federal_register: E8-5385
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-5385 | Defining Small Number of Animals for Minor Use Designation | Proposed Rule | The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of "minor use" that relied on the phrase "small number of animals" to characterize such use. At this time, FDA is proposing to amend the implementing regulations of the MUMS act. In response to Congress' charge to the agency to further define minor use, this amendment proposes a specific "small number of animals" for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use. | 2008-03-18 | 2008 | 3 | https://www.federalregister.gov/documents/2008/03/18/E8-5385/defining-small-number-of-animals-for-minor-use-designation | https://www.govinfo.gov/content/pkg/FR-2008-03-18/pdf/E8-5385.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species.... |