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

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-514.12

## Section

- **Citation:** 21 CFR § 514.12
- **Heading:** Confidentiality of data and information in an investigational new animal drug notice
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS > PART 514—NEW ANIMAL DRUG APPLICATIONS > Subpart A—General Provisions

## 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 CFR § 514.1 § 514.1 Applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.1.md)
- [21 CFR § 514.3 § 514.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.3.md)
- [21 CFR § 514.4 § 514.4 Substantial evidence.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.4.md)
- [21 CFR § 514.5 § 514.5 Presubmission conferences.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.5.md)
- [21 CFR § 514.6 § 514.6 Amended applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.6.md)
- [21 CFR § 514.7 § 514.7 Withdrawal of applications without prejudice.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.7.md)
- [21 CFR § 514.8 § 514.8 Supplements and other changes to an approved application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.8.md)
- [21 CFR § 514.11 § 514.11 Confidentiality of data and information in a new animal drug application file.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.11.md)
- [21 CFR § 514.12 § 514.12 Confidentiality of data and information in an investigational new animal drug notice.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.12.md)
- [21 CFR § 514.15 § 514.15 Untrue statements in applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.15.md)
- [21 CFR § 514.80 § 514.80 Records and reports concerning experience with approved new animal drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.80.md)
- [21 CFR § 514.87 § 514.87 Annual reports for antimicrobial animal drug sales and distribution.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.87.md)
- [21 CFR § 514.100 § 514.100 Evaluation and comment on applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.100.md)
- [21 CFR § 514.105 § 514.105 Approval of applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-514.105.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-514.12. Check the current official text before relying on it. Not legal advice.