federal_register: 00-27832
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-27832 | Enrofloxacin for Poultry; Opportunity For Hearing | Notice | The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of the new animal drug application (NADA) for use of the fluoroquinolone enrofloxacin in poultry. This action is based on CVM's determinations that the use of fluoroquinolones in poultry causes the development of fluoroquinolone- resistant Campylobacter, a human pathogen, in poultry; this resistant Campylobacter is transferred to humans and is a significant cause of the development of resistant Campylobacter infections in humans; and resistant Campylobacter infections are a human health hazard. Therefore, CVM is proposing to withdraw the approval of the new animal drug application for use of enrofloxacin in poultry on the grounds that new evidence shows that the product has not been shown to be safe as provided for in the Federal Food, Drug, and Cosmetic Act (the act). | 2000-10-31 | 2000 | 10 | https://www.federalregister.gov/documents/2000/10/31/00-27832/enrofloxacin-for-poultry-opportunity-for-hearing | https://www.govinfo.gov/content/pkg/FR-2000-10-31/pdf/00-27832.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of the new animal drug application (NADA) for use of the fluoroquinolone enrofloxacin in poultry. This action is based on CVM's... |