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HHS/FDA RIN: 0910-AF67 Publication ID: Fall 2006 
Title: Index of Legally Marketed Unapproved New Animal Drugs for 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 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 proposed 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: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 516 
Legal Authority: 21 USC 360 ccc-1 
Legal Deadline:
Action Source Description Date
Final  Statutory    08/02/2007 
NPRM  Statutory    02/02/2006 
Timetable:
Action Date FR Cite
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  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
Email: bernadette.dunham@fda.hhs.gov

 
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