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HHS/FDA RIN: 0910-AF60 Publication ID: Spring 2007 
Title: Designation of New Animal Drugs for Minor Uses or Minor Species 
Abstract: The proposed rule was published on September 27, 2005, in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The rule would implement section 573 of the MUMS Act, which sets forth the requirements for drug sponsors requesting MUMS designation for proposed new animal drugs. MUMS designation of a new animal drug allows drug sponsors to be granted 7 years of exclusive marketing rights for these limited demand new animal drugs once the drugs are approved or conditionally approved. This regulation would define content and format requirements for designation, requests changing designation ownership, and annual reporting requirements. This rule would also describe the criteria CVM will use for granting or denying these requests. Specific sections of the rule are dedicated to documentation of MUMS status in a request, granting MUMS designation, and revocation of MUMS designation. FDA intends to finalize this proposal after reviewing comments received. This is a voluntary program for animal drug sponsors. 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: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 516   
Legal Authority: 21 USC 360ccc-2   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    08/02/2008 
Final  Statutory    08/02/2009 
Action Date FR Cite
NPRM  09/27/2005  70 FR 56394   
NPRM Comment Period End  12/12/2005    
Final Rule  08/00/2007    
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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