0910-AF67 200710 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Index of Legally Marketed Unapproved New Animal Drugs for Minor Species This rule is being 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. Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 516 21 USC 360 ccc-1 Statutory NPRM 02/02/2009 Statutory Final 08/02/2010 No NPRM 08/22/2006 71 FR 48840 NPRM Comment Period Extended 10/02/2006 71 FR 57892 NPRM Comment Period End 12/20/2006 Final Action 03/00/2008 No Businesses None No No Not Collected Bernadette Dunham 0910 Food and Drug Administration FDA 240 276-9000 240 276-9001 bernadette.dunham@fda.hhs.gov HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place, Rockville MD 20855