21 U.S.C. § 379j–12 — Authority to assess and use animal drug fees

(a) Types of fees. Starting in fiscal year 2004, the FDA must charge four kinds of fees on companies that work with animal drugs. (1) Animal drug application and supplement fee. Anyone who submits an animal drug application or a supplemental application on or after September 1, 2003, owes a fee: the full fee set under subsection (c) for a regular application, except an application covered by the "combination animal drug" rule in section 360b(d)(4); or half that fee for a supplement that requires new safety or effectiveness data, an application covered by section 360b(d)(4), or a conditional-approval application for a new use of a drug already approved for a different use. The fee is due when the application or supplement is submitted. There are exceptions: if someone already paid the fee for an application or supplement that was accepted for filing but never approved, or that was withdrawn without a waiver or refund, resubmitting the same product isn't charged again — this protection extends to a licensee, buyer, or successor. Starting in fiscal year 2019, if someone already paid the conditional-approval fee for a product and now submits a regular application for the same product within the timeframe the law allows, no new fee applies. The FDA must refund 75% of the fee for any application or supplement refused for filing. If an application or supplement is withdrawn after filing, the FDA may refund the fee if no substantial work was done on it after filing — and that decision is entirely up to the FDA and cannot be challenged. (2) Animal drug product fee. Anyone named as the applicant on an application or supplement for a product submitted for listing, who had one pending after September 1, 2003, pays an annual fee for each product — due starting the year it's first listed, or relisted after being withdrawn, and every year after that it stays listed, by whichever is later: the day after that year's funding law passes, or January 31. Charged only once per product per year. (3) Animal drug establishment fee. Anyone who owns or operates a manufacturing establishment (directly or through an affiliate), is named applicant on a listed product's application, and had an application pending after September 1, 2003, owes an annual fee for each establishment listed in its approved application as a manufacturing site. This fee applies in any year the product itself is charged a product fee under (2), unless that establishment isn't actually manufacturing the drug that year. It's due by the same later-of dates described above, and each establishment pays only one fee per year. (4) Animal drug sponsor fee. Anyone who counts as an "animal drug sponsor" in a fiscal year, and had an application, supplement, or investigational submission pending after September 1, 2003, owes an annual sponsor fee, due by the same later-of dates. Each sponsor pays only one such fee a year. (b) Fee revenue amounts. For fiscal years 2024 through 2028, subject to the adjustments in subsections (c), (d), (f), and (g), these fees together must be set to raise $33,500,000 a year: 20% from application and supplement fees, 27% from product fees, 26% from establishment fees, and 27% from sponsor fees. (c) Annual fee setting and adjustments. At least 60 days before each fiscal year after September 30, 2023, the FDA must set all five fee amounts based on (b) and the adjustments below, and publish them in the Federal Register. Starting in fiscal year 2025, the FDA raises the revenue targets each year for inflation, using the same formula as elsewhere in this part of the law: one, plus the average yearly change in the FDA's per-employee personnel costs (weighted by personnel's share of total FDA costs), plus the average yearly change in a specific consumer price index (weighted by the non-personnel share of costs). Each year's adjustment compounds on top of the year before. Starting in fiscal year 2025, after the inflation adjustment, the FDA further adjusts the revenue target for workload, based on a weighted average of changes in the numbers of applications, supplements requiring safety or effectiveness data, manufacturing supplements, and investigational study and protocol submissions. This adjustment is made only in a year where it would exceed 3% — and even then, it's skipped for the very first year it crosses that mark. The FDA must publish the adjustment and its methodology. Workload adjustments can never push revenue below the inflation-adjusted target. Starting in fiscal year 2025, after the inflation and workload adjustments, the FDA must further raise fees if needed to keep at least a minimum number of weeks of operating reserve, or lower them if reserves exceed that target. The target is 22 weeks for fiscal year 2025, 20 weeks for 2026, 18 weeks for 2027, and 16 weeks for 2028. Reserves don't count carryover fees that haven't actually been appropriated yet. Any such adjustment must be explained in the Federal Register notice. No matter the adjustments, the total fees charged in a year can never exceed the FDA's actual costs that year for reviewing animal drug applications. (d) Fee waiver, reduction, and exemptions. The FDA must waive or reduce a fee if paying it would be a significant barrier to innovation given the applicant's limited resources or other circumstances; if the fees would exceed what it actually costs the FDA to review that applicant's submissions (the FDA may use standard cost estimates for this); if the application is solely for certain medicated animal feeds meant for further mixing; if the application is solely for a minor use or minor species; or if the applicant is a small business submitting its very first animal drug application. "Small business" means fewer than 500 employees, including affiliates' employees. The FDA must waive the application fee for a small business's (or its affiliate's) first application; after that, the business pays fees normally. Anyone claiming a small-business waiver must certify that they qualify, and the FDA periodically publishes a list of who has certified. Product, establishment, and sponsor fees don't apply to anyone whose application or submission involves an animal that's been genetically altered to produce a drug, device, or biological product that's already subject to fees under other specified FDA fee laws. (e) Effect of failure to pay fees. An application, supplement, or investigational submission is treated as incomplete, and the FDA won't accept it, until all owed fees are paid. The FDA can stop reviewing an application, supplement, or submission if fees aren't paid within 30 days of the due date. (f) Assessment of fees. The FDA can't charge fees for a year after 2003 unless that year's non-fee FDA salaries-and-expenses appropriation is at least as much as the 2003 level, adjusted upward for inflation. If fees were skipped for part of a year because that threshold wasn't met, and the threshold is later met that same year, the FDA can resume charging the same fees at the same rate for the rest of the year, regardless of the normal due dates. (g) Crediting and availability of fees. Fees are spendable only to the extent Congress specifically appropriates them each year, though unspent fee money stays available until it's used, and the FDA can transfer general funds to supplement fee funding for this review process. Fees collected can't exceed what's appropriated for the year, and are meant to cover cost increases above the 2003 baseline (adjusted for inflation). The FDA is considered to have met this requirement if its funded costs for the review process are within 3% of the target; if funding falls more than 3% short, fees charged two years later must be cut by the excess shortfall, as long as the shortfall itself is not more than 5%. Early fee payment is allowed if a prior year's appropriations law permits it. For fiscal years 2024 through 2028, Congress is authorized to appropriate the full revenue amount set under (b), as adjusted. If total fees collected exceed what's authorized to be appropriated, the excess is credited to the FDA's account. (h) Collection of unpaid fees. A fee more than 30 days overdue is treated as a debt owed to the federal government, handled under the standard federal debt-collection law. (i) Written requests for waivers, reductions, and refunds. To get a waiver, reduction, or refund, a person must send the FDA a written request within 180 days after the fee was due. (j) Construction. This section doesn't force staff cuts elsewhere in the Department of Health and Human Services just to offset new hires for this review process. (k) Abbreviated new animal drug applications. The FDA must, as far as practical, keep the review of abbreviated (generic-style) new animal drug applications separate from the regular review process covered by this section, and must adopt procedures to make sure this user-fee program doesn't slow down review times for those abbreviated applications.