FDA MQSA Inspection Fees | 2007 Fee Increase Under MQSRAA (72 FR 37027)
72 FR 37027–37029 · July 6, 2007 · Effective October 1, 2007 · Docket No. 2007N-0238
Last Reviewed: August 22, 2026
- Publisher
- U.S. Food and Drug Administration / Federal Register
- Author
- Jeffrey Shuren, Assistant Commissioner for Policy, FDA
- Edition
- 72 FR 37027, 2007
- Pages
- 3 pages
- Added to library
- Added August 22, 2026
Overview
Published July 6, 2007 (Federal Register Vol. 72, No. 129, pages 37027–37029), this 3-page notice is FDA's formal announcement of an updated MQSA inspection fee schedule under authority of section 354(r) of the Public Health Service Act (42 U.S.C. 263b(r)). Signed June 27, 2007 by Jeffrey Shuren, Assistant Commissioner for Policy, and effective October 1, 2007 for all inspections conducted under section 354(g) of the PHS Act, the notice was issued under Docket No. 2007N-0238 and references a supporting methodology document (Ref. 1: MQSA Inspection Fees: Methodology and Fees for Fiscal Year 2008, on display in the Division of Dockets Management). The fee increase is the first since the 2003 notice (68 FR 5289, September 4, 2003), which had set the one-unit facility fee at $1,749. An updated resource review demonstrated that annual fee collections under the 2003 schedule had been running well below the congressionally authorized level, requiring recalculation to ensure aggregate collections equal aggregate recoverable costs as mandated by section 354(r). The FY2008 total recoverable aggregate cost is estimated at $15.77 million, below the $16.4 million authorized by Congress for FY2004 collections and the $18.4 million authority requested for FY2008. The 2007 fee uses the same facility-plus-unit methodology as prior notices: a $1,900 base facility charge plus $250 per mammography unit, yielding $2,150 for a one-unit facility. A notable update from prior notices: the governmental entity exemption criteria now explicitly state that Medicare/Medicaid provider status alone does not qualify a facility as a governmental entity, and a new Form 3422 Governmental Entity Declaration process formally documents exemption claims.
Key Contents
-Published: July 6, 2007 | 72 FR 37027–37029 | 3 pages | Docket No. 2007N-0238 | FR Doc. E7–13044 Filed 7–5–07 | Effective October 1, 2007
-Authority: Section 354(r) of the Public Health Service Act (42 U.S.C. 263b(r)); first fee increase since 2003 fee notice (68 FR 5289, September 4, 2003); prior one-unit fee was $1,749 (2003–2007)
-Signed: June 27, 2007 | Jeffrey Shuren, Assistant Commissioner for Policy, FDA
-Contact: Helen J. Barr, Center for Devices and Radiological Health (HFZ-240), FDA, 1350 Piccard Dr., Rockville, MD 20850; 240-276-3332; FAX 240-276-3272
-Supporting reference: Ref. 1, U.S. Food and Drug Administration, MQSA Inspection Fees: Methodology and Fees for Fiscal Year 2008 (on display at Division of Dockets Management, 9 a.m. to 4 p.m., M to F)
-Fee calculation methodology (FY2008): base facility charge ($1,900) + per-unit charge ($250) per mammography unit; same methodology used since program inception; no new cost categories added
-Annual inspection fee schedule effective October 1, 2007 (Table 1): 1 unit = $2,150 | 2 units = $2,400 | 3 units = $2,650 | 4 units = $2,900 | 5 units = $3,150 | 6 units = $3,400 | 7 units = $3,650 | 8 units = $3,900 | 9 units = $4,150 | 10 units = $4,400
-Follow-up inspection fee: $1,144 flat (same flat-fee rationale retained: eliminates inspector variation and differential treatment; costs borne entirely by the facility requiring the follow-up)
-Total recoverable aggregate costs FY2008: $15.77 million (below $16.4 million authorized by Congress for FY2004; below $18.4 million authority requested for FY2008)
-Cost categories recoverable under 354(r) (unchanged from prior notices): (1) personnel (annual and follow-up inspections, administration and support); (2) equipment purchase, calibration, and training facility maintenance; (3) data systems (scheduling, tracking, data collection); (4) inspector training and qualification (FDA and State); (5) billing and collection; (6) tracking, coordination, and direction; (7) overhead and support; durable equipment costs recovered over useful life, not in year of purchase
-Costs NOT recoverable: governmental entity inspection costs (borne through appropriated funds; methodology explicitly does not pass governmental-entity costs to other facilities)
-Governmental entity exemption, PATH 1 (four-factor test, ALL conditions must be satisfied): (1) a Federal, State, district, territory, possession, Federally-recognized Indian tribe, city, county, or municipal entity OPERATES the facility; (2) PAYS the entire salary of all on-site personnel; (3) OWNS, rents, or leases all mammography equipment; AND (4) has ULTIMATE AUTHORITY over day-to-day management and operations
-Governmental entity exemption, PATH 2: provides services under the Breast and Cervical Cancer Mortality Prevention Act of 1990 with ≥50% of mammography screening examinations funded under that statute during the preceding 12 months
-NEW in this notice: Medicare/Medicaid providers do NOT qualify as governmental entities solely on the basis of Medicare/Medicaid program participation; they must independently satisfy PATH 1 or PATH 2
-Governmental Entity Declaration: Form 3422; facilities claiming exemption complete and return in lieu of fee payment within 30 days of receiving the bill; form is sent by FDA alongside the inspection bill
-Billing: FDA mails bill and Form 3422 within 30 days following inspection; payment due 30 days after billing date; late payment triggers Treasury prevailing rate interest + 6% late payment penalty (45 CFR 30.13) + $20 administrative fee per 30-day period balance remains due; third and final bill triggers collection: agencies, commercial credit reporting, and referral to Department of Treasury
-Billing contact: Billing Inquiries c/o Mammography Quality Assurance Program, P.O. Box 6057, Columbia, MD 21045; 1-800-838-7715
-Fee schedule subject to annual review and adjustment to ensure aggregate collected equals aggregate inspection costs for each fiscal year; FDA monitors adequacy annually for major programmatic and budget changes
-Comment period: written or electronic comments by October 1, 2007; Docket No. 2007N-0238 at Division of Dockets Management (HFA-305) or www.fda.gov/dockets/ecomments
How This Applies to Your Practice
The 2007 fee notice is the fourth in the series documenting the rising cost of operating the MQSA inspection program: from the inaugural 1995 fees (60 FR 14584), to the first increase in 1998 (63 FR 2245, also in MammoLibrary), to the 2003 update (68 FR 5289), and now to this 2007 recalibration. The trajectory illustrates a pattern directly relevant to facility budget planning: a one-unit facility's annual inspection fee rose from $1,178 (1998) to $1,749 (2003) to $2,150 (2007), and the follow-up fee rose from $878 (1998) to $1,144 (2007). Facilities that added DBT units between fee cycles saw compounding cost increases; each new unit adds the per-unit charge, and the unit-count is assessed against the then-current per-unit rate. The Medicare/Medicaid clarification added in this notice has direct operational significance for MammoComply users at Federally Qualified Health Centers, rural health clinics, hospital outpatient departments, and community health centers that bill Medicare or Medicaid for mammography. Those facilities cannot rely on Medicare/Medicaid participation as a basis for governmental entity fee exemption; they must meet the four-factor PATH 1 test (government operation, salary payment, equipment ownership, day-to-day control) or the NBCCEDP threshold test. The Form 3422 process (submitting the Governmental Entity Declaration in lieu of fee payment) is the mechanism still used today, and MammoComply users claiming governmental entity status should maintain current documentation supporting their path-specific eligibility against the criteria in this notice.
Practitioner Implications
MQSA-certified facilities should understand the 2007 fee schedule and the governmental entity exemption clarifications that this notice adds. Key action items: (1) Historical fee exposure for multi-unit facilities: a facility with 5 mammography units was assessed $3,150 per annual inspection under this 2007 schedule. Facilities that underwent inspections between October 1, 2007 and the next fee update should confirm those inspection invoices were paid and that no unresolved late payment penalties are outstanding; late payment debt accrues interest and can be referred to the Department of the Treasury. (2) Medicare/Medicaid governmental entity exclusion: facilities that have historically claimed governmental entity exemption based on Medicare/Medicaid participation should immediately evaluate whether they satisfy PATH 1 or PATH 2. This 2007 clarification is unambiguous and applies retroactively to any exemption claim made on or after October 1, 2007. Facilities with outstanding or disputed governmental entity determinations should consult legal counsel and review the Form 3422 process. (3) Form 3422, Governmental Entity Declaration: any facility claiming exemption after October 1, 2007 receives Form 3422 with the inspection bill. The form must be completed and returned within 30 days in lieu of fee payment. Facilities that received inspections after October 2007 and neither paid the fee nor submitted Form 3422 may have unresolved billing obligations. (4) Follow-up inspection cost: the $1,144 follow-up fee applies to all inspections conducted after October 1, 2007 for facilities with deficiencies requiring correction verification. Pre-inspection readiness using MammoComply's compliance modules directly avoids this additional cost exposure.
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