# 21 C.F.R. § 514.12 (2026): Confidentiality of data and information in an investigational new animal drug notice

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_12

## Section

- **Citation:** 21 C.F.R. § 514.12 (2026)
- **Heading:** Confidentiality of data and information in an investigational new animal drug notice
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 514: NEW ANIMAL DRUG APPLICATIONS / Subpart A: General Provisions / § 514.12: § 514.12   Confidentiality of data and information in an investigational new animal drug notice.

## Text

(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.

## Nearby sections

- [21 C.F.R. § 514.1 (2026) § 514.1   Applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_1.md)
- [21 C.F.R. § 514.3 (2026) § 514.3   Definitions.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_3.md)
- [21 C.F.R. § 514.4 (2026) § 514.4   Substantial evidence.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_4.md)
- [21 C.F.R. § 514.5 (2026) § 514.5   Presubmission conferences.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_5.md)
- [21 C.F.R. § 514.6 (2026) § 514.6   Amended applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_6.md)
- [21 C.F.R. § 514.7 (2026) § 514.7   Withdrawal of applications without prejudice.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_7.md)
- [21 C.F.R. § 514.8 (2026) § 514.8   Supplements and other changes to an approved application.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_8.md)
- [21 C.F.R. § 514.11 (2026) § 514.11   Confidentiality of data and information in a new animal drug application file.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_11.md)
- [21 C.F.R. § 514.12 (2026) § 514.12   Confidentiality of data and information in an investigational new animal drug notice.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_12.md)
- [21 C.F.R. § 514.15 (2026) § 514.15   Untrue statements in applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_15.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P514_S514_12. Check the current official text before relying on it. Not legal advice.