,,ib ,union ,calendar ,no4 #dac #aafth  
,,congress  #b;d ,session  ,h4 ,r4 #dhff
 ,report ,no4 #aaf-eac ,,in ,,the       
,,house ,,of ,,representatives  ,october
 #bh1 #bjai,mr4 ,pallone 7for himself   
and ,mr4 ,guthrie7 introduced the       
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,september #ag1 #bjbj;,additional       
sponsor3 ,ms4 ,spanberger  ,september   
#ag1 #bjbj,reported with an amendment2  
committed to the ,committee of the      
,whole ,house on the ,state of the      
,union and ordered to be printed,strike 
out all after the enacting clause and   
insert the part printed in italic,for   
text of introduced bill1 see copy of    
bill as introduced on ,october #bh1     
#bjai  ,a ,,bill  ,to amend the #bast   
,century ,cures ,act to provide for     
designation of institutions of higher   
education that provide research1 data1  
and leadership on continuous            
manufacturing as ,national ,centers of  
,excellence in ,continuous              

,pharmaceutical ,manufacturing1 and for 
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,national      
,centers of ,excellence in ,continuous  
,pharmaceutical ,manufacturing ,act of  
#bjbj4  #b4 ,national ,centers of       
,excellence in ,continuous              
,pharmaceutical ,manufacturing  7a7 ,in 
general ,section #cjaf of the #bast     
,century ,cures ,act 7#ba ,u4,s4,c4     
#cii;h7 is amended to read as follows3  
#cjaf4 ,national ,centers of ,excellence
 in ,continuous ,pharmaceutical         
,manufacturing  7a7 ,in general ,the    
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs-- 7#a7
 shall solicit and1 beginning not later 
than one year after the date of         
enactment of the ,national ,centers of  
,excellence in ,continuous              
,pharmaceutical ,manufacturing ,act of  
#bjbj1 receive requests from            
institutions of higher education to be  
designated as a ,national ,center of    

,excellence in ,continuous              
,pharmaceutical ,manufacturing 7in this 
section referred to as a ,national      
,center of ,excellence7 to support the  
advancement and development of          
continuous manufacturing2 and  7#b7     
shall so designate any institution of   
higher education that-- 7,a7 requests   
such designation2 and  7,b7 meets the   
criteria specified in subsection 7c74   
7b7 ,request for designation ,a request 
for designation under subsection 7a7    
shall be made to the ,secretary at such 
time1 in such manner1 and containing    
such information as the ,secretary may  
require4 ,any such request shall include
 a description of how the institution of
 higher education meets or plans to meet
 each of the criteria specified in      
subsection 7c74  7c7 ,criteria for      
designation described ,the criteria     
specified in this subsection with       
respect to an institution of higher     
education are that the institution has1 
as of the date of the submission of a   

request under subsection 7a7 by such    
institution-- 7#a7 physical and         
technical capacity for research and     
development of continuous manufacturing2
  7#b7 manufacturing knowledge-sharing  
networks with other institutions of     
higher education1 large and small       
pharmaceutical manufacturers1 generic   
and nonprescription manufacturers1      
contract manufacturers1 and other       
entities2  7#c7 proven capacity to      
design and demonstrate new1 highly      
effective technology for use in         
continuous manufacturing2  7#d7 a track 
record for creating and transferring    
knowledge with respect to continuous    
manufacturing2  7#e7 the potential to   
train a future workforce for research on
 and implementation of advanced         
manufacturing and continuous            
manufacturing2 and  7#f7 experience in  
participating in and leading a          
continuous manufacturing technology     
partnership with other institutions of  
higher education1 large and small       

pharmaceutical manufacturers1 generic   
and nonprescription manufacturers1      
contract manufacturers1 and other       
entities-- 7,a7 to support companies    
with continuous manufacturing in the    
,united ,states2  7,b7 to support       
,federal agencies with technical        
assistance1 which may include regulatory
 and quality metric guidance as         
applicable1 for advanced manufacturing  
and continuous manufacturing2  7,c7 with
 respect to continuous manufacturing1 to
 organize and conduct research and      
development activities needed to create 
new and more effective technology1      
capture and disseminate expertise1      
create intellectual property1 and       
maintain technological leadership2  7,d7
 to develop best practices for designing
 continuous manufacturing2 and  7,e7 to 
assess and respond to the workforce     
needs for continuous manufacturing1     
including the development of training   
programs if needed4  7d7 ,termination of
 designation ,the ,secretary may        

terminate the designation of any        
,national ,center of ,excellence        
designated under this section if the    
,secretary determines such ,national    
,center of ,excellence no longer meets  
the criteria specified in subsection    
7c74 ,not later than #fj days before the
 effective date of such a termination1  
the ,secretary shall provide written    
notice to the ,national ,center of      
,excellence1 including the rationale for
 such termination4  7e7 ,conditions for 
designation ,as a condition of          
designation as a ,national ,center of   
,excellence under this section1 the     
,secretary shall require that an        
institution of higher education enter   
into an agreement with the ,secretary   
under which the institution agrees--    
7#a7 to collaborate directly with the   
,food and ,drug ,administration to      
publish the reports required by         
subsection 7g72  7#b7 to share data with
 the ,food and ,drug ,administration    
regarding best practices and research   

generated through the funding under     
subsection 7f72  7#c7 to develop1 along 
with industry partners 7which may       
include large and small                 
biopharmaceutical manufacturers1 generic
 and nonprescription manufacturers1 and 
contract manufacturers7 and another     
institution or institutions designated  
under this section1 if any1 a roadmap   
for developing a continuous             
manufacturing workforce2  7#d7 to       
develop1 along with industry partners   
and other institutions designated under 
this section1 a roadmap for             
strengthening existing1 and developing  
new1 relationships with other           
institutions2 and  7#e7 to provide an   
annual report to the ,food and ,drug    
,administration regarding the           
institution's activities under this     
section1 including a description of how 
the institution continues to meet and   
make progress on the criteria listed in 
subsection 7c74  7f7 ,funding  7#a7 ,in 
general ,the ,secretary shall award     

funding1 through grants1 contracts1 or  
cooperative agreements1 to the ,national
 ,centers of ,excellence designated     
under this section for the purpose of   
studying and recommending improvements  
to continuous manufacturing1 including  
such improvements as may enable the     
,centers-- 7,a7 to continue to meet the 
conditions specified in subsection 7e72 
and  7,b7 to expand capacity for        
research on1 and development of1        
continuing manufacturing4  7#b7         
,consistency with ,,fda mission ,as a   
condition on receipt of funding under   
this subsection1 a ,national ,center of 
,excellence shall agree to consider any 
input from the ,secretary regarding the 
use of funding that would-- 7,a7 help to
 further the advancement of continuous  
manufacturing through the ,national     
,center of ,excellence2 and  7,b7 be    
relevant to the mission of the ,food and
 ,drug ,administration4  7#c7           
,authorization of appropriations ,there 
is authorized to be appropriated to     

carry out this subsection #hj1jjj1jjj   
for the period of fiscal years #bjba    
through #bjbe4  7#d7 ,rule of           
construction ,nothing in this section   
shall be construed as precluding a      
,national ,center for ,excellence       
designated under this section from      
receiving funds under any other         
provision of this ,act or any other     
,federal law4  7g7 ,annual review and   
reports  7#a7 ,annual report ,beginning 
not later than one year after the date  
on which the first designation is made  
under subsection 7a71 and annually      
thereafter1 the ,secretary shall-- 7,a7 
submit to ,congress a report describing 
the activities1 partnerships and        
collaborations1 ,federal policy         
recommendations1 previous and continuing
 funding1 and findings of1 and any other
 applicable information from1 the       
,national ,centers of ,excellence       
designated under this section2 and  7,b7
 make such report available to the      
public in an easily accessible          

electronic format on the website of the 
,food and ,drug ,administration4  7#b7  
,review of national centers of          
excellence and potential designees ,the 
,secretary shall periodically review the
 ,national ,centers of ,excellence      
designated under this section to ensure 
that such ,national ,centers of         
,excellence continue to meet the        
criteria for designation under this     
section4  7#c7 ,report on long-term     
vision of ,,fda role ,not later than #b 
years after the date on which the first 
designation is made under subsection    
7a71 the ,secretary1 in consultation    
with the ,national ,centers of          
,excellence designated under this       
section1 shall submit a report to the   
,congress on the long-term vision of the
 ,department of ,health and ,human      
,services on the role of the ,food and  
,drug ,administration in supporting     
continuous manufacturing1 including--   
7,a7 a national framework of principles 
related to the implementation and       

regulation of continuous manufacturing2 
7,b7 a plan for the development of      
,federal regulations and guidance for   
how advanced manufacturing and          
continuous manufacturing can be         
incorporated into the development of    
pharmaceuticals and regulatory          
responsibilities of the ,food and ,drug 
,administration2 and  7,c7 appropriate  
feedback solicited from the public1     
which may include other institutions1   
large and small biopharmaceutical       
manufacturers1 generic and              
nonprescription manufacturers1 and      
contract manufacturers4  7h7            
,definitions ,in this section3 7#a7     
,advanced manufacturing ,the term       
advanced manufacturing means an approach
 for the manufacturing of               
pharmaceuticals that incorporates novel 
technology1 or uses an established      
technique or technology in a new or     
innovative way 7such as continuous      
manufacturing where the input materials 
are continuously transformed within the 

process by two or more unit operations7 
that enhances drug quality or improves  
the manufacturing process4  7#b7        
,continuous manufacturing ,the term     
continuous manufacturing-- 7,a7 means a 
process where the input materials are   
continuously fed into and transformed   
within the process1 and the processed   
output materials are continuously       
removed from the system2 and  7,b7      
consists of an integrated process that  
consists of a series of two or more unit
 operations4  7#c7 ,institution of      
higher education ,the term institution  
of higher education has the meaning     
given such term in section #aja7;a7 of  
the ,higher ,education ,act of #aife    
7#bj ,u4,s4,c4 #ajja7;a774  7#d7        
,secretary ,the term ,secretary means   
the ,secretary of ,health and ,human    
,services1 acting through the           
,commissioner of ,food and ,drugs4  4   
7b7 ,transition rule ,section #cjaf of  
the #bast ,century ,cures ,act 7#ba     
,u4,s4,c4 #cii;h71 as in effect on the  

day before the date of the enactment of 
this section1 shall apply with respect  
to grants awarded under such section    
before such date of enactment4          
,september #ag1 #bjbj,reported with an  
amendment2 committed to the ,committee  
of the ,whole ,house on the ,state of   
the ,union and ordered to be printed