--- 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" 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, 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/21/355–2.md?p=a-3) 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 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 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 described in [paragraph (1)](#1), which may include, as appropriate— - (A) holding meetings with the [sponsor](/usc/21/379j–71.md?p=13) and the review team throughout the development of the medical product; - (B) providing timely advice to, and interactive communication with, the [sponsor](/usc/21/379j–71.md?p=13) regarding the development of the medical product to ensure that the development [program](/usc/21/1523.md?p=8) 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](/usc/21/1523.md?p=8) and to serve as a scientific liaison between the review team and the [sponsor](/usc/21/379j–71.md?p=13); - (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](/usc/21/1523.md?p=8) intended to expedite the development and review of a medical product; and - (G) in appropriate circumstances, permitting expanded access to the medical product 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 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” 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/21/355–2.md?p=a-3) (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.