,,ii  #aafth ,,congress  #b;d ,session  
,s4 #cghj  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #bj1      
#bjbj,mr4 ,peters introduced the        
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to encourage domestic advanced 
manufacturing of critical drugs and     
devices in order to address economic1   
health1 and security concerns1 combat   
shortages of critical drugs and devices1
 and promote increased domestic         
diversification of1 and independence    
from foreign reliance on1 pharmaceutical
 and medical device supply chains4  #a4 
,short title ,this ,act may be cited as 
the ,help ,onshore ,manufacturing       
,efficiencies for ,drugs and ,devices   
,act or the ,,home ,act4  #b4           
,investments in domestic advanced       
manufacturing and preparedness ,part ,a 
of title ,,iii of the ,public ,health   
,service ,act 7#db ,u4,s4,c4 #bda et    
seq47 is amended by adding at the end   

the following3  #caj;,b4 ,investments in
 domestic advanced manufacturing for    
critical drugs and devices  7a7         
,establishment ,there is established    
within the ,office of the ,assistant    
,secretary for ,preparedness and        
,response of the ,department of ,health 
and ,human ,services1 the ,center for   
,domestic ,advanced ,manufacturing of   
,critical ,drugs and ,devices 7referred 
to in this section as the ,center74  7b7
 ,purpose ,the purpose of the ,center   
for ,domestic ,advanced ,manufacturing  
of ,critical ,drugs and ,devices shall  
be to implement a program to invest in  
the advanced manufacturing for critical 
drugs and devices1 and to increase      
domestic production of critical drugs   
and devices1 throughout the ,united     
,states4  7c7 ,director ,the ,center    
shall be headed by a ,director 7referred
 to in this section as the #8,director'7
 who shall be appointed by the          
,secretary and to whom the ,secretary   
shall delegate such functions and       

authorities as may be necessary to      
implement this section4  7d7 ,program   
7#a7 ,in general ,the ,center for       
,domestic ,advanced ,manufacturing of   
,critical ,drugs and ,devices shall--   
7,a7 not later than #ah months after the
 date of enactment of this section-- 7i7
 establish an advisory board of experts 
from governmental entities1             
manufacturers1 other private industry   
entities1 nonprofit entities1 and       
institutions of higher education1 and   
any other entity as determined by the   
,center2 and  7ii7 compile a list of    
critical drugs and devices that should  
be prioritized for domestic advanced    
manufacturing and increased domestic    
production under the program described  
in paragraph 7#b71 based on reports to  
the ,secretary under sections #ejf;,c   
and #ejf;,j of the ,federal ,food1      
,drug1 and ,cosmetic ,act1 the drug     
shortage list under section #ejf;,e of  
such ,act1 the device shortage list     
under section #ejf;,j7g7 of such ,act1  

and the annual risk assessments         
described in section #e of the ,,home   
,act1 if available1 and update such list
 quarterly2  7,b7 establish and oversee 
the grant and forgivable loan program   
described in paragraph 7#b71 including  
by establishing requirements for        
participation in such program1          
including-- 7i7 target goals to         
substantially increase advanced         
manufacturing production for critical   
drugs and devices within the ,united    
,states2 and  7ii7 conditioning the     
receipt of funding under such program on
 an entity's agreement to commercially  
distribute the drug or device in the    
,united ,states2 and  7,c7 review the   
effects of the program described in     
paragraph 7#b7 on the percentage change 
in domestic manufacturing of critical   
drugs1 devices1 and active              
pharmaceutical ingredients4  7#b7 ,grant
 and forgivable loan program  7,a7 ,in  
general ,the ,center for ,domestic      
,advanced ,manufacturing of ,critical   

,drugs and ,devices shall establish a   
grant and forgivable loan program in    
order to support investment in-- 7i7    
advanced manufacturing and facilities   
upgrades for the domestic production of 
critical drugs1 devices1 and active     
pharmaceutical ingredients2 and  7ii7   
increased domestic production and       
diversification of critical drugs1      
devices1 and active pharmaceutical      
ingredients4  7,b7 ,eligible entities   
7i7 ,in general ,to be eligible to      
receive a grant or forgivable loan under
 this paragraph1 an entity shall meet   
the requirements established under      
paragraphs 7#a77;,a77ii7 and 7#a77;,b7  
and such criteria as the ,center shall  
develop and1 as applicable-- 7,i7 with  
respect to a critical drug1 shall be the
 holder of an application approved under
 section #eje of the ,federal ,food1    
,drug1 and ,cosmetic ,act or section    
#cea of this ,act1 or a contract        
manufacturer of the drug for such holder
 of an approved application2  7,,ii7    

with respect to an active pharmaceutical
 ingredient1 shall be the manufacturer  
of an active pharmaceutical ingredient  
of a drug approved under section #eje of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act or section #cea of this  
,act2  7,,iii7 with respect to a        
critical device1 shall have received    
approval under section #eae of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act1 clearance under section #eaj7k7 of
 such ,act 7or be exempt from the       
requirements of such section #eaj7k771  
or authorization under section          
#eac7;f77#b7 of such ,act1 or shall be a
 contract manufacturer of the device for
 such an entity2 or  7,,iv7 with respect
 to a drug or device1 shall have        
submitted an application under section  
#eje or #eae of the ,federal ,food1     
,drug1 and ,cosmetic ,act or under      
section #cea of this ,act1 a report     
under section #eaj7k71 or a request     
under section #eac7;f77#b74  7ii7       
,priority ,in awarding grants and       

forgivable loans under this paragraph   
the ,center for ,domestic ,advanced     
,manufacturing of ,critical ,drugs and  
,devices shall give priority-- 7,i7 in  
the case of manufacturers of drugs or   
active pharmaceutical ingredients1 to   
entities-- 7aa7 described in subclauses 
7,i7 and 7,,ii7 of clause 7i72 and  7bb7
 whose application for an award under   
this paragraph relates to a drug that   
was approved under section #eje7;j7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act2 and  7,,ii7 in the case of       
manufacturers of devices1 to entities   
described in clause 7i77,,iii74  7,c7   
,use of funds ,awards received under    
this paragraph shall be used for the    
advanced manufacturing and increased    
production of critical drugs and devices
 in the ,united ,states4  7,d7          
,forgivable loans ,the ,center may award
 forgivable loans under this paragraph  
under which a recipient shall receive a 
loan and be eligible for forgiveness of 
indebtedness on such loan1 under such   

conditions for receipt and forgiveness  
as the ,center may establish4  7,e7     
,grants ,the ,center may award grants   
under this section1 which shall be      
conditioned upon the recipient matching 
,federal funds so awarded4  7,f7        
,funding ,out of amounts made available 
to carry out this section1 the          
,secretary shall allocate #ejj1jjj1jjj  
toward awards of forgivable loans and   
grants under this paragraph4  7e7       
,annual reporting ,the ,secretary shall 
submit to the relevant committees of    
,congress annual reports on the program 
under this section4 ,at a minimum1 each 
such report shall-- 7#a7 identify the   
list of critical drugs and devices under
 subsection 7d77#a77;,a77ii7 and account
 for any alterations in the list2  7#b7 
describe the participants in the program
 under subsection 7d77#b7 and criteria  
for eligibility for such participation2 
7#c7 address target goals for           
substantially increased advanced        
manufacturing production for critical   

drugs and devices2 and  7#d7 review the 
percentage change in domestic           
manufacturing of critical drugs1        
devices1 and active pharmaceutical      
ingredients since the most recent       
report4  7f7 ,interagency cooperation   
7#a7 ,in general ,in carrying out       
activities under this section1 the      
,center is authorized1 subject to       
paragraph 7#b71 to enter into           
interagency agreements and other        
collaborative undertakings with other   
,federal agencies4  7#b7 ,limitation ,an
 agreement or undertaking under this    
subsection shall not authorize another  
agency to exercise the authorities      
provided by this section4  7g7          
,authorization of appropriations ,to    
carry out this section1 there is        
authorized to be appropriated such funds
 as may be necessary1 for each of fiscal
 years #bjba through #bjca4  7h7        
,definitions ,in this section-- 7#a7 the
 terms drug and device have the meanings
 given such terms in section #bja of the

 ,federal ,food1 ,drug1 and ,cosmetic   
,act2  7#b7 the term institution of     
higher education has the meaning given  
such term in section #aja7;a7 of the    
,higher ,education ,act of #aife2 and   
7#c7 the term relevant committees of    
,congress means the ,committee on       
,homeland ,security and ,governmental   
,affairs1 the ,committee on ,health1    
,education1 ,labor1 and ,pensions1 and  
the ,committee on ,armed ,services of   
the ,senate and the ,committee on       
,homeland ,security1 the ,committee on  
,energy and ,commerce1 and the          
,committee on ,armed ,services of the   
,house of ,representatives4  4  #c4     
,expedited review of certain            
supplemental applications ,section #ejf 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is  
amended by adding at the end the        
following3  7i7 ,expedited review of    
certain supplemental applications  7#a7 
,in general ,the holder of an           
application approved under section #eje 

of this ,act or license under section   
#cea of the ,public ,health ,service    
,act who submits a supplemental         
application with respect to such        
application or license may request an   
expedited review of such supplemental   
application under this subsection4  7#b7
 ,application ,to be eligible for       
expedited review under this subsection1 
the holder of the approved application  
or license with respect to a drug       
included on the most recent list of     
critical drugs and devices compiled     
under section #caj;,b7d77#a77;,a77ii7 of
 the ,public ,health ,service ,act1     
shall demonstrate in the supplemental   
application that-- 7,a7 approval of such
 supplemental application would enable  
the incorporation of a manufacturing    
change that is intended to enhance drug 
quality1 increase domestic manufacturing
 of the drug1 or incorporate the use of 
advanced manufacturing2 and  7,b7 the   
applicant's plan for producing the drug 
domestically after approval of the      

supplemental application4  7#c7 ,review 
by ,secretary ,if the ,secretary        
determines1 after preliminary evaluation
 of a supplemental application1 that the
 application demonstrates that the      
manufacturing change would enhance the  
ability of the holder of the application
 to domestically manufacture a drug on  
the list of critical drugs and devices  
described in paragraph 7#b71 the        
,secretary shall evaluate for filing1   
and may commence review of portions of1 
such supplemental application before the
 sponsor submits a complete application4
 ,the ,secretary shall commence such    
review only if the applicant provides a 
schedule for submission of information  
necessary to make the application       
complete4  4  #d4 ,long-term1           
high-volume contracts to purchase       
critical drugs and devices  7a7         
,contracting goals ,in order to further 
the needs of the ,department of ,health 
and ,human ,services and the ,department
 of ,defense1 invest in preparedness and

 the strategic national stockpile1 and  
mitigate drug and device shortages1 each
 of the ,secretary of ,health and ,human
 ,services and the ,assistant ,secretary
 of ,defense for ,health ,affairs may   
enter into contracts to purchase a drug 
or device included on the list of       
critical drugs and devices compiled     
under section #caj;,b7d77#a77;,a77ii7 of
 the ,public ,health ,service ,act 7as  
added by section #b71 including         
multi-year1 high-volume contracts1 as   
set forth in subsection 7b71 and        
otherwise in accordance with procurement
 laws and regulations4  7b7             
,responsibility determinations ,for     
purposes of meeting the goals under     
subsection 7a71 a contracting officer of
 the ,department of ,health and ,human  
,services or the ,department of ,defense
 may give preference and award a        
contract to a program participant under 
section #caj;,b7d77#b7 of the ,public   
,health ,service ,act 7as added by      
section #b71 if-- 7#a7 the program      

participant is determined by the        
contracting officer1 in consultation    
with the ,center for ,domestic ,advanced
 ,manufacturing of ,critical ,drugs and 
,devices with respect to the            
participant's performance in the program
 under section #caj;,b7d77#b7 of the    
,public ,health ,service ,act1 to be a  
responsible source with respect to      
performance of the contract2 and  7#b7  
in the estimation of the contracting    
officer1 the contract award can be made 
at a fair and reasonable price that     
offers best value to the ,united        
,states4  #e4 ,annual risk assessment   
7a7 ,in general ,not later than #a year 
after the date of enactment of this     
,act1 and annually thereafter1 the      
,secretary of ,homeland ,security1 the  
,secretary of ,health and ,human        
,services1 and the ,secretary of        
,defense shall each conduct separate    
independent risk assessments of the     
medical supply chain and report to the  
relevant committees of ,congress on the 

findings of such assessments4 ,at a     
minimum1 each risk assessment shall--   
7#a7 identify drugs and devices critical
 to each agency in responding to a      
public health emergency1 biological or  
chemical threat1 or other national      
security threat2  7#b7 identify the     
drugs and devices identified under      
paragraph 7#a7 for which there is a     
single manufacturer or distributer in   
the ,united ,states2  7#c7 list the     
drugs and devices identified under      
paragraph 7#a7 that are sourced         
exclusively from foreign sources2  7#d7 
assess current domestic manufacturing   
capability with respect to drugs and    
devices identified under paragraph 7#a71
 including advanced manufacturing       
capabilities2 and  7#e7 identify        
critical vulnerabilities and establish  
contingency plans in the event of a     
public health emergency1 biological or  
chemical threat1 or other national      
security threat4  7b7 ,risk assessment  
report conclusions ,each risk assessment

 of each secretary under subsection 7a7 
shall indicate1 at a minimum-- 7#a7 the 
existing statutory authorities the      
department has to address public health 
or national security risks that may     
arise as a result of vulnerabilities in 
the medical supply chain2  7#b7 any     
deficiencies1 lack of authorities1 or   
limitations in policy or process that   
limit the department's ability to       
address vulnerabilities identified in   
the applicable risk assessment2 and     
7#c7 the secretary's plans to address   
drug and device shortages1 control      
costs1 and prepare for public health    
emergencies1 biological or chemical     
threats1 and other national security    
threats4  7c7 ,review by ,secretaries   
,the ,secretary of ,homeland ,security1 
the ,secretary of ,health and ,human    
,services1 and the ,secretary of        
,defense1 in providing the risk         
assessments under subsection 7a7 may    
consult with each other1 as appropriate1
 regarding any similarities in          

vulnerabilities experienced by each such
 secretary and any coordination among   
the secretaries that may address such   
vulnerabilities4  7d7 ,definitions ,in  
this section-- 7#a7 the terms device and
 drug have the meanings given such terms
 in section #bja of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba72 and  7#b7 the term relevant     
committees of ,congress means the       
,committee on ,homeland ,security and   
,governmental ,affairs1 the ,committee  
on ,health1 ,education1 ,labor1 and     
,pensions1 and the ,committee on ,armed 
,services of the ,senate and the        
,committee on ,homeland ,security1 the  
,committee on ,energy and ,commerce1 and
 the ,committee on ,armed ,services of  
the ,house of ,representatives4