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HHS/FDA RIN: 0910-AF60 Publication ID: Fall 2005 
Title: Designation of New Animal Drugs for Minor Use and Minor Species 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 514.1(d)(1)(i)   
Legal Authority: 21 USC 360ccc-2   
Legal Deadline:
Action Source Description Date
Final  Statutory    08/02/2006 
NPRM  Statutory    08/02/2005 
Action Date FR Cite
NPRM  09/27/2005  70 FR 56394   
NPRM Comment Period End  12/12/2005    
Final Rule  02/00/2006    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Bernadette Dunham
Director, Office of Minor Use and Minor Species Animal Drug Development
Department of Health and Human Services
Food and Drug Administration
HFV-101, Center for Veterinary Medicine (HFV-50, MPN-4), Room 180, 7519 Standish Place,
Rockville, MD 20855
Phone:240 276-9000
Fax:240 276-9001

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