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HHS/FDA RIN: 0910-AG07 Publication ID: Spring 2008 
Title: ●Conditional Approval of New Animal Drugs for Minor Use and Minor Species 
Abstract: This proposed rule implements section 571 of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act). The MUMS act added three sections to the Federal Food, Drug, and Cosmetic Act (the Act) (571, 572, and 573), and it established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. Section 571 of the act provides for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the act. For the effectiveness component of a new animal drug approval, a reasonable expectation of effectiveness must be established prior to conditional approval under section 571 of the act. Sponsors then have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the act and achieve a complete new animal drug approval. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: First time 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 360cc 
Legal Deadline:
Action Source Description Date
NPRM  Statutory    02/00/2011 
Timetable:
Action Date FR Cite
NPRM  02/00/2009   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Gail L. Schmerfeld
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFV-100, Center for Tobacco Products, 9200 Corporate Boulevard,
Rockville, MD 20850-3229
Phone:877 287-1373
Fax:240 276-3904
Email: gail.schmerfeld@fda.hhs.gov

 
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