21 U.S.C. § 360bbb-5a Emerging Technology Program

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 360bbb-5a

(a) Program establishment

(1) In general

The Secretary shall establish a program to support the adoption of, and improve the development of, innovative approaches to drug design and manufacturing.

(2) Actions

In carrying out the program under paragraph (1), the Secretary may-

(A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative drug product design and manufacturing;

(B) solicit information regarding, and conduct or support research on, innovative approaches to drug product design and manufacturing;

(C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested persons, as appropriate;

(D) convene working groups to support drug product design and manufacturing research and development;

(E) support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing;

(F) advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing;

(G) convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing; and

(H) award grants or contracts to carry out or support the program under paragraph (1).

(3) Grants and contracts

To seek a grant or contract under this section, an entity shall submit an application-

(A) in such form and manner as the Secretary may require; and

(B) containing such information as the Secretary may require, including a description of-

(i) how the entity will conduct the activities to be supported through the grant or contract; and

(ii) how such activities will further research and development related to, or adoption of, innovative approaches to drug product design and manufacturing.