0910-AF60 200510 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 Designation of New Animal Drugs for Minor Use and Minor Species This proposed rule is being issued in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The proposed rule implements section 573 of the MUMS Act which sets forth the functional requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug will allow drug sponsors to be granted seven years of exclusive marketing rights for these limited demand new animal drugs once the drugs are approved or conditionally approved. This regulation will define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule will also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule will be dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. This is a voluntary program for animal drug sponsors. While we do not have estimates of the impact on the animal drug industry, we expect that this rule will have a net beneficial impact on the industry with those firms participating who hope to profit as a result of the market exclusivity provided by the MUMS Act. A large number of these drug companies are classified as small businesses. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 514.1(d)(1)(i) 21 USC 360ccc-2 Statutory Final 08/02/2006 Statutory NPRM 08/02/2005 No NPRM 09/27/2005 70 FR 56394 NPRM Comment Period End 12/12/2005 Final Rule 02/00/2006 No Businesses None No NA 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