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| HHS/FDA | RIN: 0910-AG03 | Publication ID: Spring 2008 |
| Title: Defining the Term "Small Numbers of Animals" for Minor Use Designation | |
| Abstract: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) (21 U.S.C. 360ccc2, 371) 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 numbers of animals” to characterize such use. At this time, FDA is proposing to amend 21 CFR part 516 (the implementing regulations of the MUMS act) to further define “minor use” by defining 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. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 516 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 360ccc2; 21 USC 371 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Margaret Oeller Director, Office of Minor Use and Minor Species Animal Drug Development Department of Health and Human Services Food and Drug Administration HFV-2, Center for Veterinary Medicine , Room 150 (MPN-4, HFV-50), 7500 Standish Place, Rockville, MD 20855 Phone:240 276-9005 Fax:240 276-9001 Email: margaret.oeller@fda.hhs.gov |
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