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HHS/FDA | RIN: 0910-AF67 | Publication ID: Spring 2008 |
Title: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species | |
Abstract: This rule was issued in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The rule implements section 572 of the MUMS Act, which provides for a public index listing of legally marketed unapproved new animal drugs for minor species of animals (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). The drugs in this index will only be indicated for use in non-food minor species or for use in early non-food life stages to food-producing minor species. This rule will, among other things, specify the procedures for requesting eligibility for indexing and for requesting addition to the index as well as the reporting requirements for index holders. This rule will also describe the criteria requestors will use for assembling a qualified expert panel to evaluate for FDA the target animal safety and effectiveness of a new animal drug proposed for indexing. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 516 | |
Legal Authority: 21 USC 360 ccc-1 |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
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 N375, MPN-2, HFV-50, 7500 Standish Place, Rockville, MD 20855 Phone:240 402-0566 Email: margaret.oeller@fda.hhs.gov |