other · Food and Drug Administration · Rule · Published 2004-08-18 · Effective 2004-11-01 · 69 FR 51162
Document
Document number
04-18846
Federal Register citation
69 FR 51162
CFR reference
21 CFR 514
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.