21 U.S.C. § 379j–62 — Authority to assess and use outsourcing facility fees

(a) Establishment and reinspection fees. (1) Starting fiscal year 2015, the Secretary must charge every outsourcing facility an annual establishment fee, and must charge a reinspection fee to any facility reinspected that year. (2) A facility reinspected more than once in a year owes a separate reinspection fee for each reinspection. (b) Fee setting. The Secretary must set the establishment and reinspection fee amounts each year using the method in (c), and publish them in the Federal Register at least 60 days before the fiscal year starts. (c) Amount of fees. (1) For each facility each year, the establishment fee — unless the small-business exception in (4) applies — equals $15,000 times the inflation adjustment factor from (2), plus the small business adjustment factor from (3). The reinspection fee equals $15,000 times the inflation adjustment factor, with no small-business add-on. (2) Starting fiscal year 2015, the FDA adjusts these fee amounts each year by publishing a Federal Register notice with an adjustment equal to: 1, plus the average yearly percent change in FDA per-employee personnel pay and benefits over the first three of the preceding four fiscal years, times the share of an average FDA position's cost that comes from pay and benefits, plus the average yearly percent change in the national urban Consumer Price Index over that same window, times the share of an average FDA position's cost that is not pay and benefits. Each year's adjustment compounds on top of every adjustment made in every year since fiscal year 2014. (3) Each year, the Secretary sets the small business adjustment factor based on estimating how many small businesses will pay the reduced fee, and how much the regular establishment fee must rise to make total collections match what they would be with no small-business exception at all. (4) A facility with gross annual sales of $1,000,000 or less, measured over the 12 months ending April 1 of the prior fiscal year, pays only one-third of the inflation-adjusted $15,000 base establishment fee, without the small-business add-on. To qualify, the business must submit a written request, in the format the FDA specifies in guidance, certifying its gross annual sales, no later than April 30 of that prior fiscal year. (5) In setting the small-business adjustment factor each year, the Secretary must credit fees forward to the next year if the prior year's small-business adjustment was overestimated, and must account for other adjustments and factors as the Secretary finds appropriate. (d) Use of fees. All fees collected under (a)(1)(A) and (B) may be spent only on overseeing outsourcing facilities. (e) Supplement not supplant. Fee money must add to — not replace — other federal funding for these activities. (f) Crediting and availability of fees. Fees may be collected and spent only as provided in advance by appropriations acts, but stay available until spent. Money may be shifted between the FDA's general salaries account and the fee account, but the transferred amount may only be spent overseeing outsourcing facilities. (g) Collection of fees. (1) A facility pays the establishment fee when it submits its yearly registration under section 353b(b). (2) The FDA must specify, in the same Federal Register notice as (b)(2), how and when reinspection fees are collected; a reinspection fee is collected after the FDA actually conducts that reinspection. (3) A facility is not considered registered under section 353b(b) until it pays that year's establishment fee. Every drug the facility makes is treated as misbranded under section 352 until all its owed establishment and reinspection fees are paid. (4) A fee not paid within 30 calendar days of its due date is treated as a debt owed to the federal government under the debt-collection law in subchapter II of chapter 37 of title 31. (h) Annual report to Congress. Within 120 calendar days after each fee-collecting fiscal year, the Secretary must report to the Senate HELP Committee and the House Energy and Commerce Committee, describing the fees assessed and collected that year, a summary of who paid them, new staff hired and placed, how fee money was used to support inspections, and how many inspections and reinspections happened. (i) Authorization of appropriations. For fiscal year 2014 and every year after, Congress is authorized to appropriate an amount equal to whatever fees are actually assessed that year.