Part 3 — Product Jurisdiction
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.
Source: 56 FR 58756, Nov. 21, 1991, unless otherwise noted.
Sections
- § 3.1 Purpose.
- § 3.2 Definitions.
- § 3.3 Scope.
- § 3.4 Designated agency component.
- § 3.5 Procedures for identifying the designated agency component.
- § 3.6 Product jurisdiction officer.
- § 3.7 Request for designation.
- § 3.8 Letter of designation.
- § 3.9 Effect of letter of designation.
- § 3.10 Stay of review time.