4 percent of collections.
FDA received 8 HDE applications and 106 supplements in FY 2011. None of these are subject to MDUFMA fees. FDA does not know if any of these would have been submitted had they been subject to a fee, therefore the extent to which this exemption resulted in any loss of revenue is unknown.
CBER received no exemption requests in FY 2011 for applications submitted under section 351 of the PHS Act for a product licensed for further manufacturing use only.
FDA did not receive any requests from state or federal government entities for exemptions in FY 2011 for products that were not intended for commercial distribution.
FDA granted exemptions for pediatric indications in FY 2011 to two 510(k)s. The total value of these exemptions was $8,696.
FDA received 185 510(k) submissions subject to third-party review in FY 2011 compared to 244 in FY 2010 and 282 in FY 2009. FDA exempted fees for these 185 submissions. The total value of these exemptions in FY 2011 was $691,767 – assuming that 28 percent (the same percent of total 2011 510(k)s submitted that paid the small business rate) of the third-party submissions would have paid the reduced small business fee.
Table 13 summarizes total waivers, reductions, and exemptions granted in FY 2010 and FY 2011 and their value.
Summary And Total Value Of All Fee Waivers,
Reductions, And Exemptions Granted
As Of September 30, 2011
REASON FY 2010 FY 2011 Small Business $8,370,548 $7,126,657 Govt. Sponsored Application not for Commercial Distribution $0 $0 Pediatric Indications $505,002 $8,696 510(k)s $831,015 $691,767 TOTAL VALUE $9,706,565 $7,827,120