# 21 CFR § 514.7: Withdrawal of applications without prejudice

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-514.7

## Section

- **Citation:** 21 CFR § 514.7
- **Heading:** Withdrawal of applications without prejudice
- **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

The sponsor may withdraw his pending application from consideration as a new animal drug application upon written notification to the Food and Drug Administration. Such withdrawal may be made without prejudice to a future filing. Upon resubmission, the time limitation will begin to run from the date the resubmission is received by the Food and Drug Administration. The original application will be retained by the Food and Drug Administration although it is considered withdrawn. The applicant shall be furnished a copy at cost on request.

## 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)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-514.7. Check the current official text before relying on it. Not legal advice.