21 U.S.C. § 360bbb–5a — Emerging technology program

(a) Program establishment (1) In general. The Secretary must set up a program to support and improve innovative approaches to designing and manufacturing drugs. (2) Actions. To run this program, the Secretary may: (A) increase communication between public and private groups, consortia, and individuals; (B) gather information about, and fund or conduct, research on innovative drug design and manufacturing; (C) hold meetings with industry, academia, other federal agencies, international agencies, and other interested people; (D) form working groups to support research and development in this area; (E) train and educate FDA regulatory staff and scientists on these innovative approaches; (F) advance the regulatory science behind developing and reviewing them; (G) join or run working groups to align international regulatory rules on this topic; and (H) give out grants or contracts to help carry out or support the program. (3) Grants and contracts. To apply for a grant or contract, an entity must submit an application (A) in the form and manner the Secretary requires, and (B) with the required information, including a description of (i) how it will carry out the funded activities, and (ii) how those activities will advance research, development, or adoption of innovative drug design and manufacturing approaches. (b) Guidance The Secretary must (1) write or update guidance to help facilitate adopting, and advance developing, innovative approaches to drug product design and manufacturing, and (2) make sure that guidance describes (A) any regulatory requirements tied to developing or reviewing the related technologies — including updates and improvements made after the product is approved — and (B) what data can be used to show that drugs made this way are the right identity, and are safe, pure, and potent. (c) Report to Congress By around December 2026, four years after December 29, 2022, the Secretary must send the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions a report covering: (1) a yearly accounting of the funds spent on this program; (2) how FDA staff were used to carry it out, including any staffing challenges or limitations; (3) how many public meetings the FDA held or joined under this section — including working-group meetings under subsection (a)(2)(D) or (G) — and what topics they covered; and (4) how many drug products have been approved or licensed, since December 29, 2022, using an innovative design or manufacturing approach.