# Presubmission Conferences
> **Food and Drug Administration** · Final rule. · Published 2004-08-18 · Effective 2004-11-01 · 69 FR 51162
## Document
- **Document number:** 04-18846
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 51162
- **CFR reference:** 21 CFR 514
- **Publication date:** 2004-08-18
- **Effective date:** 2004-11-01
- **HHS docket:** Docket No. 2000N-1399
## Abstract

The Food and Drug Administration (FDA) is issuing this final rule to amend its new animal drug regulations to implement a new provision of the Federal Food, Drug, and Cosmetic Act (the act). Under this new provision of the act, as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental NADA or to investigate a new animal drug is entitled to one or more conferences with FDA to reach an agreement establishing a submission or investigational requirement. This final rule describes the procedures for requesting, conducting, and documenting such presubmission conferences.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/08/18/04-18846/presubmission-conferences)
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