,,ii  #aaeth ,,congress  #b;d ,session  
,s4 #bcae  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,january #ag1  
#bjah,mr4 ,isakson 7for himself and ,mr4
 ,casey7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to clarify the regulatory
 framework with respect to certain      
nonprescription drugs that are marketed 
without an approved new drug            
application1 and for other purposes4    
#a4 ,short title2 table of contents  7a7
 ,short title ,this ,act may be cited as
 the ,over-the-,counter ,drug ,safety1  
,innovation1 and ,reform ,act4  7b7     
,table of contents ,the table of        
contents for this ,act is as follows3   
,sec4 #a4 ,short title2 table of        
contents4,,title ,i--,regulation of     
nonprescription drugs,sec4 #aja4        
,regulation of certain nonprescription  
drugs that are marketed without an      

approved new drug application4,sec4     
#ajb4 ,misbranding4,sec4 #ajc4          
,conforming amendments to the ,sunscreen
 ,innovation ,act4,sec4 #ajd4 ,drugs    
excluded from over-the-counter          
review4,sec4 #aje4 ,conforming          
amendment4,sec4 #ajf4 ,annual update to 
,congress on appropriate pediatric      
indication for certain cough and cold   
monograph drugs4,,title ,,ii--,fees     
relating to monograph drugs,sec4 #bja4  
,short title2 findings4,sec4 #bjb4      
,authority to access and use fees4  ,i  
,regulation of nonprescription drugs    
#aja4 ,regulation of certain            
nonprescription drugs that are marketed 
without an approved new drug application
 ,chapter ,v of the ,federal ,food1     
,drug1 and ,cosmetic ,act is amended by 
inserting after section #eje;,f 7#ba    
,u4,s4,c4 #cee;g7 the following3        
#eje;,g4 ,regulation of certain         
nonprescription drugs that are marketed 
without an approved new drug application
  7a7 ,definitions ,in this section3    

7#a7 ,nonprescription drug ,the term    
nonprescription drug means a drug1 an   
active ingredient1 or a combination of  
active ingredients that is not subject  
to section #ejc7;b77#a74  7#b7          
,requestor ,the term requestor means a  
person or group of persons marketing1   
manufacturing1 processing1 or developing
 a drug4  7#c7 ,sponsor ,the term       
sponsor means a person or group of      
persons marketing1 manufacturing1 or    
processing a drug and who has a listing 
in effect under section #eaj7;j7 for    
such drug4  7b7 ,monograph drugs  7#a7  
,in general ,with respect to a          
nonprescription drug that1 on or after  
the date of enactment of the            
,over-the-,counter ,drug ,safety1       
,innovation1 and ,reform ,act1 is       
introduced or delivered for introduction
 in interstate commerce for which an    
approved application under section #eje 
is not required1 the following shall    
apply3  7,a7 ,a nonprescription drug is 
deemed to be generally recognized as    

safe and effective within the meaning of
 section #bja7p77#a7 and not a new drug 
under section #bja7p7 if--  7i7 7,i7    
such drug is-- 7aa7 7,,aa7 subject to a 
final monograph issued under part #ccj  
of title #ba1 ,code of ,federal         
,regulations1 as of the date of         
enactment of the ,over-the-,counter     
,drug ,safety1 ,innovation1 and ,reform 
,act2 7,,bb7 in conformity with the     
conditions for nonprescription use of   
such monograph and the general          
requirements specified for              
nonprescription drugs1 including any    
modifications to those conditions made  
under subsections 7c71 7d71 and 7j72 and
 7,,cc7 except as permitted by an       
administrative order issued under       
subsection 7c7 or a minor change in the 
drug in conformity with subsection 7d71 
is in a dosage form that has been used  
to a material extent and for a material 
time within the meaning of section      
#bja7p77#b72 or  7bb7 7,,aa7 the subject
 of a tentative final monograph that is 

the most recently applicable proposal or
 determination issued under part #ccj of
 title #ba1 ,code of ,federal           
,regulations1 as of the date of         
enactment of the ,over-the-,counter     
,drug ,safety1 ,innovation1 and ,reform 
,act2 7,,bb7 classified in category ,i  
for safety and effectiveness under such 
tentative final monograph2 7,,cc7 in    
conformity with the conditions for      
nonprescription use of such tentative   
final monograph1 any subsequent         
determination by the ,secretary1 and the
 general conditions for nonprescription 
drugs1 including any modifications of   
those conditions under subsections 7c71 
7d71 and 7j72 and 7,,dd7 except as      
permitted by an administrative order    
issued under subsection 7c7 or a minor  
change in the drug in conformity with   
subsection 7d71 is in a dosage form that
 has been used to a material extent and 
for a material time within the meaning  
of section #bja7p77#b72 or  7,,ii7 the  
active ingredient in such drug is in    

conformity with-- 7aa7 the requirements 
of a final administrative order issued  
under subsection 7c7 determining that   
such drug under the specific conditions 
of use is generally recognized as safe  
and effective within the meaning of     
section #bja7p77#a72 and  7bb7 the      
general requirements for nonprescription
 drugs1 including any modifications of  
the requirements under subsections 7c71 
7d71 and 7j72 and  7ii7 such drug is--  
7,i7 not classified in ,category ,,ii   
for safety or effectiveness under a     
tentative final monograph2 or  7,,ii7   
determined by the ,secretary to be not  
safe and effective1 in a final monograph
 or preamble to a rule that is the most 
recently applicable proposal or         
determination issued under part #ccj of 
title #ba1 ,code of ,federal            
,regulations4  7,b7 ,a nonprescription  
drug may be introduced into interstate  
commerce if such drug is-- 7i7 7,i7 not 
classified in ,category ,,ii for safety 
or effectiveness under a tentative final

 monograph2 or  7,,ii7 determined by the
 ,secretary to be not safe and          
effective1 in a final monograph or      
preamble to a rule that is the most     
recently applicable proposal or         
determination issued under part #ccj of 
title #ba1 ,code of ,federal            
,regulations2 and  7ii7 7,i7 7aa7 the   
subject of a tentative final monograph  
that is the most recently applicable    
proposal or determination issued under  
part #ccj of title #ba1 ,code of        
,federal ,regulations2  7bb7 classified 
in category ,,iii for safety or         
effectiveness in the preamble of a      
proposed rule establishing such         
tentative final monograph2  7cc7 in     
conformity with the most recently       
proposed or final rule establishing or  
proposing conditions of nonprescription 
use published in the ,federal ,register 
related to such tentative final         
monograph and the general requirements  
for nonprescription drugs1 including any
 modifications of those requirements    

under subsections 7c7 and 7j72 and  7dd7
 in a dosage form that has been used to 
a material extent and for a material    
time within the meaning of section      
#bja7p77#b72 or  7,,ii7 7aa7 the subject
 of a proposed monograph or advance     
notice of proposed rulemaking that is   
the most recently applicable proposal or
 determination issued under part #ccj of
 title #ba1 ,code of ,federal           
,regulations2  7bb7 classified in       
category ,i for safety and effectiveness
 under such proposed monograph or       
advance notice of proposed rulemaking2  
7cc7 in conformity with the most        
recently proposed or final rule         
establishing or proposing conditions of 
nonprescription use published in the    
,federal ,register related to such      
proposed monograph or advance notice of 
proposed rulemaking and the general     
requirements for nonprescription drugs1 
including any modifications of those    
requirements under subsections 7c7 and  
7j72 and  7dd7 in a dosage form that has

 been used to a material extent and for 
a material time within the meaning of   
section #bja7p77#b74  7,c7 ,a           
nonprescription drug may be introduced  
into interstate commerce if-- 7i7 such  
drug is classified in category ,,ii for 
safety or effectiveness under a         
tentative final monograph1 or the       
,secretary has determined such drug not 
to be safe and effective in a final     
monograph or preamble to a rule that is 
the most recently applicable proposal or
 determination issued under part #ccj of
 title #ba1 ,code of ,federal           
,regulations2 and  7ii7 the ,secretary  
determines within #f months of the date 
of enactment of the ,over-the-,counter  
,drug ,safety1 ,innovation1 and ,reform 
,act1 that it is in the interest of     
public health to extend the period      
during which the drug may be marketed   
without an approved new drug application
 under section #eje4  7,d7 ,a drug that 
is subject to the final monograph for   
sunscreen drug products set forth at    

part #ceb of title #ba1 ,code of        
,federal ,regulations 7as published at  
volume #fd page #bgfhg of the ,federal  
,register71 shall comply with the       
requirements of that monograph1 except  
that the testing requirements for       
effectiveness and the provisions        
governing labeling shall be in          
accordance with section #bja4cbg of     
title #ba1 ,code of ,federal            
,regulations 7as in effect on the date  
of enactment of the ,over-the-,counter  
,drug ,safety1 ,innovation1 and ,reform 
,act71 or such changes to those         
requirements as may be made under       
subsections 7c71 7d71 and 7j74  7#b7    
,new drugs ,a nonprescription drug is a 
new drug within the meaning of section  
#bja7p7 and subject to the requirements 
of section #eje if the drug is--  7,a7  
not described in subparagraph 7,a71     
7,b71 or 7,d7 of paragraph 7#a7 and not 
in conformity with subsection 7d72  7,b7
 not subject to an administrative final 
order pursuant to subsection 7c72 or    

7,c7 not a nonprescription sunscreen    
active ingredient or combination of     
ingredients subject to a final sunscreen
 order1 as defined in section #ehf7b74  
7#c7 ,monograph drug ,a nonprescription 
drug that is in compliance with         
paragraph 7#a7 shall be referred to in  
this section as a monograph drug4  7#d7 
,rules of construction  7,a7 ,in general
 ,this section shall not affect the     
treatment or status of a nonprescription
 drug subject to section #eje--  7i7    
that1 on the date of enactment of the   
,over-the-,counter ,drug ,safety1       
,innovation1 and ,reform ,act1 is       
marketed without an application approved
 under section #eje2 and  7ii7 to which 
subparagraphs 7,a71 7,b71 7,c71 and 7,d7
 of paragraph 7#a7 do not apply4  7,b7  
,applicability of other provisions      
,nothing in this paragraph shall be     
construed to preclude or limit the      
applicability of any other provision of 
this ,act4  7,c7 ,no effect on other    
authorities ,nothing in this subsection 

shall be construed to prohibit the      
,secretary from issuing an order under  
this section finding a drug to be not   
generally recognized as safe and        
effective4  7c7 ,administrative orders  
7#a7 ,in general  7,a7 ,generally       
recognized as safe and effective ,the   
,secretary may1 on the initiative of the
 ,secretary or at the request of one or 
more requestors1 issue an administrative
 order determining whether there are    
requirements under which a specific     
drug1 class of such drugs1 or           
combination of such drugs is determined 
to be1 after substantive review of      
evidence--  7i7 not subject to section  
#ejc7;b77#a72  7ii7 generally recognized
 as safe and effective within the       
meaning of section #bja7p77#a72 and     
7iii7 not required to be approved under 
section #eje4  7,b7 ,not generally      
recognized as safe and effective ,the   
,secretary shall issue an order         
determining that a drug is not generally
 recognized as safe and effective within

 the meaning of section #bja7p77#a7 for 
the specified requirements if1 after    
substantive review of evidence1 the     
,secretary determines that--  7i7 the   
evidence shows that the drug is not     
generally recognized as safe and        
effective within the meaning of section 
#bja7p77#a72 or  7ii7 the evidence is   
inadequate to show that the drug is     
generally recognized as safe and        
effective within the meaning of section 
#bja7p77#a74  7#b7 ,nonapplication of   
certain requirements ,the requirements  
of subchapter ,,ii of chapter #e of     
title #e1 ,united ,states ,code1 shall  
not apply with respect to administrative
 orders issued under this section4  7#c7
 ,administrative orders initiated by the
 ,secretary2 citizen petitions  7,a7 ,in
 general ,except as provided in         
paragraph 7#e71 in issuing an           
administrative order under paragraph    
7#a7 on the initiative of the           
,secretary1 the ,secretary shall--  7i7 
not later than #b business days before  

issuance of the proposed order1         
informally communicate the pending      
issuance of the order to sponsors of    
drugs that will be subject to such      
order2  7ii7 after making any such      
informal communication-- 7,i7 issue such
 a proposed administrative order by     
publishing it on the internet website of
 the ,food and ,drug ,administration and
 include in such order the reasons for  
the issuance of such order2 and  7,,ii7 
publish notice of availability of such  
proposed order in the ,federal          
,register2  7iii7 except as provided in 
subparagraph 7,b71 provide for a public 
comment period with respect to such     
proposed order of not less than #de     
calendar days2 and  7iv7 if1 after      
satisfying the requirements of clauses  
7i7 through 7iii71 the ,secretary       
determines that it is appropriate to    
issue a final administrative order--    
7,i7 issue the final administrative     
order1 together with a detailed         
statement of reasons1 but such order    

shall not take effect until the time for
 requesting judicial review under       
paragraph 7#d77;,d77ii7 has expired2    
7,,ii7 publish a notice of availability 
of such final administrative order in   
the ,federal ,register2  7,,iii7 afford 
requestors of products that will be     
subject to such order the opportunity   
for formal dispute resolution up to the 
level of the ,director of the ,center   
for ,drug ,evaluation and ,research1    
which initially shall be requested      
within #de calendar days of the issuance
 of the order1 and1 for subsequent      
levels of appeal1 within #cj calendar   
days of the prior decision2 and  7,,iv7 
except with respect to drugs described  
in paragraph 7#d77;,b71 upon completion 
of the formal dispute resolution        
procedure1 inform the person or persons 
which sought such dispute resolution of 
their right to request a hearing4  7,b7 
,special requirements with respect to   
certain monograph drugs ,when issuing an
 administrative order under paragraph   

7#a7 on the initiative of the ,secretary
 7except as provided under paragraph    
7#e77 proposing to determine that a     
monograph drug described in subsection  
7b77#a77;,b7 is not generally recognized
 as safe and effective within the       
meaning of section #bja7p77#a71 the     
,secretary shall follow the procedures  
in subparagraph 7,a7 except that--  7i7 
the proposed order shall include notice 
of-- 7,i7 the general categories of data
 the ,secretary has determined necessary
 to establish that the drug is generally
 recognized as safe and effective within
 the meaning of section #bja7p77#a72 and
  7,,ii7 the format for submissions by  
interested persons2  7ii7 the ,secretary
 shall provide for a public comment     
period of not less than #ahj calendar   
days with respect to such proposed      
order1 except when the ,secretary       
determines1 for good cause1 that a      
shorter period is in the interest of    
public health2 and  7iii7 any person who
 submits data in such comment period    

shall include a certification that the  
person has submitted all evidence       
created1 obtained1 or received by that  
person that is both within the          
categories of data identified in the    
proposed order and relevant to a        
determination as to whether the drug is 
generally recognized as safe and        
effective within the meaning of section 
#bja7p77#a74  7,c7 ,citizen petitions   
7i7 ,in general ,the ,secretary may     
issue an administrative order under     
paragraph 7#a7 in response to a citizen 
petition submitted under section #aj4cj 
of title #ba1 ,code of ,federal         
,regulations 7or any successor          
regulation71 subject to clause 7ii74    
7ii7 ,effect of petition ,nothing in    
clause 7i7 shall be construed to provide
 an alternative to1 or otherwise        
supplant or supersede--  7,i7 the       
processes through which a requestor may 
seek an administrative order pursuant to
 paragraph 7#f72 or  7,,ii7 the fee     
structure under section                 

#gdd,l-#a7;a77#b74  7#d7 ,hearings2     
judicial review  7,a7 ,in general ,a    
person who participated in each level of
 formal dispute resolution under        
paragraph 7#c77;,a77iv77,,iii7 of an    
administrative order with respect to a  
drug may request a hearing concerning a 
final administrative order issued under 
paragraph 7#c77;,a77iv7 with respect to 
such drug4 ,such person may submit a    
request for a hearing1 which shall be   
based solely on the information in the  
administrative record1 to the ,secretary
 not later than #cj calendar days after 
receiving notice of the final decision  
of the formal dispute resolution        
procedure4  7,b7 ,no hearing required   
with respect to orders relating to      
certain drugs ,the ,secretary is not    
required to provide notice and an       
opportunity for a hearing pursuant to   
paragraph 7#c77;,a77iv7 if the final    
administrative order involved relates to
 a drug--  7i7 that is described in     
subclause 7,i7 or 7,,ii7 of subsection  

7b77#a77;,b77i72 and  7ii7 with respect 
to which no data relevant to the safety 
or effectiveness of such drug have been 
submitted to the administrative record  
since the issuance of the most recent   
tentative final monograph relating to   
such drug 7or1 as applicable1 since the 
deeming of such tentative final         
monograph as a final administrative     
order under paragraph 7#g774  7,c7      
,hearing procedures  7i7 ,denial of     
request for hearing ,if the ,secretary  
determines that a request for a hearing 
under subparagraph 7,a7 with respect to 
a final administrative order issued     
under paragraph 7#c77;,a77iv71 does not 
establish the existence of a genuine and
 substantial question of material fact1 
the ,secretary may deny such request4   
,in making such a determination1 the    
,secretary may consider only information
 and data that are based on relevant and
 reliable scientific principles and     
methodologies4  7ii7 ,single hearing for
 multiple related requests ,if more than

 one request for a hearing is submitted 
with respect to the same administrative 
order under subparagraph 7,a71 the      
,secretary may direct that a single     
hearing be conducted in which all       
persons whose hearing requests were     
granted may participate4  7iii7         
,presiding officer ,the ,secretary shall
 appoint a presiding officer of a       
hearing requested under subparagraph    
7,a7 who--  7,i7 is not an employee of  
the ,center for ,drug ,evaluation and   
,research2 and  7,,ii7 has not          
previously been involved in the         
development of the applicable           
administrative order or in the          
proceedings relating to that            
administrative order4  7iv7 ,rights of  
parties to hearing ,the parties to a    
hearing requested under subparagraph    
7,a7 shall have the right to present    
testimony1 including testimony of expert
 witnesses1 and to cross-examine        
witnesses presented by other parties4   
,where appropriate1 the presiding       

officer may require that                
cross-examination by parties            
representing substantially the same     
interests be consolidated to promote    
efficiency and avoid duplication4  7v7  
,final decision ,at the conclusion of a 
hearing requested under subparagraph    
7,a71 the presiding officer of the      
hearing shall issue a decision          
containing findings of fact and         
conclusions of law4 ,the decision of the
 presiding officer shall be final4 ,the 
final decision may not take effect until
 the period under subparagraph 7,d77ii7 
for submitting a request for judicial   
review of such decision expires4  7,d7  
,judicial review of final administrative
 order  7i7 ,in general ,the procedures 
described in section #eje7;h7 shall     
apply with respect to judicial review of
 final administrative orders issued     
under this subsection in the same manner
 and to the same extent as such section 
applies to an order described in such   
section except that the judicial review 

shall be taken by filing in an          
appropriate district court of the       
,united ,states in lieu of the appellate
 courts specified in such section4  7ii7
 ,time to submit a request for judicial 
review ,a person eligible to request a  
hearing under this paragraph and seeking
 judicial review of a final             
administrative order issued under this  
subsection shall file a request for such
 review not later than #fj calendar days
 after the latest of--  7,i7 the date on
 which notice of such order is          
published2  7,,ii7 the date on which any
 hearing with respect to such order is  
denied under subparagraph 7,c77i72      
7,,iii7 the date on which a final       
decision is made following any hearing  
with respect to such order under        
subparagraph 7,c77v72 or  7,,iv7 if no  
hearing is requested1 the date on which 
the time for requesting a hearing       
expires4  7#e7 ,expedited procedure with
 respect to administrative orders       
initiated by the ,secretary  7,a7       

,imminent hazard to the public health   
7i7 ,in general ,in the case of a       
determination by the ,secretary that a  
monograph drug poses an imminent hazard 
to the public health1 the ,secretary    
may1 after informally communicating with
 any sponsor that will be the subject of
 such determination1 not later than #dh 
hours before issuance of an order under 
this subparagraph--  7,i7 issue an      
interim final administrative order for  
such drug or combination of drugs under 
paragraph 7#a71 together with a detailed
 statement of the reasons for such      
order2  7,,ii7 publish in the ,federal  
,register a notice of availability of   
such order2 and  7,,iii7 provide for a  
public comment period of at least #de   
calendar days after issuance of such    
interim final order4  7ii7              
,nondelegation ,the ,secretary may not  
delegate the authority to issue an      
interim final administrative order under
 this subparagraph4  7,b7 ,safety       
labeling changes  7i7 ,in general ,in   

the case of a determination by the      
,secretary that a change in the labeling
 of a drug1 class of drugs1 or          
combination of drugs subject to this    
section is reasonably expected to       
mitigate a significant or unreasonable  
risk of a serious adverse event         
associated with use of the drug1 the    
,secretary may1 after informally        
communicating with any sponsor that will
 be the subject of such determination1  
not later than #dh hours before issuance
 of an order under this subparagraph--  
7,i7 issue an interim final             
administrative order in accordance with 
paragraph 7#a7 to require such change1  
together with a detailed statement of   
the reasons for such order2  7,,ii7     
publish in the ,federal ,register a     
notice of availability of such order2   
and  7,,iii7 provide for a public       
comment period of at least #de calendar 
days after issuance of such interim     
final order4  7ii7 ,content of order ,an
 interim final order issued under this  

subparagraph with respect to the        
labeling of a drug may provide for new  
warnings and other information required 
for safe use of the drug4  7,c7         
,effective date ,an order under         
subparagraph 7,a7 or 7,b7 shall take    
effect on a date specified by the       
,secretary1 which date1 in the case of  
an order under subparagraph 7,b7 that   
includes changes to the packaging of the
 drug1 shall not be earlier than the day
 after the date on which the comment    
period described in subparagraph        
7,b77i77,,iii7 ends4  7,d7 ,final order 
,after the completion of the proceedings
 in subparagraph 7,a7 or 7,b71 the      
,secretary shall-- 7i7 issue a final    
order in accordance with paragraph 7#a72
  7ii7 publish a notice of availability 
of such final administrative order in   
the ,federal ,register2 and  7iii7      
afford sponsors of drugs that will be   
subject to such an order the opportunity
 for formal dispute resolution up to the
 level of the ,director of the ,center  

for ,drug ,evaluation and ,research1    
which initially shall be within #de     
calendar days of the issuance of the    
order2 and1 for subsequent levels of    
appeal1 within #cj calendar days of the 
prior decision4  7,e7 ,hearings  7i7 ,in
 general ,a sponsor of a drug subject to
 a final order issued under subparagraph
 7,d7 who participated in each level of 
formal dispute resolution under         
subparagraph 7,d77iii7 may request a    
hearing on such order4 ,the provisions  
of subparagraphs 7,a71 7,b71 and 7,c7 of
 paragraph 7#d7 shall apply with respect
 to a hearing on such order in the same 
manner and to the same extent as such   
provisions apply with respect to a      
hearing on an administrative order      
issued under paragraph 7#c77;,a77iv74   
7ii7 ,references ,for purposes of a     
hearing under this subparagraph1 the    
references in subparagraphs 7,a71 7,b71 
and 7,c7 of paragraph 7#d7--  7,i7 to   
each level of dispute resolution under  
paragraph 7#c77;,a77iv77,,iii7 shall be 

deemed to mean each level of formal     
dispute resolution under subparagraph   
7,d77iii72 and  7,,ii7 to final         
administrative order issued under       
paragraph 7#c77;,a77iv7 shall be deemed 
to mean final order under subparagraph  
7,d77i74  7,f7 ,final order ,not later  
than #a year after the date on which an 
interim final order is issued under     
subparagraph 7,a7 or 7,b71 the          
,secretary shall issue a final order in 
accordance with paragraph 7#a7 and      
complete any required hearing4  7,g7    
,judicial review ,a final order issued  
pursuant to subparagraph 7,f7 shall be  
subject to judicial review in accordance
 with paragraph 7#d77;,d74  7,h7        
,clarification ,paragraph 7#c7 shall not
 apply to the orders issued under this  
paragraph4  7#f7 ,administrative order  
initiated by request  7,a7 ,in general  
,in issuing an administrative order     
under paragraph 7#a7 at the request of a
 requestor or a group of requestors with
 respect to certain drugs1 classes of   

drugs1 or combinations of drugs--  7i7  
the ,secretary shall1 after receiving a 
request under this subparagraph1        
determine whether the request is        
sufficiently complete and formatted to  
permit a substantive review2  7ii7      
subject to subparagraph 7,d71 if the    
,secretary determines that the request  
is sufficiently complete and formatted  
to permit a substantive review1 the     
,secretary shall--  7,i7 file the       
request2 and  7,,ii7 initiate           
proceedings with respect to issuing an  
administrative order in accordance with 
paragraphs 7#c7 and 7#d72 and  7iii7    
except as provided in subparagraph      
7,d77v71 if the ,secretary determines   
that a request does not meet the        
requirements for filing or is not       
sufficiently complete or formatted to   
permit a substantive review1 the        
requestor may elect that the ,secretary 
file the request over protest1 and the  
,secretary shall initiate proceedings to
 review the request in accordance with  

paragraph 7#c77;,a74  7,b7 ,request to  
initiate proceedings  7i7 ,in general ,a
 requestor seeking an administrative    
order with respect to certain drugs1    
classes of drugs1 or combinations of    
drugs1 shall submit to the ,secretary a 
request to initiate proceedings for such
 order in the form and manner as        
specified by the ,secretary4 ,such      
requestor may submit a request under    
this subparagraph for the issuance of an
 administrative order--  7,i7           
determining whether a drug is generally 
recognized as safe and effective within 
the meaning of section #bja7p77#a71     
exempt from section #ejc7;b77#a71 and   
not required to be the subject of an    
approved application under section #eje2
 or  7,,ii7 determining whether a change
 to a condition of use or a new         
condition of use of a drug is generally 
recognized as safe and effective within 
the meaning of section #bja7p77#a71     
exempt from section #ejc7;b77#a71 and   
not required to be the subject of an    

approved application under section #eje1
 if such drug is--  7aa7 described in   
subsection 7b77#a77;,a72 or  7bb7       
described in subsection 7b77#a77;,b71   
but only if such requestor initiates    
such request in conjunction with a      
request for the ,secretary to determine 
whether such drug is generally          
recognized as safe and effective within 
the meaning of section #bja7p77#a71     
which is filed by the ,secretary under  
subparagraph 7,a77ii77,i74  ,the        
,secretary is not required to complete  
review of the request for a change      
described in subclause 7,,ii7 if the    
,secretary determines1 in accordance    
with subparagraph 7,d71 that there is an
 inadequate basis to find the drug is   
generally recognized as safe and        
effective under paragraph 7#a7 and      
issues a final order announcing that    
determination4  7ii7 ,withdrawal of     
request ,the requestor may withdraw a   
request under this paragraph1 according 
to the procedures established by the    

,secretary4 ,notwithstanding any other  
provision of this section1 if such      
request is withdrawn1 the ,secretary    
shall cease proceedings under this      
subparagraph4  7,c7 ,product            
differentiation  7i7 ,in general ,a     
final administrative order issued in    
response to a request under this        
paragraph shall have the effect of      
providing the order requestor 7or the   
licensees1 assignees1 or successors in  
interest of such requestor with respect 
to the subject of such order and listed 
under clause 7v77 the exclusive right1  
for a period of #b years1 to market     
drugs under this section incorporating  
changes described in clause 7ii71       
subject to the limitations under clause 
7iv71 and beginning on the date the     
requestor 7or any such licensees1       
assignees1 or successors in interest of 
such requestor7 may lawfully market such
 drugs pursuant to the order4  7ii7     
,changes described ,a change described  
in this clause is a change subject to an

 order specified in clause 7i71 which-- 
7,i7 permits a drug to contain an active
 ingredient not previously incorporated 
in a marketed drug listed in clause     
7iii72 or  7,,ii7 permits a change in   
the conditions of use of a drug1 for    
which human data studies conducted or   
sponsored by the requestor 7or for which
 the requestor has an exclusive right of
 reference7 were essential to the       
issuance of such order4  7iii7 ,marketed
 drugs ,the marketed drugs listed in    
this clause are drugs-- 7,i7 marketed in
 accordance with a final monograph      
issued under part #ccj of title #ba1    
,code of ,federal ,regulations          
7including conditions of use            
thereunder71 as in effect on the day    
before the date of enactment of this    
section2  7,,ii7 marketed as category ,i
 or ,,iii in accordance with a tentative
 final monograph issued under such part 
#ccj 7including conditions of use and   
any applicable subsequent determinations
 thereunder71 as so in effect2  7,,iii7 

marketed as category ,i in accordance   
with an advance notice of proposed      
rulemaking issued under such part #ccj  
7including conditions of use and any    
applicable subsequent determinations    
thereunder71 as so in effect2  7,,iv7   
marketed in accordance with a final     
order issued under this section2 or     
7,v7 described in subsection            
7b77#a77;,c71 other than drugs subject  
to an active enforcement action under   
section #cjc4  7iv7 ,limitations on     
product differentiation  7,i7 ,only one 
period ,only one #b-year period may be  
granted per drug under clause 7i7 with  
respect to any change described in      
clause 7ii74  7,,ii7 ,exclusions ,no    
period of product differentiation under 
this subparagraph shall apply to changes
 to a drug that are--  7aa7 ,tier #b    
changes described in section            
#gdd,l7#ad77;,a72  7bb7 safety-related  
changes described in section            
#gdd,l-#a7;a77#b77;,c71 required under  
paragraph 7#e71 or any other change the 

,secretary determines necessary to      
ensure safe use2 or  7cc7 changes       
related to methods of testing safety or 
efficacy4  7v7 ,listing of licensees1   
assignees1 or successors in interest    
,the requestors of an order described in
 clause 7i7 shall1 as applicable1 submit
 to the ,secretary1 at a time when a    
finished dosage form subject to such    
order is introduced or delivered for    
introduction into interstate commerce1 a
 list of licensees1 assignees1 or       
successors in interest that have the    
exclusive right described in such       
clause4  7vi7 ,human data defined ,for  
purposes of this subparagraph1 the term 
human data means data from clinical     
trials of safety or effectiveness1 or   
pharmacokinetics or bioavailability     
studies4  7,d7 ,information regarding   
safe nonprescription marketing and use  
as a condition for filing a ,,grase     
request  7i7 ,in general ,in response to
 a request under this paragraph that a  
drug described in clause 7ii7 be        

generally recognized as safe and        
effective1 the ,secretary--  7,i7 may   
file such request1 if the request       
includes information specified under    
clause 7iii7 with respect to safe       
nonprescription marketing and use of    
such drug2 or  7,,ii7 if the request    
fails to include information specified  
under clause 7iii71 shall refuse to file
 such request and may require that      
nonprescription marketing of the drug be
 pursuant to a new drug application as  
described in clause 7iv74  7ii7 ,drug   
described ,a drug described in this     
clause is a monograph drug that contains
 an active ingredient not previously    
incorporated in a drug--  7,i7 marketed 
in accordance with a final monograph    
issued under part #ccj of title #ba1    
,code of ,federal ,regulations          
7including conditions of use under such 
part71 as in effect on the day before   
the date of enactment of this section2  
7,,ii7 marketed as category ,i in       
accordance with a tentative final       

monograph issued under part #ccj of     
title #ba1 ,code of ,federal            
,regulations 7including conditions of   
use and any applicable subsequent       
determinations under such part71 as in  
effect on the day before the date of    
enactment of this section2 or  7,,iii7  
marketed in accordance with a final     
order issued under this section4  7iii7 
,sufficient information for a threshold 
demonstration of nonprescription        
marketing and use ,information specified
 in this subparagraph1 with respect to a
 request described in clause 7i77,i71   
is--  7,i7 information sufficient for a 
threshold demonstration that the drug   
subject to such request has a verifiable
 history of being marketed and safely   
used by consumers in the ,united ,states
 as a nonprescription drug under        
comparable conditions of use2  7,,ii7 if
 the drug has not been previously       
marketed in the ,united ,states as a    
nonprescription drug1 information       
sufficient for a threshold demonstration

 that the drug was marketed and safely  
used in a foreign country under         
conditions of marketing and use--  7aa7 
for such period of time as needed to    
provide reasonable assurances concerning
 the safe nonprescription use of the    
drug2 and  7bb7 during such period of   
time1 was subject to sufficient         
monitoring by a regulatory body of any  
country listed in section               
#hjb7;b77#a77;,a7 or any country        
designated by the ,secretary in         
accordance with section                 
#hjb7;b77#a77;,b72 or  7,,iii7 if the   
,secretary determines that information  
described in subclause 7,i7 or 7,,ii7 is
 not needed to provide a threshold      
demonstration that the drug can be      
safely marketed and used as a           
nonprescription drug1 other information 
the ,secretary determines sufficient for
 such purposes4  7iv7 ,marketing        
pursuant to new drug application ,in the
 case of a request described in clause  
7i77,,ii71 the drug subject to such     

request may be re-submitted for filing  
only if--  7,i7 the drug is marketed as 
a nonprescription drug1 under conditions
 of use comparable to the requirements  
specified in the request1 for such      
period of the time as the ,secretary    
determines appropriate 7not to exceed #e
 consecutive years7 pursuant to an      
application approved under section #eje2
 and  7,,ii7 during such period of time1
 #a1jjj1jjj retail packages of the drug1
 or an equivalent quantity of the active
 ingredient or ingredients of such drug 
as determined by the ,secretary1 were   
distributed for retail sale1 as         
determined in such manner as the        
,secretary may require4  7v7 ,rule of   
application ,if the ,secretary refuses  
to file a request under this            
subparagraph1 the requestor may not file
 over protest under subparagraph        
7,a77iii7 unless the request involves a 
drug described in section #ehf7i7 as in 
effect on ,january #a1 #bjag4  7#g7     
,treatment of final and tentative final 

monographs ,a final monograph or        
tentative final monograph establishing  
requirements of use for a drug described
 in subsection 7b77#a7 shall be deemed  
to be a final administrative order under
 this subsection and may be amended1    
revoked1 or otherwise modified in       
accordance with the procedures of this  
subsection4  7#h7 ,packaging  7,a7 ,in  
general ,an administrative order issued 
under paragraph 7#c71 7#e77;,a71 or 7#f7
 may include requirements for the       
packaging of a drug1 such as to promote 
use in accordance with labeling1 unit   
dose packaging1 or requirements to      
prevent accidental overdose or          
ingestion1 misuse1 or abuse1 including  
by pediatric populations4 ,the          
,secretary shall consider1 as           
appropriate1 any such nonprescription   
drugs currently available1 and the      
impact of the removal of such drugs     
without such packaging and the changing 
of such packaging on patients and       
manufacturers when establishing such    

requirements4  7,b7 ,effective date     
,requirements for packaging in an       
administrative order under paragraph    
7#e77;,b7 shall not take effect earlier 
than the day after the date on which the
 comment period under paragraph         
7#e77;,b77i77,,iii7 ends4  7,c7         
,clarification ,this paragraph does not 
authorize the ,secretary to require     
special packaging or child-resistant    
packaging under the ,poison ,prevention 
,packaging ,act of #aigj4  7d7          
,procedure for minor changes  7#a7 ,in  
general ,minor changes in the dosage    
form of a drug that is described in     
clause 7i77,i77aa77,,cc7 or 7ii7 of     
subsection 7b77#a77;,a7 may be made by a
 requestor without the issuance of an   
administrative order under subsection   
7c7 if--  7,a7 the requestor maintains  
information necessary to demonstrate    
that the change-- 7i7 will not affect   
the safety or effectiveness of the drug2
 and  7ii7 will not materially affect   
the extent of absorption or other       

exposure to the active ingredient in    
comparison to a suitable reference      
product2  7,b7 the requestor submits    
updated drug listing information for the
 drug in accordance with the            
requirements of section #eaj7;j7 within 
#cj calendar days of the date on which  
the drug is first introduced into       
interstate commerce with the change2 and
  7,c7 the change is in conformity with 
the requirements of an applicable       
administrative order issued by the      
,secretary under paragraph 7#c74  7#b7  
,additional information  7,a7 ,access to
 records ,the requestor shall submit to 
the ,secretary1 under section           
#gjd7;a77#d71 records requested by the  
,secretary related to a minor change    
within #ae business days of receiving   
such request1 or such longer period as  
the ,secretary may provide4 ,such       
request shall be specific to a company  
and limited to the product and the minor
 change that prompted such request4     
,such request shall be specific to a    

company and limited to the product and  
the minor change that prompted such     
request4  7,b7 ,insufficient information
 ,if the ,secretary determines that the 
information contained in such records is
 not sufficient to demonstrate that the 
change does not affect the safety or    
effectiveness of the drug or materially 
affect the extent of absorption or other
 exposure to the active ingredient1 the 
,secretary--  7i7 may so inform the     
requestor of the drug in writing2 and   
7ii7 provide the requestor of the drug  
with a reasonable opportunity to provide
 additional information4  7,c7 ,failure 
to submit sufficient information ,if the
 requestor fails to provide such        
additional information within the       
prescribed time1 or if the ,secretary   
determines that such additional         
information does not demonstrate that   
the change does not affect the safety or
 effectiveness of the drug or materially
 affect the extent of absorption or     
other exposure to the active ingredient1

 the drug as modified is a new drug     
within the meaning of section #bja7p7   
and shall be deemed to be misbranded    
under section #ejb7;ee74  7#c7          
,determining whether change will affect 
safety or effectiveness  7,a7 ,in       
general ,the ,secretary shall issue one 
or more administrative orders under     
subsection 7c7 specifying requirements  
for determining whether a minor change  
made by a requestor pursuant to this    
subsection will affect the safety or    
effectiveness of a drug or materially   
affect the extent of absorption or other
 exposure to an active ingredient in the
 drug in comparison to a suitable       
reference product1 together with        
guidance for applying those orders to   
specific dosage forms4  7,b7 ,standard  
practices and special needs of          
populations ,the orders and guidance    
issued by the ,secretary under          
subparagraph 7,a7 shall take into       
account relevant public standards and   
standard practices for evaluating the   

quality of drug products and may take   
into account special needs of           
populations1 including children4  7e7   
,information submitted by requestors    
7#a7 ,confidential information ,any     
information1 including reports of       
testing conducted on the drug or drugs  
involved1 that is submitted by a        
requestor in connection with proceedings
 on an administrative order under this  
section 7or any minor change under      
subsection 7d77 and is a trade secret or
 confidential information subject to    
section #eeb7;b77#d7 of title #e1       
,united ,states ,code1 or section #aije 
of title #ah1 ,united ,states ,code1    
shall not be disclosed to the public    
unless the requestor consents to that   
disclosure4  7#b7 ,public availability  
limitations ,the ,secretary shall make  
available to the public any information 
7other than information contained in    
subject-level data sets1 such as those  
derived from individual case report     
forms7 submitted by a requestor in      

support of a request under subsection   
7c77#f77;,a7 as of the date on which the
 proposed order is issued unless--  7,a7
 the information pertains to            
pharmaceutical quality1 unless such     
information is necessary to establish   
standards under which a drug is         
generally recognized as safe and        
effective within the meaning of section 
#bja7p77#a72  7,b7 the information is   
submitted in a requestor-initiated      
request1 but the requestor withdraws    
such request before the ,secretary      
issues the proposed order in accordance 
with withdrawal procedures established  
by the ,secretary2 or  7,c7 the         
,secretary otherwise obtains the        
information under subsection 7d74  7f7  
,public availability of administrative  
orders ,the ,secretary shall establish1 
maintain1 update 7as the ,secretary     
determines necessary1 but not less      
frequently than annually71 and make     
available on the internet website of the
 ,food and ,drug ,administration--  7#a7

 a repository of each final             
administrative order and interim final  
order issued under subsection 7c7 that  
is in effect1 including the complete    
text of the administrative order2 and   
7#b7 a listing of all administrative    
orders proposed and under development on
 the initiative of the ,secretary under 
this section1 including--  7,a7 a brief 
description of the administrative order2
 and  7,b7 the expectations of the      
,secretary1 for issuance of proposed    
administrative orders over a #c-year    
period4  7g7 ,updates to drug listing   
information ,a sponsor who makes a      
change to a drug other than a change in 
dosage form1 which is in conformity with
 the requirements under subparagraph    
7,a7 or 7,b7 of subsection 7b77#a71     
shall not be subject to the requirements
 of subsection 7c7 or 7d7 with respect  
to such change1 and shall submit updated
 drug listing information for the drug  
in accordance with the requirements of  
section #eaj7;j7 within #cj calendar    

days of the date on which the drug1 with
 the change1 is first introduced or     
delivered for introduction into         
interstate commerce4  7h7 ,approvals    
under section #eje ,this section shall  
not be construed to preclude a sponsor  
of a drug or requestor from seeking or  
maintaining the approval of an          
application for such drug under         
subsection 7b77#a71 7b77#b71 or 7j7 of  
section #eje4 ,a determination under    
this section that a drug is not subject 
to section #ejc7;b77#a71 is generally   
recognized as safe and effective within 
the meaning of section #bja7p77#a71 and 
is not a new drug under section #bja7p71
 shall constitute a finding of safety   
and effectiveness for purposes of       
section #eje7;b77#b7 so that the        
applicant shall be required to submit   
only that information needed to support 
the modification of the drug that is    
subject to the determination under this 
section4  7i7 ,development advice to    
requestors or sponsors  7#a7 ,in general

 ,the ,secretary shall establish        
procedures under which requestors may   
meet with appropriate officials of the  
,food and ,drug ,administration to      
obtain advice on the studies and other  
information necessary to support        
requests under this section and other   
matters relevant to the regulation of   
monograph drugs and the development of  
new monograph drugs under this section4 
7#b7 ,participation of multiple sponsors
 ,the ,secretary shall establish        
procedures to facilitate efficient      
participation by multiple requestors in 
proceedings under this section1         
including provision for joint meetings  
with multiple requestors or with        
organizations nominated by requestors to
 represent their interests in a         
proceeding4  7#c7 ,private meetings with
 requestors ,the procedures established 
under this subsection shall include     
appropriate provision for confidential  
meetings with requestors with respect to
 discussion of matters involving        

confidential commercial information or  
trade secrets4  7j7 ,effect on existing 
regulations governing nonprescription   
drugs  7#a7 ,regulations of general     
applicability to nonprescription drugs  
,except as provided in this subsection1 
nothing in this section supersedes      
regulations establishing general        
requirements for nonprescription drugs1 
including regulations of general        
applicability contained in parts #bja1  
#bej1 and #ccj of title #ba1 ,code of   
,federal ,regulations1 or any successor 
regulations4 ,the ,secretary shall      
establish or modify such regulations by 
means of rulemaking in accordance with  
section #eec of title #e1 ,united       
,states ,code4  7#b7 ,regulations       
establishing requirements for specific  
nonprescription drugs  7,a7 ,in general 
,section #caj4ede of title #ba1 ,code of
 ,federal ,regulations1 as in effect on 
the date of enactment of this section1  
shall be deemed to be final             
administrative order under subsection   

7c74  7,b7 ,other regulations           
,regulations establishing requirements  
for specific nonprescription drugs      
marketed pursuant to this section that  
are in effect on the day before the date
 of enactment of this section 7including
 such requirements in parts #bja1 #bej1 
and #ccj of title #ba1 ,code of ,federal
 ,regulations71 shall be deemed to be   
final administrative orders under       
subsection 7c7 only as such requirements
 apply to monograph drugs4  7,c7        
,effective date period ,unless withdrawn
 or revised by the ,secretary1 the      
regulations under title #ba of the ,code
 of ,federal ,regulations that are      
described in subparagraph 7,b7 shall    
remain in effect with respect to drugs  
not subject to subparagraph 7,a71 7,b71 
7,c71 or 7,d7 of subsection 7b77#a74    
7#c7 ,withdrawal of regulations ,the    
,secretary shall withdraw regulations   
establishing final monographs and the   
procedures governing the                
over-the-counter drug review under part 

#ccj and other relevant parts of title  
#ba1 ,code of ,federal ,regulations 7as 
in effect on the day before the date of 
enactment of this ,act71 or make        
technical changes to such regulations to
 ensure conformity with appropriate     
terminology and cross references1 to the
 extent needed to effectuate or         
harmonize the provisions of this        
section4 ,notwithstanding subchapter    
,,ii of chapter #e of title #e1 ,united 
,states ,code1 any such withdrawal or   
technical amendments shall be made      
without public notice and comment and be
 effective upon publication through     
notice in the ,federal ,register 7or    
upon such date as specified in such     
notice74  7k7 ,guidance  7#a7 ,issuance 
,the ,secretary shall issue guidance    
that provides-- 7,a7 the procedures and 
principles for formal meetings between  
the ,secretary and sponsors or          
requestors for drugs subject to this    
section2  7,b7 the format and content of
 data submissions to the ,secretary     

under this section2  7,c7 the format of 
electronic submissions to the ,secretary
 under this section2  7,d7 consolidated 
proceedings and the procedures for such 
proceedings where appropriate2 and  7,e7
 for minor changes in drugs1            
recommendations on how to comply with   
the requirements in administrative      
orders issued under subsection 7c77#c74 
7l7 ,electronic format ,all submissions 
under this section shall be in an       
electronic format specified by the      
,secretary after providing a period for 
public comment4  7m7 ,inapplicability of
 ,paperwork ,reduction ,act ,chapter #ce
 of title #dd1 ,united ,states ,code1   
shall not apply to collections of       
information made under this section4  4 
#ajb4 ,misbranding ,section #ejb of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #ceb7 is amended by 
inserting after subsection 7dd7 the     
following3  7ee7 ,if it is a            
nonprescription drug that is not the    
subject of an application approved under

 section #eje1 and does not comply with 
the requirements under section #eje;,g4 
7ff7 ,if it is a drug for which fees    
under section #gdd,l-#a have been       
assessed but have not been paid4  4     
#ajc4 ,conforming amendments to the     
,sunscreen ,innovation ,act  7a7 ,review
 of nonprescription ingredients subject 
to ,sunscreen ,innovation ,act  7#a7    
,pending sunscreen ingredients          
,nonprescription sunscreen active       
ingredients or combinations of sunscreen
 active ingredients subject1 on the date
 of enactment of this ,act1 to a        
proposed sunscreen order1 as defined in 
section #ehf7g7 of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;fff7#g771 shall--  7,a7 continue  
to be reviewed in accordance with       
section #ehf;,c of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;fff-#c72 or  7,b7 be reviewed     
under section #eje;,g of such ,act upon 
notification of the ,secretary by the   
sponsor that such sponsor elects to have

 such ingredient or combination of      
ingredients reviewed under such section 
#eje;,g1 and such proposed sunscreen    
order under such section #ehf;,c shall  
be considered a proposed administrative 
order under section                     
#eje;,g7c77#c77;,a77ii7 of such ,act4   
7#b7 ,pending nonsunscreen ingredients  
,the sponsor of any application         
described in section #ehf;,f of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 that   
was submitted to the ,secretary of      
,health and ,human ,services 7referred  
to in this section as the ,secretary7   
pursuant to section #ccj4ad of title    
#ba1 ,code of ,federal ,regulations 7as 
in effect on the day before the date of 
enactment of this ,act71 shall--  7,a7  
notify the ,secretary that the sponsor  
elects to withdraw such application2 or 
7,b7 notify the ,secretary that the     
sponsor elects for such ingredient to be
 considered under section #eje;,g of the
 ,federal ,food1 ,drug1 and ,cosmetic   

,act1 and any proposed order under such 
section #ehf;,f shall be considered a   
proposed administrative order under     
section #eje;,g7c77#c77;,a77ii7 of that 
,act4  7#c7 ,ingredients submitted after
 the date of enactment of section       
#ejf;,g ,any ingredient that is eligible
 for review under section #ejf;,g of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act and is submitted after the date of 
enactment of this ,act shall be         
considered under that section4  7b7     
,meetings regarding sunscreen           
ingredients ,section #ehf;,c7b7 of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is 
amended by adding at the end the        
following3  7#aa7 ,meetings with        
sponsors ,a sponsor may request an      
individual1 confidential meeting to     
discuss the data requirements to support
 a general recognition of safety and    
effectiveness with respect to the       
subject of a pending sunscreen          
ingredient4 ,the ,secretary shall       

respond within #ad calendar days of the 
request and schedule such meeting within
 #de calendar days1 or within such      
timeline as specified in the letters    
described in section #bja of the        
,over-the-,counter ,drug ,safety1       
,innovation1 and ,reform ,act4 ,if a    
sponsor requests more than one          
confidential meeting for the same       
request1 the ,secretary may refuse to   
grant an additional confidential meeting
 request if the ,secretary determines   
such additional confidential meeting is 
not reasonably necessary for the sponsor
 to advance its request4 ,the ,secretary
 shall publish a post-meeting summary on
 the internet website of the ,food and  
,drug ,administration of any            
confidential meeting that does not      
disclose confidential business          
information4 ,such meetings shall not be
 required to comply with guidance issued
 by the ,secretary addressing formal    
meetings for sponsors of human drug     
applications1 as defined in section     

#gce4  4  7c7 ,product differentiation  
,section #ehf;,c of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;fff-#c7 is amended by adding at   
the end the following3  7f7 ,product    
differentiation  7#a7 ,in general ,a    
final sunscreen order shall have the    
effect of providing the order requestor 
7or the licensees1 assignees1 or        
successors in interest of such requestor
 with respect to the subject of such    
request and listed under paragraph 7#e77
 the exclusive right1 for a period of #b
 years1 to market a sunscreen ingredient
 under this section incorporating       
changes described in paragraph 7#b7     
subject to the limitations under        
paragraph 7#d71 beginning on the date   
the requestor 7or any licensees1        
assignees1 or successors in interest of 
such requestor with respect to the      
subject of such request and listed under
 paragraph 7#e77 may lawfully market    
such sunscreen ingredient pursuant to   
the order4  7#b7 ,changes described ,a  

change described in this paragraph is a 
change subject to an order specified in 
paragraph 7#a7 that--  7,a7 permits a   
sunscreen to contain an active          
ingredient not previously incorporated  
in a marketed sunscreen listed in       
paragraph 7#c72 or  7,b7 permits a      
change in the conditions of use of a    
sunscreen ingredient1 for which human   
data studies conducted or sponsored by  
the requestor 7or for which the         
requestor has an exclusive right of     
reference7 were essential to the        
issuance of such order4  7#c7 ,marketed 
sunscreen ,the marketed sunscreen       
ingredients described this paragraph are
 sunscreen ingredients-- 7,a7 marketed  
in accordance with a final monograph    
issued under part #ccj of title #ba1    
,code of ,federal ,regulations          
7including conditions of use            
thereunder71 as in effect on the day    
before the date of enactment of this    
section2  7,b7 marketed as category ,i  
or ,,iii in accordance with a tentative 

final monograph issued under such part  
#ccj 7including conditions of use and   
any applicable subsequent determinations
 thereunder71 as so in effect2  7,c7    
marketed as category ,i in accordance   
with an advance notice of proposed      
rulemaking issued under such part #ccj  
7including conditions of use and any    
applicable subsequent determinations    
thereunder71 as so in effect2 or  7,d7  
marketed in accordance with a final     
order issued under this section4  7#d7  
,limitations on product differentiation 
7,a7 ,only one period ,only one #b-year 
period may be granted per ingredient    
under paragraph 7#a74  7,b7 ,exclusions 
,no period of product differentiation   
under this subparagraph shall apply to  
changes to a sunscreen that are--  7i7  
,tier #b changes described in section   
#gdd,l7#ad77;,a72  7ii7 safety-related  
changes described in section            
#gdd,l-#a7;a77#b77;,c71 required under  
section #eje;,g7c77#e71 or any other    
change the ,secretary determines        

necessary to ensure safe use2 or  7iii7 
changes related to methods of testing   
safety or efficacy4  7#e7 ,listing of   
licensees1 assignees1 or successors in  
interest ,requestors shall submit to the
 ,secretary at the time when a final    
dosage form subject to such request is  
introduced or delivered for introduction
 into interstate commerce1 a list of    
licensees1 assignees1 or successors in  
interest that have the exclusive right  
described in paragraph 7#a74  7#f7      
,human data defined ,for purposes of    
this subsection1 the term human data    
means data from clinical trials of      
safety or effectiveness 7including      
actual use studies71 pharmacokinetics1  
or bioavailability4  4  7d7 ,sunscreen  
,innovation ,act amendments ,section    
#ehf;,c7e7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cfj;fff-#c7;e77 is amended by striking 
paragraph 7#c7 and inserting the        
following3  7#c7 ,relationship to orders
 under section #eje;,g ,a final         

sunscreen order shall be deemed to be a 
final administrative order under section
 #eje;,g and subject to the applicable  
provisions under such section #eje;,g1  
including with respect to amendment of  
such order4  4  7e7 ,preclusion of new  
sunscreen submissions2 option ,to       
transfer submissions to ,,otc monograph 
order process  7#a7 ,sunset ,beginning  
on the date of enactment of this ,act1  
section #ehf;,a of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;fff-#a7 shall have no force or    
effect4  7#b7 ,option ,to transfer      
submissions to ,,otc monograph order    
process  7,a7 ,in general ,any person   
who submitted a request described in    
subparagraph 7,b7 may1 at any time prior
 to the sunset of subchapter ,i of      
chapter ,v of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cfj;fff et seq47 under section #ehf;,h 
of such ,act1 withdraw such request from
 the process under such subchapter and  
resubmit such request as an order       

request under section #eje;,g of such   
,act4  7,b7 ,requests ,a request        
described in this subparagraph is-- 7i7 
a request under section #ehf;,a of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act submitted before the date of       
enactment of this ,act2 or  7ii7 a      
pending request described in section    
#ehf7f74  7f7 ,treatment of authority   
regarding finalization of sunscreen     
monograph ,section #ehf;,e of the       
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;fff-#e7 is     
amended to read as follows3  #ehf;,e4   
,sunscreen order  7a7 ,in general  7#a7 
,revision of final sunscreen order ,not 
later than ,november #bf1 #bjai1 the    
,secretary shall amend and revise the   
final administrative order concerning   
nonprescription sunscreen 7referred to  
in this section as the sunscreen order7 
for which the substance1 prior to the   
date of enactment of the                
,over-the-,counter ,drug ,safety1       
,innovation1 and ,reform ,act1 was      

represented by stayed regulations under 
part #ceb of title #ba1 ,code of        
,federal ,regulations4  7#b7 ,issuance  
of revised sunscreen order2 effective   
date ,a revised sunscreen order         
described in paragraph 7#a7 shall be--  
7,a7 effective not later than ,november 
#bf1 #bjai2 and  7,b7 issued by the     
,secretary at least #cj calendar days   
prior to such date4  7b7 ,reports ,if a 
revised sunscreen order issued under    
subsection 7a7 does not include         
provisions related to the effectiveness 
of various sun protection factor levels1
 and does not address all dosage forms  
known to the ,secretary to be used in   
sunscreens marketed in the ,united      
,states without a new drug application  
approved under section #eje1 the        
,secretary shall submit a report to the 
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives on   
the rationale for omission of such      

provisions from such order1 and a plan  
and timeline to compile any information 
necessary to address such provisions    
through such order4  4  7g7 ,sunset of  
process under ,sunscreen ,innovation    
,act ,subchapter ,i of chapter ,v of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;fff et seq471  
as amended by subsection 7f71 is further
 amended by inserting at the end the    
following new section3  #ehf;,h4 ,sunset
 ,this subchapter shall no longer be    
effective upon the later of-- 7#a7 a    
final determination by the ,secretary   
under this subchapter with respect to   
every request described in section      
#ehf;,a7b77#b7 7other than any withdrawn
 requests and requests resubmitted as   
order requests under section #eje;,g72  
or  7#b7 the effective date of the      
revised sunscreen order described in    
section #ehf;,e7a77#b74  4  #ajd4 ,drugs
 excluded from over-the-counter review  
7a7 ,in general ,nothing in this ,act   
7or the amendments made by this ,act7   

shall apply to any nonprescription drug 
which was excluded by the ,food and     
,drug ,administration from the          
,over-the-,counter ,drug ,review in     
accordance with the statement set out at
 page #idff of volume #cg of the        
,federal ,register1 published on ,may   
#aa1 #aigb4  7b7 ,rule of construction  
,nothing in this section shall be       
construed to preclude or limit the      
applicability of any provision of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act4  #aje4 ,conforming amendment      
,section #gea7;d77#a7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cgir7d77#a77 is amended--    
7#a7 in the matter preceding            
subparagraph 7,a7--  7,a7 by striking   
final regulation and inserting final    
order2 and  7,b7 by striking and not    
misbranded2 and  7#b7 in subparagraph   
7,a71 by striking regulation in effect  
and inserting regulation or order in    
effect4  #ajf4 ,annual update to        
,congress on appropriate pediatric      

indication for certain cough and cold   
monograph drugs  7a7 ,in general ,not   
later than one year after the date of   
enactment of this ,act and annually     
thereafter1 the ,secretary of ,health   
and ,human ,services 7referred to in    
this section as the ,secretary7 shall   
submit to the ,committee on ,health1    
,education1 ,labor1 and ,pensions of the
 ,senate and the ,committee on ,energy  
and ,commerce of the ,house of          
,representatives a letter describing the
 progress of the ,food and ,drug        
,administration--  7#a7 in evaluating   
the cough and cold monograph described  
in subsection 7b7 with respect to       
children under age #f2 and  7#b7 as     
appropriate1 revising such cough and    
cold monograph to address such children1
 through the administrative order       
process under section #eje;,g7b7 of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as added by section #aja4  7b7    
,cough and cold monograph described ,the
 cough and cold monograph described in  

this subsection consists of the         
conditions under which nonprescription  
drug products containing antitussive1   
expectorant1 nasal decongestant1 or     
antihistamine active ingredients 7or    
combinations thereof7 are generally     
recognized as safe and effective1 as    
specified in part #cda of title #ba1    
,code of ,federal ,regulations 7as in   
effect on the day before the date of    
enactment of this ,act71 and included in
 an administrative order deemed         
established under such section          
#eje;,g7b7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act4  7c7 ,duration of  
authority ,subsection 7a7 shall have no 
force or effect beginning on the date on
 which the ,secretary submits a letter  
under subsection 7a7 in which the       
,secretary indicates that the ,food and 
,drug ,administration has completed its 
evaluation and revised1 in a final      
administrative order1 as applicable1 the
 cough and cold monograph in accordance 
with this section4  ,,ii ,fees relating 

to monograph drugs  #bja4 ,short title2 
findings  7a7 ,short title ,this title  
may be cited as the ,over-the-,counter  
,monograph ,user ,fee ,act of #bjah4    
7b7 ,findings ,the ,congress finds that 
the fees authorized by the amendments   
made in this title will be dedicated    
toward the regulation of monograph drugs
 under section #eje;,g of the ,federal1 
,food1 ,drug1 and ,cosmetic ,act1 as set
 forth in the goals identified for      
purposes of such section1 in the letters
 from the ,secretary of ,health and     
,human ,services to the ,chairman of the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions of the ,senate and
 the ,chairman of the ,committee on     
,energy and ,commerce of the ,house of  
,representatives1 as set forth in the   
,congressional ,record4  #bjb4          
,authority to access and use fees       
,subchapter ,c of chapter ,,vii of the  
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is  
amended by adding at the end the        

following3  #aj ,fees ,relating to      
monograph drugs  #gdd,l4 ,definitions   
,for purposes of this part3 7#a7 ,the   
term affiliate means a business entity  
that has a relationship with a second   
business entity if1 directly or         
indirectly--  7,a7 one business entity  
controls1 or has the power to control1  
the other business entity2 or  7,b7 a   
third party controls1 or has power to   
control1 both of the business entities4 
7#b7 the term contract manufacturing    
organization facility means a monograph 
drug facility where neither the owner of
 such manufacturing facility nor any    
affiliate of such owner or facility     
sells such monograph drug produced at   
such facility directly to wholesalers1  
retailers1 or consumers in the ,united  
,states4  7#c7 ,the term costs of       
resources allocated for monograph drug  
activities means the expenses in        
connection with monograph drug          
activities for-- 7,a7 officers and      
employees of the ,food and ,drug        

,administration1 contractors of the     
,food and ,drug ,administration1        
advisory committees1 and costs related  
to such officers1 employees1 and        
committees and to contracts with such   
contractors2  7,b7 management of        
information1 and the acquisition1       
maintenance1 and repair of computer     
resources2  7,c7 leasing1 maintenance1  
renovation1 and repair of facilities and
 acquisition1 maintenance1 and repair of
 fixtures1 furniture1 scientific        
equipment1 and other necessary materials
 and supplies2 and  7,d7 collecting fees
 under section #gdd,l-#a and accounting 
for resources allocated for monograph   
drug activities4  7#d7 ,the term firm   
establishment identifier is the unique  
number automatically generated by the   
,field ,accomplishments and ,compliance 
,tracking ,system of the ,food and ,drug
 ,administration4  7#e7 ,the term       
monograph drug shall have the meaning   
given the term under section #eje;,g4   
7#f7 ,the term monograph drug activities

 means activities of the ,secretary     
associated with monograph drug products 
and inspection of facilities associated 
with such products1 including--  7,a7   
the activities necessary for review and 
evaluation of monograph drugs and       
monograph drug order requests1          
including--  7i7 orders proposing or    
finalizing applicable requirements of   
use for monograph drugs products2  7ii7 
orders affecting status regarding       
general recognition of safety and       
effectiveness of a monograph drug       
ingredient or combination of ingredients
 under specified requirements of use2   
7iii7 all monograph drug development and
 review activities1 including           
intra-agency collaboration2  7iv7       
regulation and policy development       
activities related to monograph drugs2  
7v7 development of product standards for
 products subject to review and         
evaluation2  7vi7 meetings regarding    
monograph drug activities2  7vii7 review
 of labeling prior to issuance of orders

 related to monograph drugs or          
conditions of use2 and  7viii7          
regulatory science activities related to
 monograph drugs2  7,b7 inspections     
related to monograph drugs2  7,c7       
monitoring of clinical and other        
research conducted in connection with   
monograph drugs2  7,d7 safety activities
 with respect to monograph drugs1       
including--  7i7 collecting1 developing1
 and reviewing safety information on    
monograph drugs1 including adverse event
 reports2  7ii7 developing and using    
improved adverse event data-collection  
systems1 including information          
technology systems2 and  7iii7          
developing and using improved analytical
 tools to assess potential safety risks1
 including access to external databases2
 and  7,e7 other activities necessary   
for implementation of section #eje;,g4  
7#g7 7,a7 ,the term monograph drug      
facility means a foreign or domestic    
business or other entity--  7i7 that is 
under one management1 either direct or  

indirect2  7ii7 at one geographic       
location or address engaged in          
manufacturing or processing a monograph 
drug in finished dosage form2  7iii7    
includes a finished dosage form         
manufacturer facility or an affiliate   
thereof in a contractual relationship   
with a monograph drug requestor or      
requestors to manufacture or process    
monograph drugs2 and  7iv7 does not     
include a business or other entity whose
 only manufacturing or processing       
activities relate to--  7,i7 production 
of clinical research supplies2  7,,ii7  
testing2 or  7,,iii7 packaging of       
packaged final dosages in a manner that 
does not affect the drug4  7,b7 ,for    
purposes of subparagraph 7,a71 separate 
buildings or locations within close     
proximity are considered to be at #a    
geographic location or address if the   
activities conducted in them are--  7i7 
closely related to the same business    
enterprise2  7ii7 under the supervision 
of the same local management2 and  7iii7

 under a single firm establishment      
identifier and capable of being         
inspected by the ,food and ,drug        
,administration during a single         
inspection4  7,c7 ,if a business or     
other entity would meet the definition  
of a facility under this paragraph but  
for being under multiple management1 the
 business or other entity is deemed to  
constitute multiple facilities1 one per 
management entity1 for purposes of this 
paragraph4  7#h7 ,the term monograph    
drug meeting means any meeting regarding
 the content of a proposed monograph    
drug order request4  7#i7 ,the term     
monograph drug product means a monograph
 drug product that is marketed without  
an approved new drug application in     
accordance with section #eje;,g4  7#aj7 
,the term monograph drug order request  
means a request for an order under      
section #eje;,g for the issuance of an  
administrative order for a change to the
 monograph drug product4  7#aa7 ,the    
term monograph drug requestor means an  

entity submitting a monograph drug order
 request or a monograph drug meeting    
request or any other inquiry relating to
 a request for an order or development  
of a monograph drug order request4      
7#ab7 ,the term person includes an      
affiliate thereof4  7#ac7 ,the term     
,tier #a monograph drug order request   
means any monograph drug order request  
not determined to be a ,tier #b         
monograph drug order request4  7#ad7    
7,a7 ,the term ,tier #b monograph drug  
order request means subject to          
subparagraph 7,b71 a monograph drug     
order request for-- 7i7 the reordering  
of existing information in the drug     
facts label of a monograph drug product2
  7ii7 the addition of information to   
the other information section of the    
drug facts label of a nonprescription   
drug product1 as limited by part        
#bja4ff7;c77#g7 of title #ba1 ,code of  
,federal ,regulations2  7iii7           
modification to the directions for use  
section of the drug facts label of a    

nonprescription drug product1 if such   
changes conform to changes made pursuant
 to section #eje;,g7d72  7iv7 the       
standardization of the concentration or 
dose of a specific finalized ingredient 
within a particular finalized monograph2
  7v7 a change to ingredient            
nomenclature to align with nomenclature 
of a standards-setting organization2 or 
7vi7 addition of an interchangeable term
 in accordance with part #ccj4a of title
 #ba1 ,code of ,federal ,regulations4   
7,b7 ,the ,secretary may1 based on      
program implementation experience or    
other factors found appropriate by the  
,secretary1 characterize any monograph  
drug order request as a ,tier #b        
monograph drug order request 7including 
recategorizing a request from ,tier #a  
to ,tier #b7 and publish such           
determination in a proposed order issued
 pursuant to section #eje;,g7c74        
#gdd,l-#a4 ,authority to assess and use 
monograph drug fees  7a7 ,types of fees 
,beginning with fiscal year #bjah1 the  

,secretary shall assess and collect fees
 in accordance with this section as     
follows3  7#a7 ,facility fee  7,a7 ,in  
general ,except as provided in          
subparagraph 7,b71 each person that owns
 a facility identified as a monograph   
drug facility on ,december #ca of the   
fiscal year or at any time during the   
preceding #ab-month period shall be     
assessed an annual fee for each such    
facility as determined under subsection 
7c74  7,b7 ,exception  7i7 ,in general  
,a fee shall not be assessed under      
subparagraph 7,a7 if the identified     
monograph drug facility has ceased all  
activities related to monograph drug    
products prior to the publication of the
 ,notice under subparagraph ,c and has  
updated its registration to reflect such
 change under the requirements for drug 
establishment registration set forth in 
section #eaj4  7ii7 ,fee amount ,the    
amount of the fee for a contract        
manufacturing organization facility     
shall be equal to two-thirds the amount 

of the fee for a monograph drug facility
 that is not a contract manufacturing   
organization facility4  7,c7 ,due date  
,for each fiscal year1 the facility fees
 required under subparagraph 7,a7 shall 
be due on the later of--  7i7 the first 
business day of ,april of such year2 and
  7ii7 the first business day after the 
date of enactment of an appropriations  
,act providing for the collection and   
obligation of fees under this section   
for such year4  7#b7 ,monograph drug    
order request fee  7,a7 ,in general     
,each person that submits a monograph   
drug order request shall be subject to a
 fee for a monograph drug order request4
 ,the monograph drug order request fee  
under paragraph 7#b7 shall be--  7i7 for
 a ,tier #a monograph drug order        
request1 #ejj1jjj1 adjusted for         
inflation for the fiscal year 7as       
determined under subsection 7c77#a772   
and  7ii7 for a ,tier #b monograph drug 
order request other than a ,tier #a     
request1 #ajj1jjj adjusted for inflation

 for the fiscal year 7as determined     
under subsection 7c77#a774  7,b7 ,due   
date ,the monograph drug order request  
fees required under subparagraph 7,a7   
shall be due on the date of submission  
of the monograph drug order request4    
7,c7 ,exception for certain safety      
changes ,a person who is named as the   
requestor in a monograph drug order     
shall not be subject to a fee under     
subparagraph 7,a7 if the ,secretary     
finds that the monograph drug order     
request seeks to change the ,drug ,facts
 labeling of a monograph drug product in
 a way that would add to or strengthen--
  7i7 a contraindication1 warning1 or   
precaution2  7ii7 a statement about risk
 associated with misuse or abuse2 or    
7iii7 an instruction about dosage and   
administration that is intended to      
increase the safe use of the monograph  
drug product4  7,d7 ,refund of fee if   
order request is recategorized as a tier
 #b monograph drug order request ,if the
 ,secretary determines that a monograph 

drug request initially characterized as 
,tier #a should be re-characterized as a
 ,tier #b monograph drug order request1 
and the requestor has paid a ,tier #a   
fee in accordance with subparagraph     
7,a77i71 the ,secretary shall refund the
 requestor the difference between the   
,tier #a and ,tier #b fees determined   
under subparagraphs 7,a77i7 and         
7,a77ii71 respectively4  7,e7 ,refund of
 fee if order request refused for filing
 or withdrawn before filing ,the        
,secretary shall refund #ge percent of  
the fee paid under subparagraph 7,b7 for
 any order request that is refused for  
filing4  7,f7 ,fees for order requests  
previously refused for filing or        
withdrawn before filing ,a monograph    
drug order request that was submitted   
but was refused for filing1 or was      
withdrawn before being accepted or      
refused for filing1 shall be subject to 
the full fee under subparagraph 7,a7    
upon being resubmitted or filed over    
protest4  7,g7 ,refund of fee if order  

request withdrawn ,if an order request  
is withdrawn after the order request was
 filed1 the ,secretary may refund the   
fee or a portion of the fee if no       
substantial work was performed on the   
order request after the application was 
filed4 ,the ,secretary shall have the   
sole discretion to refund a fee or a    
portion of the fee under this           
subparagraph4 ,a determination by the   
,secretary concerning a refund under    
this paragraph shall not be reviewable4 
7#c7 ,refunds  7,a7 ,in general ,other  
than refunds under subparagraphs 7,d7   
through 7,g7 of paragraph 7#b71 the     
,secretary shall not refund any fee paid
 under this subsection1 except as       
provided in subparagraph 7,b74  7,b7    
,disputes concerning fees ,to qualify   
for the return of a fee claimed to have 
been paid in error under this paragraph1
 a person shall submit to the ,secretary
 a written request justifying such      
return within #ahj calendar days after  
such fee was paid4  7b7 ,fee revenue    

amounts  7#a7 ,fiscal year #bjah ,for   
fiscal year #bjah1 fees under subsection
 7a77#a7 shall be established to        
generate a total facility fee revenue   
amount equal to the sum of--  7,a7 the  
annual base revenue for fiscal year     
#bjah 7as determined under paragraph    
7#c772  7,b7 the dollar amount equal to 
the operating reserve adjustment for the
 fiscal year1 if applicable 7as         
determined under subsection 7c77#b772   
and  7,c7 additional direct cost        
adjustments 7as determined under        
subsection 7c77#c774  7#b7 ,subsequent  
fiscal years ,for each of the fiscal    
years #bjai through #bjbb1 fees under   
subsection 7a77#a7 shall be established 
to generate a total facility fee revenue
 amount equal to the sum of--  7,a7 the 
annual base revenue for the fiscal year 
7as determined under paragraph 7#c772   
7,b7 the dollar amount equal to the     
inflation adjustment for the fiscal year
 7as determined under subsection        
7c77#a772  7,c7 the dollar amount equal 

to the operating reserve adjustment for 
the fiscal year1 if applicable 7as      
determined under subsection 7c77#b772   
7,d7 additional direct cost adjustments 
7as determined under subsection         
7c77#c772 and  7,e7 additional dollar   
amounts for each fiscal year as follows3
  7i7 #g1jjj1jjj for fiscal year #bjai4 
7ii7 #f1jjj1jjj for fiscal year #bjbj4  
7iii7 #g1jjj1jjj for fiscal year #bjba4 
7iv7 #c1jjj1jjj for fiscal year #bjbb4  
7#c7 ,annual base revenue ,for purposes 
of paragraphs 7#a77;,a7 and 7#b77;,a71  
the dollar amount of the annual base    
revenue for a fiscal year shall be--    
7,a7 for fiscal year #bjah1 #h1jjj1jjj2 
and  7,b7 for fiscal years #bjai through
 #bjbb1 the dollar amount of the total  
revenue amount established under this   
subsection for the previous fiscal year1
 not including any adjustments made     
under subsection 7c77#b7 or 7c77#c74    
7c7 ,adjustments2 annual fee setting    
7#a7 ,inflation adjustment  7,a7 ,in    
general ,for purposes of subsection     

7b77#b77;,b71 the dollar amount of the  
inflation adjustment to the annual base 
revenue for fiscal year #bjai and each  
subsequent fiscal year shall be equal to
 the product of--  7i7 such annual base 
revenue for the fiscal year under       
subsection 7b77#b72 and  7ii7 the       
inflation adjustment percentage under   
subparagraph 7,b74  7,b7 ,inflation     
adjustment percentage ,the inflation    
adjustment percentage under this        
subparagraph for a fiscal year is equal 
to-- 7i7 for each of fiscal years #bjai 
through #bjbj1 the average annual       
percent change that occurred in the     
,consumer ,price ,index for urban       
consumers 7,washington-,baltimore1      
,,dc-,,md-,,va-,,wv2 ,not ,seasonally   
,adjusted2 ,all items2 ,annual ,index7  
for the first #c years of the preceding 
#d years of available data2 and  7ii7   
for each of fiscal years #bjba and      
#bjbb1 the sum of-- 7,i7 the average    
annual percent change in the cost1 per  
full-time equivalent position of the    

,food and ,drug ,administration1 of all 
personnel compensation and benefits paid
 with respect to such positions for the 
first #c years of the preceding #d      
fiscal years1 multiplied by the         
proportion of personnel compensation and
 benefits costs to total costs of       
monograph drug activities 7as defined in
 subsection 7a77 for the first #c years 
of the preceding #d fiscal years2 and   
7,,ii7 the average annual percent change
 that occurred in the ,consumer ,price  
,index for urban consumers              
7,washington-,baltimore1                
,,dc-,,md-,,va-,,wv2 ,not ,seasonally   
,adjusted2 ,all items2 ,annual ,index7  
for the first #c years of the preceding 
#d years of available data multiplied by
 the proportion of all costs other than 
personnel compensation and benefits     
costs to total costs of monograph drug  
activities for the first #c years of the
 preceding #d fiscal years4  7#b7       
,operating reserve adjustment  7,a7 ,for
 fiscal year #bjah and subsequent fiscal

 years1 the ,secretary may1 in addition 
to adjustments under paragraphs 7#a7 and
 7#b71 further increase the fee revenue 
and fees if such an adjustment is       
necessary to provide operating reserves 
of carryover user fees for monograph    
drug activities for the number of weeks 
specified in subparagraph 7,b74  7,b7   
,for each fiscal year the number of     
weeks of operating reserves shall be no 
more than-- 7i7 #c weeks for fiscal year
 #bjah2  7ii7 #g weeks for fiscal year  
#bjai2  7iii7 #aj weeks for fiscal year 
#bjbj2  7iv7 #aj weeks for fiscal year  
#bjba2 and  7v7 #aj weeks for fiscal    
year #bjbb4  7,c7 ,if1 for fiscal years 
#bjai through #bjbb1 the ,secretary has 
carryover balances for monograph drug   
activities in excess of the number of   
weeks of such operating reserves        
specified in subparagraph ,b1 the       
,secretary shall reduce such fee revenue
 and fees to provide for not more than  
the number of weeks of such operating   
reserves specified in subparagraph      

7,b77v74  7,d7 ,if an adjustment under  
this paragraph is made1 the rationale   
for the amount of the increase or       
decrease 7as applicable7 in fee revenue 
and fees shall be contained in the      
annual ,federal ,register notice under  
paragraph 7#e7 establishing fee revenue 
and fees for the fiscal year involved4  
7#c7 ,additional direct cost adjustment 
,the ,secretary shall1 in addition to   
adjustments under paragraphs 7#a7 and   
7#b71 further increase the fee revenue  
by an amount equal to--  7,a7           
#ad1jjj1jjj for fiscal year #bjah2  7,b7
 #g1jjj1jjj for fiscal year #bjai2  7,c7
 #d1jjj1jjj for fiscal year #bjbj2  7,d7
 #c1jjj1jjj for fiscal year #bjba2 and  
7,e7 #c1jjj1jjj for fiscal year #bjbb4  
7#d7 ,annual fee setting  7,a7 ,fiscal  
year #bjah ,the ,secretary shall1 not   
later than ,january #ca1 #bjah--  7i7   
establish monograph drug facility fees  
for fiscal year #bjah under subsection  
7a77#a71 based on the revenue amount for
 such year under subsection 7b7 and the 

adjustments provided under this         
subsection2 and  7ii7 publish such fee  
revenue and facility fees in the        
,federal ,register4  7,b7 ,subsequent   
fiscal years ,the ,secretary shall1 not 
later than ,january #ca of each fiscal  
year that begins after ,september #cj1  
#bjah1 establish for each such fiscal   
year1 based on the revenue amounts under
 subsection 7b7 and the adjustments     
provided under this subsection--  7i7   
monograph drug facility fees under      
subsection 7a77#a72  7ii7 monograph drug
 order request fees under subsection    
7a77#b72 and  7iii7 publish such fee    
revenue1 facility fees1 and monograph   
drug order request fees in the ,federal 
,register4  7d7 ,identification of      
facilities ,each person that owns a     
monograph drug facility shall submit to 
the ,secretary the information required 
under this subsection each year4 ,such  
information shall1 for each fiscal      
year--  7#a7 be submitted as part of the
 requirements for drug establishment    

registration set forth in section #eaj2 
and  7#b7 include for each such         
facility1 at a minimum1 identification  
of the facility's business operation as 
that of a monograph drug facility4  7e7 
,effect of failure ,to pay fees  7#a7   
,in general ,a monograph drug order     
request submitted by a person subject to
 fees under subsection 7a7 shall be     
considered incomplete and shall not be  
accepted for filing by the ,secretary   
until all fees owed by such person have 
been paid4  7#b7 ,effect on eligibility 
for meetings ,if a monograph drug       
requestor fails to pay a fee assessed   
under subsection 7a71 the requestor     
shall be considered ineligible for      
monograph drug meetings4  7f7 ,monograph
 drug facility fee ,failure to pay the  
fee under subsection 7a77#a7 within #bj 
calendar days of the due date as        
specified in subparagraph 7,d7 of such  
subsection shall result in the          
,secretary placing the facility on a    
publicly available arrears list until   

such fee has been paid4  7g7 ,crediting 
and availability of fees  7#a7 ,in      
general ,subject to paragraph 7#b77;,d71
 fees authorized under subsection 7a7   
shall be collected and available for    
obligation only to the extent and in the
 amount provided in advance in          
appropriations ,acts4 ,such fees are    
authorized to remain available until    
expended4 ,such sums as may be necessary
 may be transferred from the ,food and  
,drug ,administration salaries and      
expenses appropriation account without  
fiscal year limitation to such          
appropriation account for salaries and  
expenses with such fiscal year          
limitation4 ,the sums transferred shall 
be available solely for monograph drug  
activities4  7#b7 ,collections and      
appropriation acts  7,a7 ,in general    
,subject to subparagraphs 7,c7 and 7,d71
 the fees authorized by this section    
shall be collected and available in each
 fiscal year in an amount not to exceed 
the amount specified in appropriation   

,acts1 or otherwise made available for  
obligation1 for such fiscal year4  7,b7 
,use of fees and limitation ,the fees   
authorized by this section shall be     
available to defray increases in the    
costs of the resources allocated for    
monograph drug activities 7including    
increases in such costs for an          
additional number of full-time          
equivalent positions in the ,department 
of ,health and ,human ,services to be   
engaged in such activities71 only if the
 ,secretary allocates for such purpose  
an amount for such fiscal year          
7excluding amounts from fees collecting 
under this section7 no less than        
#ab1jjj1jjj1 multiplied by the          
adjustment factor applicable to the     
fiscal year involved4  7,c7 ,compliance 
,the ,secretary shall be considered to  
have met the requirements of            
subparagraph 7,b7 in any fiscal year if 
the costs funded by appropriations and  
allocated for the monograph drug        
activities are not more than #ae percent

 below the level specified in such      
subparagraph4  7,d7 ,fee collection     
during first program year ,until the    
date of enactment of an ,act making     
appropriations and providing for the    
collection and obligation of fees under 
this section through ,september #cj1    
#bjah1 for the salaries and expenses    
account of the ,food and ,drug          
,administration1 fees authorized by this
 section for fiscal year #bjah may be   
collected and shall be credited to such 
account and remain available until      
expended4  7,e7 ,provision for early    
payments in subsequent years ,payment of
 fees authorized under this section for 
a fiscal year 7after fiscal year #bjah71
 prior to the due date for such fees1   
may be accepted by the ,secretary in    
accordance with authority provided in   
advance in a prior year appropriations  
,act4  7#c7 ,authorization of           
appropriations ,for each of the fiscal  
years #bjah through #bjbb1 there is     
authorized to be appropriated for fees  

under this section an amount equal to   
the total amount of fees assessed for   
such fiscal year under this section4    
7h7 ,collection of unpaid fees ,in any  
case where the ,secretary does not      
receive payment of a fee assessed under 
subsection 7a7 within #cj calendar days 
after it is due1 such fee shall be      
treated as a claim of the ,united       
,states ,government subject to          
subchapter ,,ii of chapter #cg of title 
#ca4  7i7 ,construction ,this section   
may not be construed to require that the
 number of full-time equivalent         
positions in the ,department of ,health 
and ,human ,services1 for officers1     
employers1 and advisory committees not  
engaged in monograph drug activities1 be
 reduced to offset the number of        
officers1 employees1 and advisory       
committees so engaged4  #gdd,l-#b4      
,reauthorization2 reporting requirements
  7a7 ,performance report ,beginning    
with fiscal year #bjah1 and not later   
than #abj calendar days after the end of

 each fiscal year thereafter for which  
fees are collected under this part1 the 
,secretary shall prepare and submit to  
the ,committee on the ,health1          
,education1 ,labor1 and ,pensions of the
 ,senate and the ,committee on ,energy  
and ,commerce of the ,house of          
,representatives a report concerning the
 progress of the ,food and ,drug        
,administration in achieving the goals  
identified in the letters described in  
section #bja of the during such fiscal  
year and the future plans of the ,food  
and ,drug ,administration for meeting   
such goals4  7b7 ,fiscal report ,not    
later than #abj calendar days after the 
end of fiscal year #bjah and each       
subsequent fiscal year for which fees   
are collected under this part1 the      
,secretary shall prepare and submit to  
the ,committee on ,health1 ,education1  
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives a    
report on the implementation of the     

authority for such fees during such     
fiscal year and the use1 by the ,food   
and ,drug ,administration1 of the fees  
collected for such fiscal year4  7c7    
,public availability ,the ,secretary    
shall make the reports required under   
subsections 7a7 and 7b7 available to the
 public on the internet website of the  
,food and ,drug ,administration4  7d7   
,reauthorization  7#a7 ,consultation ,in
 developing recommendations to present  
to ,congress with respect to the goals  
described in subsection 7a71 and plans  
for meeting the goals1 for monograph    
drug activities for the first #e fiscal 
years after fiscal year #bjbb1 and for  
the reauthorization of this part for    
such fiscal years1 the ,secretary shall 
consult with--  7,a7 the ,committee on  
,health1 ,education1 ,labor1 and        
,pensions of the ,senate2  7,b7 the     
,committee on ,energy and ,commerce of  
the ,house of ,representatives2  7,c7   
scientific and academic experts2  7,d7  
health care professionals2  7,e7        

representatives of patient and consumer 
advocacy groups2 and  7,f7 the regulated
 industry4  7#b7 ,public review of      
recommendations ,after negotiations with
 the regulated industry1 the ,secretary 
shall-- 7,a7 present the recommendations
 developed under paragraph 7#a7 to the  
congressional committees specified in   
such paragraph2  7,b7 publish such      
recommendations in the ,federal         
,register2  7,c7 provide for a period of
 #cj calendar days for the public to    
provide written comments on such        
recommendations2  7,d7 hold a meeting at
 which the public may present its views 
on such recommendations2 and  7,e7 after
 consideration of such public views and 
comments1 revise such recommendations as
 necessary4  7#c7 ,transmittal of       
recommendations ,not later than ,january
 #ae1 #bjbb1 the ,secretary shall       
transmit to ,congress the revised       
recommendations under paragraph 7#b71 a 
summary of the views and comments       
received under such paragraph1 and any  

changes made to the recommendations in  
response to such views and comments4  4