--- kind: "section" citation: "21 U.S.C. § 360bbb–3c" title: "21" title_heading: "Food and Drugs" number: "360bbb–3c" heading: "Expedited development and review of medical products for emergency uses" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/360bbb-3c" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter V — Drugs and Devices" - "Part E — General Provisions Relating to Drugs and Devices" --- # §360bbb–3c. Expedited development and review of medical products for emergency uses - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) of Defense may request that the [Secretary](/usc/21/321.md?p=d) of Health and Human Services, acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), take actions to expedite the development of a medical [product](/usc/21/360eee.md?p=13), review of investigational [new drug](/usc/21/321.md?p=p) applications under [section 355(i) of this title](/usc/21/355.md?p=i), review of investigational [device](/usc/21/321.md?p=h-1) exemptions under [section 360j(g) of this title](/usc/21/360j.md?p=g), and review of applications for approval and clearance of medical [products](/usc/21/360eee.md?p=13) under sections [355](/usc/21/355.md), [360(k)](/usc/21/360.md?p=k), and [360e](/usc/21/360e.md) of this title and [section 262 of title 42](/usc/42/262.md), including applications for licensing of vaccines or blood as biological [products](/usc/21/360eee.md?p=13) under such [section 262 of title 42](/usc/42/262.md), or applications for review of regenerative medicine advanced therapy [products](/usc/21/360eee.md?p=13) under [section 356(g) of this title](/usc/21/356.md?p=g), if there is a military emergency, or significant potential for a military emergency, involving a specific and imminently life-threatening risk to United States military forces of attack with an agent or agents, and the medical [product](/usc/21/360eee.md?p=13) that is the subject of such application, submission, or notification would be reasonably likely to diagnose, prevent, treat, or mitigate such life-threatening risk. - (2) **Actions—** Upon a request by the [Secretary](/usc/21/321.md?p=d) of Defense under [paragraph (1)](#1), the [Secretary](/usc/21/321.md?p=d) of Health and Human Services, acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall take action to expedite the development and review of an applicable application or notification with respect to a medical [product](/usc/21/360eee.md?p=13) described in [paragraph (1)](#1), which may include, as appropriate— - (A) holding meetings with the [sponsor](/usc/21/360fff.md?p=8) and the review team throughout the development of the medical [product](/usc/21/360eee.md?p=13); - (B) providing timely advice to, and interactive communication with, the [sponsor](/usc/21/360fff.md?p=8) regarding the development of the medical [product](/usc/21/360eee.md?p=13) to ensure that the development program to gather the nonclinical and clinical data necessary for approval or clearance is as efficient as practicable; - (C) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; - (D) assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the [sponsor](/usc/21/360fff.md?p=8); - (E) taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; - (F) applying any applicable [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration program intended to expedite the development and review of a medical [product](/usc/21/360eee.md?p=13); and - (G) in appropriate circumstances, permitting expanded access to the medical [product](/usc/21/360eee.md?p=13) during the investigational phase, in accordance with applicable requirements of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration. - (3) **Enhanced collaboration and communication—** In order to facilitate enhanced collaboration and communication with respect to the most current priorities of the [Department](/usc/21/321.md?p=c) of Defense— - (A) the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration shall meet with the [Department](/usc/21/321.md?p=c) of Defense and any other appropriate development partners, such as the Biomedical Advanced Research and Development Authority, on a semi-annual basis for the purposes of conducting a full review of the relevant [products](/usc/21/360eee.md?p=13) in the [Department](/usc/21/321.md?p=c) of Defense portfolio; and - (B) the Director of the Center for Biologics Evaluation and Research shall meet quarterly with the [Department](/usc/21/321.md?p=c) of Defense to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical [products](/usc/21/360eee.md?p=13) and projects that are the highest priorities to the [Department](/usc/21/321.md?p=c) of Defense (which may include freeze dried plasma [products](/usc/21/360eee.md?p=13) and platelet alternatives), unless the [Secretary](/usc/21/321.md?p=d) of Defense determines that any such meetings are not necessary. - (4) **Medical product—** In this subsection, the term “medical [product](/usc/21/360eee.md?p=13)” means a [drug](/usc/21/321.md?p=g-1) (as defined in [section 321 of this title](/usc/21/321.md)), a [device](/usc/21/321.md?p=h-1) (as defined in such [section 321 of this title](/usc/21/321.md)), or a biological [product](/usc/21/360eee.md?p=13) (as defined in [section 262 of title 42](/usc/42/262.md)). ## Source credit (Pub. L. 115–92, § 1(b), Dec. 12, 2017, 131 Stat. 2023.) ## Notes ### Editorial Notes ### Codification Section was enacted as part of Pub. L. 115–92, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.