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          CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review ProcessSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process
					
		
		December 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
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			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				Dockets Management
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				 All written comments should be identified with this document's docket number: FDA-2023-D-3740
	Docket Number:
		    FDA-2023-D-3740
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine


The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in March 2020, added section 512A *Priority zoonotic animal drugs* to the FD&C Act, which provides for the designation of a new animal drug as a PZAD.  This legislation is intended to expedite the development and review of certain new animal drugs that have the potential to prevent or treat a zoonotic disease in animals, including a vector-borne disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.

This guidance outlines the eligibility criteria a new animal drug should meet to obtain PZAD designation and describes the process sponsors may use to request such designation.  In addition, this guidance identifies enhancements to expedite the PZAD review process.




  
	Questions?
	
  Contact Point
          Dr. Michelle Hyre
				    		    	
		    		    	Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-133
Rockville, MD 20855
		michelle.hyre@fda.hhs.gov
		    
		    		    	240-402-0593

                                                                                  Content current as of:
      12/15/2023
         
                  
Regulated Product(s)
		 Animal & Veterinary
			  			     			  						              
						  Animal DrugsTopic(s)
			  Premarket
				    				       				    					
				          
				  Investigational New Animal Drug (INAD)
				  				     				  				     New Animal Drug Application (NADA)Search for FDA Guidance Documents

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