Citizen Petitions and Petitions 
for Stay of Action Subject to 
Section 505(q) of the Federal 
Food, Drug, and Cosmetic Act 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2019 
Procedural 
 
Revision 2 
 
OMB Control No. 0910-0679 
Expiration Date 6/30/2020    
See additional PRA statement in section IV of this guidance 
 
 
 
 
      
Citizen Petitions and Petitions 
for Stay of Action Subject to 
Section 505(q) of the Federal 
Food, Drug, and Cosmetic Act 
 
Guidance for Industry 
 
 
 
 
 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
September 2019 
Procedural 
 
Revision 2 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Scope of Section 505(q) .................................................................................................................. 2 
B.  Determination of Delay Necessary To Protect the Public Health .............................................. 3 
C.  Certification and Verification ....................................................................................................... 3 
D.  Final Agency Action ....................................................................................................................... 3 
E.  Judicial Review .............................................................................................................................. 4 
F.  Exceptions and Reporting ............................................................................................................. 4 
III.  DISCUSSION .................................................................................................................... 4 
A.  How Does FDA Determine Whether Section 505(q) Applies to a Particular Petition? ........... 5 
1. Petition Submitted on or After September 27, 2007, or July 9, 2012 .............................................. 5 
2. Petition Submitted in Writing and Pursuant to  10.30 or 10.35 .................................................... 6 
3. ANDA, 505(b)(2) Application, or 351(k) Application Is Pending at the Time the Petition Is 
Submitted and the Applications User Fee Goal Date Is on or Before the 150-Day Deadline for 
Final Agency Action on the Petition ................................................................................................ 7 
4. Petition Requests an Action That Could Delay Approval of a Pending ANDA, 505(b)(2) 
Application, or 351(k) Application .................................................................................................. 8 
5. Petition Does Not Fall Within Any of the Exceptions Described in Section 505(q)(4) ................... 8 
B.  How Does FDA Determine Whether a Petition Would Delay Approval of an ANDA, a 
505(b)(2) Application, or a 351(k) Application? ......................................................................... 8 
C.  How Does FDA Apply the Certification Requirements in Section 505(q)(1)(H)? .................. 10 
1. Determination of Whether a Certification Is Complete ................................................................. 11 
2. What a Petitioner Should Do If a Certification Is Deficient .......................................................... 12 
D.  How Does FDA Apply the Verification Requirements in Section 505(q)(1)(I)? ..................... 13 
E.  What Is the Relationship Between the Review of Petitions Under Section 505(q) and the 
Review of ANDAs, 505(b)(2) Applications, and 351(k) Applications for Which the Agency 
Has Not Yet Made a Final Decision on Approvability? ........................................................... 14 
F.    What Considerations May Suggest That a Petition Was Submitted for the Primary Purpose 
of Delaying Approval of an Application? .................................................................................. 15 
IV.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 17 
  
 
  i  Contains Nonbinding Recommendations 
 
Citizen Petitions and Petitions for Stay of Action Subject to  
Section 505(q) of the Federal Food, Drug, and Cosmetic Act 
 
Guidance for Industry1 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.  
 
 
 
I.  INTRODUCTION  
 
This guidance provides information regarding FDAs current thinking on interpreting section 
505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(q)).  Section 
505(q) of the FD&C Act2 governs certain citizen petitions and petitions for stay of Agency 
action that request that FDA take any form of action related to a pending application described in 
section 505(b)(2) or 505(j) of the FD&C Act3 or a pending application described in section 
351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).4   
 
This guidance describes FDAs interpretation of section 505(q) regarding how the Agency 
determines if (1) the provisions of section 505(q) addressing the treatment of citizen petitions 
and petitions for stay of Agency action (collectively, petitions) apply to a particular petition and 
(2) a petition would delay approval of a pending abbreviated new drug application (ANDA), 
505(b)(2) application, or 351(k) application.  This guidance also describes how FDA interprets 
the provisions of section 505(q) requiring that (1) a petition include a certification and (2) 
supplemental information or comments on a petition include a verification.  It also addresses the 
relationship between the review of petitions and pending ANDAs, 505(b)(2) applications, and 
351(k) applications for which the Agency has not yet made a decision on approvability.        
 
This guidance revises and supersedes the guidance for industry Citizen Petitions and Petitions 
for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act issued 
                                                 
1 This guidance has been prepared by the Office of Regulatory Policy in the Center for Drug Evaluation and 
Research (CDER) at the Food and Drug Administration.  
2 For brevity, in this guidance, references to section 505(q) of the FD&C Act are cited as section 505(q). 
3 In this guidance, an application described in section 505(b)(2) of the FD&C Act is referred to as a 505(b)(2) 
application and an application submitted under section 505(j) of the FD&C Act is referred to as an abbreviated new 
drug application (ANDA). 
4 In this guidance, an application submitted under section 351(k) of the PHS Act is referred to as a 351(k) 
application. 
 
  1  Contains Nonbinding Recommendations 
 
in November 2014.  This revision updates the November 2014 guidance to account for recent 
regulatory changes to add  10.31 (21 CFR 10.31)5 to FDAs regulations and modify  10.30 
and 10.35 (21 CFR 10.30 and 10.35).  The revision also describes a change in FDAs current 
thinking on what constitutes a 505(q) petition.  In addition, the revision describes some of the 
considerations that FDA will take into account in determining whether a petition is submitted 
with the primary purpose of delaying the approval of an application under section 505(q)(1)(E).  
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
II.  BACKGROUND 
 
The Food and Drug Administration Amendments Act of 2007 (FDAAA) was enacted on 
September 27, 2007.  Section 914 of Title IX of FDAAA took effect on the date of enactment 
and amended section 505 of the FD&C Act by adding a new subsection (q).6   
 
Section 505(q), as enacted by FDAAA, applies to certain petitions that request that FDA take 
any form of action related to a pending ANDA or 505(b)(2) application and governs the manner 
in which these petitions are treated.   
 
The Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted on July 9, 
2012.7  Section 1135 of FDASIA amended section 505(q) of the FD&C Act in two ways.  First, 
it shortened from 180 days to 150 days FDAs deadline for final Agency action on the petitions 
subject to section 505(q).  Second, with the exceptions noted below, it expanded the scope of 
section 505(q) to include certain petitions related to 351(k) applications. 
 
The provisions of section 505(q) are described in greater detail below. 
 
A.  Scope of Section 505(q)   
 
Section 505(q)(1)(A), together with section 505(q)(5), describes the general scope of  ection 
505(q).  Section 505(q)(1)(A) provides:  
  s
The Secretary shall not delay approval of a pending application submitted under 
subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act 
because of any request to take any form of action relating to the application, either before 
or during consideration of the request, unless 
   
                                                 
5 On Nov. 8, 2016, FDA issued a final rule amending certain regulations relating to citizen petitions, petitions for 
stay of action, and the submission of documents to FDA (81 FR 78500). 
6 Pub.L. 110-85, 121 Stat. 823 (as amended by Pub.L. 110-316, 122 Stat. 3509). 
7 Pub.L. 112-144, 126 Stat. 993. 
  2  Contains Nonbinding Recommendations 
 
(i)  the request is in writing and is a petition submitted to the Secretary pursuant 
to section 10.30 or 10.35 of title 21, Code of Federal Regulations (or any 
successor regulations); and 
(ii) the Secretary determines, upon reviewing the petition, that a delay is 
necessary to protect the public health. 
 
In section 505(q)(5), the term application is defined as an application submitted under section 
505(b)(2) or 505(j) of the FD&C Act or 351(k) of the PHS Act and the term petition is defined as 
a request described in section 505(q)(1)(A)(i). 
 
B.  Determination of Delay Necessary To Protect the Public Health 
 
If FDA determines that a delay of approval of an ANDA, a 505(b)(2) application, or a 351(k) 
application is necessary to protect the public health, FDA is required to provide to the applicant 
not later than 30 days after making the determination:  
 
  Notification that the determination has been made 
  If applicable, any clarification or additional data that the applicant should submit to 
the petition docket to allow FDA to review the petition promptly  
  A brief summary of the specific substantive issues raised in the petition which form 
the basis of the determination8  
 
At FDAs discretion, the information is to be conveyed by either a document or a meeting with 
the applicant.9  The information conveyed as part of the notification is to be considered part of 
the application and subject to the disclosure requirements applicable to information in such 
application.10 
 
C.  Certification and Verification 
 
Under  ection 505(q)(1)(H), FDA may not consider a petition for review unless the petition is in 
writing and signed and contains a certification that is specified in that section.  In addition, FDA 
may nost accept for review any supplemental information or comments on a petition unless the 
submission is in writing and signed and contains a specific verification.11 
 
D.  Final Agency Action 
 
Section 505(q)(1)(F) governs the time frame for final Agency action on a petition.  Under this 
provision, FDA shall take final Agency action on a petition not later than 150 days after the date 
on which the petition is submitted.  The 150-day period is not to be extended for any reason, 
including any determination made under  ection 505(q)(1)(A) regarding delay of approval of an 
application, the submission of comments or supplemental information, or the consent of the 
petitioner.    s
 
                                                 
8 Section 505(q)(1)(B). 
9 Section 505(q)(1)(C). 
10 Section 505(q)(1)(D).   
11 Section 505(q)(1)(I). 
  3  Contains Nonbinding Recommendations 
 
Under section 505(q)(1)(E), FDA may deny a petition at any point if the Agency determines that 
a petition or a supplement to the petition was submitted with the primary purpose of delaying the 
approval of an application and the petition does not on its face raise valid scientific or regulatory 
issues.  As discussed further in section III.F of this guidance, section 505(q)(1)(E) also provides 
that FDA may issue guidance to describe the factors that will be used to determine whether a 
petition is submitted with the primary purpose of delaying the approval of an application.  
 
E.  Judicial Review 
 
Section 505(q)(2) governs judicial review of final Agency action.  Section 505(q)(2) does not 
apply to a petition addressing issues concerning a 351(k) application.12   
 
Under section 505(q)(2)(A), FDA shall be considered to have taken final Agency action on a 
petition if FDA makes a final decision within the meaning of 21 CFR 10.45(d) during the 150-
day period or the 150-day period expires without FDA having made a final decision.  Under 
section 505(q)(2)(B), if a civil action is filed against the Secretary with respect to any issues 
raised in the petition before final Agency action, a court shall dismiss the action without 
prejudice for failure to exhaust administrative remedies.  Section 505(q)(2)(C) describes the 
information to be included in the administrative record. 
 
F.  Exceptions and Reporting 
 
Section 505(q)(4) exempts certain categories of petitions from the provisions of section 505(q) 
 in particular, petitions relating to 180-day generic drug exclusivity under section 
505(j)(5)(B)(iv) and petitions from a 505(b)(2), an ANDA, or a 351(k) applicant regarding FDA 
actions with respect to that application.  Section 505(q)(3) and section 914(b) of FDAAA also 
provide for certain reporting requirements from FDA to Congress.   
 
 
III.  DISCUSSION    
 
As described in section II of this guidance, the provisions of section 505(q) addressing the 
treatment of petitions apply only to certain petitions.13  These provisions include, for example, 
the requirements that approval of an ANDA, a 505(b)(2) application, or a 351(k) application not 
be delayed by a petition absent an Agency determination that a delay is necessary to protect the 
public health, the provisions requiring final Agency action on the petition within 150 days of 
submission, and the provisions requiring a certification or a verification.  
We describe below how we determine: 
    If the provisions of  ection 505(q) apply to a particular petition  
  If a petition would delay approval of a pending ANDA, 505(b)(2) application, or 
351(k) application  s
 
                                                 
12 Section 505(q)(4)(B). 
13 If a petition is not subject to section 505(q), we will review and respond to the petition in accordance with our 
regulations. 
  4  Contains Nonbinding Recommendations 
 
We also describe how we interpret: 
  ection 505(q)(1)(H) requiring that a petition include a certification  
  ection 505(q)(1)(I) requiring that supplemental information or comments on a 
Spetition include a verification  
  SSection 505(q)(1)(E) stating that the Agency may deny a petition or a supplement to a 
petition that was submitted with the primary purpose of delaying approval of an 
application and that does not on its face raise valid scientific or regulatory issues, and 
stating that the Agency may issue guidance to describe the factors that will be used to 
determine whether a petition is submitted with the primary purpose of delaying the 
approval of an application 
 
In addition, we describe the relationship between the review of petitions under section 505(q) 
and the review of ANDAs, 505(b)(2) applications, and 351(k) applications for which the Agency 
has not yet made a final decision on approvability. 
 
A.  How Does FDA Determine if Section 505(q) Applies to a Particular Petition? 
 
We interpret section 505(q) to apply to a petition only if the petition meets all of the following: 
 
  The petition is submitted to FDA on or after September 27, 2007 (if the subject matter 
of the petition relates to approval of an ANDA or a 505(b)(2) application), or on or 
after July 9, 2012 (if the subject matter of the petition relates to approval of a 351(k) 
application). 
  The petition is submitted in writing and pursuant to 21 CFR 10.30 or 10.35. 
  An ANDA, a 505(b)(2) application, or a 351(k) application related to the subject 
matter of the petition is pending at the time the petition is submitted to FDA, and the 
applications user fee goal date is on or before the 150-day deadline for final Agency 
action on the petition.  
  The petitioner requests an action that could delay approval of a pending ANDA, 
505(b)(2) application, or 351(k) application. 
  The petition does not fall within any of the exceptions described in section 505(q)(4). 
 
We discuss each criterion in greater detail below.   
 
1.  Petition Submitted on or After September 27, 2007, or July 9, 2012 
 
Because section 914 of FDAAA became effective on September 27, 2007, we believe that the 
provisions of section 505(q) only apply to petitions that are submitted on or after September 27, 
2007 (if the subject matter of the petition relates to approval of an ANDA or a 505(b)(2) 
application).  We do not believe that  ection 505(q) applies to any petitions that were submitted 
before September 27, 2007, because  ection 505(q) does not state that it applies retroactively to 
petitions submitted before the effectivse date.  Likewise, we do not believe that  ection 505(q) 
applies to any petitions whose subjecst matter relates to the approval of a 351(k) application if 
those petitions were submitted before July 9, 2012, because section 505(q) doess not state that it 
applies retroactively to those petitions.  In addition, either of these interpretations might impose a 
  5  Contains Nonbinding Recommendations 
 
statutory-day deadline for final Agency action on a petition after the deadline has already 
passed.14 
 
Even if section 505(q) were interpreted to apply retroactively, FDA would not be able to review 
any petition submitted before the applicable date because those petitions would not contain the 
required certification and, as explained in section III.C of this guidance, the statute does not 
permit a petitioner to cure the deficiency by supplementing a petition to add the certification to 
the petition.   
 
2.  Petition Submitted in Writing and Pursuant to  10.30 or 10.35 
 
Under section 505(q) of the FD&C Act, a petition must be submitted in writing and pursuant to 
 10.30 or 10.35.  Section 10.30 of our regulations describes FDAs general requirements for 
submitting a citizen petition, and  10.35 describes our requirements for submitting a request for 
administrative stay of action.  If these requirements are not met, we will not consider section 
505(q) to apply to the petition.    
 
We note that communications with the Agency regarding any issues with the potential to delay 
the approval of an ANDA, a 505(b)(2) application, or a 351(k) application (regardless of whether 
the communications are considered to be petitions subject to section 505(q)) are appropriately 
submitted through the petition process pursuant to  10.30 or 10.35 rather than as 
correspondence to the new drug application (NDA), ANDA, 505(b)(2) application, a biologics 
license application (BLA) submitted under  351(a) of the PHS Act (42 U.S.C. 262(a)),15 351(k) 
application, or another process.16  Similarly, any communications regarding a citizen petition 
should be filed as comments in the appropriate docket, not to the NDA, ANDA, 505(b)(2) 
application, 351(a) BLA, or 351(k) application. 
 
We also remind persons that they may not cross-reference or rely upon information that is not 
included in the petition.  Under  10.30(b) and 10.35(b), petitions must be submitted in 
accordance with  10.20 (21 CFR 10.20).  Section 10.20(c) requires that [i]nformation referred 
to or relied upon in a submission is to be included in full and may not be incorporated by 
reference, unless previously submitted in the same proceeding.  In addition, the certification 
required for petitions subject to section 505(q) (described in section III.C of this guidance) and 
the certification required for citizen petitions under  10.30(b) require the petitioner to certify 
that this petition includes all information and views upon which the petition relies.  A petition 
therefore is required to include all information referred to or relied upon by the petitioner.  In 
addition, the petition should contain all information, both favorable and unfavorable, regarding 
the petitioners claims.  
 
                                                 
14 A petition subject to section 505(q) that was submitted on or after September 27, 2007, but before July 9, 2012, is 
subject to the 180-day deadline.  A petition subject to section 505(q) that was submitted on or after July 9, 2012, is 
subject to the 150-day deadline. 
15 In this guidance, an application submitted under section 351(a) of the PHS Act is referred to as a 351(a) BLA. 
16 For example, as discussed below, interested persons can express their views on issues related to bioequivalence 
for a drug product by submitting comments in response to a Federal Register notice regarding draft product-specific 
bioequivalence recommendations, instead of by submitting a petition concerning bioequivalence standards for a 
drug product. 
  6  Contains Nonbinding Recommendations 
 
3.  ANDA, 505(b)(2) Application, or 351(k) Application Is Pending at the Time the 
Petition Is Submitted and the Applications User Fee Goal Date Is on or Before 
the 150-Day Deadline for Final Agency Action on the Petition 
Section 505(q)(1)(A) describes the scope of section 505(q) (see section II of this guidance).  
Section  505(q)( 1)(A) specifically references pending applications and contemplates the 
possibility that approval could be delayed by issues raised in a petition.  Therefore, we are 
implementing section 505(q) to apply only to petitions for which, at the time the petition is 
submitted, at least one ANDA, 505(b)(2) application, or 351(k) application related to the subject 
matter of the petition is pending17 and at least one such applications user fee goal date is on or 
before the 150-day deadline for final Agency action on the petition.18   
 
If there is no related ANDA, 505(b)(2) application, or 351(k) application pending at the time that 
the petition is submitted, then we will not consider the provisions of section 505(q) to apply to 
the petition.  Likewise, if there is a related ANDA, 505(b)(2) application, or 351(k) application 
pending at the time that the petition is submitted but the applicable user fee goal date is after the 
150-day deadline for final Agency action on the petition, then we will not consider the provisions 
of section 505(q) to apply to the petition.19  FDA has determined that this way of implementing 
section 505(q) aligns with the public health mission of the new drug and generic drug review 
programs and FDAs commitments under the Prescription Drug User Fee Act, the Generic Drug 
User Fee Amendments, and the Biosimilar User Fee Act.  In particular, the Agency believes that 
implementation of the processes described in this guidance will align the timelines to review and 
respond to petitions with the timelines for review of the applications themselves, which will 
provide greater efficiency for both efforts while still ensuring that scientific and regulatory issues 
raised in a petition are considered prior to ANDA, 505(b)(2) application, or 351(k) application 
approval.  This approach will help ensure Agency experts do not have to consider petitions 
separately from application review and therefore prematurely. 
                                                 
17 Although the existence of a pending application generally is not made public by FDA, a potential petitioner may 
be aware of the existence of a pending ANDA or 505(b)(2) application because of (1) a paragraph IV patent 
notification, from the applicant to the NDA holder and the patent owner, stating that the application has been 
submitted and explaining the factual and legal bases for the applicants opinion that the patent is invalid or not 
infringed (see section 505(b)(2)(B) and (j)(2)(B) of the FD&C Act); (2) a public announcement by the applicant 
disclosing the submission of the application; or (3) the tentative approval of an ANDA or 505(b)(2) application 
made public by FDA or the applicant.  In addition, FDAs website identifies drug products for which the Agency has 
received an ANDA with a paragraph IV certification.  A potential petitioner may be aware of the existence of a 
pending 351(k) application because of (1) information exchanged under provisions of section 351(l) of the PHS Act, 
(2) patent infringement proceedings between a biologics license application holder and a 351(k) applicant, or (3) a 
public announcement by the applicant disclosing the submission of the application.
18 User fee goal dates reflect commitments made with respect to the Prescription Drug User Fee Act, Pub. L. 102-
571 (as amended by Pub. L. 115-52, Tit. I) for 505(b)(2) applications; the Generic D rug User Fee Amendments, 
Pub. L. 112-144, Tit. III (as amended by Pub. L. 115-52, Tit. III) for ANDAs; and the Biosimilar User Fee Act, Pub. 
L. 112-144, Tit. IV (as amended by Pub. L. 115-52, Tit. IV) for 351(k) applications.       
19 If we determine that the provisions of section 505(q) do not apply to a particular petition (e.g., if an application is 
pending but the applicable user fee goal date is after the 150-day deadline for final Agency action on the petition), 
we intend to address the issues raised in the petition in a timely manner so that we are not delayed in taking action 
on pending applications and respond to the petition in an appropriate time frame.  See generally the Generic Drug 
User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022, 
available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.   
 
  7  Contains Nonbinding Recommendations 
 
We also believe our approach is appropriate to ensure the fair and orderly implementation of 
 section 505(q).  The evaluation of whether a related ANDA, 505(b)(2) application, or 351(k) 
application is pending (and thus the evaluation of whether a petition is subject to the provisions 
of section 505(q)) will be made at the time that the petition is submitted.  If we were to take a 
rolling evaluation approach, the status of the petition could change at any time from (1) a 
petition that is not subject to section 505(q) to one that is subject to section 505(q) should a 
submission for a related ANDA, 505(b)(2) application, or 351(k) application with a goal date 
within the 150-day period be submitted before we have taken final Agency action on the petition 
or (2) a petition that is subject to section 505(q) to one that is not subject to section 505(q) if the 
related ANDA(s), 505(b)(2) application(s), or 351(k) application(s) are subsequently withdrawn 
or approved and there are no longer any related applications pending with a goal date within the 
150-day period.  Such a change in the status of the petition would disrupt the orderly application 
of the provisions of section 505(q) and the Agencys processing of the petition and also could 
prejudice petitioners and commenters.  
4.  Petition Requests an Action That Could Delay Approval of a Pending ANDA, 
  505(b)(2) Application, or 351(k) Application 
 
As noted, section 505(q)(1)(A) contemplates the possibility that approval of a pending ANDA, 
505(b)(2) application, or 351(k) application could be delayed by issues raised in the petition.  
Therefore, we are implementing section 505(q) by applying it only to petitions that request an 
action that could delay approval of a pending ANDA, 505(b)(2) application, or 351(k) 
application.  If the action requested by the petition does not have the potential to delay approval 
of the pending application under any reasonable theory, we will not consider the provisions of 
section 505(q) to apply to the petition.   
 
5.  Petition Does Not Fall Within Any of the Exceptions Described in Section 
505(q)(4) 
 
Section 505(q)(4) provides that section 505(q) will not apply to any petitions that: 
 
  Relate solely to the timing of approval of an application pursuant to the 180-day 
exclusivity provision in section 505(j)(5)(B)(iv) of the FD&C Act, or  
  Are from the applicant of the ANDA, 505(b)(2) application, or 351(k) application and 
seek only to have FDA take or refrain from taking any action with respect to that 
application 
 
If either of these exceptions applies, we will not consider the provisions of section 505(q) to 
apply to the petition. 
 
B.  How Does FDA Determine if a Petition Would Delay Approval of an ANDA, a 
505(b)(2) Application, or a 351(k) Application? 
 
Under  ection 505(q)(1)(A), FDA shall not delay approval of an ANDA, a 505(b)(2) application, 
or a 351(k) application because of a petition unless the Agency determines 
s   To implement this provision, first we determine if the 
that a delay is 
n  ecessary to protect the public health. 8  Contains Nonbinding Recommendations 
 
provisions of  ection 505(q) apply to the petition based on the considerations described in 
section III.A of this guidance.  If the provisions apply, we then determine if the petition may be 
summarily densied as described in section 505(q)(1)(E) (which allows denial of a petition that 
was submitted with the primary purpose of delaying approval of an application and does not on 
its face raise valid scientific or regulatory issues).20   
 
If we do not find that the petition may be summarily denied, we will determine if the petition 
would be the cause of a delay in an approval of an ANDA, a 505(b)(2) application, or a 351(k) 
application by using a but for test.  In other words, would the ANDA, 505(b)(2) application, or 
351(k) application be ready for approval but for the issues raised by the petition?   
 
  If, regardless of the petition, the ANDA, 505(b)(2) application, or 351(k) application 
would not be ready for approval within the 150-day period for final Agency action on 
the petition (e.g., because the applicant receives a complete response letter during the 
150-day period), then the petition would not delay the approval, and  ection 
505(q)(1)(A) would not be implicated.   
  s
  If the ANDA, 505(b)(2) application, or 351(k) application would be ready for 
approval but for the resolution of the issues raised in the petition within the 150-day 
period for final Agency action on the petition, then  ection 505(q)(1)(A) would be 
implicated, and we would next determine if a delay of approval is necessary to protect 
the public health.    s
 
We determine if a delay of approval is necessary to protect the public health based on our 
preliminary evaluation of the issues raised in the petition.  The Agency considers the following 
scenario: 
 
If the application were to be approved before the Agency completed the 
substantive review of the issues in the petition and, after further review, the 
Agency concluded that the petitioners arguments against approval were 
meritorious, could the presence on the market of drug products that did not meet 
the requirements for approval identified by the petitioner negatively affect the 
public health?   
 
If, after undertaking this analysis, we conclude that the public health could be negatively affected 
under these circumstances, the Agency will conclude that a delay is necessary to protect the 
public health and will delay approval of the pending application until the issues raised in the 
petition are resolved.  Issues that could implicate the public health include, for example, (1) 
whether a proposed generic drug product is bioequivalent to the reference listed drug or (2) 
whether an indication can be safely omitted from the labeling because that indication is protected 
by a patent.   
 
If we determine that a delay of approval of an application is necessary to protect the public 
health, we will notify the applicant as required by  ection 505(q)(1)(B) and (C) of the FD&C 
s
                                                 
20 See section III.F of this guidance.   
  9  Contains Nonbinding Recommendations 
 
Act.  Under these provisions, we are required to provide the following information to the 
applicant not later than 30 days after making the determination:  
  Notification that the determination has been made  
  If applicable, any clarification or additional data that the applicant should submit to 
the petition docket to allow FDA to review the petition promptly  
  A brief summary of the specific substantive issues raised in the petition that form the 
basis of the determination  
 
We will convey this information to the applicant by either a letter or a meeting with the 
applicant.21  As provided in  ection 505(q)(1)(D), we will consider the information conveyed in 
the notification to be part of the application and subject to the disclosure requirements applicable 
to information in such applicsation.  We do not intend to notify the petitioner if a determination 
has been made that a delay in approval of an application is necessary to protect the public health 
because the provisions of  ection 505(q) do not require such a notification to the petitioner.  We 
will resolve any public health issues before approving the application.  If we, in the course of 
considering the petition, laster determine that a delay of approval is no longer necessary to protect 
the public health, we will proceed with approving the application. 
 
Regardless of whether we determine that a delay of approval of an application is or is not 
necessary to protect the public health, we will continue to consider the 150-day period for final 
Agency action under section 505(q)(1)(F) to apply to the petition.  
 
C.  How Does FDA Apply the Certification Requirements in Section 505(q)(1)(H)?  
 
Section 505(q)(1)(H) of the FD&C Act provides that FDA shall not consider a petition for 
review unless the petition is in writing and signed and contains the following certification:    
 
I certify that, to my best knowledge and belief:  (a) this petition includes all information 
and views upon which the petition relies; (b) this petition includes representative data 
and/or information known to the petitioner which are unfavorable to the petition; and (c) I 
have taken reasonable steps to ensure that any representative data and/or information 
which are unfavorable to the petition were disclosed to me.  I further certify that the 
information upon which I have based the action requested herein first became known to 
the party on whose behalf this petition is submitted on or about the following date:  
_________[in the blank space, provide the date on which such information first became 
known to such party].  If I received or expect to receive payments, including cash and 
other forms of consideration, to file this information or its contents, I received or expect 
to receive those payments from the following persons or organizations:  ________ [in the 
blank space, provide the names of such persons or organizations].  I verify under penalty 
of perjury that the foregoing is true and correct as of the date of the submission of this 
petition. 
 
In addition, 21 CFR 10.31 requires certain citizen petitions and petitions for stay of action, 
including those petitions subject to section 505(q), to contain this certification.  Therefore, all 
petitions that fall within the scope of  ection 505(q) must be in writing and signed and contain 
                                                 
s
21 See section 505(q)(1)(C). 
 
  10  Contains Nonbinding Recommendations 
 
the complete 505(q) certification to be considered for review by FDA.22  If, based on the 
considerations described in section II.A of this guidance,  ection 505(q) applies to the petition, 
but the petition is not in writing or signed, or does not contain the complete certification, we will 
not review the petition.  s
 
  1.  Determination of Whether a Certification Is Complete 
 
As part of our determination of whether a petition contains the complete 505(q) certification, we 
will evaluate whether (1) the language of the certification in the petition exactly mirrors the 
language provided in section 505(q) and (2) the petitioner provided a date on which the 
information first became known to the party on whose behalf the petition is submitted.23  
Because section 505(q) sets forth the exact words to be used in the certification, we will consider 
a certification to be deficient if every word in the petitioners certification does not match every 
word of the certification provided in section 505(q).  In other words, the petitioners certification 
must correspond verbatim to the certification in section 505(q).  For example, if, rather than 
using the phrase first became known to the party on whose behalf this petition is submitted, the 
petitioner substitutes the phrase first became known to me, we will consider the certification to 
be deficient.  We believe this interpretation is mandated by the statutory language because 
section 505(q) specifies the exact text of the certification.   
 
Section 505(q) also requires that the petitioner provide in the certification the date on or about 
which the information first became known to the party.  Section 505(q) includes a blank space in 
the certification for that information.  We consider a date to include a month, day, and year.  
Therefore, we will consider a certification to be deficient if the petitioner has not provided the 
month, day, and year on or about which the information first became known to the party on 
whose behalf the petition is submitted.  For example, if the petitioner provides May 2010 as 
the date in the certification, we would consider the certification to be deficient.  The text of the 
certification provided in section 505(q) includes a qualification that the petitioner learned of the 
information on or about the following date.  Therefore, we believe the certification would 
accommodate instances in which a petitioner may not know the exact date on which it became 
aware of the information.  To the extent that a petitioner believes further explanation of the date 
is needed, we believe that the blank space in the certification allows for the insertion of 
additional information.  In addition, there may be instances in which different types of 
information became known to the petitioner over a period of time.  In that case, the petitioner 
should provide each estimated relevant date and identify the information associated with the 
particular date.  We caution that when adding information, the petitioner should ensure that the 
words of the certification (except for what is provided in the blank space) continue to exactly 
match the words of the certification as provided by section 505(q).   
 
For example, a certification that we would consider to be complete and acceptable could include 
additional information explaining the petitioners specified date or dates as follows: 
 
                                                 
22  ection 505(q)(1)(H) and 21 CFR 10.31.  Please note that under  10.31(a)(1), certification is required for 
every petition that requests any form of action that could, if taken, delay approval of one of the types of applications 
deSscerei bsed therein, regardless of whether that petition is ultimately found to be subject to the statutory deadline in 
section 505(q)(1)(F). 
23 See also  10.31. 
  11  Contains Nonbinding Recommendations 
 
I certify that, to my best knowledge and belief:  (a) this petition includes all information 
and views upon which the petition relies; (b) this petition includes representative data 
and/or information known to the petitioner which are unfavorable to the petition; and (c) I 
have taken reasonable steps to ensure that any representative data and/or information 
which are unfavorable to the petition were disclosed to me.  I further certify that the 
information upon which I have based the action requested herein first became known to 
the party on whose behalf this petition is submitted on or about the following date:  
September 21, 1995 (information about bioavailability issues with the innovator drug); 
November 12, 2009 (publication of a draft bioequivalence guidance for the drug); March 
30, 2010 (information that an ANDA had been submitted).  If I received or expect to 
receive payments, including cash and other forms of consideration, to file this 
information or its contents, I received or expect to receive those payments from the 
following persons or organizations:  Company A.  I verify under penalty of perjury that 
the foregoing is true and correct as of the date of the submission of this petition. 
 
2.  What a Petitioner Should Do If a Certification Is Deficient 
 
We interpret  ection 505(q)(1)(H) to require that the certification be included in the original 
petition.  Section 505(q)(1)(H) refers to the petition as the subject document that must contain 
the certificatison.  Because  ection 505(q)(1)(E) and (q)(1)(I) distinguish between petitions and 
supplements to petitions,24 the reference to a petition in  ection 505(q)(1)(H) refers only to the 
original petition and not tos a supplement.  Therefore, if a petition is missing the complete 
certification, we will not permit a petitioner to cure the dseficiency by submitting a supplement to 
add the certification to the petition.  
 
If a petitioner has submitted a petition that is missing the required certification but is otherwise 
within the scope of  ection 505(q) and the petitioner would like FDA to review the petition, the 
petitioner should (1) submit a letter withdrawing the deficient petition pursuant to  10.30(g) and 
(2) submit a new pestition that contains the certification.  In this case, the provisions of  ection 
505(q) governing the treatment of petitions will apply only to the new petition that includes the 
required certification because we cannot review the deficient petition under  ection  s
505(q)(1)(H).  In particular, we consider the 150-day time frame for FDA to take final Agency 
action on the petition to begin from the date of submission of the new, compslete petition and not 
the original, deficient petition.  
 
FDA will not review a petition that is subject to  ection 505(q) but is missing the required 
certification.  Under 21 CFR 10.31(c), all petitioners raising issues that could delay the approval 
of a possible ANDA, 505(b)(2) application, or 35s1(k) application must include the certification 
in their petitions to ensure FDA consideration.  Although we may contact a petitioner to notify 
him or her of a missing or deficient certification, we note that it is the responsibility of the 
petitioner to ensure that his or her petition complies with the applicable requirements of  ection 
505(q) and  10.31(c), as well as all other applicable statutory and regulatory requirements.   
  s
 
                                                 
24  Section 505(q)(1)(I) requires that supplemental information include a verification as described in  ection III.D of 
this guidance.  
s
  12  Contains Nonbinding Recommendations 
 
 
D.  How Does FDA Apply the Verification Requirements in Section 505(q)(1)(I)? 
 
Section 505(q)(1)(I) provides that FDA shall not accept for review any supplemental information 
or comments on a petition unless the supplemental information or comments are in writing, 
signed, and contain the following verification: 
 
I certify that, to my best knowledge and belief:  (a) I have not intentionally delayed 
submission of this document or its contents; and (b) the information upon which I have 
based the action requested herein first became known to me on or about _________[in 
the blank space, provide the date on which such information first became known to such 
party].  If I received or expect to receive payments, including cash and other forms of 
consideration, to file this information or its contents, I received or expect to receive those 
payments from the following persons or organizations:  ________ [in the blank space, 
provide the names of such persons or organizations].  I verify under penalty of perjury 
that the foregoing is true and correct as of the date of the submission of this petition. 
 
Section 505(q)(1)(I) applies to any supplemental information or comments that are submitted to 
a petition that is subject to  ection 505(q).  If any such supplemental information or comments 
do not include the required verification, FDA will not review the submission.   
  s
In addition, 21 CFR 10.31 requires supplemental information or comments on certain citizen 
petitions and petitions for stay of action, including those petitions subject to section 505(q), to 
contain this verification.  However, as explained in the preamble of the final rule enacting 21 
CFR 10.31 (81 FR 78500, November 8, 2016), the language of the verification included in the 
regulation contains one minor technical correction to the language of the verification set out in 
the statute.  We changed I verify under penalty of perjury that the foregoing is true and correct 
as of the date of the submission of this petition to I verify under penalty of perjury that the 
foregoing is true and correct as of the date of the submission of this document (emphasis 
added).   
 
We will consider a verification to be deficient if it does not exactly mirror the words of the 
verification either in section 505(q)(1)(I) of the FD&C Act or 21 CFR 10.31(d).  Because the 
statute specifies the word petition and the regulation specifies the word document, we will 
accept either petition or document in the last sentence of the verification.   
 
As with our approach to the certification as explained in section III.C of this guidance, we also 
will consider a verification to be deficient if the petitioner or commenter does not provide a 
month, day, and year for the date in the verification. 
 
If a petitioner or commenter has submitted supplemental information or comments without the 
required verification or with an incomplete verification and the petitioner or commenter would 
like FDA to review the submission, the petitioner or commenter should resubmit the 
supplemental information or comments with the required verification to FDA.   
 
FDA will not review any supplemental information or comments on petitions that are subject to 
section 505(q) if the supplemental information or comments are missing the required 
  13  Contains Nonbinding Recommendations 
 
verification.25  All of these petitioners or commenters must include the verification in their 
supplemental information or comments on a petition to ensure FDA consideration.  Petitioners 
and commenters should not rely on FDA reviewers to notify them that their supplements or 
comments will not be reviewed because of a missing or deficient verification.  In some instances, 
FDA receives numerous supplements and comments in a docket, and it would be 
administratively burdensome to monitor all the dockets for 505(q) petitions and notify 
commenters about the statutory requirement.  It is the responsibility of petitioners and 
commenters to ensure that their supplemental information or comments comply with the 
applicable requirements of  ection 505(q), as well as all other applicable statutory and regulatory 
requirements.   
  s
E.  What Is the Relationship Between the Review of Petitions Under Section 505(q) and 
the Review of ANDAs, 505(b)(2) Applications, and 351(k) Applications for Which 
the Agency Has Not Yet Made a Final Decision on Approvability? 
 
A petition may request that FDA take an action related to a specific aspect of a pending ANDA, 
505(b)(2) application, or 351(k) application for which the Agency will not have made a final 
decision regarding approvability by the date that the petition response is due.  As described in 
section II.D of this guidance, section 505(q)(1)(F) requires FDA to take final Agency action on a 
petition within 150 days of submission.  The review of applications that may be affected by the 
petition is governed by a separate review process, which will not necessarily be completed by the 
date the petition response is due.26  If a petition requests that the Agency take an action related to 
a specific aspect of a pending application, we will consider the review status of the affected 
application(s) in determining how it would be appropriate for the Agency to respond to the 
request to take the action requested in the petition within the 150-day time frame.   
 
The provisions in section 505 of the FD&C Act and FDAs regulations in part 314 (21 CFR part 
314) establish certain procedures by which the Agency reviews an NDA or ANDA and notifies 
an applicant if it determines that an application is approved ( 314.105) or may not be approved 
(section 505(c) and 505(j);  314.125 and 314.127), or identifies the deficiencies in the 
application and the steps an applicant may take to respond to the deficiencies ( 314.110).  In 
addition, the statute and regulations describe a specific process through which an applicant 
whose application the Agency has found not to meet the requirements for approval may 
challenge the Agencys determination (section 505(c)(1)(B) and (d), 505(j)(5)(E);  314.200).  
Under this process, the Agency must give the applicant notice of an opportunity for a hearing on 
whether the application is approvable, with a specific time frame and process should the 
applicant request such a hearing.  These procedures ensure that applicants have an adequate 
opportunity to challenge a finding by the Agency that a product does not meet the requirements 
for approval.27   
 
By contrast, responses to petitions, including petitions subject to section 505(q), constitute final 
Agency action and are subject to immediate review by the courts, subject to the exception stated 
                                                 
25  ection 505(q)(1)(I) and 21 CFR 10.31(d). 
26 Even though the application will have a user fee goal date that falls on or before the 150 days for FDA to take 
finSael eA sgency action on the related petition, the action on the user fee goal date may be a complete response rather 
than an approval.  
27 For procedures applicable to 351(k) applications, see 21 CFR part 601. 
  14  Contains Nonbinding Recommendations 
 
in section II.E of this guidance.  They therefore carry with them none of the procedural rights for 
the affected applicants that attach to a decision to deny approval of an application.  If we were to 
respond substantively to a petitioners request regarding the approvability of a certain aspect of a 
pending application before we have taken a final action on the approvability of the application as 
a whole, such response could interfere with the statutory and regulatory scheme governing the 
review of applications and related procedural rights of applicants.28  There is no evidence that in 
enacting section 505(q), Congress intended to limit applicants procedural rights by requiring 
that the Agency make decisions that constitute final Agency action on the approvability of 
specific aspects of a pending application (e.g., the acceptability of a proposed trade name, 
specific claims proposed in a drug products labeling) on a piecemeal basis outside of the process 
established under the FD&C Act and regulations.29  
 
 In light of these considerations, we do not interpret section 505(q) to require a substantive final 
Agency decision within 150 days on the approvability of a specific aspect of a pending 
application.  In particular, we do not interpret section 505(q) to require such a decision when a 
final decision on the approvability of the application as a whole has not yet been made and when 
rendering such a decision could deprive an applicant of procedural rights established by statute 
and regulations.  In such a situation, as described in the preceding sentence, we would expect in 
the ordinary course to deny a petition without comment on the substantive approval issue. 
 
F.    What Considerations May Suggest That a Petition Was Submitted for the Primary 
Purpose of Delaying Approval of an Application? 
 
Section 505(q)(1)(E) provides that FDA may issue guidance to describe the considerations that 
will be used to determine whether a petition is submitted with the primary purpose of delaying 
the approval of an application.  Although each case is unique, the following are some of the 
considerations that FDA expects to take into account in determining whether a petition has been 
submitted with the primary purpose of delaying the approval of an application as contemplated 
by section 505(q)(1)(E) (this list is not intended to be exhaustive, and in any given case no single 
factor may be outcome determinative):  
 
  Submission of a petition when it appears, based on the date that relevant information 
relied upon in the petition became known to the petitioner (or reasonably should have 
                                                 
28 We also note that under applicable statutory and regulatory provisions, we are generally prohibited from 
disclosing information regarding applications that have not yet been approved.  Depending upon the nature and 
specificity of a petition, these limitations on disclosure also may circumscribe the Agencys ability to respond 
substantively to issues raised in a petition that affect a pending application.    
29 In the past, we have responded to requests related to general standards for approval (e.g., bioequivalence criteria 
for generic drug products) that may pertain to one or more pending drug applications, without commenting on the 
approvability of any particular aspect of a specific pending application.  We distinguish our approach of responding 
to petitions that involve general policies or standards for approval of a drug application from our approach described 
above, which applies to petitions that involve narrow issues of approvability of a specific aspect or aspects of a 
pending application or those in which our review of a given application would inform our decisions regarding the 
sufficiency of the specific data and information needed for approval.  We will continue to evaluate each citizen 
petition on a case-by-case basis with respect to the appropriateness of responding to the petitioners requests vis-a-
vis any pending applications. 
  15  Contains Nonbinding Recommendations 
 
been known to the petitioner), that the petitioner has taken an unreasonable length of time 
to submit the petition  
  Submission of multiple and/or serial petitions or supplements to petitions raising issues 
that reasonably could have been known to the petitioner at the time of submission of the 
earlier petition or petitions  
  Submission of a petition close in time to a known, first date upon which an ANDA, a 
505(b)(2) application, or a 351(k) application could be approved (e.g., submission close 
in time to the expiration of exclusivity or, for 505(b)(2) applications and ANDAs, a 
patent that may affect the timing of an applications final approval) 
  Submission of a petition with little or no data or information in support of the scientific 
positions set forth in the petition 
  Submission of a petition raising the same or substantially similar issues as a prior petition 
to which FDA has already substantively responded, particularly when the subsequent 
submission closely follows in time the earlier response 
  Submission of a petition concerning standards for approval of a drug product for which 
FDA has provided an opportunity for public input (such as when FDA has issued draft or 
final product-specific guidance applicable to the drug product) and the petitioner has not 
provided comment other than through the petition30 
  Submission of a petition requesting that other applicants be required to meet standards for 
testing, data, or labeling for their products that are more onerous or rigorous than the 
standards FDA has determined are necessary for the applicable listed drug and/or 
petitioners version of the same product (e.g., requesting that the generic company be 
required to adopt restrictions on distribution of its product that are similar to restrictions 
that have been voluntarily adopted by the brand company) or for the applicable reference 
product and/or a biosimilar or interchangeable biosimilar to that reference product 
  Other relevant considerations including the history of the petitioner with the Agency 
(such as whether the petitioner has a history of submitting petitions that we have 
determined were submitted with the primary purpose of delay)   
 
If FDA determines that a petition has been submitted with the primary purpose of delaying an 
application, we will then determine if the petition may be summarily denied as described in 
section 505(q)(1)(E) (which allows denial of a petition that was submitted with the primary 
purpose of delay and does not on its face raise valid scientific or regulatory issues).  We will 
determine, on a case-by-case basis, whether a petition that was submitted with the primary 
purpose of delay also does not on its face raise valid scientific or regulatory issues and therefore 
may be summarily denied.   
 
We may note our determination regarding the primary purpose of delaying an application and 
our basis for that determination in our petition response.  In addition, if we determine that a 
                                                 
30 For example, we note that there are means other than submission of a petition by which interested persons can 
express their views on issues related to bioequivalence.  FDA has been posting draft product-specific bioequivalence 
recommendations on its website at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm and 
announcing in a Federal Register notice the availability of these recommendations and the opportunity for the public 
to consider and comment on the recommendations.  We encourage interested persons to submit any comments 
related to bioequivalence issues in response to a Federal Register notice announcing the recommendations. 
 
  16  Contains Nonbinding Recommendations 
 
petition has been submitted with the primary purpose of delaying an application, we intend to 
refer the matter to the Federal Trade Commission.31  Finally, we will highlight in our annual 
report to Congress our determinations regarding petitions submitted with the primary purpose of 
delaying application approvals.32 
 
 
IV.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). 
 
The time required to complete this information collection is estimated to average 30 minutes to 
prepare a certification under section 505(q)(1)(H) of the FD&C Act for citizen petitions and 
petitions for stay of action, 30 minutes to prepare a verification under section 505(q)(1)(I) of the 
FD&C Act for supplements to and comments on citizen petitions and supplements to and 
comments on petitions for stay of action, and 30 minutes to prepare a letter withdrawing a 
deficient petition for stay of action that is missing the required certification.  These estimates 
include the time to review instructions, search existing data sources, gather the data needed, and 
complete and review the information collection.  Send comments regarding this burden estimate 
or suggestions for reducing this burden to: 
 
Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-
0002. 
 
This guidance also refers to previously approved collections of information found in FDA 
regulations.  The collections of information in  10.20, 10.30, and 10.35 have been approved 
under OMB control number 0910-0191; the collections of information in  10.31 have been 
approved under OMB control number 0910-0679; and the collections of information in   
314.54, 314.94, and 314.102 have been approved under OMB control number 0910-0001.   
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  The OMB 
control number for this information collection is 0910-0679 (expires 6/30/2020). 
 
                                                 
31 We note that similar considerations may arise with respect to petitions that are not subject to section 505(q).  As 
appropriate, we may take similar actions with respect to those petitions. 
During the comment period for this guidance, the Federal Trade Commission submitted comments stating that they 
share the FDAs concern about abuse of its citizen petition process to delay beneficial, procompetitive generic or 
biosimilar entry, and that they stand ready to work closely with the FDA on citizen-petition abuse and other issues 
that may harm competition.  Federal Trade Commission comments at pp. 5-6, available at 
https://www.regulations.gov/document?D=FDA-2009-D-0008-0030.  
32 See section 505(q)(3).  
  17