Administrative Practices and Procedures; Formal Hearings

This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations found in 21 CFR Part 10, 21 CFR Parts 12 through 16, and 21 CFR Part 19 (21 CFR §§ 10, 12-16, and 19). These regulations are established in accordance with the Administrative Procedures Act and implement administrative practice and procedures to give instructions to those conducting business with FDA.

The latest form for Administrative Practices and Procedures; Formal Hearings expires 2026-08-31 and can be found here.

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Federal Enterprise Architecture: Health - Consumer Health and Safety