---
kind: "section"
citation: "21 U.S.C. § 360bbb–5a"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–5a"
heading: "Emerging technology program"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-5a"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–5a. Emerging technology program

- (a) **Program establishment—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish a program to support the adoption of, and improve the development of, innovative approaches to [drug](/usc/21/321.md?p=g-1) design and manufacturing.
  - (2) **Actions—** In carrying out the program under [paragraph (1)](#a-1), the [Secretary](/usc/21/321.md?p=d) may—
    - (A) facilitate and increase communication between public and private entities, consortia, and individuals with respect to innovative [drug product](/usc/21/321.md?p=dd) design and manufacturing;
    - (B) solicit information regarding, and conduct or support research on, innovative approaches to [drug product](/usc/21/321.md?p=dd) design and manufacturing;
    - (C) convene meetings with representatives of industry, academia, other Federal agencies, international agencies, and other interested [persons](/usc/21/321.md?p=e), as appropriate;
    - (D) convene working groups to support [drug product](/usc/21/321.md?p=dd) design and manufacturing research and development;
    - (E) support education and training for regulatory staff and scientists related to innovative approaches to [drug product](/usc/21/321.md?p=dd) design and manufacturing;
    - (F) advance regulatory science related to the development and review of innovative approaches to [drug product](/usc/21/321.md?p=dd) 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](/usc/21/321.md?p=dd) design and manufacturing; and
    - (H) award grants or contracts to carry out or support the program under [paragraph (1)](#a-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](/usc/21/321.md?p=d) may require; and
    - (B) containing such information as the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=dd) design and manufacturing.
- (b) **Guidance—** The [Secretary](/usc/21/321.md?p=d) shall—
  - (1) issue or update guidance to help facilitate the adoption of, and advance the development of, innovative approaches to [drug product](/usc/21/321.md?p=dd) design and manufacturing; and
  - (2) include in such guidance descriptions of—
    - (A) any regulatory requirements related to the development or review of technologies related to innovative approaches to [drug product](/usc/21/321.md?p=dd) design and manufacturing, including updates and improvements to such technologies after [product](/usc/21/360eee.md?p=13) approval; and
    - (B) data that can be used to demonstrate the identity, safety, purity, and potency of [drugs](/usc/21/321.md?p=g-1) manufactured using such technologies.
- (c) **Report to Congress—** Not later than 4 years after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing—
  - (1) an annual accounting of the allocation of funds made available to carry out this section;
  - (2) a description of how [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration staff were utilized to carry out this section and, as applicable, any challenges or limitations related to staffing;
  - (3) the number of public meetings held or participated in by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration pursuant to this section, including meetings convened as part of a working group described in subparagraph [(D)](#a-2-D) or [(G)](#a-2-G) of subsection (a)(2), and the topics of each such meeting; and
  - (4) the number of [drug products](/usc/21/321.md?p=dd) approved or [licensed](/usc/21/360eee.md?p=9), after December 29, 2022, using an innovative approach to [drug product](/usc/21/321.md?p=dd) design and manufacturing.

## Source credit

(June 25, 1938, ch. 675, § 566A, as added Pub. L. 117–328, div. FF, title III, § 3203, Dec. 29, 2022, 136 Stat. 5814.)