FDA MQSA Inspection Fees | First Fee Increase Since Program Inception (63 FR 2245, 1998)

Overview

Published January 14, 1998 (Federal Register Vol. 63, No. 9, pages 2245–2248), this 4-page notice is FDA's formal announcement of the first increase in MQSA inspection fees since the original fee was established in March 1995 (60 FR 14584). Signed December 23, 1997 by William K. Hubbard, Associate Commissioner for Policy Coordination, and effective February 13, 1998, the notice was issued under Docket No. 94N-0335 pursuant to section 354(r) of the Public Health Service Act (42 U.S.C. 263b(r)), which requires FDA to assess and collect fees to cover the costs of annual MQSA inspections. The fee increase reflects the dramatic scaling of the MQSA inspection program between FY1995 and FY1998: the number of facilities inspected grew from approximately 4,900 in FY95 to roughly 10,000 in FY98, deploying 250 inspectors under State contracts that grew 64% over the same period. State-contracted inspection activity accounts for 72 percent of the total FY98 inspection budget. Data systems costs alone increased by nearly $800,000 over FY95 levels to support integrated inspector laptops and headquarters communications. Total recoverable aggregate program costs for FY1998 are estimated at $12.8 million, below the $14 million authorized by Congress. The FY98 fee uses a facility-plus-unit methodology: a $1,345 base facility charge plus $204 per mammography unit, yielding $1,549 for a one-unit facility. FDA expected the schedule to remain constant through FY1999. Although the MQSA does not require FDA to solicit comments on fee assessment, FDA invited public comment on its methodology for any subsequent years.

Key Contents

How This Applies to Your Practice

MQSA inspection fees are a direct operational cost for every non-governmental mammography facility, and understanding the fee structure's history (established here for the first time above the 1995 baseline) is directly relevant to facility budget planning and historical compliance records. The per-facility-plus-per-unit methodology documented in this 1998 notice remains the structural basis for MQSA inspection fee calculations today: fees scale with the number of mammography units operated, not with patient volume or inspection outcomes. Facilities that have added DBT units or additional digital mammography systems since their last fee cycle should verify that their unit count is accurately reflected in FDA's records, as each additional unit increases the annual inspection fee assessed. The governmental entity exemption criteria established here (particularly the Breast and Cervical Cancer Mortality Prevention Act pathway) directly affect facilities that participate in the CDC's National Breast and Cervical Cancer Early Detection Program (NBCCEDP). Facilities whose governmental entity status has changed since their initial determination, or that have increased the proportion of NBCCEDP-funded screenings past the 50% threshold, should confirm their current exemption status with FDA. The Ombudsman-based appeals process described in this notice is the structural mechanism still used for governmental entity disputes. The follow-up inspection fee structure documented here reinforces the cost-effectiveness of MammoComply's pre-inspection readiness framework: every avoidable follow-up inspection is also a direct monetary cost to the facility.