,,ii  #aaith ,,congress  #ast ,session  
,s4 #cdfi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #aa1 
#bjbe,mr4 ,peters 7for himself and ,mr4 
,hagerty7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,homeland ,security   
and ,governmental ,affairs  ,a ,,bill   
,to prohibit contracting with certain   
biotechnology providers4  #a4 ,short    
title ,this ,act may be cited as the    
,,biosecure ,act of #bjbe4  #b4         
,prohibition on contracting with certain
 biotechnology providers  7a7 ,in       
general ,the head of an executive agency
 may not-- 7#a7 procure or obtain any   
biotechnology equipment or service      
produced or provided by a biotechnology 
company of concern2 or  7#b7 enter into 
a contract1 or extend or renew a        
contract1 with any entity that-- 7,a7   
uses biotechnology equipment or services
 produced or provided by a biotechnology
 company of concern and acquired after  
the applicable effective date in        

subsection 7c7 in performance of the    
contract with the executive agency2 or  
7,b7 enters into any contract the       
performance of which such entity knows  
will require1 in performance of the     
contract with the executive agency1 the 
use of biotechnology equipment or       
services produced or provided by a      
biotechnology company of concern and    
acquired after the applicable effective 
date in subsection 7c74  7b7            
,prohibition on loan and grant funds    
,the head of an executive agency may not
 obligate or expend loan or grant funds 
to1 and a loan or grant recipient may   
not use loan or grant funds to-- 7#a7   
procure1 obtain1 or use any             
biotechnology equipment or services     
produced or provided by a biotechnology 
company of concern2 or  7#b7 enter into 
a contract1 or extend or renew a        
contract1 with an entity described in   
subsection 7a77#b74  7c7 ,effective     
dates  7#a7 ,certain entities ,with     
respect to the biotechnology companies  

of concern covered by subsection        
7f77#b77;,a71 the prohibitions under    
subsections 7a7 and 7b7 shall take      
effect #fj days after the ,federal      
,acquisition ,regulation is revised     
pursuant to subsection 7h74  7#b7 ,other
 entities ,with respect to the          
biotechnology companies of concern      
covered by subparagraphs 7,b7 or 7,c7 of
 subsection 7f77#b71 the prohibitions   
under subsections 7a7 and 7b7 shall take
 effect #ij days after the ,federal     
,acquisition ,regulation is revised     
pursuant to subsection 7h74  7#c7 ,rules
 of construction  7,a7 ,exclusions      
,prior to the date that is five years   
after a revision to the ,federal        
,acquisition ,regulation pursuant to    
subsection 7h7 that identifies a        
biotechnology company of concern covered
 by subsection 7f77#b71 subsections     
7a77#b7 and 7b77#b7 shall not apply to  
biotechnology equipment or services     
produced or provided under a contract or
 agreement1 including previously        

negotiated contract options1 entered    
into before the applicable effective    
date under paragraphs 7#a7 and 7#b74    
7,b7 ,safe harbor ,the term             
biotechnology equipment or services     
produced or provided by a biotechnology 
company of concern shall not be         
construed to refer to any biotechnology 
equipment or services that were         
formerly1 but are no longer1 produced or
 provided by biotechnology companies of 
concern4  7d7 ,waiver authorities  7#a7 
,specific biotechnology exception  7,a7 
,waiver ,the head of the applicable     
executive agency may waive the          
prohibition under subsections 7a7 and   
7b7 on a case-by-case basis-- 7i7 with  
the approval of the ,director of the    
,office of ,management and ,budget2 and 
7ii7 if such head submits a notification
 and justification to the appropriate   
congressional committees not later than 
#cj days after granting such waiver4    
7,b7 ,duration  7i7 ,in general ,except 
as provided in clause 7ii71 a waiver    

granted under subparagraph 7,a7 shall   
last for a period of not more than #cfe 
days4  7ii7 ,extension ,the head of the 
applicable executive agency1 with the   
approval of the ,director of the ,office
 of ,management and ,budget1 and in     
coordination with the ,secretary of     
,defense1 may extend a waiver granted   
under subparagraph 7,a7 one time1 for a 
period up to #ahj days after the date on
 which the waiver would otherwise       
expire1 if such an extension is in the  
national security interests of the      
,united ,states and if such head submits
 a notification and justification to the
 appropriate congressional committees   
not later than #aj days after granting  
such waiver extension4  7#b7 ,overseas  
health care services ,the head of an    
executive agency may waive the          
prohibitions under subsections 7a7 and  
7b7 with respect to a contract1         
subcontract1 or transaction for the     
acquisition or provision of health care 
services overseas on a case-by-case     

basis-- 7,a7 if the head of such        
executive agency determines that the    
waiver is-- 7i7 necessary to support the
 mission or activities of the employees 
of such executive agency described in   
subsection 7e77#b77;,a72 and  7ii7 in   
the interest of the ,united ,states2    
7,b7 with the approval of the ,director 
of the ,office of ,management and       
,budget1 in consultation with the       
,secretary of ,defense2 and  7,c7 if    
such head submits a notification and    
justification to the appropriate        
congressional committees not later than 
#cj days after granting such waiver4    
7e7 ,exceptions ,the prohibitions under 
subsections 7a7 and 7b7 shall not apply 
to-- 7#a7 any activity subject to the   
reporting requirements under title ,v of
 the ,national ,security ,act of #aidg  
7#ej ,u4,s4,c4 #cjia et seq47 or any    
authorized intelligence activities of   
the ,united ,states2  7#b7 the          
acquisition or provision of health care 
services overseas for-- 7,a7 7i7        

employees of the ,united ,states1       
including members of the uniformed      
services 7as defined in section #aja7;a7
 of title #aj1 ,united ,states ,code71  
and dependents of such employees2  7ii7 
covered beneficiaries 7as defined in    
section #ajgb of title #aj1 ,united     
,states ,code7 not otherwise described  
in clause 7i72 or  7iii7 any other      
beneficiary if such acquisition or      
provision is carried out or administered
 by the head of a department or agency  
of the ,federal ,government2 or  7,b7   
employees of contractors or             
subcontractors of the ,united ,states-- 
7i7 who are performing under a contract 
that directly supports the missions or  
activities of individuals described in  
subparagraph 7,a77i72 and  7ii7 whose   
primary duty stations are located       
overseas or are on permissive temporary 
duty travel overseas2  7#c7 the         
acquisition1 use1 or distribution of    
human multiomic data1 lawfully compiled1
 that is commercially or publicly       

available2 or  7#d7 the procurement of  
medical countermeasures1 medical        
products1 and related supplies1         
including ancillary medical supplies1 in
 direct response to a public health     
emergency declared pursuant to section  
#cai of the ,public ,health ,service    
,act 7#db ,u4,s4,c4 #bdg;d74  7f7       
,evaluation of certain biotechnology    
entities  7#a7 ,entity consideration    
,not later than one year after the date 
of the enactment of this ,act1 the      
,director of the ,office of ,management 
and ,budget shall publish a list of the 
entities that constitute biotechnology  
companies of concern based on a list of 
suggested entities that shall be        
provided by the ,secretary of ,defense  
in coordination with the ,attorney      
,general1 the ,secretary of ,health and 
,human ,services1 the ,secretary of     
,commerce1 the ,director of ,national   
,intelligence1 the ,secretary of        
,homeland ,security1 the ,secretary of  
,state1 and the ,national ,cyber        

,director4  7#b7 ,biotechnology         
companies of concern defined ,in this   
section1 the term biotechnology company 
of concern means any of the following3  
7,a7 ,an entity that-- 7i7 is to any    
extent involved in the manufacturing1   
distribution1 provision1 or procurement 
of any biotechnology equipment or       
service1 as determined by the process   
established in paragraph 7#a72 and  7ii7
 is identified in the annual list       
published in the ,federal ,register by  
the ,department of ,defense of ,chinese 
military companies operating in the     
,united ,states pursuant to section     
#abfj;,h of the ,william ,m4 7,mac7     
,thornberry ,national ,defense          
,authorization ,act for ,fiscal ,year   
#bjba 7,public ,law #aaf-bhc2 #acd      
,stat4 #cife2 #aj ,u4,s4,c4 #aac note74 
7,b7 ,any entity that is determined by  
the process established in paragraph    
7#a7 to meet each of the following      
criteria3 7i7 ,is subject to the        
administrative governance structure1    

direction1 control1 or operates on      
behalf of the government of a foreign   
adversary4  7ii7 ,is to any extent      
involved in the manufacturing1          
distribution1 provision1 or procurement 
of a biotechnology equipment or service4
  7iii7 ,poses a risk to the national   
security of the ,united ,states based   
on-- 7,i7 engaging in joint research    
with1 being supported by1 or being      
affiliated with a foreign adversary's   
military1 internal security forces1 or  
intelligence agencies2  7,,ii7 providing
 multiomic data obtained via            
biotechnology equipment or services to  
the government of a foreign adversary2  
or  7,,iii7 obtaining human multiomic   
data via the biotechnology equipment or 
services without express and informed   
consent4  7,c7 ,any subsidiary1 parent1 
or successor of an entity described in  
subparagraphs 7,a7 or 7,b71 provided it 
meets the criteria set forth in clauses 
7i7 through 7iii7 of subparagraph 7,b71 
as determined by the process established

 in paragraph 7#a74  7#c7 ,guidance ,not
 later than #ahj days after publication 
of the list pursuant to paragraph 7#a71 
and any update to the list pursuant to  
paragraph 7#d71 the ,director of the    
,office of ,management and ,budget1 in  
coordination with the ,secretary of     
,defense1 the ,attorney ,general1 the   
,secretary of ,health and ,human        
,services1 the ,secretary of ,commerce1 
the ,director of ,national              
,intelligence1 the ,secretary of        
,homeland ,security1 the ,secretary of  
,state1 and the ,national ,cyber        
,director1 shall establish guidance as  
necessary to implement the requirements 
of this section4  7#d7 ,updates ,the    
,director of the ,office of ,management 
and ,budget1 in coordination with or    
based on a recommendation provided by   
the ,secretary of ,defense1 the         
,attorney ,general1 the ,secretary of   
,health and ,human ,services1 the       
,secretary of ,commerce1 the ,director  
of ,national ,intelligence1 the         

,secretary of ,homeland ,security1 the  
,secretary of ,state1 and the ,national 
,cyber ,director1 or upon receipt of a  
request pursuant to paragraph 7#g71     
shall periodically1 though not less than
 annually1 review and1 as appropriate1  
add entities to or remove entities from 
the list of biotechnology companies of  
concern1 and notify the appropriate     
congressional committees of any such    
modifications4  7#e7 ,notice of a       
designation and review  7,a7 ,in general
 ,a notice of a designation as a        
biotechnology company of concern under  
paragraph 7#b77;,b7 shall be issued to  
any biotechnology company of concern    
named in the designation-- 7i7 advising 
that a designation has been made2  7ii7 
identifying the criteria relied upon    
under such subparagraph and1 to the     
extent consistent with national security
 and law enforcement interests1 the     
information that formed the basis for   
the designation2  7iii7 advising that1  
within #ij days after receipt of notice1

 the biotechnology company of concern   
may submit information and arguments in 
opposition to the designation2  7iv7    
describing the procedures governing the 
review and possible issuance of a       
designation pursuant to paragraph 7#a72 
and  7v7 where practicable1 identifying 
mitigation steps that could be taken by 
the biotechnology company of concern    
that may result in the rescission of the
 designation4  7,b7 ,congressional      
notification requirements  7i7 ,notice  
of designation ,the ,director of the    
,office of ,management and ,budget shall
 submit the notice required under       
subparagraph 7,a7 to the ,committee on  
,homeland ,security and ,governmental   
,affairs of the ,senate and the         
,committee on ,oversight and ,government
 ,reform of the ,house of               
,representatives4  7ii7 ,information and
 argument in opposition to designations 
,not later than #g days after receiving 
any information and arguments in        
opposition to a designation pursuant to 

subparagraph 7,a77iii71 the ,director of
 the ,office of ,management and ,budget 
shall submit such information to the    
,committee on ,homeland ,security and   
,governmental ,affairs of the ,senate   
and the ,committee on ,oversight and    
,government ,reform of the ,house of    
,representatives4  7#f7 ,no immediate   
public release ,any designation made    
under paragraph 7#a7 or paragraph 7#d7  
shall not be made publicly available    
until the ,director of the ,office of   
,management and ,budget1 in coordination
 with appropriate agencies1 reviews all 
information submitted under paragraph   
7#e77;,a77iii7 and issues a final       
determination that a company shall      
remain listed as a biotechnology company
 of concern4  7#g7 ,removal requests ,if
 an entity on the list of biotechnology 
companies of concern believes it no     
longer meets the definition of a        
biotechnology company of concern as     
described in paragraph 7#b71 then it may
 provide information and arguments to   

request removal from the list of        
biotechnology companies of concern to   
the ,director of the ,office of         
,management and ,budget4 ,the ,director 
shall review such information and reply 
to the entity within #ij days4  7g7     
,evaluation of national security risks  
posed by foreign adversary acquisition  
of american multiomic data  7#a7        
,assessment ,not later than #bgj days   
after the enactment of this ,act1 the   
,director of ,national ,intelligence1 in
 consultation with the ,secretary of    
,defense1 the ,attorney ,general of the 
,united ,states1 the ,secretary of      
,health and ,human ,services1 the       
,secretary of ,commerce1 the ,secretary 
of ,homeland ,security1 the ,secretary  
of ,state1 and the ,national ,cyber     
,director1 shall complete an assessment 
of risks to national security posed by  
human multiomic data from ,united       
,states citizens that is collected or   
stored by a foreign adversary from the  
provision of biotechnology equipment or 

services4  7#b7 ,report requirement ,not
 later than #cj days after the          
completion of the assessment developed  
under paragraph 7#a71 the ,director of  
,national ,intelligence shall submit a  
report with such assessment to the      
appropriate congressional committees4   
7#c7 ,form ,the report required under   
paragraph 7#b7 shall be in unclassified 
form1 but may include a classified      
annex4  7h7 ,regulations ,not later than
 one year after the date of             
establishment of guidance required under
 subsection 7f77#c71 and as necessary   
for subsequent updates1 the ,federal    
,acquisition ,regulatory ,council shall 
revise the ,federal ,acquisition        
,regulation as necessary to implement   
the requirements of this section4  7i7  
,reporting on intelligence on nefarious 
activities of biotechnology companies   
with human multiomic data ,not later    
than #ahj days after the date of the    
enactment of this ,act1 and annually    
thereafter1 the ,director of ,national  

,intelligence1 in consultation with the 
heads of executive agencies1 shall      
submit to the appropriate congressional 
committees a report on any intelligence 
in possession of such agencies related  
to nefarious activities conducted by    
biotechnology companies with human      
multiomic data4 ,the report shall       
include information pertaining to       
potential threats to national security  
or public safety from the selling1      
reselling1 licensing1 trading1          
transferring1 sharing1 or otherwise     
providing or making available to any    
foreign country of any forms of         
multiomic data of a ,united ,states     
citizen4  7j7 ,no additional funds ,no  
additional funds are authorized to be   
appropriated for the purpose of carrying
 out this section4  7k7 ,definitions ,in
 this section3 7#a7 ,appropriate        
congressional committees ,the term      
appropriate congressional committees    
means-- 7,a7 the ,committee on ,armed   
,services1 the ,select ,committee on    

,intelligence1 the ,committee on        
,homeland ,security and ,governmental   
,affairs1 the ,committee on ,health1    
,education1 ,labor1 and ,pensions1 the  
,committee on ,commerce1 ,science1 and  
,transportation1 and the ,committee on  
,foreign ,relations of the ,senate2 and 
7,b7 the ,committee on ,armed ,services1
 the ,permanent ,select ,committee on   
,intelligence1 the ,committee on        
,foreign ,affairs1 the ,committee on    
,oversight and ,government ,reform1 the 
,committee on ,energy and ,commerce1 and
 the ,select ,committee on ,strategic   
,competition between the ,united ,states
 and the ,chinese ,communist ,party of  
the ,house of ,representatives4  7#b7   
,biotechnology equipment or service ,the
 term biotechnology equipment or service
 means-- 7,a7 equipment1 including      
genetic sequencers1 or any other        
instrument1 apparatus1 machine1 or      
device1 including components and        
accessories thereof1 that is designed   
for use in the research1 development1   

production1 or analysis of biological   
materials as well as any software1      
firmware1 or other digital components   
that are specifically designed for use  
in1 and necessary for the operation of1 
such equipment2  7,b7 any service for   
the research1 development1 production1  
analysis1 detection1 or provision of    
information1 including data storage and 
transmission related to biological      
materials1 including-- 7i7 advising1    
consulting1 or support services with    
respect to the use or implementation of 
an instrument1 apparatus1 machine1 or   
device described in subparagraph 7,a72  
and  7ii7 disease detection1            
genealogical information1 and related   
services2 and  7,c7 any other service1  
instrument1 apparatus1 machine1         
component1 accessory1 device1 software1 
or firmware that is designed for use in 
the research1 development1 production1  
or analysis of biological materials that
 the ,director of the ,office of        
,management and ,budget1 in consultation

 with the heads of executive agencies1  
as determined appropriate by the        
,director of the ,office of ,management 
and ,budget1 determines appropriate in  
the interest of national security4  7#c7
 ,contract ,except as the term is used  
under subsection 7b77#b7 and subsection 
7c77#c71 the term contract means-- 7,a7 
any contract subject to the ,federal    
,acquisition ,regulation issued under   
section #acjc7;a77#a7 of title #da1     
,united ,states ,code2 or  7,b7 any     
transaction 7other than a contract1 a   
grant1 or a cooperative agreement7      
entered into under section #djba of     
title #aj1 ,united ,states ,code4  7#d7 
,control ,the term control has the      
meaning given to that term in section   
#hjj4bjh of title #ca1 ,code of ,federal
 ,regulations1 or any successor         
regulations4  7#e7 ,executive agency    
,the term executive agency has the      
meaning given the term ,executive agency
 in section #aje of title #e1 ,united   
,states ,code4  7#f7 ,foreign adversary 

,the term foreign adversary has the     
meaning given the term covered nation in
 section #dhgb7;f7 of title #aj1 ,united
 ,states ,code4  7#g7 ,multiomic ,the   
term multiomic means data types that    
include genomics1 epigenomics1          
transcriptomics1 proteomics1 and        
metabolomics4  7#h7 ,overseas ,the term 
overseas means any area outside of the  
,united ,states1 the ,commonwealth of   
,puerto ,rico1 or a territory or        
possession of the ,united ,states4  7l7 
,compliance with limitation on drug     
prices ,for the purposes of section     
#aibg7;a77#a7 of the ,social ,security  
,act 7#db ,u4,s4,c4 #acifr-#h7;a77#a771 
a manufacturer is deemed to meet the    
requirements of section #habf of title  
#ch1 ,united ,states ,code1 including   
the requirement of entering into a      
master agreement with the ,secretary of 
,veterans ,affairs under such section1  
if the ,secretary of ,veterans ,affairs 
determines that the manufacturer would  
comply 7and has offered to comply7 with 

the provisions of section #habf of title
 #ch1 ,united ,states ,code1 and would  
have entered into a master agreement    
under such section1 but for the         
prohibitions under subsections 7a7 and  
7b7 of this section4