Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs

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.
A.

DISCUSSION .................................................................................................................... 4
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 Application’s 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 Industry 1

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 FDA’s 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 Act 2 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 Act 3 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 FDA’s 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 FDA’s regulations and modify §§ 10.30
and 10.35 (21 CFR 10.30 and 10.35). The revision also describes a change in FDA’s 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, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s 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 FDA’s 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 section
505(q). Section 505(q)(1)(A) provides:
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 determination 8

At FDA’s 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 section 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 not 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 section 505(q)(1)(A) regarding delay of approval of an
application, the submission of comments or supplemental information, or the consent of the
petitioner.

8

Section 505(q)(1)(B).
Section 505(q)(1)(C).
10
Section 505(q)(1)(D).
11
Section 505(q)(1)(I).
9

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 150day 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 section 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

12

Section 505(q)(4)(B).
If a petition is not subject to section 505(q), we will review and respond to the petition in accordance with our
regulations.
13

4

Contains Nonbinding Recommendations
We also describe how we interpret:
• Section 505(q)(1)(H) requiring that a petition include a certification
• Section 505(q)(1)(I) requiring that supplemental information or comments on a
petition include a verification
• Section 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
application’s 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 section 505(q) applies to any petitions that were submitted
before September 27, 2007, because section 505(q) does not state that it applies retroactively to
petitions submitted before the effective date. Likewise, we do not believe that section 505(q)
applies to any petitions whose subject matter relates to the approval of a 351(k) application if
those petitions were submitted before July 9, 2012, because section 505(q) does 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 FDA’s 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 petitioner’s 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 Application’s 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 pending 17 and at least one such application’s 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 FDA’s 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 applicant’s 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, FDA’s 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. 102571 (as amended by Pub. L. 115-52, Tit. I) for 505(b)(2) applications; the Generic Drug 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 Agency’s 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 section 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 that a delay is
necessary to protect the public health. To implement this provision, first we determine if the
8

Contains Nonbinding Recommendations
provisions of section 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 denied 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 section
505(q)(1)(A) would not be implicated.

•

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 section 505(q)(1)(A) would be
implicated, and we would next determine if a delay of approval is necessary to protect
the public health.

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 petitioner’s 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 section 505(q)(1)(B) and (C) of the FD&C
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 section 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 application. 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 section 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, later 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 section 505(q) must be in writing and signed and contain
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, section 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.
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 petitioner’s certification does not match every
word of the certification provided in section 505(q). In other words, the petitioner’s 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 petitioner’s specified date or dates as follows:
See section 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
described 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.
22

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 section 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 certification. Because section 505(q)(1)(E) and (q)(1)(I) distinguish between petitions and
supplements to petitions, 24 the reference to a petition in section 505(q)(1)(H) refers only to the
original petition and not to a supplement. Therefore, if a petition is missing the complete
certification, we will not permit a petitioner to cure the deficiency 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 section 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 petition that contains the certification. In this case, the provisions of section
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 section
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, complete petition and not
the original, deficient petition.
FDA will not review a petition that is subject to section 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 351(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 section
505(q) and § 10.31(c), as well as all other applicable statutory and regulatory requirements.

Section 505(q)(1)(I) requires that supplemental information include a verification as described in section III.D of
this guidance.

24

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 section 505(q). If any such supplemental information or comments
do not include the required verification, FDA will not review the submission.
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 section 505(q), as well as all other applicable statutory and regulatory
requirements.
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 FDA’s 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 Agency’s 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
See section 505(q)(1)(I) and 21 CFR 10.31(d).
Even though the application will have a user fee goal date that falls on or before the 150 days for FDA to take
final Agency 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.
25
26

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 petitioner’s 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 product’s 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 Agency’s 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 petitioner’s requests vis-àvis 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 application’s 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 petition 30
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
petitioner’s 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 209930002.
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 FDA’s 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