Title 21, Food and DrugsRelease 119-110

§360bbb–5a Emerging Technology Program

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part E — General Provisions Relating to Drugs and Devices › § 360bbb–5a

Last updated Sep 22, 2026|Official source

Summary

The Secretary must create a program to help adopt and improve new ways to design and make drugs. The program may increase communication between public and private groups, fund or do research, hold meetings and working groups, train staff, support regulatory science, work with international partners to align rules, and award grants or contracts. Groups that want a grant or contract must apply in the form the Secretary requires and explain how they will do the work and how it will help research or adoption. The Secretary must also issue or update guidance to help use these new methods and explain any regulatory rules and what data can show a drug’s identity, safety, purity, and potency. No later than 4 years after December 29, 2022, the Secretary must report to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions. The report must show yearly fund use, how FDA staff were used and any staffing limits, the number and topics of public meetings and working groups, and how many drug products approved or licensed after December 29, 2022 used an innovative approach.

Full Legal Text

Title 21, §360bbb–5a

Food and Drugs, Source: USLM XML via OLRC

(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.

(b)Guidance

The Secretary shall—

(1)issue or update guidance to help facilitate the adoption of, and advance the development of, innovative approaches to drug product 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 design and manufacturing, including updates and improvements to such technologies after product approval; and

(B)data that can be used to demonstrate the identity, safety, purity, and potency of drugs manufactured using such technologies.

(c)Report to Congress

Not later than 4 years after December 29, 2022, the Secretary shall submit to the Committee on Energy and Commerce 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 and Drug 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 and Drug Administration pursuant to this section, including meetings convened as part of a working group described in subparagraph (D) or (G) of subsection (a)(2), and the topics of each such meeting; and

(4)the number of drug products approved or licensed, after December 29, 2022, using an innovative approach to drug product design and manufacturing.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360bbb–5a

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110