,,ii  #aagth ,,congress  #ast ,session  
,s4 #bibe  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #d1   
#bjba,ms4 ,rosen 7for herself and ,mr4  
,cassidy7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
provide for a strategic plan for the    
domestic manufacture of necessary       
medical supplies or supplies needed to  
facilitate emergency or medical         
response1 and for other purposes4  #a4  
,short title ,this ,act may be cited as 
the ,strategic ,planning for ,emergency 
,medical ,manufacturing ,act4  #b4      
,domestic back-up manufacturing network 
,title ,,iii of the ,public ,health     
,service ,act is amended by inserting   
after section #cai;,f-#d of such ,act   
7#db ,u4,s4,c4 #bdg;d-#f;e7 the         
following3  #cai;,f-#e4 ,domestic       
back-up manufacturing network  7a7 ,in  
general ,the ,secretary1 acting through 
the ,assistant ,secretary for           

,preparedness and ,response 7referred to
 in this section as the ,assistant      
,secretary71 shall develop and maintain 
a network of manufacturers-- 7#a7 whose 
manufacturing facilities are in the     
,united ,states 7including small        
business concerns1 as defined in section
 #c of the ,small ,business ,act72  7#b7
 who manufacture certain items          
identified by the ,assistant ,secretary1
 which shall primarily be medical       
supplies or supplies needed to          
facilitate emergency or medical         
response2 and  7#c7 that have           
voluntarily opted in for inclusion in   
such network1 in order to provide for   
the domestic manufacture of necessary   
supplies during times of emergency or   
disruption of the usual supply chain4   
7b7 ,distribution of network ,the       
,assistant ,secretary shall make        
information about the network described 
in subsection 7a7 available to ,states1 
local governmental entities1 ,indian    
,tribes1 ,tribal organizations1 and     

urban ,indian organizations1 medical    
suppliers1 hospitals1 and other health  
care providers1 as the ,assistant       
,secretary determines appropriate1 when 
critical supply shortfalls are          
anticipated4  7c7 ,plans developed in   
conjunction with participating          
manufacturers ,domestic manufacturers   
opting to participate as described in   
subsection 7a7 shall develop1 in        
coordination with the ,assistant        
,secretary1 a comprehensive plan that   
identifies-- 7#a7 the items that the    
manufacturer could produce1 which may   
include-- 7,a7 items such manufacturer  
has current capacity to produce1 or the 
ability to rapidly expand capacity to   
produce2 and  7,b7 information about the
 manufacturer's general capacity and    
equipment and willingness to work with  
the ,assistant ,secretary to identify   
other products likely to be needed      
during an emergency that fit within the 
manufacturer's operational capabilities2
  7#b7 manufacturing capacity1 including

 options for partial operations and full
 capacity operations1 and the time      
needed to switch from standard product  
manufacturing to the needed emergency   
supply2  7#c7 technical assistance      
needed for production of items needed   
during times of emergency1 such as      
equipment1 staff training1 and          
regulatory compliance1 including scope1 
duration1 and the appropriate ,federal  
agency to provide assistance2 and  7#d7 
the frequency of testing by the         
manufacturer to ensure that the plan is 
operational and meets quality metrics   
and other obligations under ,federal    
purchasing contracts 7including with    
respect to contracts for supplies for   
the ,strategic ,national ,stockpile     
under section #cai;,f-#b7 or to meet    
other requirements determined by the    
,assistant ,secretary4  7d7 ,guidance   
,the ,secretary shall issue guidance on 
the quality standards for items         
identified by the ,assistant ,secretary 
as described in subsection 7a77#b71 by  

product type or category1 that apply    
with respect to such items produced by  
manufacturers included in the network4  
7e7 ,coordination with other agencies   
,the ,secretary shall coordinate with   
other ,federal agencies to provide      
contracting opportunities for ,federal  
purchasing of items identified by the   
,assistant ,secretary as described in   
subsection 7a77#b71 as such items are   
needed1 provided that such items meet   
all quality standards and other         
requirements and are produced as part of
 an agreement with the ,federal         
,government4  7f7 ,limits on            
participation2 opportunities for        
consideration  7#a7 ,limits ,the        
,secretary may limit the number of      
manufacturers that have active          
manufacturing plans under subsection 7c7
 and manufacturers that are active      
participants in the network described in
 subsection 7a71 taking into account    
diversity of product and geography of   
production facilities4  7#b7            

,opportunities for future consideration 
,all manufacturers wishing to           
participate in such network shall have  
access to a point of contact within the 
,office of the ,assistant ,secretary for
 ,preparedness and ,response and1 if not
 included in such network1 shall have   
the option to add their name to a       
simplified list for future consideration
 for such participation1 unless the     
,assistant ,secretary determines there  
to be any substantial cause for removal 
of the manufacturer from such list4  4