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

(a) Types of fees. Starting in fiscal year 2009, the FDA (called "the Secretary" here) must charge four kinds of fees on companies that work with generic new animal drugs. (1) Abbreviated application fee. Anyone who files an abbreviated (streamlined) application for a generic new animal drug on or after July 1, 2008, must pay a fee set under subsection (c). It's due when the application is submitted. There are exceptions: if someone already paid the fee for an application that was accepted for filing but never approved, or that was withdrawn without getting a waiver or refund, they don't have to pay again to resubmit the same product — and that break carries over to their licensee, buyer, or successor. An application covered by the "combination animal drug" rule in section 360b(d)(4), submitted on or after October 1, 2013, owes only half the normal fee. If the FDA refuses to even accept an application for filing, it must refund 75% of the fee. If an application is withdrawn after being filed, the FDA may refund all or part of the fee, but only if no real work was done on it after filing — and that refund decision is entirely up to the FDA and cannot be challenged. (2) Generic new animal drug product fee. Anyone named as the applicant on an abbreviated application (or a supplement to one) for a product submitted for listing, who had an application pending after September 1, 2008, must pay an annual fee for each such product. The fee is first due for the fiscal year the product is submitted for listing (or relisting, if it was withdrawn and is coming back). After that, it's due every year the product stays listed, by whichever is later: the first business day after Congress passes that year's funding law, or January 31. Each product is charged only once per fiscal year. (3) Generic new animal drug sponsor fee. Anyone who counts as a "generic new animal drug sponsor" in a given fiscal year, and who had an application, supplement, or investigational submission pending after September 1, 2008, owes an annual sponsor fee, due by the same later-of dates as above. Each sponsor pays only one sponsor fee a year, but the amount depends on how many abbreviated applications they've had approved: 100% of the published fee for more than 6 approved applications, 75% for 2 to 6, and 50% for 1 or none. (4) Generic investigational new animal drug file fee. Anyone who asks to open a new "generic investigational new animal drug file" on or after October 1, 2023, owes a fee when making that request. Anyone who makes their first submission on or after October 1, 2023, to a file that was already open before that date also owes a fee, due with that first submission. Two exceptions: no fee for a submission that closes out the file, and no fee for a submission that just transfers the file to a different sponsor. (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 $25,000,000 a year. Of that total: 20% comes from the abbreviated-application fees and the investigational-file fees combined, 40% comes from the product fees, and 40% comes from the sponsor fees. (c) Annual fee setting and adjustments. At least 60 days before each fiscal year starting after September 30, 2023, the FDA must set the abbreviated-application fees (based on the revenue targets in (b), the adjustments below, and how much it expects to collect from the investigational-file fees), the sponsor and product fees (based on (b) and the adjustments), and a flat $50,000 fee for each investigational-file request or submission described in (a)(4)(A). Starting in fiscal year 2025, the FDA raises the revenue targets each year for inflation, by notice in the Federal Register. The increase equals one, plus the average yearly change in the FDA's per-employee personnel costs over the first 3 of the last 4 years (weighted by personnel's share of total FDA costs), plus the average yearly change in a specific consumer price index over the same period (weighted by the non-personnel share of costs). Each year's inflation adjustment builds on top of the year before, compounding. 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 abbreviated applications, manufacturing supplements, investigational study and protocol submissions, file-opening requests, and meeting requests it receives. If this workload adjustment would exceed 25%, it's capped at 25%. The FDA must publish the resulting fees and its methodology. For fiscal years 2026 through 2028, if the workload adjustment would raise fees, that increase must be reduced (down to zero, if needed) by the amount of any "excess collections" — money collected two years earlier beyond what was authorized, as described in subsection (g)(4). But no matter what, workload adjustments can never push revenue below the inflation-adjusted target. For fiscal year 2028 only, the FDA may raise fees further, beyond the other adjustments, to build up to 3 months of operating reserves for the start of the next fiscal year — but only if it doesn't already have more than 3 months of reserves. If it does this, it must explain why in that year's fee-setting notice. No matter the adjustments, the total fees charged in a year can never exceed what the FDA actually spends that year reviewing generic new animal drug applications. (d) Fee waiver or reduction. The FDA must waive or reduce a fee if the generic new animal drug is meant solely for a "minor use" or a "minor species" — that is, a small market. (e) Effect of failure to pay fees. An abbreviated application, an investigational submission, or a request to open an investigational file is treated as incomplete, and the FDA won't accept it, until every fee owed has been paid. If someone hasn't paid what they owe within 30 days after it's due, the FDA can stop reviewing their application, supplement, or submission altogether. (f) Assessment of fees. The FDA can't charge these fees for a fiscal year after 2008 unless Congress has appropriated at least as much money for the FDA's regular salaries and expenses (not counting fee money) as it did in fiscal year 2003, adjusted upward using the inflation formula defined in subsection (k)(2). If the FDA skips charging fees for part of a year because that funding threshold wasn't met, and later in the year the threshold is met, the FDA can start charging the same fees at the same rates for the rest of the year, even past the normal due dates. (g) Crediting and availability of fees. These fees can only be spent to the extent Congress specifically approves in that year's appropriations law, though unspent fee money stays available until it's used. The FDA may also transfer money from its general budget to supplement fee funding for this review process. Fees collected in a year can't exceed what Congress authorizes for that year, and are meant to cover cost increases — above the 2008 baseline, adjusted for inflation — in resources devoted to reviewing these applications, including hiring more staff. The FDA is considered to have met this funding requirement if its appropriated funding for the review process is no more than 3% below the target. If it's more than 3% below, fees charged two years later must be cut by the amount of the shortfall above 3%, as long as the shortfall itself is not more than 5% below target. The FDA may accept fee payments early if a prior year's appropriations law allows it. For fiscal years 2024 through 2028, Congress is authorized to appropriate the full revenue amount set under (b), as adjusted under (c). If total fees collected in a year exceed what was authorized to be appropriated, the excess is credited to the FDA's account. And if the amount actually collected and appropriated for fiscal year 2024 falls short of what was authorized, that shortfall is added to the amount collected for fiscal year 2026; a 2025 shortfall is added to 2027; and any 2026-or-2027 shortfall (using estimated 2027 collections) is added to 2028. (h) Collection of unpaid fees. If the FDA doesn't get paid within 30 days of when a fee is due, the debt is treated like any other unpaid claim 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 the FDA to cut staff elsewhere in the agency — those not reviewing these applications — just to offset the extra staff hired for this review process. (k) Definitions. - "Abbreviated application for a generic new animal drug" (or "abbreviated application") means an application for approval of a generic new animal drug filed under section 360b(b)(2). It does not include a supplemental abbreviated application. - "Adjustment factor" for a fiscal year is the Consumer Price Index for October of the previous fiscal year, divided by the Index for October 2002 (for purposes of subsection (f)(1)) or for October 2007 (for purposes of subsection (g)(2)(A)(ii)). - "Costs of resources allocated for the process..." covers FDA staff and contractor costs (including travel, training, and hiring) for reviewing these applications; computer systems; facilities, equipment, and supplies; and the cost of collecting these fees and tracking the resources devoted to review. - "Final dosage form" means a finished form of the drug ready to give to an animal without further manufacturing, including drugs meant to be mixed into animal feed. - "Generic new animal drug" means a new animal drug that is the subject of an abbreviated application. - "Generic new animal drug product" means a specific strength of an active ingredient, made by a specific manufacturer, identified by its national drug code, for which an abbreviated application or supplement has been approved. - "Generic new animal drug sponsor" means either the applicant on an abbreviated application that hasn't been withdrawn or lost its approval, or a person with an investigational submission that hasn't been terminated or made inactive. - "Generic investigational new animal drug meeting request" means a sponsor's request to meet with the FDA about an investigational submission. - "Investigational submission for a generic new animal drug" means either a claim for an investigational exemption under section 360b(j), or information submitted to help the FDA judge a drug's safety or effectiveness in connection with an abbreviated application. - "Person" includes an affiliated company, as defined in section 379g(11). - "Process for the review of abbreviated applications for generic new animal drugs" covers all the FDA's review-related work: reviewing applications, supplements, and investigational submissions; issuing approval or deficiency letters; inspecting drug-making facilities as part of a pending review; monitoring related research; writing regulations and policy; developing standards; meeting with sponsors; reviewing ads and labels before (but not after) approval; and work under mutual-recognition inspection agreements with the European Union and United Kingdom, and similar agreements. - "Request to establish a generic investigational new animal drug file" means a request to the FDA to open a file that will hold investigational submissions for a generic new animal drug. - "Supplemental abbreviated application for generic new animal drug" means a request to the FDA to approve a change to an already-approved abbreviated application.