,,ib ,union ,cal5d> ,no4 #fbg #aah?     
,,congress  #b;d ,session  ,h4 ,r4 #debi
 ,report ,no4 #aah-gef ,,9 ,,! ,,h\se   
,,( ,,repres5tatives  ,july #aa1        
#bjbc,mrs4 ,rodg]s ( ,wa%+ton introduc$ 
! foll[+ bill2 :i* 0 ref]r$ to !        
,committee on ,en]gy & ,comm]ce         
,novemb] #ai1 #bjbd;,additional sponsor3
 ,mr4 ,cr5%aw  ,novemb] #ai1            
#bjbd,report$ ) an am5dm5t1 committ$ to 
! ,committee ( ! ,:ole ,h\se on ! ,/ate 
( ! ,union1 & ord]$ to be printed,strike
 out all aft] ! enact+ clause & ins]t ! 
"p pr9t$ 9 italic,for text ( introduc$  
bill1 see copy ( bill z introduc$ on    
,july #aa1 #bjbc  ,a ,,bill  ,to am5d ! 
,public ,heal? ,s]vice ,act reg>d+      
guidance docum5ts ( ! ,c5t]s = ,disease 
,control & ,prev5tion1 & = o!r purposes4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,public ,heal? ,guidance ,transp>5cy
 & ,acc\ntability ,act ( #bjbc4  #b4    
,,cdc guidance docum5ts ,! ,public      
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bja 
et seq47 is am5d$ by ins]t+ aft] section

 #cag,v ( su* ,act 7#db ,u4,s4,c4       
#bdg;b-#bd7 ! foll[+3  #cag,w4 ,,cdc    
guidance docum5ts  7a7 ,good guidance   
practices  7#a7 ,9 g5]al ,! ,secret>y1  
act+ ?r\gh ! ,director ( ! ,c5t]s =     
,disease ,control & ,prev5tion 79 ?is   
section ref]r$ to z ! ,secret>y71 %all1 
by regulation1 develop1 e/abli%1 &      
ma9ta9 good guidance practices sett+ =? 
! policies & proc$ures ( ! ,c5t]s = !   
developm5t1 issuance1 dissem9ation1 &   
use ( guidance docum5ts ( ! ,c5t]s =    
,disease ,control & ,prev5tion4  7#b7   
,cont5ts ,! regulation requir$ by       
p>agraph 7#a7 %all-- 7,a7 incorporate   
ea* requirem5t ( subsections 7b7 ?r\gh  
7j72 &  7,b7 require guidance docum5ts (
 ! ,c5t]s = ,disease ,control &         
,prev5tion to be develop$ ) public      
p>ticipation4  7#c7 ,initial regulation 
,! ,secret>y %all-- 7,a7 n lat] ?an #cj 
days aft] ! date ( enactm5t ( ! ,public 
,heal? ,guidance ,transp>5cy &          
,acc\ntability ,act ( #bjbc1 initiate ! 
rulemak+ process = ! initial regulation 

"u p>agraph 7#a72 &  7,b7 n lat] ?an #b 
ye>s aft] ! date ( enactm5t ( ! ,public 
,heal? ,guidance ,transp>5cy &          
,acc\ntability ,act ( #bjbc1 f9alize su*
 regulation4  7b7 ,no creation1 conf]r+1
 re/rict+1 or revok+ ( rights1          
responsibilities1 or liabilities        
,guidance docum5ts ( ! ,c5t]s = ,disease
 ,control & ,prev5tion may pres5t views 
on matt]s "u ! jurisdiction ( ! ,c5t]s1 
b %all n-- 7#a7 create1 conf]1 re/rict1 
or revoke any rights1 responsibilities1 
or liabilities = or on any p]son2  7#b7 
be treat$ 7includ+ 9 any civil or       
crim9al proce$+7 z hav+ ! =ce & effect (
 law2 or  7#c7 include any provision t--
 7,a7 is b9d+ on ! public or a ,/ate1   
local1 ,tribal1 or ,t]ritorial gov]nm5t2
 or  7,b7 requires an individual to take
 or refra9 f an action4  7c7 ,tra9+ ,!  
,secret>y %all-- 7#a7 provide tra9+ to  
employees ( ! ,c5t]s = ,disease ,control
 & ,prev5tion 9 h[ to develop1 issue1   
dissem9ate1 & use guidance docum5ts ( ! 
,c5t]s 9 accordance ) ! regulation "u   

subsection 7a77#a72 &  7#b7 monitor !   
developm5t1 issuance1 dissem9ation1 &   
use ( su* docum5ts to ensure compliance 
) ! regulation "u subsection 7a77#a74   
7d7 ,public p>ticipation 9 process  7#a7
 ,9 g5]al ,subject to p>agraph 7#b71 !  
,secret>y %all ensure t public          
p>ticipation requir$ by subsection      
7a77#b77;,b7 occurs prior to f9alization
 & implem5tation ( any guidance docum5t 
( ! ,c5t]s = ,disease ,control &        
,prev5tion1 includ+ any guidance docum5t
 t sets =?-- 7,a7 initial int]pretations
 ( a /atute1 a regulation1 or an em]g+  
public heal? situation2  7,b7 *anges or 
updates 9 int]pretation or policy t are 
( m ?an a m9or nature2  7,c7 complex    
sci5tific issues2 or  7,d7 highly       
controv]sial issues4  7#b7 ,exceptions  
,! ,secret>y may provide = public       
p>ticipation requir$ by subsection      
7a77#b77;,b7 ) respect to a guidance    
docum5t ( ! ,c5t]s = ,disease ,control &
 ,prev5tion to occur aft] ! guidance    
docum5t has be5 f9aliz$ & aft]          

implem5tation ( ! guidance docum5t has  
begun if-- 7,a7 ! ,secret>y det]m9es t  
comm5c+ public p>ticipation soon] is n  
feasible or appropriate2 or  7,b7 !     
guidance docum5t sets =? only exi/+     
practices or m9or *anges 9 policy4  7#c7
 ,consid]ation ,9 f9aliz+1 implem5t+1 & 
revis+ a guidance docum5t ( ! ,c5t]s =  
,disease ,control & ,prev5tion1 !       
,secret>y %all take into acc\nt public  
comm5ts receiv$ dur+ public p>ticipation
 on ! guidance docum5t4  7e7 ,uni=m     
nom5clature ,9 develop+ guidance        
docum5ts ( ! ,c5t]s = ,disease ,control 
& ,prev5tion1 ! ,secret>y %all ensure   
uni=m nom5clature = su* docum5ts & uni=m
 int]nal proc$ures = approval ( su*     
docum5ts4  7f7 ,indication ( nonb9d+    
nature ,! ,secret>y %all ensure t       
guidance docum5ts ( ! ,c5t]s = ,disease 
,control & ,prev5tion & revisions ( su* 
docum5ts are prop]ly dat$ & indicate !  
nonb9d+ nature ( ! docum5ts4  7g7       
,p]iodic review ,! ,secret>y %all       
p]iodically review all guidance docum5ts

 ( ! ,c5t]s = ,disease ,control &       
,prev5tion &1 :]e appropriate1 revise   
su* docum5ts4  7h7 ,li/ ( docum5ts ,!   
,secret>y %all ma9ta9 electronically1 & 
update & publi% p]iodically 9 ! ,f$]al  
,regi/]1 a li/ ( all guidance docum5ts (
 ! ,c5t]s = ,disease ,control &         
,prev5tion4  7i7 ,public availability ,!
 ,secret>y %all make available to !     
public ! li/ "u subsection 7h7 & all    
guidance docum5ts ( ! ,c5t]s = ,disease 
,control & ,prev5tion1 includ+ by po/+  
on ! public website ( ! ,c5t]s4  7j7    
,appeals me*anism ,! ,secret>y %all     
ensure t an effective appeals me*anism  
is 9 place to address compla9ts t       
guidance docum5ts ( ! ,c5t]s = ,disease 
,control & ,prev5tion are n be+         
develop$1 issu$1 dissem9at$1 or us$ 9   
accordance ) ?is section4  4  ,novemb]  
#ai1 #bjbd,report$ ) an am5dm5t1        
committ$ to ! ,committee ( ! ,:ole ,h\se
 on ! ,/ate ( ! ,union1 & ord]$ to be   
pr9t$