21 U.S.C. § 360b–1 — Priority zoonotic animal drugs

(a) In general. At the request of a sponsor planning to file a new animal drug application under section 360b(b)(1) of this title, or a conditional approval application under section 360ccc of this title, the Secretary must speed up development and review of the drug if preliminary clinical evidence shows it — alone or combined with other animal drugs — has the potential to prevent or treat a "zoonotic disease" in animals, including a vector-borne disease, that could seriously harm human health or cause serious or life-threatening disease in humans. (b) Request for designation. The sponsor may ask the Secretary to designate the drug a "priority zoonotic animal drug." This request can be made at the same time as, or any time after, opening an investigational new animal drug file under section 360b(j) of this title, or filing an application under section 360b(b)(1) or 360ccc of this title. (c) Designation (1) In general. Within 60 calendar days of receiving the request, the Secretary must decide whether the drug meets the subsection (a) criteria. If it does, the Secretary designates it a priority zoonotic animal drug and takes appropriate action to speed up its development and review. (2) Actions. Those actions may include, as appropriate — (A) making clinical trial design as efficient as practicable, when scientifically appropriate, including through novel trial designs or drug development tools such as biomarkers that may reduce the number of animals needed; (B) giving the sponsor timely advice and interactive communication, which may include meetings with the sponsor and review team, so the development program is as efficient as practicable; (C) involving senior managers and review staff experienced in zoonotic or vector-borne disease for collaborative, cross-disciplinary review, including across agency centers where appropriate; and (D) making additional administrative or process enhancements as necessary for an efficient review and development program.