Verification for supplements to petitions for stay of agency action 505(q)(1) (I)

Guidance for Industry
Citizen Petitions and Petitions
for Stay of Action Subject to
Section 505(q) of the Federal
Food, Drug, and Cosmetic Act

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Procedural
June 2011
OMB Control No. 0910-0679
Expiration Date: 4/30/2014
See additional PRA statement in section IV of this guidance

Guidance for Industry
Citizen Petitions and Petitions
for Stay of Action Subject to
Section 505(q) of the Federal
Food, Drug, and Cosmetic Act

Additional copies are available from:
Office of Communication
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.,
Bldg. 51, Room 2201
Silver Spring, MD 20993-0002
(Tel) 301-796-3400
http://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)
Procedural
June 2011

Contains Nonbinding Recommendations
TABLE OF CONTENTS

I.

INTRODUCTION............................................................................................................. 1

II.

BACKGROUND ............................................................................................................... 2

A.

Scope of Section 505(q).................................................................................................................. 2

B.

Determination of Delay.................................................................................................................. 2

C.

Certification and Verification....................................................................................................... 3

D.

Final Agency Action....................................................................................................................... 3

E.

Judicial Review .............................................................................................................................. 3

F.

Exceptions and Reporting ............................................................................................................. 4

III.
A.

DISCUSSION .................................................................................................................... 4
How Does FDA Determine if Section 505(q) Applies to a Particular Petition?........................ 4

1. Petition Submitted on or after September 27, 2007 ......................................................................... 5
2. Petition Submitted in Writing and Pursuant to § 10.30 or 10.35 .................................................... 5
3. ANDA or 505(b)(2) Application Is Pending at the Time the Petition Is Submitted ......................... 6
4. Petition Requests an Action That Could Delay Approval of a Pending ANDA or 505(b)(2)
Application ........................................................................................................................................... 7
5. Petition Does Not Fall Within Any of the Exceptions Described in Section 505(q)(4) ................... 7
B. How Does FDA Determine if a Petition Would Delay Approval of an ANDA or 505(b)(2)
Application? ............................................................................................................................................ 7
C.

How Does FDA Apply the Certification Requirements in Section 505(q)(1)(H)?.................... 9

1. Determination of Whether a Certification Is Complete. .................................................................. 9
2. What a Petitioner Should Do if a Certification Is Deficient .......................................................... 11
D. How Does FDA Apply the Verification Requirements in Section 505(q)(1)(I)?..................... 11
E.

What Is the Relationship Between the Review of Petitions Under Section 505(q) and the

Review of ANDAs and 505(b)(2) Applications for Which the Agency Has Not Yet Made a Final
Decision on Approvability?.................................................................................................................. 12

IV.

PAPERWORK REDUCTION ACT OF 1995.............................................................. 13

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Contains Nonbinding Recommendations

Guidance for Industry1
Citizen Petitions and Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food, Drug, and Cosmetic Act
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.

I.

INTRODUCTION

This guidance provides information regarding FDA’s (or the Agency’s) current thinking on
interpreting section 914 of Title IX of the Food and Drug Administration Amendments Act
(FDAAA). 2 Section 914 of FDAAA adds new section 505(q) to the Federal Food, Drug, and
Cosmetic Act (the Act) 3 and 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 submitted
under section 505(b)(2) or 505(j) of the Act. 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) or
505(b)(2) 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 to a petition include a verification 5 and addresses the relationship

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
Public Law 110-85 (as amended by Public Law 110-316).
3
21 U.S.C. 355(q). For brevity, in this guidance, references to section 505(q) of the Act are cited as section 505(q).
4
21 U.S.C. 355(b)(2) and (j). In this guidance, an application submitted under section 505(b)(2) of the Act is
referred to as a 505(b)(2) application and an application submitted under section 505(j) of the Act is referred to as an
abbreviated new drug application (ANDA).
5
Section 505(q)(1)(E) 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. This guidance
does not address the factors under section 505(q)(1)(E). Any guidance issued pursuant to section 505(q)(1)(E) will
be issued separately from this guidance. FDA also is planning to issue regulations through notice and comment
rulemaking to further implement section 505(q).
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between the review of petitions and pending ANDAs and 505(b)(2) applications for which the
Agency has not yet made a decision on approvability.
FDA’s guidance documents, including this guidance, 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

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 Act by adding a new subsection (q).
Section 505(q) 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 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) because of any request to take any form of action relating to the
application, either before or during consideration of the request, unless−
(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 Act and the term petition is defined as a request described in
505(q)(1)(A)(i).
B.

Determination of Delay

If FDA determines that a delay of approval of an ANDA or 505(b)(2) 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:
1. notification that the determination has been made,
2. if applicable, any clarification or additional data that the applicant should submit to
the petition docket to allow FDA to review the petition promptly, and

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3. a brief summary of the specific substantive issues raised in the petition which form
the basis of the determination. 6
At FDA’s discretion, the information is to be conveyed by either a document or a meeting with
the applicant. 7 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. 8
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. 9
D.

Final Agency Action

Section 505(q)(1)(F) governs the timeframe for final Agency action on a petition. Under this
provision, FDA shall take final Agency action on a petition not later than 180 days after the date
on which the petition is submitted. The 180-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.
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. 10 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. 11
E.

Judicial Review

Section 505(q)(2) governs judicial review of final Agency action. 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 180-day period or the 180-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

6

Section 505(q)(1)(B).
Section 505(q)(1)(C).
8
Section 505(q)(1)(D).
9
Section 505(q)(1)(I).
10
Section 505(q)(1)(E).
11
Section 505(q)(1)(E). As noted in footnote 5, any guidance issued pursuant to section 505(q)(1)(E) will be issued
separately from this guidance.
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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 and petitions from a
505(b)(2) or ANDA 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. These provisions include, for example, the
requirements that approval of an ANDA or 505(b)(2) 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 180 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 or 505(b)(2) application
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
We also describe the relationship between the review of petitions under section 505(q) and the
review of ANDAs and 505(b)(2) 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
criteria:
•
•
•
•

The petition is submitted to FDA on or after September 27, 2007.
The petition is submitted in writing and pursuant to 21 CFR 10.30 or 10.35.
An ANDA or 505(b)(2) application is pending at the time the petition is submitted to
FDA.
The petitioner requests an action that could delay approval of a pending ANDA or
505(b)(2) application.
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Contains Nonbinding Recommendations
•

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

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. 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. In addition, such an interpretation might impose a
180-day deadline for responding to a petition after the 180 days have already expired.
Even if section 505(q) were interpreted to retroactively apply to pre-September 27, 2007,
petitions, FDA would not be able to review any petition submitted before September 27, 2007,
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 pre-September 27, 2007, 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 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 criteria 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 intended to delay the
approval of an ANDA or 505(b)(2) 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 NDA, ANDA,
or 505(b)(2) application or another process. Similarly, any communications regarding a citizen
petition should be filed as comments in the appropriate docket, not to the NDA, ANDA, or
505(b)(2) 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 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.

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3.

ANDA or 505(b)(2) Application Is Pending at the Time the Petition Is Submitted

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 interpret
section 505(q) to apply only to petitions for which, at the time the petition is submitted, at least
one ANDA or 505(b)(2) application related to the subject matter of the petition is pending. 12 If
there is no related ANDA or 505(b)(2) 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. We
believe this interpretation is appropriate because if no related ANDA or 505(b)(2) application is
pending at the time that a petition is submitted, the references in section 505(q)(1)(A) to a
pending application and delay of approval by a petition would be inapplicable.
We also believe our interpretation is appropriate to ensure the fair and orderly implementation of
section 505(q). Because application of the provisions of section 505(q) flows from a
determination that a petition is within the scope of section 505(q), the evaluation of whether a
related ANDA or 505(b)(2) application is pending needs to 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 related ANDA or 505(b)(2) application 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) or 505(b)(2) application(s) are
subsequently withdrawn or approved and there are no longer any related applications pending.
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.
For example, as described in sections III.C and D of this guidance, to be reviewed by FDA, any
petition subject to section 505(q) must include a certification and any comments to a petition
subject to section 505(q) must include a verification. If, after submission, a petition’s status were
converted from not being subject to section 505(q) to being subject to section 505(q), a petitioner
who did not include a certification in the petition and/or commenter who did not include a
verification in the comments would be prejudiced because the petition or the comments would
not be eligible for review by FDA.
For these reasons, we interpret section 505(q) to apply only to petitions for which, at the time the
petition is submitted, at least one ANDA or 505(b)(2) application related to the subject matter of
the petition is pending. We recognize that petitioners may not be aware of the existence of a
12

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 new drug application (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 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 Web site identifies drug products for which
the Agency has received an ANDA with a paragraph IV certification.
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pending application. Therefore, we encourage all petitioners challenging the approvability of a
possible ANDA or 505(b)(2) application to include the certification required in section
505(q)(1)(H).
4.

Petition Requests an Action That Could Delay Approval of a Pending ANDA or
505(b)(2) Application

As noted, section 505(q)(1)(A) contemplates the possibility that approval of a pending ANDA or
505(b)(2) application could be delayed by issues raised in the petition. 13 Therefore, we interpret
section 505(q) to apply only to petitions that request an action that could delay approval of a
pending ANDA or 505(b)(2) application. If the action requested by the petition could not delay
approval of the 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:
1. relate solely to the timing of approval of an application pursuant to the 180-day
exclusivity provision at section 505(j)(5)(B)(iv) of the Act, or
2. are from the sponsor of the ANDA or 505(b)(2) 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 or
505(b)(2) Application?

Under section 505(q)(1)(A), FDA shall not delay approval of an ANDA or 505(b)(2) 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 provisions of section 505(q) apply
to the petition based on the criteria 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).

13

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 Web site at
http://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.
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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 or 505(b)(2) application by using a but
for test. In other words, would the ANDA or 505(b)(2) application be ready for approval but for
the issues raised by the petition?
•

If, regardless of the petition, the ANDA or 505(b)(2) application would not be ready
for approval, then section 505(q)(1)(A) would not be implicated. 14

•

If the ANDA or 505(b)(2) application would be ready for approval but for the
petition, then 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:
If the application were 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 negatively affect the public health?
If, after undertaking this analysis, we conclude that the public health could be negatively
affected, the Agency will conclude that a delay “is necessary to protect the public health” and
will delay approval of the pending application. 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 is necessary, we will notify the applicant as required by section
505(q)(1)(B) and (C) of the 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 which form
the basis of the determination
At our discretion, we will convey this information to the applicant by either a letter or a meeting
with the applicant. 15 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
14

We note, however, that a petition would still be subject to section 505(q) as long as a relevant application is
pending at the time the petition is submitted.
15
See section 505(q)(1)(C).
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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 180-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 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.

This certification includes statements in addition to those described under § 10.30(b) for the
certification in citizen petitions.
We apply section 505(q)(1)(H) to require that all petitions that fall within the scope of section
505(q) be in writing and signed, and contain the complete 505(q) certification to be considered
for review by FDA. If, based on the criteria 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. 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
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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:
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.

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2.

What a Petitioner Should Do if a Certification Is Deficient

We also 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 sections 505(q)(1)(E) and 505(q)(1)(I) distinguish between petitions
and supplements to petitions, 16 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 180-day timeframe for FDA to respond to the petition to begin
from the date of submission of the new, complete petition and not the original, deficient petition.
Because FDA will not review a petition that is subject to section 505(q) but is missing the
required certification, all petitioners raising issues that could delay the approval of a possible
ANDA or 505(b)(2) application should 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 its
petition complies with the applicable requirements of section 505(q), as well as all other
applicable statutory and regulatory requirements.
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.

16

Section 505(q)(1)(E) states that if FDA determines that a petition or a supplement to the petition was submitted
with the primary purpose of delaying approval of an application, the Agency may deny the petition at any point.
Section 505(q)(1)(I) requires that supplemental information include a verification as described in section III.D of
this guidance.
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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. As with our approach
to the certification as explained in section III.C of this guidance, we will consider a verification
to be deficient if it does not exactly mirror the words of the verification in section 505(q)(1)(I) of
the Act or 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.
For petitions that are subject to section 505(q), because FDA will not review any supplemental
information or comments that are missing the required verification, all petitioners or commenters
should include the verification in their supplemental information or comments to a petition that
includes the 505(q) certification 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 and 505(b)(2) 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
or 505(b)(2) 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., section
505(q)(1)(F) requires FDA to take final Agency action on a petition within 180 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. 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 whether it would be appropriate for the Agency to respond to the request to take the
action requested in the petition within the 180-day timeframe.
The provisions in section 505 of the Act and FDA’s regulations at 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
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Contains Nonbinding Recommendations
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 timeframe 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.
By contrast, responses to citizen petitions, including petitions subject to section 505(q),
constitute final Agency action and are subject to immediate review by the courts. 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. 17 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 Act and regulations. 18
Therefore, we do not interpret section 505(q) to require a substantive final Agency decision
within 180 days on the approvability of a specific aspect of a pending application when a final
decision on the approvability of the application as a whole has not yet been made and when to
render such a decision could deprive an applicant of procedural rights established by statute and
regulations. In such a situation, we would expect to deny a petition without comment on the
substantive approval issue.

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 act for citizen petitions and petitions for
17

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.
18
In the past, we have responded to requests related to general standards for approval (e.g., bioequivalence criteria
for generic drug products or the appropriateness of omitting certain protected information from proposed drug
product labeling) 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. 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-à-vis any pending applications.
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stay of action, 30 minutes to prepare a verification under section 505(q)(1)(I) of the act for
supplements and comments to citizen petitions and supplements and comments to 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 6223, Silver Spring, MD 20993-0002.
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 10.20, 10.30, and 10.35 have been
approved under OMB Control Number 0910-0183 and the collections of information in 21 CFR
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 4/30/2014).

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