,,ii  #aagth ,,congress  #ast ,session  
,s4 #behi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,august #c1    
#bjba,mrs4 ,blackburn 7for herself and  
,mr4 ,menendez7 introduced the following
 bill2 which was read twice and referred
 to the ,committee on ,health1          
,education1 ,labor1 and ,pensions  ,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 advanced and 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 ,securing ,america's ,medicine  
,cabinet ,act of #bjba4  #b4 ,national  
,centers of ,excellence in ,advanced and
 ,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 ,advanced and
 ,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 ,securing ,america's   
,medicine ,cabinet ,act of #bjba1       
receive requests from institutions of   
higher education1 or consortia of       
institutions of higher education1 to be 
designated as a ,national ,center of    
,excellence in ,advanced and ,continuous
 ,pharmaceutical ,manufacturing 7in this
 section referred to as a ,national     
,center of ,excellence7 to support the  
advancement1 development1 and           
implementation of advanced and          
continuous pharmaceutical manufacturing2
 and  7#b7 shall so designate not more  
than #e institutions of higher education
 or consortia of such institutions      
that-- 7,a7 request such designation2   

and  7,b7 meet 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 education1
 or consortium of institutions of higher
 education1 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 education1 or     
consortium of institutions of higher    
education1 are that the institution or  
consortium has1 as of the date of the   
submission of a request under subsection
 7a7 by such institution or consortium--
 7#a7 physical and technical capacity   
for research1 development1              
implementation1 and demonstration of    
advanced and continuous pharmaceutical  

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 relevant entities2  7#c7      
proven capacity to design1 develop1     
implement1 and demonstrate new1 highly  
effective technologies for use in       
advanced and continuous pharmaceutical  
manufacturing2  7#d7 a track record for 
creating1 preserving1 and transferring  
knowledge with respect to advanced and  
continuous pharmaceutical manufacturing2
  7#e7 the proven ability to facilitate 
training of an adequate future workforce
 for research on1 and implementation of1
 advanced and continuous pharmaceutical 
manufacturing2 and  7#f7 experience in  
participating in and leading advanced   
and continuous pharmaceutical           
manufacturing technology partnerships   
with other institutions of higher       
education1 large and small              

pharmaceutical manufacturers1 generic   
and nonprescription manufacturers1      
contract manufacturers1 and other       
relevant entities-- 7,a7 to support     
companies seeking to implement advanced 
and continuous pharmaceutical           
manufacturing in the ,united ,states2   
7,b7 to support ,federal agencies with  
technical assistance and employee       
training1 which may include regulatory  
and quality metric guidance as          
applicable1 and hands-on training1 for  
advanced and continuous pharmaceutical  
manufacturing2  7,c7 with respect to    
advanced and continuous pharmaceutical  
manufacturing1 to organize and conduct  
research and development activities     
needed to create new and more effective 
technology1 develop and share knowledge1
 create intellectual property1 and      
maintain technological leadership2  7,d7
 to develop best practices for designing
 and implementing advanced and          
continuous pharmaceutical manufacturing 
processes2 and  7,e7 to assess and      

respond to the national workforce needs 
for advanced and continuous             
pharmaceutical manufacturing1 including 
the development and implementing of     
training programs4  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 #ij 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 or      
consortium of institutions of higher    
education enters into an agreement with 

the ,secretary under which the          
institution or consortium 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 research    
organizations or contract manufacturers 
that carry out drug development and     
manufacturing activities7 and another   
institution or consortium designated    
under this section1 if any1 a roadmap   
for developing an advanced and          
continuous pharmaceutical manufacturing 
workforce2  7#d7 to develop1 along with 
industry partners and other institutions
 or consortia of such institutions      
designated under this section1 a roadmap

 for strengthening existing1 and        
developing new1 relationships with other
 institutions of higher education or    
consortia thereof2 and  7#e7 to provide 
an annual report to the ,food and ,drug 
,administration regarding the           
institution's or consortium's activities
 under this section1 including a        
description of how the institution or   
consortium continues to meet and make   
progress on the criteria specified 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 advanced and continuous              
pharmaceutical manufacturing1 including 
such improvements as may enable the     
,centers-- 7,a7 to continue to meet the 
conditions specified in subsection 7e72 
7,b7 to expand capacity for research on1
 and development of1 advanced and       

continuous pharmaceutical manufacturing2
 and  7,c7 to implement research        
infrastructure in advanced and          
continuous pharmaceutical manufacturing 
suitable for accelerating the           
development of drug products needed to  
respond to emerging medical threats1    
such as emerging drug shortages1 quality
 issues disrupting the supply chain1    
epidemics and pandemics1 and other such 
situations requiring the rapid          
development of new products or new      
manufacturing processes4  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 advanced and
 continuous pharmaceutical 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 #bjbb through #bjbf4  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       
,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     
advanced and continuous pharmaceutical  
manufacturing1 including-- 7,a7 a       

national framework of principles related
 to the implementation and regulation of
 advanced and continuous pharmaceutical 
manufacturing2  7,b7 a plan for the     
development of ,federal regulations and 
guidance for how advanced and continuous
 pharmaceutical manufacturing can be    
incorporated into the development of    
pharmaceuticals and regulatory          
responsibilities of the ,food and ,drug 
,administration2  7,c7 a plan for       
development of ,federal regulations or  
guidance for how advanced and continuous
 pharmaceutical manufacturing will be   
reviewed by the ,food and ,drug         
,administration2 and  7,d7 appropriate  
feedback solicited from the public1     
which may include other institutions of 
higher education1 large and small       
biopharmaceutical manufacturers1 generic
 and nonprescription manufacturers1 and 
contract manufacturers4  7h7            
,definitions ,in this section3 7#a7     
,advanced ,the term advanced1 with      
respect to pharmaceutical manufacturing1

 refers to an approach that incorporates
 novel technology1 or uses an           
established technique or technology in a
 new or innovative way1 that enhances   
drug quality or improves the performance
 of a manufacturing process4  7#b7      
,continuous ,the term continuous1 with  
respect to pharmaceutical manufacturing1
 refers to a process-- 7,a7 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 that consists of an integrated
 process that consists of a series of   
two or more simultaneous 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