,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #fgjh  ,,in ,,the ,,house ,,of  
,,representatives  ,may #e1 #bjbj,mr4   
,buchanan introduced the following bill2
 which was referred to the ,committee on
 ,energy and ,commerce  ,a ,,bill  ,to  
support the advanced manufacturing      
technologies program of the ,food and   
,drug ,administration1 to establish     
,national ,centers of ,excellence in    
,advanced ,pharmaceutical               
,manufacturing1 and for other purposes4 
#a4 ,short title ,this ,act may be cited
 as the ,securing ,america's ,medicine  
,cabinet ,act of #bjbj4  #b4 ,advanced  
manufacturing technologies program      
,subchapter ,a of chapter ,v of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
amended by adding at the end the        
following3  #ebd;,b4 ,advanced          
manufacturing technologies program  7a7 
,in general ,not later than #a year     
after the date of enactment of the      
,securing ,america's ,medicine ,cabinet 

,act of #bjbj1 the ,secretary shall     
continue in effect the program to       
evaluate and approve new drug           
manufacturing technologies that are     
included in an application1 or          
supplement to an application1 for a drug
 under subsection 7b7 or 7j7 of section 
#eje of this ,act or for a biological   
product submitted under subsection 7a7  
or 7k7 of section #cea of the ,public   
,health ,service ,act4  7b7 ,designation
 ,the ,secretary shall designate a      
method of manufacturing a drug as an    
advanced manufacturing technology under 
this section if the drug manufacturer   
demonstrates that such technology is    
likely to-- 7#a7 prevent or resolve a   
drug shortage2  7#b7 maintain an        
adequate supply of critical medications 
for national emergencies2 or  7#c7      
promote the adoption of innovative      
approaches to drug product design and   
manufacturing4  7c7 ,consultation ,if   
the ,secretary designates a method of   
manufacturing as an advanced            

manufacturing technology under this     
section1 the ,secretary shall take      
actions to expedite the development and 
implementation of such method of        
manufacture for purposes of approval of 
the application under subsection 7c7 or 
7j7 of section #eje of this ,act or     
subsection 7a7 or 7k7 of section #cea of
 the ,public ,health ,service ,act1     
which may include1 as appropriate-- 7#a7
 holding meetings between the sponsor of
 the application and appropriate ,food  
and ,drug ,administration staff         
throughout the development of the       
technology2  7#b7 providing timely      
advice to1 and interactive communication
 with1 the sponsor regarding the        
development of the technology2 and  7#c7
 involving senior managers and          
experienced staff of the ,food and ,drug
 ,administration1 as appropriate1 in a  
collaborative1 cross-disciplinary review
 of the method of manufacturing4  7d7   
,evaluation of an ,advanced             
,manufacturing ,technology  7#a7        

,package ,a sponsor who receives        
designation of an advanced manufacturing
 technology under this section shall    
provide the ,secretary with a package of
 scientific evidence supporting the     
implementation of the advanced          
manufacturing technology in a particular
 context-of-use4  7#b7 ,evaluation      
,within #ij days of receiving the       
package1 the ,secretary shall determine 
whether a designated advanced           
manufacturing technology is validated   
for the proposed context of use based on
 the scientific merit the supporting    
evidence provided by the sponsor4  7#c7 
,effect of ,approval ,upon approval1 the
 same sponsor may rely upon the advanced
 manufacturing technology for use across
 multiple manufacturing product lines   
within the same context-of-use without  
having to re-submit data to the         
,secretary validating the underlying    
technology4  7e7 ,implementation and    
,reporting  7#a7 ,public meeting ,the   
,secretary shall publish in the ,federal

 ,register a notice of a public meeting 
to be held no later than #a year after  
the date of enactment of the ,securing  
,america's ,medicine ,cabinet ,act of   
#bjbj to discuss and obtain input and   
recommendations from stakeholders       
regarding the goals and scope of1 and a 
suitable framework and procedures and   
requirements for1 the program under this
 section4  7#b7 ,program guidance ,the  
,secretary shall-- 7,a7 not later than  
#a year after the date of enactment of  
the ,securing ,america's ,medicine      
,cabinet ,act of #bjbj1 issue draft     
guidance regarding the goals and        
implementation of the program under this
 section2 and  7,b7 not later than #b   
years after the date of enactment of the
 ,securing ,america's ,medicine ,cabinet
 ,act of #bjbj1 issue final guidance    
with respect to the implementation of   
such program4  7#c7 ,report ,the        
,secretary shall make available on the  
internet website of the ,food and ,drug 
,administration an annual report on the 

progress of the program under this      
section4  4  #c4 ,national ,center of   
,excellence in ,advanced ,pharmaceutical
 ,manufacturing ,chapter ,x of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cia et seq47 is    
amended by adding at the end the        
following3  #ajae4 ,national ,center of 
,excellence in ,advanced ,pharmaceutical
 ,manufacturing  7a7 ,in general ,the   
,secretary shall designate institutions 
of higher education as ,national        
,centers of ,excellence in ,advanced    
,pharmaceutical ,manufacturing1         
including continuous pharmaceutical     
manufacturing4  7b7 ,eligibility ,to be 
eligible for designation under          
subsection 7a7 an entity shall-- 7#a7 be
 an institution of higher education2    
7#b7 demonstrate-- 7,a7 the physical and
 technical capacity for research and    
development of advanced pharmaceutical  
manufacturing2  7,b7 a record of        
transferring scientific knowledge to the
 marketplace2  7,c7 scalable            

manufacturing knowledge1 which may be   
through collaborations of other         
institutions of higher education1       
biopharmaceutical manufacturers1 or     
other entities2  7,d7 the ability to    
train a future workforce for research on
 and implementation of advanced         
pharmaceutical manufacturing2 and  7,e7 
the ability to support ,federal agencies
 with technical assistance for advanced 
pharmaceutical technologies1 with an    
emphasis on creating a secure national  
pharmaceutical stockpile and the ability
 to rapidly address drug shortages2 and 
7#c7 submit an application to the       
,secretary at such time1 in such form1  
and in such manner as the ,secretary may
 require4  7c7 ,termination ,the        
,secretary may terminate the designation
 of an entity designated under          
subsection 7a7 upon a determination that
 the entity no longer meets the         
requirements of subsection 7b74  7d7    
,annual report ,not later than #a year  
after the date on which the first       

designation is made under subsection    
7a71 and annually thereafter1 the       
,secretary shall submit a report to     
,congress on the activities of the      
entities designated under such          
subsection4  7e7 ,authorization of      
appropriations ,to carry out this       
section1 there are authorized to be     
appropriated #ajj1jjj1jjj for the period
 of fiscal year #bjba through #bjbe4  4