,,ii  #aafth ,,congress  #b;d ,session  
,s4 #ddbg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,august #d1    
#bjbj,ms4 ,hassan 7for herself1 ,mr4    
,braun1 and ,ms4 ,murkowski7 introduced 
the following bill2 which was read twice
 and referred to the ,committee on      
,health1 ,education1 ,labor1 and        
,pensions  ,a ,,bill  ,to provide for   
transparency in emergency use           
authorization of vaccine products1 and  
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,safe    
,authorization for ,vaccines during     
,emergencies ,act or the ,,save ,act4   
#b4 ,transparency in emergency use      
authorization of vaccine products  7a7  
,emergency use authorizations  7#a7 ,in 
general ,section #efd of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;bbb-#c7 is amended by    
adding at the end the following3  7n7   
,requirements with respect to vaccine   
products during public health           
emergencies  7#a7 ,emergency meeting and

 recommendations  7,a7 ,emergency       
meeting ,during a public health         
emergency declared by the ,secretary    
under section #cai of the ,public       
,health ,service ,act and with respect  
to a request to authorize the use of an 
unapproved product that is a vaccine or 
an unapproved use of an approved product
 that is a vaccine intended to address  
the public health threat that is the    
subject of such public health emergency1
 prior to authorizing use of such       
product1 subject to subparagraph 7,b71  
the ,secretary shall convene a meeting  
at which the ,food and ,drug            
,administration and the sponsor of the  
product present data and information on 
the product to the ,vaccines and        
,related ,biological ,products ,advisory
 ,committee for the purpose of reviewing
 and providing recommendations with     
respect to emergency use of the product4
  7,b7 ,exception ,if the ,secretary1 in
 consultation with the ,commissioner1   
determines that a meeting under         

subparagraph 7,a7 with respect to a     
product described in such subparagraph  
would not be in the public interest1 the
 ,secretary may make a determination not
 to convene such a meeting4 ,in the     
event that the ,secretary determines not
 to convene such a meeting pursuant to  
this subparagraph1 the ,secretary shall 
issue a report to the ,committee on     
,health1 ,education1 ,labor1 and        
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives that     
includes justification and relevant     
public health grounds for such          
determination4  7#b7 ,requirement to    
seek licensure ,an authorization under  
this section with respect to an         
unapproved product that is a vaccine or 
an unapproved use of an approved product
 that is a vaccine shall be conditioned 
on the sponsor seeking licensure of the 
product1 or the use1 as applicable1     
under section #cea of the ,public       
,health ,service ,act1 at the discretion

 of the ,secretary1 within a time period
 determined by the ,secretary4  4  7#b7 
,confidential information ,section      
#efd7;h77#a7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb-#c7;h77#a77 is amended-- 7,a7 
by inserting 1 including a summary      
review1 after data or information2  7,b7
 by striking #eje7;i71 #eab7;j71 or     
#ebj7;g7 and inserting #eje1 #eaj7k71   
#eab7;j71 #eac7;f71 #eae1 #ebj7;g71 or  
#efd of this ,act or section #cea of the
 ,public ,health ,service ,act2 and     
7,c7 by striking may indirectly reveal  
the existence of such application and   
inserting 1 including a summary review1 
may indirectly reveal the existence of  
such application or contain data or     
information submitted in an application 
under such sections4  7b7               
,recommendations with respect to        
vaccines ,to address a public health    
emergency ,section #cai of the ,public  
,health ,service ,act 7#db ,u4,s4,c4    
#bdg;d7 is amended by adding at the end 

the following3  7c7 ,recommendations    
,during a public health emergency       
declared by the ,secretary under        
subsection 7a71 not later than #ae days 
after the authorization under section   
#efd of the ,federal ,food1 ,drug1 and  
,cosmetic ,act of an unapproved product 
that is a vaccine or an unapproved use  
of an approved product that is a vaccine
 intended to address the public health  
threat that is the subject of such      
public health emergency1 the ,advisory  
,committee on ,immunization ,practices  
shall submit to the ,director of the    
,centers for ,disease ,control and      
,prevention1 the ,secretary1 the        
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate1   
and the ,committee on ,energy and       
,commerce of the ,house of              
,representatives-- 7#a7 recommendations 
regarding vaccination1 including        
prioritization of populations for which 
the vaccine is authorized2 or  7#b7 a   
report recommending that the ,secretary 

seek additional data or information in  
order for the committees to develop     
recommendations described in paragraph  
7#a74  4