,i  #aadth ,,congress  #ast ,session    
,h4 ,r4 #bdbe  ,,in ,,the ,,house ,,of  
,,representatives  ,may #ai1 #bjae ,mr4 
,shimkus introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act with respect to the      
recognition of standards4  #a4          
,recognition of standards ,section      
#ead7;c7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cfj;d7c77 is amended-- 7#a7 in         
paragraph 7#a71 by inserting after      
subparagraph 7,b7 the following new     
subparagraphs3  7,c7  7i7 ,any person   
may submit a request for recognition    
under subparagraph 7,a7 of all or part  
of an appropriate standard established  
by a nationally or internationally      
recognized standard organization4  7ii7 
,not later than #fj days after the      
,secretary receives such a request1 the 
,secretary shall--  7,i7 make a         
determination to recognize all1 part1 or

 none of the standard that is the       
subject of the request2 and  7,,ii7     
issue to the person who submitted such  
request a response in writing that      
states the ,secretary's rationale for   
that determination1 including the       
scientific1 technical1 regulatory1 or   
other basis for such determination2     
7iii7 ,the ,secretary make a response   
issued under clause 7ii77,,ii7 publicly 
available1 in such manner as the        
,secretary determines appropriate4  7iv7
 ,the ,secretary shall take such actions
 as may be necessary to implement all or
 part of a standard recognized under    
subclause 7,i71 in accordance with      
subparagraph 7,a74  7,d7 ,the ,secretary
 shall make publicly available1 in such 
manner as the ,secretary determines     
appropriate1 the rationale for          
recognition under subparagraph 7,a7 of  
part of a standard1 including the       
scientific1 technical1 regulatory1 or   
other basis for such recognition4  2 and
  7#b7 by adding at the end the         

following new paragraphs3  7#d7         
,training on use of standards ,the      
,secretary shall provide to all         
employees of the ,food and ,drug        
,administration who review premarket    
submissions for devices periodic        
training on the concept and use of      
recognized standards for purposes of    
meeting a premarket submission          
requirement or other applicable         
requirement under this ,act1 including  
standards relevant to an employee's area
 of device review4  7#e7 ,guidance  7,a7
 ,draft guidance ,the ,secretary shall  
publish guidance identifying the        
principles for recognizing standards    
under this section4 ,in publishing such 
guidance1 the ,secretary shall consider 
the experience with1 and reliance on1 a 
standard by other ,federal regulatory   
authorities and the device industry1 and
 whether recognition of a standard will 
promote harmonization among regulatory  
authorities in the regulation of        
devices4  7,b7 ,timing ,the ,secretary  

shall publish-- 7i7 draft guidance under
 subparagraph 7,a7 not later than #ab   
months after the date of the enactment  
of the #bast ,century ,cures ,act2 and  
7ii7 final guidance not later than #ab  
months of the close of the public       
comment period for the draft guidance   
under clause 7i74  4