federal_register: 00-21692
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-21692 | Presubmission Conferences | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend its new animal drug regulations to describe the procedures to be followed for requesting, conducting, and documenting presubmission conferences. Under the Federal Food, Drug, and Cosmetic Act (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 proposed regulation describes how a person would request a presubmission conference and describes the procedures for the conduct of the presubmission conference. | 2000-08-25 | 2000 | 8 | https://www.federalregister.gov/documents/2000/08/25/00-21692/presubmission-conferences | https://www.govinfo.gov/content/pkg/FR-2000-08-25/pdf/00-21692.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend its new animal drug regulations to describe the procedures to be followed for requesting, conducting, and documenting presubmission conferences. Under the Federal Food, Drug, and Cosmetic Act... |