21 CFR 514.12 - Confidentiality of data and information in an investigational new animal drug notice.

Regulations last checked for updates: May 03, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart A [§ 514.1 - § 514.15]

§ 514.12 - Confidentiality of data and information in an investigational new animal drug notice.

(a) The existence of an INAD notice will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.

(b) The availability for public disclosure of all data and information in an INAD file shall be handled in accordance with provisions established in § 514.11.

authority: 21 U.S.C. 321,331,351,352,354,356a,360b,360ccc,371,379e,381

source: 40 FR 13825, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 514.12