21 U.S.C. § 360b-1

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 360b-1 - Priority zoonotic animal drugs

(a) In general

The Secretary shall, at the request of the sponsor intending to submit an application for approval of a new animal drug under section 360b(b)(1) of this title or an application for conditional approval of a new animal drug under section 360ccc of this title, expedite the development and review of such new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.

(b) Request for designation

The sponsor of a new animal drug may request the Secretary to designate a new animal drug described in subsection (a) as a priority zoonotic animal drug. A request for the designation may be made concurrently with, or at any time after, the opening of an investigational new animal drug file under section 360b(j) of this title or the filing of an application under section 360b(b)(1) or 360ccc of this title.

(c) Designation

(1) In general

Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the new animal drug that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the new animal drug meets the criteria, the Secretary shall designate the new animal drug as a priority zoonotic animal drug and shall take such actions as are appropriate to expedite the development and review of the application for approval or conditional approval of such new animal drug.

(2) Actions

The actions to expedite the development and review of an application under paragraph (1) may include, as appropriate-

(A) taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, such as by utilizing novel trial designs or drug development tools (including biomarkers) that may reduce the number of animals needed for studies;

(B) providing timely advice to, and interactive communication with, the sponsor (which may include meetings with the sponsor and review team) regarding the development of the new animal drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;

(C) involving senior managers and review staff with experience in zoonotic or vector-borne disease to facilitate collaborative, cross-disciplinary review, including, as appropriate, across agency centers; and

(D) implementing additional administrative or process enhancements, as necessary, to facilitate an efficient review and development program.

21 U.S.C. § 360b-1

June 25, 1938, ch. 675, §512A, as added Pub. L. 116-136, div. A, title III, §33023302,, 134 Stat. 384.