CFR›Title 21›Chapter I›Part 316›Subpart A ContainsSections 316.1–316.4CorpusDaily eCFRDisplayed edition2026-05-22Last updated2026-05-22 Subpart A—General Provisions Sections 316.1 § 316.1 Scope of this part. 316.2 § 316.2 Purpose. 316.3 § 316.3 Definitions. 316.4 § 316.4 Address for submissions. Next B Subpart B—Written Recommendations for Investigations of Orphan Drugs