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

---
identifier: "/us/cfr/t21/s514.12"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 514.12 - Confidentiality of data and information in an investigational new animal drug notice."
title_number: 21
title_name: "Food and Drugs"
section_number: "514.12"
section_name: "Confidentiality of data and information in an investigational new animal drug notice."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "514"
part_name: "NEW ANIMAL DRUG APPLICATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 360ddd, 360ddd-1, 371, 379e, 381."
regulatory_source: "40 FR 13825, Mar. 27, 1975, unless otherwise noted."
cfr_part: "514"
---


# 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.